Vyvanse USA ENG

HIGHLIGHTS OF PRESCRIBING INFORMATION -------------------------------CONTRAINDICATIONS------------------------------
These highlights do not include all the information needed to use • Known hypersensitivity to amphetamine products or other ingredients in
VYVANSE safely and effectively. See full prescribing information for VYVANSE (4)
VYVANSE. • Use with monoamine oxidase (MAO) inhibitor, or within 14 days of the
last MAO inhibitor dose (4, 7.1)
VYVANSE® (lisdexamfetamine dimesylate) capsules, for oral use, CII
VYVANSE® (lisdexamfetamine dimesylate) chewable tablets, for oral use, ------------------------WARNINGS AND PRECAUTIONS----------------------
CII -
Initial U.S. Approval: 2007 • Risks to Patients with Serious Cardiac Disease: Avoid use in patients
with known structural cardiac abnormalities, cardiomyopathy, serious
WARNING: ABUSE, MISUSE, AND ADDICTION cardiac arrhythmia, coronary artery disease, or other serious cardiac
See full prescribing information for complete boxed warning. disease (5.2)
• Increased Blood Pressure and Heart Rate: Monitor blood pressure and
VYVANSE has a high potential for abuse and misuse, which can lead pulse. (5.3)
to the development of a substance use disorder, including addiction. • Psychiatric Adverse Reactions: Prior to initiating VYVANSE, screen
Misuse and abuse of CNS stimulants, including VYVANSE, can result patients for risk factors for developing a manic episode. If new psychotic
in overdose and death (5.1, 9.2, 10): or manic symptoms occur, consider discontinuing VYVANSE. (5.4)
• Before prescribing VYVANSE, assess each patient’s risk for • Long-Term Suppression of Growth in Pediatric Patients: Closely monitor
abuse, misuse, and addiction. growth (height and weight) in pediatric patients. Pediatric patients not
• Educate patients and their families about these risks, proper growing or gaining height or weight as expected may need to have their
storage of the drug, and proper disposal of any unused drug. treatment interrupted. (5.5)
• Throughout treatment, reassess each patient’s risk and frequently • Peripheral Vasculopathy, including Raynaud’s phenomenon: Careful
monitor for signs and symptoms of abuse, misuse, and addiction. observation for digital changes is necessary during VYVANSE treatment.
Further clinical evaluation (e.g., rheumatology referral) may be
---------------------------RECENT MAJOR CHANGES--------------------------- appropriate for patients who develop signs or symptoms of peripheral
Boxed Warning 10/2023 vasculopathy. (5.6)
Dosage and Administration (2.1) 10/2023 • Serotonin Syndrome: Increased risk when co-administered with
Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.8) 10/2023 serotonergic agents (e.g., SSRIs, SNRIs, triptans), but also during
overdosage situations. If it occurs, discontinue VYVANSE and initiate
----------------------------INDICATIONS AND USAGE--------------------------- supportive treatment (4, 5.7, 10)
VYVANSE is a central nervous system (CNS) stimulant indicated for the • Motor and Verbal Tics, and Worsening of Tourette’s Syndrome: Before
treatment of (1): initiating VYVANSE, assess the family history and clinically evaluate
• Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients for tics or Tourette’s syndrome. Regularly monitor patients for
patients 6 years and older the emergence or worsening of tics or Tourette’s syndrome. Discontinue
• Moderate to severe binge eating disorder (BED) in adults treatment if clinically appropriate. (5.8)
Limitations of Use: ------------------------------ADVERSE REACTIONS-------------------------------

• Pediatric patients with ADHD younger than 6 years of age experienced more Most common adverse reactions (incidence ≥5% and at a rate at least twice
long-term weight loss than patients 6 years and older (8.4) placebo) in pediatric patients ages 6 to 17 years, and/or adults with ADHD
• VYVANSE is not indicated for weight loss. Use of other sympathomimetic were anorexia, anxiety, decreased appetite, decreased weight, diarrhea,
drugs for weight loss has been associated with serious cardiovascular dizziness, dry mouth, irritability, insomnia, nausea, upper abdominal pain, and
adverse events. The safety and effectiveness of VYVANSE for the vomiting (6.1)
treatment of obesity have not been established (5.2)
Most common adverse reactions (incidence ≥ 5% and at a rate at least twice
------------------------DOSAGE AND ADMINISTRATION---------------------- placebo) in adults with BED were dry mouth, insomnia, decreased appetite,
Indicated Initial Titration Recommended Maximum increased heart rate, constipation, feeling jittery, and anxiety (6.1)
Population Dose Schedule Dose Dose
ADHD 30 mg 10 mg or 30 mg to 70 70 mg per To report SUSPECTED ADVERSE REACTIONS, contact Takeda
(Adults and every 20 mg mg per day day Pharmaceuticals at 1-800-828-2088 or FDA at 1-800-FDA-1088 or
pediatric morning weekly www.fda.gov/medwatch.
patients 6 years
and older) (2.2) -------------------------------DRUG INTERACTIONS------------------------------
Acidifying and Alkalinizing Agents: Agents that alter urinary pH can alter
BED (Adults) 30 mg 20 mg 50 mg to 70 70 mg per blood levels of amphetamine. Acidifying agents decrease amphetamine blood
(2.3) every weekly mg per day day levels, while alkalinizing agents increase amphetamine blood levels. Adjust
morning VYVANSE dosage accordingly (2.6, 7.1)
• Prior to treatment, assess for presence of cardiac disease (2.4)
------------------------USE IN SPECIFIC POPULATIONS-----------------------
• Severe renal impairment: Maximum dose is 50 mg/day (2.5)
• Pregnancy: May cause fetal harm (8.1)
• End stage renal disease (ESRD): Maximum dose is 30 mg/day (2.5)
• Lactation: Breastfeeding not recommended (8.2)
-----------------------DOSAGE FORMS AND STRENGTHS-------------------
See 17 for PATIENT COUNSELING INFORMATION and Medication
• Capsules: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg (3) Guide.
• Chewable tablets: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg (3) Revised: 10/2023
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: ABUSE, MISUSE, AND ADDICTION 8 USE IN SPECIFIC POPULATIONS
1 INDICATIONS AND USAGE 8.1 Pregnancy
2 DOSAGE AND ADMINISTRATION 8.2 Lactation
2.1 Pretreatment Screening 8.4 Pediatric Use
2.2 General Administration Information 8.5 Geriatric Use
2.3 Dosage for Treatment of ADHD 8.6 Renal Impairment
2.4 Dosage for Treatment of Moderate to Severe BED in Adults 9 DRUG ABUSE AND DEPENDENCE
2.5 Dosage in Patients with Renal Impairment 9.1 Controlled Substance
2.6 Dosage Modifications due to Drug Interactions 9.2 Abuse
3 DOSAGE FORMS AND STRENGTHS 9.3 Dependence
4 CONTRAINDICATIONS 10 OVERDOSAGE
5 WARNINGS AND PRECAUTIONS 11 DESCRIPTION
5.1 Abuse, Misuse, and Addiction 12 CLINICAL PHARMACOLOGY
5.2 Risks to Patients with Serious Cardiac Disease 12.1 Mechanism of Action
5.3 Increased Blood Pressure and Heart Rate 12.2 Pharmacodynamics
5.4 Psychiatric Adverse Reactions 12.3 Pharmacokinetics
5.5 Long-Term Suppression of Growth in Pediatric Patients 13 NONCLINICAL TOXICOLOGY
5.6 Peripheral Vasculopathy, including Raynaud’s Phenomenon 13.1 Carcinogenesis, Mutagenesis, and Impairment of Fertility
5.7 Serotonin Syndrome 13.2 Animal Toxicology and/or Pharmacology
5.8 Motor and Verbal Tics, and Worsening of Tourette’s Syndrome 14 CLINICAL STUDIES
6 ADVERSE REACTIONS 14.1 Attention Deficit Hyperactivity Disorder (ADHD)
6.1 Clinical Trials Experience 14.2 Binge Eating Disorder (BED)
6.2 Postmarketing Experience 16 HOW SUPPLIED/STORAGE AND HANDLING
7 DRUG INTERACTIONS 16.1 How Supplied
7.1 Drugs Having Clinically Important Interactions with Amphetamines 16.2 Storage and Handling
7.2 Drugs Having No Clinically Important Interactions with VYVANSE 17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing information are not listed.
Page 2 of 37
FULL PRESCRIBING INFORMATION
WARNING: ABUSE, MISUSE, AND ADDICTION
VYVANSE has a high potential for abuse and misuse, which can lead to the development
of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants,
including VYVANSE, can result in overdose and death [see Overdosage (10)], and this risk
is increased with higher doses or unapproved methods of administration, such as snorting
or injection.
Before prescribing VYVANSE, assess each patient’s risk for abuse, misuse, and addiction.
Educate patients and their families about these risks, proper storage of the drug, and
proper disposal of any unused drug. Throughout VYVANSE treatment, reassess each
patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and
symptoms of abuse, misuse, and addiction [see Warnings and Precautions (5.1), Drug Abuse
and Dependence (9.2)].
1 INDICATIONS AND USAGE
VYVANSE® is indicated for the treatment of:
• Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years
and older [see Clinical Studies (14.1)]
• Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)].
Limitations of Use:
• Pediatric patients with ADHD younger than 6 years of age experienced more long-term
weight loss than patients 6 years and older [see Use in Specific Populations (8.4)].
• VYVANSE is not indicated or recommended for weight loss. Use of other
sympathomimetic drugs for weight loss has been associated with serious cardiovascular
adverse events. The safety and effectiveness of VYVANSE for the treatment of obesity
have not been established [see Warnings and Precautions (5.2)].
2 DOSAGE AND ADMINISTRATION
2.1 Pretreatment Screening
Prior to treating patients with VYVANSE, assess:
• for the presence of cardiac disease (i.e., perform a careful history, family history of sudden
death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions (5.2)].
• the family history and clinically evaluate patients for motor or verbal tics or Tourette’s
syndrome before initiating VYVANSE [see Warnings and Precautions (5.8)].
Page 3 of 37
2.2 General Administration Information
Take VYVANSE orally in the morning with or without food; avoid afternoon doses because of
the potential for insomnia. VYVANSE may be administered in one of the following ways:
Information for VYVANSE capsules:
• Swallow VYVANSE capsules whole, or

• Open capsules, empty and mix the entire contents with yogurt, water, or orange juice. If
the contents of the capsule include any compacted powder, a spoon may be used to break
apart the powder. The contents should be mixed until completely dispersed. Consume
the entire mixture immediately. It should not be stored. The active ingredient dissolves
completely once dispersed; however, a film containing the inactive ingredients may
remain in the glass or container once the mixture is consumed.
Information for VYVANSE chewable tablets:
• VYVANSE chewable tablets must be chewed thoroughly before swallowing.
VYVANSE capsules can be substituted with VYVANSE chewable tablets on a unit per unit/mg
per mg basis (for example, 30 mg capsules for 30 mg chewable tablet) [see Clinical
Pharmacology (12.3)].
Do not take anything less than one capsule or chewable tablet per day. A single dose should not
be divided.
2.3 Dosage for Treatment of ADHD
The recommended starting dosage in adults and pediatric patients 6 years and older is 30 mg
once daily in the morning. Dosage may be adjusted in increments of 10 mg or 20 mg at
approximately weekly intervals up to maximum recommended dosage of 70 mg once daily [see
Clinical Studies (14.1)].
2.4 Dosage for Treatment of Moderate to Severe BED in Adults
The recommended starting dosage in adults is 30 mg once daily to be titrated in increments of 20

mg at approximately weekly intervals to achieve the recommended target dose of 50 mg to 70
mg once daily. The maximum recommended dosage is 70 mg once daily [see Clinical Studies
(14.2)]. Discontinue VYVANSE if binge eating does not improve.
2.5 Dosage in Patients with Renal Impairment
In patients with severe renal impairment (GFR 15 to < 30 mL/min/1.73 m2), the maximum
dosage should not exceed 50 mg once daily. In patients with end stage renal disease (ESRD,
GFR < 15 mL/min/1.73 m2), the maximum recommended dosage is 30 mg once daily [see Use
in Specific Populations (8.6)].
Page 4 of 37
2.6 Dosage Modifications due to Drug Interactions
Agents that alter urinary pH can impact urinary excretion and alter blood levels of amphetamine.
Acidifying agents (e.g., ascorbic acid) decrease blood levels, while alkalinizing agents (e.g.,
sodium bicarbonate) increase blood levels. Adjust VYVANSE dosage accordingly [see Drug
Interactions (7.1)].
3 DOSAGE FORMS AND STRENGTHS
VYVANSE (lisdexamfetamine dimesylate) capsules:
• Capsules 10 mg: pink body/pink cap (imprinted with S489 and 10 mg)
• Capsules 20 mg: ivory body/ivory cap (imprinted with S489 and 20 mg)
• Capsules 30 mg: white body/orange cap (imprinted with S489 and 30 mg)
• Capsules 40 mg: white body/blue green cap (imprinted with S489 and 40 mg)
• Capsules 50 mg: white body/blue cap (imprinted with S489 and 50 mg)
• Capsules 60 mg: aqua blue body/aqua blue cap (imprinted with S489 and 60 mg)
• Capsules 70 mg: blue body/orange cap (imprinted with S489 and 70 mg)
VYVANSE (lisdexamfetamine dimesylate) chewable tablets:
• Chewable tablets 10 mg: White to off-white round shaped tablet debossed with ‘10’ on
one side and ‘S489’ on the other
• Chewable tablets 20 mg: White to off-white hexagonal shaped tablet debossed with ‘20’
on one side and ‘S489’ on the other
• Chewable tablets 30 mg: White to off-white arc triangular shaped tablet debossed with
‘30’ on one side and ‘S489’ on the other
• Chewable tablets 40 mg: White to off-white capsule shaped tablet debossed with ‘40’ on
one side and ‘S489’ on the other
• Chewable tablets 50 mg: White to off-white arc square shaped tablet debossed with ‘50’
on one side and ‘S489’ on the other
• Chewable tablets 60 mg: White to off-white arc diamond shaped tablet debossed with
‘60’ on one side and ‘S489’ on the other
4 CONTRAINDICATIONS
VYVANSE is contraindicated in patients with:
• Known hypersensitivity to amphetamine products or other ingredients of VYVANSE.

Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have been
observed in postmarketing reports [see Adverse Reactions (6.2)].
• Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping
MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of
an increased risk of hypertensive crisis [see Warnings and Precautions (5.7) and Drug
Interactions (7.1)].
Page 5 of 37
5 WARNINGS AND PRECAUTIONS
5.1 Abuse, Misuse, and Addiction
VYVANSE has a high potential for abuse and misuse. The use of VYVANSE exposes
individuals to the risks of abuse and misuse, which can lead to the development of a substance
use disorder, including addiction. VYVANSE can be diverted for non-medical use into illicit
channels or distribution [see Drug Abuse and Dependence (9.2)]. Misuse and abuse of CNS
stimulants, including VYVANSE, can result in overdose and death [see Overdosage (10)], and
this risk is increased with higher doses or unapproved methods of administration, such as
snorting or injection.
Before prescribing VYVANSE, assess each patient’s risk for abuse, misuse, and addiction.
Educate patients and their families about these risks and proper disposal of any unused drug.
Advise patients to store VYVANSE in a safe place, preferably locked, and instruct patients to
not give VYVANSE to anyone else. Throughout VYVANSE treatment, reassess each patient’s
risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse,
misuse, and addiction.
5.2 Risks to Patients with Serious Cardiac Disease
Sudden death has been reported in patients with structural cardiac abnormalities or other serious
cardiac disease who were treated with CNS stimulants at the recommended ADHD dosage.
Avoid VYVANSE use in patients with known structural cardiac abnormalities, cardiomyopathy,
serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease.
5.3 Increased Blood Pressure and Heart Rate
CNS stimulants cause an increase in blood pressure (mean increase about 2 to 4 mm Hg) and
heart rate (mean increase about 3 to 6 bpm). Some patients may have larger increases.
Monitor all VYVANSE-treated patients for potential tachycardia and hypertension.
5.4 Psychiatric Adverse Reactions
Exacerbation of Pre-existing Psychosis

CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in
patients with a pre-existing psychotic disorder.
Induction of a Manic Episode in Patients with Bipolar Disorder

CNS stimulants may induce a manic or mixed episode. Prior to initiating VYVANSE treatment,
screen patients for risk factors for developing a manic episode (e.g., comorbid or history of
depressive symptoms or a family history of suicide, bipolar disorder, and depression).
New Psychotic or Manic Symptoms

CNS stimulants, at the recommended dosage, may cause psychotic or manic symptoms (e.g.,
hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic
Page 6 of 37
illness or mania. In a pooled analysis of multiple short-term, placebo-controlled studies of CNS
stimulants, psychotic or manic symptoms occurred in approximately 0.1% of CNS stimulant-
treated patients compared to 0% of placebo-treated patients. If such symptoms occur, consider
discontinuing VYVANSE.
5.5 Long-Term Suppression of Growth in Pediatric Patients
CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric
patients.
In a 4-week, placebo-controlled trial of VYVANSE in pediatric patients ages 6 to 12 years old

with ADHD, there was a dose-related decrease in weight in the VYVANSE groups compared to
weight gain in the placebo group. Additionally, in studies of another stimulant, there was
slowing of the increase in height [see Adverse Reactions (6.1)].
Closely monitor growth (weight and height) in VYVANSE-treated pediatric patients. Patients
who are not growing or gaining height or weight as expected may need to have their treatment
interrupted. VYVANSE is not approved for use in pediatric patients below 6 years of age [see
Use in Specific Populations (8.4)].
5.6 Peripheral Vasculopathy, including Raynaud’s Phenomenon
CNS stimulants, including VYVANSE, used to treat ADHD are associated with peripheral
vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent
and mild; however, sequelae have included digital ulceration and/or soft tissue breakdown.
Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in post-
marketing reports and at the therapeutic dosages of CNS stimulants in all age groups throughout
the course of treatment. Signs and symptoms generally improved after dosage reduction or
discontinuation of the CNS stimulant.
Careful observation for digital changes is necessary during VYVANSE treatment. Further
clinical evaluation (e.g., rheumatology referral) may be appropriate for VYVANSE-treated
patients who develop signs or symptoms of peripheral vasculopathy.
5.7 Serotonin Syndrome
Serotonin syndrome, a potentially life-threatening reaction, may occur when amphetamines are
used in combination with other drugs that affect the serotonergic neurotransmitter systems such
as monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs),
serotonin norepinephrine reuptake inhibitors (SNRIs), triptans, tricyclic antidepressants,
fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort [see Drug Interactions
(7.1)]. The co-administration with cytochrome P450 2D6 (CYP2D6) inhibitors may also increase
the risk with increased exposure to the active metabolite of VYVANSE (dextroamphetamine). In
these situations, consider an alternative non-serotonergic drug or an alternative drug that does not
inhibit CYP2D6 [see Drug Interactions (7.1)].
Page 7 of 37
Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations,
delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness,
diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity,
myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g.,
nausea, vomiting, diarrhea).
Concomitant use of VYVANSE with MAOI drugs is contraindicated [see Contraindications

(4)].
Discontinue treatment with VYVANSE and any concomitant serotonergic agents immediately if
symptoms of serotonin syndrome occur, and initiate supportive symptomatic treatment. If
concomitant use of VYVANSE with other serotonergic drugs or CYP2D6 inhibitors is clinically
warranted, initiate VYVANSE with lower doses, monitor patients for the emergence of serotonin
syndrome during drug initiation or titration, and inform patients of the increased risk for
serotonin syndrome.
5.8 Motor and Verbal Tics, and Worsening of Tourette’s Syndrome
CNS stimulants, including amphetamine, have been associated with the onset or exacerbation of
motor and verbal tics. Worsening of Tourette’s syndrome has also been reported [see Adverse
Reactions (6.2)].
Before initiating VYVANSE, assess the family history and clinically evaluate patients for tics or
Tourette’s syndrome. Regularly monitor VYVANSE-treated patients for the emergence or
worsening of tics or Tourette’s syndrome, and discontinue treatment if clinically appropriate.
6 ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in other sections of the labeling:
• Known hypersensitivity to amphetamine products or other ingredients of VYVANSE

[see Contraindications (4)]
• Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors [see
Contraindications (4) and Drug Interactions (7.1)]
• Abuse, Misuse, and Addiction [see Boxed Warning, Warnings and Precautions (5.1), and
Drug Abuse and Dependence (9.2, 9.3)]
• Risks to Patients with Serious Cardiac Disease [see Warnings and Precautions (5.2)]
• Increased Blood Pressure and Heart Rate [see Warnings and Precautions (5.3)]
• Psychiatric Adverse Reactions [see Warnings and Precautions (5.4)]
• Long-Term Suppression of Growth in Pediatric Patients [see Warnings and Precautions
(5.5)]
• Peripheral Vasculopathy, including Raynaud’s phenomenon [see Warnings and
Precautions (5.6)]
• Serotonin Syndrome [see Warnings and Precautions (5.7)]
• Motor and Verbal Tics, and Worsening of Tourette’s Syndrome [see Warnings and
Precautions (5.8)]
Page 8 of 37
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates
observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials
of another drug and may not reflect the rates observed in practice.
Attention Deficit Hyperactivity Disorder
The safety data in this section is based on data from the 4-week controlled parallel-group clinical
studies of VYVANSE in pediatric and adult patients with ADHD [see Clinical Studies (14.1)].
Adverse Reactions Associated with Discontinuation of Treatment in ADHD Clinical Trials

In the controlled trial in pediatric patients ages 6 to 12 years (Study 1), 8% (18/218) of
VYVANSE-treated patients discontinued due to adverse reactions compared to 0% (0/72) of
placebo-treated patients. The most frequently reported adverse reactions (1% or more and twice
rate of placebo) were ECG voltage criteria for ventricular hypertrophy, tic, vomiting,
psychomotor hyperactivity, insomnia, decreased appetite and rash [2 instances for each adverse
reaction, i.e., 2/218 (1%)]. Less frequently reported adverse reactions (less than 1% or less than
twice rate of placebo) included abdominal pain upper, dry mouth, weight decreased, dizziness,
somnolence, logorrhea, chest pain, anger and hypertension.
In the controlled trial in pediatric patients ages 13 to 17 years (Study 4), 3% (7/233) of
VYVANSE-treated patients discontinued due to adverse reactions compared to 1% (1/77) of
placebo-treated patients. The most frequently reported adverse reactions (1% or more and twice
rate of placebo) were decreased appetite (2/233; 1%) and insomnia (2/233; 1%). Less frequently
reported adverse reactions (less than 1% or less than twice rate of placebo) included irritability,
dermatillomania, mood swings, and dyspnea.
In the controlled adult trial (Study 7), 6% (21/358) of VYVANSE-treated patients discontinued
due to adverse reactions compared to 2% (1/62) of placebo-treated patients. The most frequently
reported adverse reactions (1% or more and twice rate of placebo) were insomnia (8/358; 2%),
tachycardia (3/358; 1%), irritability (2/358; 1%), hypertension (4/358; 1%), headache (2/358;
1%), anxiety (2/358; 1%), and dyspnea (3/358; 1%). Less frequently reported adverse reactions
(less than 1% or less than twice rate of placebo) included palpitations, diarrhea, nausea,
decreased appetite, dizziness, agitation, depression, paranoia and restlessness.
Adverse Reactions Occurring at an Incidence of ≥5% or More Among VYVANSE Treated

Patients with ADHD in Clinical Trials
The most common adverse reactions (incidence ≥5% and at a rate at least twice placebo)
reported in pediatric patients ages 6 to 17 years, and/or adults were anorexia, anxiety, decreased
appetite, decreased weight, diarrhea, dizziness, dry mouth, irritability, insomnia, nausea, upper
abdominal pain, and vomiting.
Adverse Reactions Occurring at an Incidence of 2% or More Among VYVANSE Treated Patients

with ADHD in Clinical Trials
Page 9 of 37
Adverse reactions reported in the controlled trials in pediatric patients ages, 6 to 12 years (Study
1), pediatric patients ages 13 to 17 years (Study 4), and adult patients (Study 7) treated with
VYVANSE or placebo are presented in Tables 1, 2 and 3 below.
Table 1 Adverse Reactions Reported by 2% or More of Pediatric Patients Ages 6 to

12 Years with ADHD Taking VYVANSE and Greater than or Equal to
Twice the Incidence in Patients Taking Placebo in a 4-Week Clinical Trial
(Study 1)
VYVANSE Placebo
(n=218) (n=72)
Decreased Appetite 39% 4%
Insomnia 22% 3%
Abdominal Pain Upper 12% 6%
Irritability 10% 0%
Vomiting 9% 4%
Weight Decreased 9% 1%
Nausea 6% 3%
Dry Mouth 5% 0%
Dizziness 5% 0%
Affect lability 3% 0%
Rash 3% 0%
Pyrexia 2% 1%
Somnolence 2% 1%
Tic 2% 0%
Anorexia 2% 0%
Table 2 Adverse Reactions Reported by 2% or More of Pediatric Patients Ages 13 to

17 Years with ADHD Taking VYVANSE and Greater than or Equal to
Twice the Incidence in Patients Taking Placebo in a 4-Week Clinical Trial
(Study 4)
VYVANSE Placebo
(n=233) (n=77)
Insomnia 13% 4%
Weight Decreased 9% 0%
Dry Mouth 4% 1%
Palpitations 2% 1%
Anorexia 2% 0%
Tremor 2% 0%
Page 10 of 37
Table 3 Adverse Reactions Reported by 2% or More of Adult Patients with ADHD
Taking VYVANSE and Greater than or Equal to Twice the Incidence in
Patients Taking Placebo in a 4-Week Clinical Trial (Study 7)
VYVANSE Placebo
(n=358) (n=62)
Insomnia 27% 8%
Dry Mouth 26% 3%
Diarrhea 7% 0%
Nausea 7% 0%
Anxiety 6% 0%
Anorexia 5% 0%
Feeling Jittery 4% 0%
Agitation 3% 0%
Increased Blood Pressure 3% 0%
Hyperhidrosis 3% 0%
Restlessness 3% 0%
Decreased Weight 3% 0%
Dyspnea 2% 0%
Increased Heart Rate 2% 0%
Tremor 2% 0%
Palpitations 2% 0%
In addition, in the adult population erectile dysfunction was observed in 2.6% of males on
VYVANSE and 0% on placebo; decreased libido was observed in 1.4% of subjects on
VYVANSE and 0% on placebo.
Weight Loss and Slowing Growth Rate in Pediatric Patients with ADHD
In a controlled trial of VYVANSE in pediatric patients ages 6 to 12 years (Study 1), mean weight
loss from baseline after 4 weeks of therapy was -0.9, -1.9, and -2.5 pounds, respectively, for
patients receiving 30 mg, 50 mg, and 70 mg of VYVANSE, compared to a 1 pound weight gain
for patients receiving placebo. Higher doses were associated with greater weight loss with 4
weeks of treatment. Careful follow-up for weight in pediatric patients ages 6 to 12 years who
received VYVANSE over 12 months suggests that consistently medicated pediatric patients (i.e.,
treatment for 7 days per week throughout the year) have a slowing in growth rate, measured by
body weight as demonstrated by an age- and sex-normalized mean change from baseline in
percentile, of -13.4 over 1 year (average percentiles at baseline and 12 months were 60.9 and
47.2, respectively). In a 4-week controlled trial of VYVANSE in pediatric patients ages 13 to 17
years, mean weight loss from baseline to endpoint was -2.7, -4.3, and -4.8 lbs., respectively, for
patients receiving 30 mg, 50 mg, and 70 mg of VYVANSE, compared to a 2.0 pound weight
gain for patients receiving placebo.
Page 11 of 37
Careful follow-up of weight and height in pediatric patients ages 7 to 10 years who were
randomized to either methylphenidate or non-medication treatment groups over 14 months, as
well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated
pediatric patients over 36 months (to the ages of 10 to 13 years), suggests that consistently
medicated pediatric patients ages 7 to 13 years (i.e., treatment for 7 days per week throughout the
year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in
height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound
during this period of development. In a controlled trial of amphetamine (d- to l-enantiomer ratio
of 3:1) in pediatric patients ages 13 to 17 years, mean weight change from baseline within the
initial 4 weeks of therapy was -1.1 pounds and -2.8 pounds, respectively, for patients receiving
10 mg and 20 mg of amphetamine. Higher doses were associated with greater weight loss within
the initial 4 weeks of treatment [see Warnings and Precautions (5.5)].
Weight Loss in Adults with ADHD

In the controlled adult trial (Study 7), mean weight loss after 4 weeks of therapy was 2.8 pounds,
3.1 pounds, and 4.3 pounds, for patients receiving final doses of 30 mg, 50 mg, and 70 mg of
VYVANSE, respectively, compared to a mean weight gain of 0.5 pounds for patients receiving
placebo.
Binge Eating Disorder
The safety data in this section is based on data from two 12-week parallel group, flexible-dose,
placebo-controlled studies in adults with BED [see Clinical Studies 14.2]. Patients with
cardiovascular risk factors other than obesity and smoking were excluded.
Adverse Reactions Associated with Discontinuation of Treatment in BED Clinical Trials

In controlled trials of patients ages 18 to 55 years, 5.1% (19/373) of VYVANSE-treated patients
discontinued due to adverse reactions compared to 2.4% (9/372) of placebo-treated patients. No
single adverse reaction led to discontinuation in 1% or more of VYVANSE-treated patients.
Less commonly reported adverse reactions (less than 1% or less than twice rate of placebo)
included increased heart rate, headache, abdominal pain upper, dyspnea, rash, insomnia,
irritability, feeling jittery and anxiety.
Adverse Reactions Occurring at an Incidence of 5% or More and At Least Twice Placebo Among
VYVANSE Treated Patients with BED in Clinical Trials
The most common adverse reactions (incidence ≥5% and at a rate at least twice placebo)
reported in adults were dry mouth, insomnia, decreased appetite, increased heart rate,
constipation, feeling jittery, and anxiety.
Adverse Reactions Occurring at an Incidence of 2% or More and At Least Twice Placebo Among
VYVANSE Treated Patients with BED in Clinical Trials
Adverse reactions reported in the pooled controlled trials in adult patients (Study 11 and 12)
treated with VYVANSE or placebo are presented in Table 4 below.
Page 12 of 37
Table 4 Adverse Reactions Reported by 2% or More of Adult Patients with BED
Taking VYVANSE and Greater than or Equal to Twice the Incidence in
Patients Taking Placebo in 12-Week Clinical Trials (Study 11 and 12)
VYVANSE Placebo
(N=373) (N=372)
Dry Mouth 36% 7%
Insomnia1 20% 8%
Increased Heart Rate2 7% 1%
Feeling Jittery 6% 1%
Constipation 6% 1%
Anxiety 5% 1%
Diarrhea 4% 2%
Decreased Weight 4% 0%
Hyperhidrosis 4% 0%
Vomiting 2% 1%
Gastroenteritis 2% 1%
Paresthesia 2% 1%
Pruritus 2% 1%
Upper Abdominal Pain 2% 0%
Energy Increased 2% 0%
Urinary Tract Infection 2% 0%
Nightmare 2% 0%
Restlessness 2% 0%
Oropharyngeal Pain 2% 0%
1
Includes all preferred terms containing the word “insomnia.”
2
Includes the preferred terms “heart rate increased” and “tachycardia.”
6.2 Postmarketing Experience
The following adverse reactions have been identified during post-approval use of VYVANSE.
Because these reactions are reported voluntarily from a population of uncertain size, it is not
always possible to reliably estimate their frequency or establish a causal relationship to drug
exposure. These events are as follows: cardiomyopathy, mydriasis, diplopia, difficulties with
visual accommodation, blurred vision, eosinophilic hepatitis, anaphylactic reaction,
hypersensitivity, dyskinesia, dysgeusia, motor and verbal tics, bruxism, depression,
dermatillomania, alopecia, aggression, Stevens-Johnson Syndrome, chest pain, angioedema,
urticaria, seizures, libido changes, frequent or prolonged erections, constipation, rhabdomyolysis,
and intestinal ischemia.
7 DRUG INTERACTIONS
7.1 Drugs Having Clinically Important Interactions with Amphetamines
Page 13 of 37
Table 5 Drugs having clinically important interactions with amphetamines.
MAO Inhibitors (MAOI)

Clinical Impact MAOI antidepressants slow amphetamine metabolism, increasing
amphetamines effect on the release of norepinephrine and other
monoamines from adrenergic nerve endings causing headaches and other
signs of hypertensive crisis. Toxic neurological effects and malignant
hyperpyrexia can occur, sometimes with fatal results.
Intervention Do not administer VYVANSE during or within 14 days following the
administration of MAOI [see Contraindications (4)].
Serotonergic Drugs
Clinical Impact The concomitant use of VYVANSE and serotonergic drugs increases the
risk of serotonin syndrome.
Intervention Initiate with lower doses and monitor patients for signs and symptoms of
serotonin syndrome, particularly during VYVANSE initiation or dosage
increase. If serotonin syndrome occurs, discontinue VYVANSE and the
concomitant serotonergic drug(s) [see Warnings and Precautions (5.7)].
CYP2D6 Inhibitors
Clinical Impact The concomitant use of VYVANSE and CYP2D6 inhibitors may increase
the exposure of dextroamphetamine, the active metabolite of VYVANSE
compared to the use of the drug alone and increase the risk of serotonin
syndrome.
Intervention Initiate with lower doses and monitor patients for signs and symptoms of
serotonin syndrome particularly during VYVANSE initiation and after a
dosage increase. If serotonin syndrome occurs, discontinue VYVANSE
and the CYP2D6 inhibitor [see Warnings and Precautions (5.7) and
Overdosage (10)].
Alkalinizing Agents
Clinical Impact Urinary alkalinizing agents can increase blood levels and potentiate the
action of amphetamine.
Intervention Co-administration of VYVANSE and urinary alkalinizing agents should
be avoided.
Acidifying Agents
Clinical Impact Urinary acidifying agents can lower blood levels and efficacy of
amphetamines.
Intervention Increase dose based on clinical response.
Tricyclic Antidepressants
Clinical Impact May enhance the activity of tricyclic or sympathomimetic agents causing
striking and sustained increases in the concentration of d-amphetamine in
the brain; cardiovascular effects can be potentiated.
Intervention Monitor frequently and adjust or use alternative therapy based on clinical
response.
Page 14 of 37
7.2 Drugs Having No Clinically Important Interactions with VYVANSE
From a pharmacokinetic perspective, no dose adjustment of VYVANSE is necessary when

VYVANSE is co-administered with guanfacine, venlafaxine, or omeprazole. In addition, no
dose adjustment of guanfacine or venlafaxine is needed when VYVANSE is co-administered
[see Clinical Pharmacology (12.3)].
From a pharmacokinetic perspective, no dose adjustment for drugs that are substrates of
CYP1A2 (e.g., theophylline, duloxetine, melatonin), CYP2D6 (e.g., atomoxetine, desipramine,
venlafaxine), CYP2C19 (e.g., omeprazole, lansoprazole, clobazam), and CYP3A4 (e.g.,
midazolam, pimozide, simvastatin) is necessary when VYVANSE is co-administered [see
Clinical Pharmacology (12.3)].
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to
ADHD medications during pregnancy. Healthcare providers are encouraged to register patients
by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visiting
online at https://womensmentalhealth.org/clinical-and researchprograms/pregnancyregistry/adhd-
medications/.
Risk Summary
The limited available data from published literature and postmarketing reports on use of
VYVANSE in pregnant women are not sufficient to inform a drug-associated risk for major birth
defects and miscarriage. Adverse pregnancy outcomes, including premature delivery and low
birth weight, have been seen in infants born to mothers dependent on amphetamines [see
Clinical Considerations]. In animal reproduction studies, lisdexamfetamine dimesylate (a
prodrug of d-amphetamine) had no effects on embryo-fetal morphological development or
survival when administered orally to pregnant rats and rabbits throughout the period of
organogenesis. Pre- and postnatal studies were not conducted with lisdexamfetamine
dimesylate. However, amphetamine (d- to l- ratio of 3:1) administration to pregnant rats during
gestation and lactation caused a decrease in pup survival and a decrease in pup body weight that
correlated with a delay in developmental landmarks at clinically relevant doses of amphetamine.
In addition, adverse effects on reproductive performance were observed in pups whose mothers
were treated with amphetamine. Long-term neurochemical and behavioral effects have also been
reported in animal developmental studies using clinically relevant doses of amphetamine [see
Data].
The estimated background risk of major birth defects and miscarriage for the indicated
population is unknown. All pregnancies have a background risk of birth defect, loss or other
adverse outcomes. In the U.S. general population, the estimated background risk of major birth
defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Page 15 of 37
Clinical Considerations
Fetal/Neonatal Adverse Reactions
Amphetamines, such as VYVANSE, cause vasoconstriction and thereby may decrease placental
perfusion. In addition, amphetamines can stimulate uterine contractions increasing the risk of
premature delivery. Infants born to amphetamine-dependent mothers have an increased risk of
premature delivery and low birth weight.
Monitor infants born to mothers taking amphetamines for symptoms of withdrawal such as
feeding difficulties, irritability, agitation, and excessive drowsiness.
Data
Animal Data
Lisdexamfetamine dimesylate had no apparent effects on embryo-fetal morphological
development or survival when administered orally to pregnant rats and rabbits throughout the
period of organogenesis at doses of up to 40 and 120 mg/kg/day, respectively. These doses are
approximately 5.5 and 33 times, respectively, the maximum recommended human dose (MRHD)
of 70 mg/day given to adults, on a mg/m2 body surface area basis.
A study was conducted with amphetamine (d- to l- enantiomer ratio of 3:1) in which pregnant
rats received daily oral doses of 2, 6, and 10 mg/kg from gestation day 6 to lactation day 20. All
doses caused hyperactivity and decreased weight gain in the dams. A decrease in pup survival
was seen at all doses. A decrease in pup body weight was seen at 6 and 10 mg/kg which
correlated with delays in developmental landmarks, such as preputial separation and vaginal
opening. Increased pup locomotor activity was seen at 10 mg/kg on day 22 postpartum but not at
5 weeks postweaning. When pups were tested for reproductive performance at maturation,
gestational weight gain, number of implantations, and number of delivered pups were decreased
in the group whose mothers had been given 10 mg/kg.
A number of studies from the literature in rodents indicate that prenatal or early postnatal
exposure to amphetamine (d- or d, l-) at doses similar to those used clinically can result in long-
term neurochemical and behavioral alterations. Reported behavioral effects include learning and
memory deficits, altered locomotor activity, and changes in sexual function.
8.2 Lactation
Risk Summary
Lisdexamfetamine is a pro-drug of dextroamphetamine. Based on limited case reports in
published literature, amphetamine (d-or d, l-) is present in human milk, at relative infant doses of
2% to 13.8% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between
1.9 and 7.5. There are no reports of adverse effects on the breastfed infant. Long-term
neurodevelopmental effects on infants from amphetamine exposure are unknown. It is possible
that large dosages of dextroamphetamine might interfere with milk production, especially in
women whose lactation is not well established. Because of the potential for serious adverse
reactions in nursing infants, including serious cardiovascular reactions, blood pressure and heart
rate increase, suppression of growth, and peripheral vasculopathy, advise patients that
breastfeeding is not recommended during treatment with VYVANSE.
Page 16 of 37
8.4 Pediatric Use
ADHD
Safety and effectiveness of VYVANSE have been established in pediatric patients with ADHD
ages 6 to 17 years [see Dosage and Administration (2.3), Adverse Reactions (6.1), Clinical
Pharmacology (12.3), and Clinical Studies (14.1)].
Safety and effectiveness of VYVANSE have not been established in pediatric patients below the
age of 6 years.
Safety and efficacy of VYVANSE were evaluated in a double-blind, randomized, parallel-group,

placebo-controlled, fixed-dose study in pediatric patients ages 4 to 5 years with ADHD, followed
by a 1-year open-label extension study. In these studies, patients experienced elevated rates of
adverse reactions, including weight loss, decreased BMI, decreased appetite, insomnia,
infections (upper respiratory and nasopharyngitis), irritability, and affect lability.
With the same VYVANSE dose, mean steady state exposure of dextroamphetamine was
approximately 44% higher in pediatric patients ages 4 to 5 years compared to the pediatric
patients ages 6 to 11 years.
BED
Safety and effectiveness of VYVANSE have not been established in pediatric patients with BED
less than 18 years of age.
Growth Suppression
Growth should be monitored during treatment with stimulants, including VYVANSE, and
pediatric patients who are not growing or gaining weight as expected may need to have their
treatment interrupted [see Warnings and Precautions (5.5) and Adverse Reactions (6.1)].
Juvenile Animal Data

Studies conducted in juvenile rats and dogs at clinically relevant doses showed growth
suppression that partially or fully reversed in dogs and female rats but not in male rats after a
four-week drug-free recovery period.
A study was conducted in which juvenile rats received oral doses of 4, 10, or 40 mg/kg/day of
lisdexamfetamine dimesylate from day 7 to day 63 of age. These doses are approximately 0.3,
0.7, and 3 times the maximum recommended human daily dose of 70 mg on a mg/m2 basis for a
child. Dose-related decreases in food consumption, bodyweight gain, and crown-rump length
were seen; after a four-week drug-free recovery period, bodyweights and crown-rump lengths
had significantly recovered in females but were still substantially reduced in males. Time to
vaginal opening was delayed in females at the highest dose, but there were no drug effects on
fertility when the animals were mated beginning on day 85 of age.
In a study in which juvenile dogs received lisdexamfetamine dimesylate for 6 months beginning
at 10 weeks of age, decreased bodyweight gain was seen at all doses tested (2, 5, and
12 mg/kg/day, which are approximately 0.5, 1, and 3 times the maximum recommended human
Page 17 of 37
daily dose on a mg/m2 basis for a child). This effect partially or fully reversed during a four-
week drug-free recovery period.
8.5 Geriatric Use
Clinical studies of VYVANSE did not include sufficient numbers of subjects aged 65 and over to
determine whether they respond differently from younger subjects. Other reported clinical
experience and pharmacokinetic data [see Clinical Pharmacology (12.3)] have not identified
differences in responses between the elderly and younger patients. In general, dose selection for
an elderly patient should start at the low end of the dosing range, reflecting the greater frequency
of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug
therapy.
8.6 Renal Impairment
Due to reduced clearance in patients with severe renal impairment (GFR 15 to < 30 mL/min/1.73
m2), the maximum dose should not exceed 50 mg/day. The maximum recommended dose in
ESRD (GFR < 15 mL/min/1.73 m2) patients is 30 mg/day [see Clinical Pharmacology (12.3)].
Lisdexamfetamine and d-amphetamine are not dialyzable.
9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
VYVANSE contains lisdexamfetamine, a prodrug of amphetamine, a Schedule II controlled

substance.
9.2 Abuse
VYVANSE has a high potential for abuse and misuse which can lead to the development of a
substance use disorder, including addiction [see Warnings and Precautions (5.1)]. VYVANSE
can be diverted for non-medical use into illicit channels or distribution.
Abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired
psychological or physiological effect. Misuse is the intentional use, for therapeutic purposes, of a
drug by an individual in a way other than prescribed by a health care provider or for whom it was
not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena
that may include a strong desire to take the drug, difficulties in controlling drug use (e.g.,
continuing drug use despite harmful consequences, giving a higher priority to drug use than other
activities and obligations), and possible tolerance or physical dependence.
Misuse and abuse of lisdexamfetamine, a prodrug of amphetamine, may cause increased heart
rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness;
insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or
abdominal pain. Anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation
have also been observed with CNS stimulants abuse and/or misuse. Misuse and abuse of CNS
Page 18 of 37
stimulants, including VYVANSE, can result in overdose and death [see Overdosage (10)], and
this risk is increased with higher doses or unapproved methods of administration, such as
snorting or injection.
Studies of VYVANSE in Drug Abusers

A randomized, double-blind, placebo-control, cross-over, abuse liability study in 38 patients with
a history of drug abuse was conducted with single-doses of 50, 100, or 150 mg of VYVANSE,
40 mg of immediate-release d-amphetamine sulphate (a controlled II substance), and 200 mg of
diethylpropion hydrochloride (a controlled IV substance). VYVANSE 100 mg produced
significantly less “Drug Liking Effects” as measured by the Drug Rating Questionnaire-Subject
score, compared to d-amphetamine 40 mg; and 150 mg of VYVANSE demonstrated similar
“Drug-Liking Effects” compared to 40 mg of d-amphetamine and 200 mg of diethylpropion.
Intravenous administration of 50 mg lisdexamfetamine dimesylate to individuals with a history of

drug abuse produced positive subjective responses on scales measuring “Drug Liking”,
“Euphoria”, “Amphetamine Effects”, and “Benzedrine Effects” that were greater than placebo but
less than those produced by an equivalent dose (20 mg) of intravenous d-amphetamine.
9.3 Dependence
Physical Dependence
VYVANSE may produce physical dependence. Physical dependence is a state that develops as a
result of physiological adaptation in response to repeated drug use, manifested by withdrawal
signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug.
Withdrawal signs and symptoms after abrupt discontinuation or dose reduction following
prolonged use of CNS stimulants including VYVANSE include dysphoric mood; depression;
fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and
psychomotor retardation or agitation.
Tolerance
VYVANSE may produce tolerance. Tolerance is a physiological state characterized by a reduced
response to a drug after repeated administration (i.e., a higher dose of a drug is required to
produce the same effect that was once obtained at a lower dose).
10 OVERDOSAGE
Clinical Effects of Overdose

Overdose of CNS stimulants is characterized by the following sympathomimetic effects:
• Cardiovascular effects including tachyarrhythmias, and hypertension or hypotension.
Vasospasm, myocardial infarction, or aortic dissection may precipitate sudden cardiac
death. Takotsubo cardiomyopathy may develop.
• CNS effects including psychomotor agitation, confusion, and hallucinations. Serotonin
syndrome, seizures, cerebral vascular accidents, and coma may occur.
• Life-threatening hyperthermia (temperatures greater than 104°F) and rhabdomyolysis
may develop.
Page 19 of 37
Overdose Management
Consider the possibility of multiple drug ingestion. The pharmacokinetic profile of VYVANSE
should be considered when treating patients with overdose. Lisdexamfetamine and d-
amphetamine are not dialyzable. Consider contacting the Poison Help line (1-800-222-1222) or a
medical toxicologist for additional overdose management recommendations.
11 DESCRIPTION
VYVANSE (lisdexamfetamine dimesylate), a CNS stimulant, is for once-a-day oral

administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-
N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is
C15H25N3O•(CH4O3S)2, which corresponds to a molecular weight of 455.60. The chemical
structure is:
Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792

mg/mL).
Information for VYVANSE capsules:
VYVANSE capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of
lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg,
34.7 mg, and 40.5 mg of lisdexamfetamine).
Inactive ingredients: microcrystalline cellulose, croscarmellose sodium, and magnesium stearate.

The capsule shells contain gelatin, titanium dioxide, and one or more of the following: FD&C
Red #3, FD&C Yellow #6, FD&C Blue #1, Black Iron Oxide, and Yellow Iron Oxide.
Information for VYVANSE chewable tablets:
VYVANSE chewable tablets contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg of
lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, and
34.7 mg of lisdexamfetamine).
Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, guar gum, magnesium
stearate, mannitol, microcrystalline cellulose, sucralose, artificial strawberry flavor.
Page 20 of 37
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Lisdexamfetamine is a prodrug of dextroamphetamine. Amphetamines are non-catecholamine

sympathomimetic amines with CNS stimulant activity. The exact mode of therapeutic action in
ADHD and BED is not known.
12.2 Pharmacodynamics
Amphetamines block the reuptake of norepinephrine and dopamine into the presynaptic neuron
and increase the release of these monoamines into the extraneuronal space. The parent drug,
lisdexamfetamine, does not bind to the sites responsible for the reuptake of norepinephrine and
dopamine in vitro.
12.3 Pharmacokinetics
Pharmacokinetic studies after oral administration of lisdexamfetamine dimesylate have been

conducted in healthy adult (capsule and chewable tablet formulations) and pediatric (6 to 12
years) patients with ADHD (capsule formulation). After single dose administration of
lisdexamfetamine dimesylate, pharmacokinetics of dextroamphetamine was found to be linear
between 30 mg and 70 mg in a pediatric study (6 to 12 years), and between 50 mg and 250 mg in
an adult study. Dextroamphetamine pharmacokinetic parameters following administration of
lisdexamfetamine dimesylate in adults exhibited low inter-subject (<25%) and intra-subject
(<8%) variability. There is no accumulation of lisdexamfetamine and dextroamphetamine at
steady state in healthy adults.
Absorption
Capsule formulation
Following single-dose oral administration of VYVANSE capsule (30 mg, 50 mg, or 70 mg) in
patients ages 6 to 12 years with ADHD under fasted conditions, Tmax of lisdexamfetamine and
dextroamphetamine was reached at approximately 1 hour and 3.5 hours post dose, respectively.
Weight/Dose normalized AUC and Cmax values were the same in pediatric patients ages 6 to
12 years as the adults following single doses of 30 mg to 70 mg VYVANSE capsule.
Effect of food on capsule formulation

Neither food (a high fat meal or yogurt) nor orange juice affects the observed AUC and Cmax of
dextroamphetamine in healthy adults after single-dose oral administration of 70 mg of
VYVANSE capsules. Food prolongs Tmax by approximately 1 hour (from 3.8 hours at fasted
state to 4.7 hours after a high fat meal or to 4.2 hours with yogurt). After an 8-hour fast, the
AUC for dextroamphetamine following oral administration of lisdexamfetamine dimesylate in
solution and as intact capsules were equivalent.
Chewable Tablet formulation

After a single dose administration of 60 mg VYVANSE chewable tablet in healthy subjects
under fasted conditions, Tmax of lisdexamfetamine and dextroamphetamine was reached at
Page 21 of 37
approximately 1 hour and 4.4 hours post dose, respectively. Compared to 60 mg VYVANSE
capsule, exposure (Cmax and AUC) to lisdexamfetamine was about 15% lower. The exposure
(Cmax and AUCinf) of dextroamphetamine is similar between VYVANSE chewable tablet and
VYVANSE capsule.
Effect of food on tablet formulation

Administration of 60 mg VYVANSE chewable tablet with food (a high-fat meal) decreases the
exposure (Cmax and AUCinf) of dextroamphetamine by about 5% to 7%, and prolongs mean Tmax
by approximately 1 hour (from 3.9 hours at fasted state to 4.9 hours).
Elimination
Plasma concentrations of unconverted lisdexamfetamine are low and transient, generally
becoming non-quantifiable by 8 hours after administration. The plasma elimination half-life of
lisdexamfetamine typically averaged less than one hour in volunteers ages 6 years and older.
The plasma elimination half-life of dextroamphetamine was approximately 8.6 to 9.5 hours in
pediatric patients 6 to 12 years and 10 to 11.3 hours in healthy adults.
Metabolism
Lisdexamfetamine is converted to dextroamphetamine and l-lysine primarily in blood due to the
hydrolytic activity of red blood cells after oral administration of lisdexamfetamine dimesylate.
In vitro data demonstrated that red blood cells have a high capacity for metabolism of
lisdexamfetamine; substantial hydrolysis occurred even at low hematocrit levels (33% of
normal). Lisdexamfetamine is not metabolized by cytochrome P450 enzymes.
Excretion
Following oral administration of a 70 mg dose of radiolabeled lisdexamfetamine dimesylate to
6 healthy subjects, approximately 96% of the oral dose radioactivity was recovered in the urine
and only 0.3% recovered in the feces over a period of 120 hours. Of the radioactivity recovered
in the urine, 42% of the dose was related to amphetamine, 25% to hippuric acid, and 2% to intact
lisdexamfetamine.
Specific Populations
Exposures of dextroamphetamine in specific populations are summarized in Figure 1.
Page 22 of 37
Figure 1: Specific Populations*:
*Figure 1 shows the geometric mean ratios and the 90% confidence limits for C max and AUC of d-amphetamine.
Comparison for gender uses males as the reference. Comparison for age uses 55-64 years as the reference.
Drug Interaction Studies

Effects of other drugs on the exposures of dextroamphetamine are summarized in Figure 2.
Figure 2: Effect of Other Drugs on VYVANSE:
Page 23 of 37
The effects of VYVANSE on the exposures of other drugs are summarized in Figure 3.
Figure 3: Effect of VYVANSE on Other Drugs:
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, and Impairment of Fertility
Carcinogenesis
Carcinogenicity studies of lisdexamfetamine dimesylate have not been performed. No evidence
of carcinogenicity was found in studies in which d-, l-amphetamine (enantiomer ratio of 1:1) was
administered to mice and rats in the diet for 2 years at doses of up to 30 mg/kg/day in male mice,
19 mg/kg/day in female mice, and 5 mg/kg/day in male and female rats.
Mutagenesis
Lisdexamfetamine dimesylate was not clastogenic in the mouse bone marrow micronucleus test
in vivo and was negative when tested in the E. coli and S. typhimurium components of the Ames
test and in the L5178Y/TK+/- mouse lymphoma assay in vitro.
Impairment of Fertility
Amphetamine (d- to l-enantiomer ratio of 3:1) did not adversely affect fertility or early
embryonic development in the rat at doses of up to 20 mg/kg/day.
13.2 Animal Toxicology and/or Pharmacology
Acute administration of high doses of amphetamine (d- or d, l-) has been shown to produce long-
lasting neurotoxic effects, including irreversible nerve fiber damage, in rodents. The significance
of these findings to humans is unknown.
Page 24 of 37
14 CLINICAL STUDIES
14.1 Attention Deficit Hyperactivity Disorder (ADHD)
Pediatric Patients Ages 6 to 12 Years with ADHD

A double-blind, randomized, placebo-controlled, parallel-group study (Study 1) was conducted
in pediatric patients ages 6 to 12 years (N=290) who met DSM-IV criteria for ADHD (either the
combined type or the hyperactive-impulsive type). Patients were randomized to receive final
doses of 30 mg, 50 mg, or 70 mg of VYVANSE or placebo once daily in the morning for a total
of four weeks of treatment. All patients receiving VYVANSE were initiated on 30 mg for the
first week of treatment. Patients assigned to the 50 mg and 70 mg dose groups were titrated by
20 mg per week until they achieved their assigned dose. The primary efficacy outcome was
change in Total Score from baseline to endpoint in investigator ratings on the ADHD Rating
Scale (ADHD-RS), an 18-item questionnaire with a score range of 0-54 points that measures the
core symptoms of ADHD which includes both hyperactive/impulsive and inattentive subscales.
Endpoint was defined as the last post-randomization treatment week (i.e., Weeks 1 through 4) for
which a valid score was obtained. All VYVANSE dose groups were superior to placebo in the
primary efficacy outcome. Mean effects at all doses were similar; however, the highest dose
(70 mg/day) was numerically superior to both lower doses (Study 1 in Table 6). The effects
were maintained throughout the day based on parent ratings (Conners’ Parent Rating Scale) in
the morning (approximately 10 am), afternoon (approximately 2 pm), and early evening
(approximately 6 pm).
A double-blind, placebo-controlled, randomized, crossover design, analog classroom study

(Study 2) was conducted in pediatric patients ages 6 to 12 years (N=52) who met DSM-IV
criteria for ADHD (either the combined type or the hyperactive-impulsive type). Following a 3-
week open-label dose optimization with Adderall XR, patients were randomly assigned to
continue their optimized dose of Adderall XR (10 mg, 20 mg, or 30 mg), VYVANSE (30 mg,
50 mg, or 70 mg), or placebo once daily in the morning for 1 week each treatment. Efficacy
assessments were conducted at 1, 2, 3, 4.5, 6, 8, 10, and 12 hours post-dose using the Swanson,
Kotkin, Agler, M.Flynn, and Pelham Deportment scores (SKAMP-DS), a 4-item subscale of the
SKAMP with scores ranging from 0 to 24 points that measures deportment problems leading to
classroom disruptions. A significant difference in patient behavior, based upon the average of
investigator ratings on the SKAMP-DS across the 8 assessments were observed between patients
when they received VYVANSE compared to patients when they received placebo (Study 2 in
Table 6). The drug effect reached statistical significance from hours 2 to 12 post-dose, but was
not significant at 1 hour.
A second double-blind, placebo-controlled, randomized, crossover design, analog classroom

study (Study 3) was conducted in pediatric patients ages 6 to 12 years (N=129) who met DSM-
IV criteria for ADHD (either the combined type or the hyperactive-impulsive type). Following a
4-week open-label dose optimization with VYVANSE (30 mg, 50 mg, 70 mg), patients were
randomly assigned to continue their optimized dose of VYVANSE or placebo once daily in the
morning for 1 week each treatment. A significant difference in patient behavior, based upon the
average of investigator ratings on the SKAMP-Deportment scores across all 7 assessments
conducted at 1.5, 2.5, 5.0, 7.5, 10.0, 12.0, and 13.0 hours post-dose, were observed between
Page 25 of 37
patients when they received VYVANSE compared to patients when they received placebo
(Study 3 in Table 6, Figure 4).
Pediatric Patients Ages 13 to 17 Years with ADHD

in pediatric patients ages 13 to 17 years (N=314) who met DSM-IV criteria for ADHD. In this
study, patients were randomized in a 1:1:1:1 ratio to a daily morning dose of VYVANSE
(30 mg/day, 50 mg/day or 70 mg/day) or placebo for a total of four weeks of treatment. All
patients receiving VYVANSE were initiated on 30 mg for the first week of treatment. Patients
assigned to the 50 mg and 70 mg dose groups were titrated by 20 mg per week until they
achieved their assigned dose. The primary efficacy outcome was change in Total Score from
baseline to endpoint in investigator ratings on the ADHD Rating Scale (ADHD-RS). Endpoint
was defined as the last post-randomization treatment week (i.e., Weeks 1 through 4) for which a
valid score was obtained. All VYVANSE dose groups were superior to placebo in the primary
efficacy outcome (Study 4 in Table 6).
Pediatric Patients Ages 6 to 17 Years: Short-Term Treatment in ADHD

A double-blind, randomized, placebo- and active-controlled parallel-group, dose-optimization
study (Study 5) was conducted in pediatric patients ages 6 to 17 years (n=336) who met DSM-IV
criteria for ADHD. In this eight-week study, patients were randomized to a daily morning dose
of VYVANSE (30, 50 or 70 mg/day), an active control, or placebo (1:1:1). The study consisted
of a Screening and Washout Period (up to 42 days), a 7-week Double-blind Evaluation Period
(consisting of a 4-week Dose-Optimization Period followed by a 3-week Dose-Maintenance
Period), and a 1-week Washout and Follow-up Period. During the Dose Optimization Period,
subjects were titrated until an optimal dose, based on tolerability and investigator’s judgment,
was reached. VYVANSE showed significantly greater efficacy than placebo. The placebo-
adjusted mean reduction from baseline in the ADHD-RS-IV total score was 18.6. Subjects on
VYVANSE also showed greater improvement on the Clinical Global Impression-Improvement
(CGI-I) rating scale compared to subjects on placebo (Study 5 in Table 6).
Pediatric Patients Ages 6 to 17 Years: Maintenance Treatment in ADHD

Maintenance of Efficacy Study (Study 6) – A double-blind, placebo-controlled, randomized
withdrawal study was conducted in pediatric patients ages 6 to 17 years (N=276) who met the
diagnosis of ADHD (DSM-IV criteria). A total of 276 patients were enrolled into the study, 236
patients participated in Study 5 and 40 subjects directly enrolled. Subjects were treated with
open-label VYVANSE for at least 26 weeks prior to being assessed for entry into the
randomized withdrawal period. Eligible patients had to demonstrate treatment response as
defined by CGI-S <3 and Total Score on the ADHD-RS ≤22. Patients that maintained treatment
response for 2 weeks at the end of the open label treatment period were eligible to be randomized
to ongoing treatment with the same dose of VYVANSE (N=78) or switched to placebo (N=79)
during the double-blind phase. Patients were observed for relapse (treatment failure) during the
6 week double blind phase. A significantly lower proportion of treatment failures occurred
among VYVANSE subjects (15.8%) compared to placebo (67.5%) at endpoint of the
randomized withdrawal period. The endpoint measurement was defined as the last post-
randomization treatment week at which a valid ADHD-RS Total Score and CGI-S were
observed. Treatment failure was defined as a ≥50% increase (worsening) in the ADHD-RS Total
Page 26 of 37
Score and a ≥2-point increase in the CGI-S score compared to scores at entry into the double-
blind randomized withdrawal phase. Subjects who withdrew from the randomized withdrawal
period and who did not provide efficacy data at their last on-treatment visit were classified as
treatment failures (Study 6, Figure 5).
Adults: Short-Term Treatment in ADHD

in adults ages 18 to 55 (N=420) who met DSM-IV criteria for ADHD. In this study, patients
were randomized to receive final doses of 30 mg, 50 mg, or 70 mg of VYVANSE or placebo for
a total of four weeks of treatment. All patients receiving VYVANSE were initiated on 30 mg for
the first week of treatment. Patients assigned to the 50 mg and 70 mg dose groups were titrated
by 20 mg per week until they achieved their assigned dose. The primary efficacy outcome was
change in Total Score from baseline to endpoint in investigator ratings on the ADHD Rating
Scale (ADHD-RS). Endpoint was defined as the last post-randomization treatment week (i.e.,
Weeks 1 through 4) for which a valid score was obtained. All VYVANSE dose groups were
superior to placebo in the primary efficacy outcome (Study 7 in Table 6).
The second study was a multi-center, randomized, double-blind, placebo-controlled, cross-over,

modified analog classroom study (Study 8) of VYVANSE to simulate a workplace environment
in 142 adults ages 18 to 55 who met DSM-IV-TR criteria for ADHD. There was a 4-week open-
label, dose optimization phase with VYVANSE (30 mg/day, 50 mg/day, or 70 mg/day in the
morning). Patients were then randomized to one of two treatment sequences: 1) VYVANSE
(optimized dose) followed by placebo, each for one week, or 2) placebo followed by
VYVANSE, each for one week. Efficacy assessments occurred at the end of each week, using
the Permanent Product Measure of Performance (PERMP), a skill-adjusted math test that
measures attention in ADHD. PERMP total score results from the sum of the number of math
problems attempted plus the number of math problems answered correctly. VYVANSE
treatment, compared to placebo, resulted in a statistically significant improvement in attention
across all post-dose time points, as measured by average PERMP total scores over the course of
one assessment day, as well as at each time point measured. The PERMP assessments were
administered at pre-dose (-0.5 hours) and at 2, 4, 8, 10, 12, and 14 hours post-dose (Study 8 in
Table 6, Figure 6).
Adults: Maintenance Treatment in ADHD

A double-blind, placebo-controlled, randomized withdrawal design study (Study 9) was
conducted in adults ages 18 to 55 (N=123) who had a documented diagnosis of ADHD or met
DSM-IV criteria for ADHD. At study entry, patients must have had documentation of treatment
with VYVANSE for a minimum of 6 months and had to demonstrate treatment response as
defined by Clinical Global Impression Severity (CGI-S) ≤3 and Total Score on the ADHD-RS
<22. ADHD-RS Total Score is a measure of core symptoms of ADHD. The CGI-S score
assesses the clinician’s impression of the patient’s current illness state and ranges from 1 (not at
all ill) to 7 (extremely ill). Patients that maintained treatment response at Week 3 of the open
label treatment phase (N=116) were eligible to be randomized to ongoing treatment with the
same dose of VYVANSE (N=56) or switched to placebo (N=60) during the double-blind phase.
Patients were observed for relapse (treatment failure) during the 6-week double-blind phase. The
efficacy endpoint was the proportion of patients with treatment failure during the double-blind
Page 27 of 37
phase. Treatment failure was defined as a ≥50% increase (worsening) in the ADHD-RS Total
Score and ≥2-point increase in the CGI-S score compared to scores at entry into the double-blind
phase. Maintenance of efficacy for patients treated with VYVANSE was demonstrated by the
significantly lower proportion of patients with treatment failure (9%) compared to patients
receiving placebo (75%) at endpoint during the double-blind phase (Study 9, Figure 7).
Table 6: Summary of Primary Efficacy Results from Short-term Studies of VYVANSE in

Pediatric Patients (Ages 6 to 17) and Adults with ADHD
Study Primary Treatment Group Mean Baseline Score LS Mean Change Placebo-subtracted
Number Endpoint (SD) from Baseline (SE) Differencea (95% CI)
(Age
range)
Study 1 ADHD-RS-
VYVANSE (30 mg/day)* 43.2 (6.7) -21.8 (1.6) -15.6 (-19.9, -11.2)
(6 – 12 IV
years) VYVANSE (50 mg/day)* 43.3 (6.7) -23.4 (1.6) -17.2 (-21.5, -12.9)
VYVANSE (70 mg/day)* 45.1(6.8) -26.7 (1.5) -20.5 (-24.8, -16.2)
Placebo 42.4 (7.1) -6.2 (1.6) --
Study 2
Average
(6 – 12 VYVANSE (30, 50 or 70 mg/day)* -- b 0.8 (0.1) d -0.9 (-1.1, -0.7)
SKAMP-DS
years)
Placebo -- b 1.7 (0.1) d --
Study 3 Average
VYVANSE (30, 50 or 70 mg/day)* 0.9 (1.0)c 0.7 (0.1)d -0.7 (-0.9, -0.6)
(6 – 12 SKAMP-DS
years) Placebo 0.7 (0.9)c 1.4 (0.1)d --
Study 4 ADHD-RS-
VYVANSE (30 mg/day)* 38.3 (6.7) -18.3 (1.2) -5.5 (-9.0, -2.0)
(13 – 17 IV
VYVANSE (70 mg/day)* 37.0 (7.3) -20.7 (1.3) -7.9 (-11.4, -4.5)
Placebo 38.5 (7.1) -12.8 (1.2) --
Study 5 ADHD-RS-
VYVANSE (30, 50 or 70 mg/day)* 40.7 (7.3) -24.3 (1.2) -18.6 (-21.5, -15.7)
(6 – 17 IV
years) Placebo 41.0 (7.1) -5.7 (1.1) --
Study 7 ADHD-RS-
VYVANSE (30 mg/day)* 40.5 (6.2) -16.2 (1.1) -8.0 (-11.5, -4.6)
(18 – 55 IV
VYVANSE (70 mg/day)* 41.0 (6.0) -18.6 (1.0) -10.4 (-13.9, -6.9)
Placebo 39.4 (6.4) -8.2 (1.4) --
Study 8 Average c d
VYVANSE (30, 50 or 70 mg/day)* 260.1 (86.2) 312.9 (8.6) 23.4 (15.6, 31.2)
(18 – 55 PERMP
c d
years) Placebo 261.4 (75.0) 289.5 (8.6) --
SD: standard deviation; SE: standard error; LS Mean: least-squares mean; CI: confidence interval.
a
Difference (drug minus placebo) in least-squares mean change from baseline.
b
Pre-dose SKAMP-DS was not collected.
c
Pre-dose SKAMP-DS (Study 3) or PERMP (Study 8) total score, averaged over both periods.
d
LS Mean for SKAMP-DS (Study 2 and 3) or PERMP (Study 8) is post-dose average score over all sessions of the treatment day, rather than
change from baseline.
* Doses statistically significantly superior to placebo.
Page 28 of 37
Figure 4 LS Mean SKAMP Deportment Subscale Score by Treatment and Time-
point for Pediatric Patients Ages 6 to 12 with ADHD after 1 Week of
Double Blind Treatment (Study 3)
Higher score on the SKAMP-Deportment scale indicates more severe symptoms
Page 29 of 37
Figure 5 Kaplan-Meier Estimated Proportion of Patients with Treatment Failure for
Pediatric Patients Ages 6 to 17 (Study 6)
Page 30 of 37
Figure 6 LS Mean (SE) PERMP Total Score by Treatment and Time-point for
Adults Ages 18 to 55 with ADHD after 1 Week of Double Blind Treatment
(Study 8)
Higher score on the PERMP scale indicates less severe symptoms.
Page 31 of 37
Figure 7 Kaplan-Meier Estimated Proportion of Subjects with Relapse in Adults with
ADHD (Study 9)
14.2 Binge Eating Disorder (BED)
A phase 2 study evaluated the efficacy of VYVANSE 30, 50 and 70 mg/day compared to
placebo in reducing the number of binge days/week in adults with at least moderate to severe
BED. This randomized, double-blind, parallel-group, placebo-controlled, forced-dose titration
study (Study 10) consisted of an 11-week double-blind treatment period (3 weeks of forced-dose
titration followed by 8 weeks of dose maintenance). VYVANSE 30 mg/day was not statistically
different from placebo on the primary endpoint. The 50 and 70 mg/day doses were statistically
superior to placebo on the primary endpoint.
The efficacy of VYVANSE in the treatment of BED was demonstrated in two 12-week
randomized, double-blind, multi-center, parallel-group, placebo-controlled, dose-optimization
studies (Study 11 and Study 12) in adults aged 18-55 years (Study 11: N=374, Study 12: N=350)
with moderate to severe BED. A diagnosis of BED was confirmed using DSM-IV criteria for
BED. Severity of BED was determined based on having at least 3 binge days per week for 2
weeks prior to the baseline visit and on having a Clinical Global Impression Severity (CGI-S)
score of ≥4 at the baseline visit. For both studies, a binge day was defined as a day with at least
1 binge episode, as determined from the subject’s daily binge diary.
Both 12-week studies consisted of a 4-week dose-optimization period and an 8-week dose-
maintenance period. During dose-optimization, subjects assigned to VYVANSE began treatment
Page 32 of 37
at the titration dose of 30 mg/day and, after 1 week of treatment, were subsequently titrated to 50
mg/day. Additional increases to 70 mg/day were made as tolerated and clinically indicated.
Following the dose-optimization period, subjects continued on their optimized dose for the
duration of the dose-maintenance period.
The primary efficacy outcome for the two studies was defined as the change from baseline at
Week 12 in the number of binge days per week. Baseline is defined as the weekly average of the
number of binge days per week for the 14 days prior to the baseline visit. Subjects from both
studies on VYVANSE had a statistically significantly greater reduction from baseline in mean
number of binge days per week at Week 12. In addition, subjects on VYVANSE showed greater
improvement as compared to placebo across key secondary outcomes with higher proportion of
subjects rated improved on the CGI-I rating scale, higher proportion of subjects with 4-week
binge cessation, and greater reduction in the Yale-Brown Obsessive Compulsive Scale Modified
for Binge Eating (Y-BOCS-BE) total score.
Table 7: Summary of Primary Efficacy Results in BED
Study
Treatment Group Primary Efficacy Measure: Binge Days per Week at Week 12
Number
LS Mean Change from Placebo-subtracted
Mean Baseline Score (SD)
Baseline (SE) Differencea (95% CI)
Study 11 VYVANSE (50 or 70 mg/day)* 4.79 (1.27) -3.87 (0.12) -1.35 (-1.70, -1.01)
Placebo 4.60 (1.21) -2.51 (0.13) --
Study 12 VYVANSE (50 or 70 mg/day)* 4.66 (1.27) -3.92 (0.14) -1.66 (-2.04, -1.28)
Placebo 4.82 (1.42) -2.26 (0.14) --
SD: standard deviation; SE: standard error; LS Mean: least-squares mean; CI: confidence interval.
a
Difference (drug minus placebo) in least-squares mean change from baseline.
* Doses statistically significantly superior to placebo.
A double-blind, placebo controlled, randomized withdrawal design study (Study 13) was
conducted to evaluate maintenance of efficacy based on time to relapse between VYVANSE and
placebo in adults aged 18 to 55 (N=267) with moderate to severe BED. In this longer-term study
patients who had responded to VYVANSE in the preceding 12-week open-label treatment phase
were randomized to continuation of VYVANSE or placebo for up to 26 weeks of observation for
relapse. Response in the open-label phase was defined as 1 or fewer binge days each week for
four consecutive weeks prior to the last visit at the end of the 12-week open-label phase and a
CGI-S score of 2 or less at the same visit. Relapse during the double-blind phase was defined as
having 2 or more binge days each week for two consecutive weeks (14 days) prior to any visit
and having an increase in CGI-S score of 2 or more points compared to the randomized-
withdrawal baseline. Maintenance of efficacy for patients who had an initial response during the
open-label period and then continued on VYVANSE during the 26-week double-blind
randomized-withdrawal phase was demonstrated with VYVANSE being superior over placebo
as measured by time to relapse.
Page 33 of 37
Figure 8 Kaplan-Meier Estimated Proportions of Subjects with Relapse in Adults with
BED (Study 13)
Examination of population subgroups based on age (there were no patients over 65), gender, and
race did not reveal any clear evidence of differential responsiveness in the treatment of BED.
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
VYVANSE (lisdexamfetamine dimesylate) capsules:
• VYVANSE capsules 10 mg: pink body/pink cap (imprinted with S489 and 10 mg),
bottles of 100, NDC 59417-101-10
• VYVANSE capsules 20 mg: ivory body/ivory cap (imprinted with S489 and 20 mg),
bottles of 100, NDC 59417-102-10
• VYVANSE capsules 30 mg: white body/orange cap (imprinted with S489 and 30 mg),
bottles of 100, NDC 59417-103-10
• VYVANSE capsules 40 mg: white body/blue green cap (imprinted with S489 and
40 mg), bottles of 100, NDC 59417-104-10
• VYVANSE capsules 50 mg: white body/blue cap (imprinted with S489 and 50 mg),
bottles of 100, NDC 59417-105-10
• VYVANSE capsules 60 mg: aqua blue body/aqua blue cap (imprinted with S489 and
60 mg), bottles of 100, NDC 59417-106-10
Page 34 of 37
• VYVANSE capsules 70 mg: blue body/orange cap (imprinted with S489 and 70 mg),
bottles of 100, NDC 59417-107-10
VYVANSE (lisdexamfetamine dimesylate) chewable tablets:
• VYVANSE chewable tablets 10 mg: White to off-white round shaped tablet debossed
with ‘10’ on one side and ‘S489’ on the other, bottles of 100, NDC 59417-115-01
• VYVANSE chewable tablets 20 mg: White to off-white hexagonal shaped tablet
debossed with ‘20’ on one side and ‘S489’ on the other, bottles of 100, NDC 59417-116-
01
• VYVANSE chewable tablets 30 mg: White to off-white arc triangular shaped tablet
01
• VYVANSE chewable tablets 40 mg: White to off-white capsule shaped tablet debossed
with ‘40’ on one side and ‘S489’ on the other, bottles of 100, NDC 59417-118-01
• VYVANSE chewable tablets 50 mg: White to off-white arc square shaped tablet
01
• VYVANSE chewable tablets 60 mg: White to off-white arc diamond shaped tablet
01
16.2 Storage and Handling
Dispense in a tight, light-resistant container as defined in the USP.
Store at room temperature, 20°C to 25°C (68°F to 77°F). Excursions permitted between 15°C
and 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Abuse, Misuse, and Addiction
Educate patients and their families about the risks of abuse, misuse, and addiction of
VYVANSE, which can lead to overdose and death, and proper disposal of any unused drug [see
Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2), Overdosage (10)]. Advise
patients to store VYVANSE in a safe place, preferably locked, and instruct patients to not give
VYVANSE to anyone else.
Risks to Patients with Serious Cardiac Disease

Advise patients that there are potential risks to patients with serious cardiac disease, including
sudden death, with VYVANSE use. Instruct patients to contact a healthcare provider
immediately if they develop symptoms such as exertional chest pain, unexplained syncope, or
other symptoms suggestive of cardiac disease [see Warnings and Precautions (5.2)].
Page 35 of 37
Increased Blood Pressure and Heart Rate
Instruct patients that VYVANSE can cause elevations of their blood pressure and pulse rate and
they should be monitored for such effects.
Psychiatric Adverse Reactions

Advise patients that VYVANSE at recommended doses may cause psychotic or manic symptoms
even in patients without prior history of psychotic symptoms or mania [see Warnings and
Precautions (5.4)].
Long-Term Suppression of Growth in Pediatric Patients

Advise patients that VYVANSE may cause slowing of growth including weight loss [see
Warnings and Precautions (5.5)].
Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud’s

phenomenon]
Instruct patients beginning treatment with VYVANSE about the risk of peripheral vasculopathy,
including Raynaud’s phenomenon, and associated signs and symptoms: fingers or toes may feel
numb, cool, painful, and/or may change from pale, to blue, to red. Instruct patients to report to
their physician any new numbness, pain, skin color change, or sensitivity to temperature in
fingers or toes. Instruct patients to call their physician immediately with any signs of
unexplained wounds appearing on fingers or toes while taking VYVANSE. Further clinical
evaluation (e.g., rheumatology referral) may be appropriate for certain patients [see Warnings
and Precautions (5.6)].
Serotonin Syndrome
Caution patients about the risk of serotonin syndrome with concomitant use of VYVANSE and
other serotonergic drugs including SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl,
lithium, tramadol, tryptophan, buspirone, St. John’s Wort, and with drugs that impair metabolism
of serotonin (in particular MAOIs, both those intended to treat psychiatric disorders and also
others such as linezolid [see Contraindications (4), Warnings and Precautions (5.7) and Drug
Interactions (7.1)]. Advise patients to contact their healthcare provider or report to the
emergency room if they experience signs or symptoms of serotonin syndrome.
Concomitant Medications
Advise patients to notify their physicians if they are taking, or plan to take, any prescription or
over-the-counter drugs because there is a potential for interactions [see Drug Interactions (7.1)].
Motor and Verbal Tics, and Worsening of Tourette’s Syndrome

Advise patients that motor and verbal tics and worsening of Tourette’s Syndrome may occur
during treatment with VYVANSE. Instruct patients to notify their healthcare provider if
emergence of new tics or worsening of tics or Tourette’s syndrome occurs [see Warnings and
Precautions (5.8)].
Pregnancy Registry
Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in
women exposed to VYVANSE during pregnancy [see Use in Specific Populations (8.1)].
Page 36 of 37
Pregnancy
Advise patients of the potential fetal effects from the use of VYVANSE during pregnancy.
Advise patients to notify their healthcare provider if they become pregnant or intend to become
pregnant during treatment with VYVANSE [see Use in Specific Populations (8.1)].
Lactation
Advise women not to breastfeed if they are taking VYVANSE [see Use in Specific Populations
(8.2)].
Administration Instructions
• Capsules: Advise patients to take the capsules whole or empty and mix the entire contents with
yogurt, water, or orange juice. Advise patients to consume the mixture immediately and not to
store for future use [see Dosage and Administration (2.2)].
• Chewable tablets: Advise patients that chewable tablets must be chewed thoroughly before
swallowing [see Dosage and Administration (2.2)].
Distributed by:
Takeda Pharmaceuticals America, Inc.
Lexington, MA 02421
Made in USA
For more information call 1-800-828-2088
VYVANSE® and the VYVANSE Logo® are registered trademarks of Takeda Pharmaceuticals
U.S.A., Inc.
©2023 Takeda Pharmaceuticals U.S.A., Inc. All rights reserved.
US Pat No. 7,105,486, 7,223,735, 7,655,630, 7,659,253, 7,659,254, 7,662,787, 7,662,788,

7,671,030, 7,671,031, 7,674,774, 7,678,770, 7,678,771, 7,687,466, 7,687,467, 7,713,936,
7,718,619, 7,723,305
Page 37 of 37
MEDICATION GUIDE
VYVANSE® (Vi’ – vans)
(lisdexamfetamine dimesylate)
Capsules and Chewable Tablets, CII
What is the most important information I should know about VYVANSE?
VYVANSE may cause serious side effects, including:
• Abuse, misuse, and addiction. VYVANSE has a high chance for abuse and misuse and may lead to
substance use problems, including addiction. Misuse and abuse of VYVANSE, other amphetamine
containing medicines, and methylphenidate containing medicines, can lead to overdose and death. The risk
of overdose and death is increased with higher doses of VYVANSE or when it is used in ways that are not
approved, such as snorting or injection.
• Your healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before
starting treatment with VYVANSE and will monitor you or your child during treatment.
• VYVANSE may lead to physical dependence after prolonged use, even if taken as directed by your
healthcare provider.
• Do not give VYVANSE to anyone else. See “What is VYVANSE?” for more information.
• Keep VYVANSE in a safe place and properly dispose of any unused medicine. See "How should I store
VYVANSE?" for more information.
• Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol,
prescription medicines, or street drugs.
• Risks for people with serious heart disease. Sudden death has happened in people who have heart defects or
other serious heart disease.
Your healthcare provider should check you or your child carefully for heart problems before starting treatment
with VYVANSE. Tell your healthcare provider if you or your child have any heart problems, heart disease, or
heart defects.
Call your healthcare provider right away or go to the nearest hospital emergency room right away if you
or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting during
treatment with VYVANSE.
• Increased blood pressure and heart rate.
Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment
with VYVANSE.
• Mental (psychiatric) problems, including:
• new or worse behavior and thought problems
• new or worse bipolar illness
• new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new
manic symptoms
Tell your healthcare provider about any mental problems you or your child have or about a family history of
suicide, bipolar illness, or depression.
Call your healthcare provider right away if you or your child have any new or worsening mental
symptoms or problems during treatment with VYVANSE, especially hearing voices, seeing or believing
things that are not real, or new manic symptoms.
What is VYVANSE?
VYVANSE is a central nervous system (CNS) stimulant prescription medicine used for the treatment of:
• Attention Deficit Hyperactivity Disorder (ADHD) in adults and children 6 years of age and older. VYVANSE may
help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.
• Moderate to severe binge eating disorder (BED) in adults. VYVANSE may help reduce the number of binge
eating days in people with BED.
VYVANSE is not for use in children under 6 years of age with ADHD.
VYVANSE is not for weight loss. It is not known if VYVANSE is safe and effective for the treatment of obesity.
Page 1 of 4
It is not known if VYVANSE is safe and effective for use in children with BED.
VYVANSE is a federally controlled substance (CII) because it contains lisdexamfetamine dimesylate that can
be a target for people who abuse prescription medicines or street drugs. Keep VYVANSE in a safe place to
protect it from theft. Never give your VYVANSE to anyone else because it may cause death or harm them. Selling or
giving away VYVANSE may harm others and is against the law.
Do not take VYVANSE if you or your child are:
• allergic to amphetamine products or any of the ingredients in VYVANSE. See the end of this Medication Guide for
a complete list of ingredients in VYVANSE.
• taking, or have stopped taking in the last 14 days, a medicine called a Monoamine Oxidase Inhibitor (MAOI).
• being treated with the antibiotic linezolid or intravenous methylene blue.
Before taking VYVANSE, tell your healthcare provider about all medical conditions, including if you or your
child:
• have heart problems, heart disease, heart defects, or high blood pressure
• have mental problems including psychosis, mania, bipolar illness, or depression or have a family history of
suicide, bipolar illness, or depression
• have circulation problems in fingers and toes
• have kidney problems
• have or had repeated movements or sounds (tics) or Tourette’s syndrome, or have a family history of tics or
Tourette’s syndrome
• are pregnant or plan to become pregnant. VYVANSE may harm the unborn baby.
o There is a pregnancy registry for females who are exposed to VYVANSE during pregnancy. The purpose of
the registry is to collect information about the health of females exposed to VYVANSE and their baby. If you
or your child becomes pregnant during treatment with VYVANSE, talk to your healthcare provider about
registering with the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visit online at
https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/adhd-medications/.
• are breastfeeding or plan to breastfeed. VYVANSE passes into breast milk. You should not breastfeed during
treatment with VYVANSE. Talk to your healthcare provider about the best way to feed the baby during treatment
with VYVANSE.
Tell your healthcare provider about all the medicines that you or your child take, including prescription and
over-the-counter medicines, vitamins, and herbal supplements.
VYVANSE can affect the way other medicines work and other medicines may affect how VYVANSE works. Taking
VYVANSE with other medicines can cause serious side effects. Sometimes the doses of other medicines will need to
be changed while taking VYVANSE.
Especially tell your healthcare provider if you or your child take:
• selective serotonin reuptake inhibitors (SSRIs) • serotonin norepinephrine reuptake inhibitors (SNRIs)
• medicines used to treat migraine headaches called • tricyclic antidepressants
triptans
• lithium • fentanyl
• tramadol • tryptophan
• buspirone • St. John’s Wort
Keep a list of all medicines to show your healthcare provider and pharmacist when you get a new medicine. Your
healthcare provider will decide if VYVANSE can be taken with other medicines.
Do not start any new medicine during treatment with VYVANSE without talking to your healthcare provider
first.
How should VYVANSE be taken?
• Take VYVANSE exactly as prescribed by your healthcare provider.
Page 2 of 4
• Your healthcare provider may change the dose if needed.
• Take VYVANSE 1 time each day in the morning with or without food.
• VYVANSE comes in capsules or chewable tablets.
Taking VYVANSE Capsules:
• VYVANSE capsules may be swallowed whole.
• If VYVANSE capsules cannot be swallowed whole, the capsule may be opened and the entire contents
sprinkled onto yogurt, or poured into water or orange juice.
o Using a spoon, break apart any powder that is stuck together. Stir the VYVANSE powder and yogurt,
water, or orange juice until they are completely mixed together.
o Swallow all the yogurt, water, or orange juice mixture right away. Do not store the yogurt, water, or
orange juice mixture.
o It is normal to see a filmy coating on the inside of your glass or container after you eat or drink all the
VYVANSE mixture.
Taking VYVANSE Chewable Tablets:
• Chew VYVANSE tablets completely before swallowing.
If you or your child take too much VYVANSE, call your healthcare provider or Poison Help line at 1-800-222-1222 or
go to the nearest hospital emergency room right away.
What are the possible side effects of VYVANSE?

VYVANSE may cause serious side effects, including:
• See “What is the most important information I should know about VYVANSE?”
• Slowing of growth (height and weight) in children. Children should have their height and weight checked often
during treatment with VYVANSE. VYVANSE treatment may be stopped if your child is not growing or gaining
weight.
• Circulation problems in fingers and toes (Peripheral vasculopathy, including Raynaud’s phenomenon).
Signs and symptoms may include:
o Fingers or toes may feel numb, cool, painful
o Fingers or toes may change color from pale, to blue, to red
Tell your healthcare provider if you or your child have numbness, pain, skin color change, or sensitivity to
temperature in your fingers or toes.
Call your healthcare provider right away if you or your child have any signs of unexplained wounds appearing on
fingers or toes during treatment with VYVANSE.
• New or worsening tics or worsening Tourette’s syndrome. Tell your healthcare provider if you or your child
get any new or worsening tics or worsening Tourette’s syndrome during treatment with VYVANSE.
• Serotonin Syndrome. A potentially life-threatening problem called serotonin syndrome may happen when
VYVANSE is taken with certain other medicines. Stop taking VYVANSE and call your healthcare provider or go to
the nearest hospital emergency room right away if you or your child develop any of the following signs and
symptoms of serotonin syndrome:
o agitation o fast heartbeat
o flushing o seizures
o coma o sweating
o loss of coordination o confusion
o dizziness o tremors, stiff muscles, or muscle twitching
o seeing or hearing things that are not real (hallucination) o changes in blood pressure
o high body temperature (hyperthermia) o nausea, vomiting, diarrhea
Page 3 of 4
The most common side effects of VYVANSE in children 6 to 17 years old and adults with ADHD include:
• loss of appetite (anorexia) • anxiety
• decreased appetite • weight loss
• diarrhea • dizziness
• dry mouth • irritability
• trouble sleeping • nausea
• stomach pain • vomiting
The most common side effects of VYVANSE in adults with BED include:
• dry mouth • trouble sleeping
• decreased appetite • increased heart rate
• constipation • feeling jittery
• anxiety
These are not all the possible side effects of VYVANSE.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store VYVANSE?
• Store VYVANSE in a safe place (like a locked cabinet) and in a tightly closed container at room temperature
between 68°F to 77°F (20°C to 25°C).
• Protect VYVANSE from light.
• Dispose of remaining, unused, or expired VYVANSE by a medicine take-back program at a U.S. Drug
Enforcement Administration (DEA) authorized collection site. If no take-back program or DEA authorized collector
is available, mix VYVANSE with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee
grounds to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic
bag and throw away VYVANSE in the household trash. Visit www.fda.gov/drugdisposal for additional information
on disposal of unused medicines.
Keep VYVANSE and all medicines out of the reach of children.
General information about the safe and effective use of VYVANSE.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use
VYVANSE for a condition for which it was not prescribed. Do not give VYVANSE to other people, even if they have
the same symptoms that you have. It may harm them and it is against the law. You can ask your pharmacist or
healthcare provider for information about VYVANSE that is written for healthcare professionals.
What are the ingredients in VYVANSE?
Active ingredient: lisdexamfetamine dimesylate
Capsule Inactive ingredients: microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The
capsule shells (imprinted with S489) contain gelatin, titanium dioxide, and one or more of the following: FD&C Red
#3, FD&C Yellow #6, FD&C Blue #1, Black Iron Oxide, and Yellow Iron Oxide.
Chewable Tablet Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, guar gum, magnesium
stearate, mannitol, microcrystalline cellulose, sucralose, artificial strawberry flavor.
Distributed by: Takeda Pharmaceuticals America, Inc., Lexington, MA 02421. VYVANSE® and the VYVANSE Logo® are registered trademarks of Takeda
Pharmaceuticals U.S.A., Inc. © 2023 Takeda Pharmaceuticals U.S.A., Inc. All rights reserved.
For more information, go to www.vyvanse.com or call 1-800-828-2088.
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 10/2023
FPI-0322
Page 4 of 4

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HIGHLIGHTS OF PRESCRIBING INFORMATION -------------------------------CONTRAINDICATIONS------------------------------

Limitations of Use: ------------------------------ADVERSE REACTIONS-------------------------------

WARNING: ABUSE, MISUSE, AND ADDICTION

1 INDICATIONS AND USAGE

VYVANSE® is indicated for the treatment of:

2 DOSAGE AND ADMINISTRATION

2.1 Pretreatment Screening

Prior to treating patients with VYVANSE, assess:

Information for VYVANSE capsules:

• Swallow VYVANSE capsules whole, or

Information for VYVANSE chewable tablets:

• VYVANSE chewable tablets must be chewed thoroughly before swallowing.

2.3 Dosage for Treatment of ADHD

2.4 Dosage for Treatment of Moderate to Severe BED in Adults

The recommended starting dosage in adults is 30 mg once daily to be titrated in increments of 20

2.5 Dosage in Patients with Renal Impairment

3 DOSAGE FORMS AND STRENGTHS

VYVANSE (lisdexamfetamine dimesylate) capsules:

VYVANSE (lisdexamfetamine dimesylate) chewable tablets:

VYVANSE is contraindicated in patients with:

• Known hypersensitivity to amphetamine products or other ingredients of VYVANSE.

5.1 Abuse, Misuse, and Addiction

5.2 Risks to Patients with Serious Cardiac Disease

5.3 Increased Blood Pressure and Heart Rate

Monitor all VYVANSE-treated patients for potential tachycardia and hypertension.

5.4 Psychiatric Adverse Reactions

Exacerbation of Pre-existing Psychosis

Induction of a Manic Episode in Patients with Bipolar Disorder

New Psychotic or Manic Symptoms

5.5 Long-Term Suppression of Growth in Pediatric Patients

In a 4-week, placebo-controlled trial of VYVANSE in pediatric patients ages 6 to 12 years old

5.6 Peripheral Vasculopathy, including Raynaud’s Phenomenon

5.7 Serotonin Syndrome

Concomitant use of VYVANSE with MAOI drugs is contraindicated [see Contraindications

5.8 Motor and Verbal Tics, and Worsening of Tourette’s Syndrome

• Known hypersensitivity to amphetamine products or other ingredients of VYVANSE

Attention Deficit Hyperactivity Disorder

Adverse Reactions Associated with Discontinuation of Treatment in ADHD Clinical Trials

Adverse Reactions Occurring at an Incidence of ≥5% or More Among VYVANSE Treated

Adverse Reactions Occurring at an Incidence of 2% or More Among VYVANSE Treated Patients

Table 1 Adverse Reactions Reported by 2% or More of Pediatric Patients Ages 6 to

Table 2 Adverse Reactions Reported by 2% or More of Pediatric Patients Ages 13 to

Weight Loss in Adults with ADHD

Binge Eating Disorder

Adverse Reactions Associated with Discontinuation of Treatment in BED Clinical Trials

6.2 Postmarketing Experience

7.1 Drugs Having Clinically Important Interactions with Amphetamines

MAO Inhibitors (MAOI)

From a pharmacokinetic perspective, no dose adjustment of VYVANSE is necessary when

8 USE IN SPECIFIC POPULATIONS

Pregnancy Exposure Registry

Safety and efficacy of VYVANSE were evaluated in a double-blind, randomized, parallel-group,

Juvenile Animal Data

8.5 Geriatric Use

8.6 Renal Impairment

Lisdexamfetamine and d-amphetamine are not dialyzable.

9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

VYVANSE contains lisdexamfetamine, a prodrug of amphetamine, a Schedule II controlled