Looking for birth

control that helps

with heavy periods?
Get to know Mirena® — the only IUD that is
FDA-approved to treat heavy menstrual
bleeding (HMB) for up to 5 years in women
who choose an IUD for birth control.

Mirena® is a hormone-releasing IUD (intrauterine device)

that prevents pregnancy for up to 7 years. Mirena also
treats heavy periods for up to 5 years in women who choose
intrauterine contraception.
2 For more information, visit Mirena.com.
 Effective birth control that
helps with heavy periods
Choosing birth control is personal, and for women who
want to prevent pregnancy and get help with heavy
periods, it’s important to know there are options that can
do both. If you’re considering an IUD but also struggle with
heavy periods, get to know Mirena®:

• 
Over 99% effective at preventing pregnancy for up to
7 years
• The first and only hormone-releasing IUD that is
FDA approved to treat heavy periods, also known as
heavy menstrual bleeding (HMB) for up to 5 years, in
women who choose an IUD for birth control
• Can be used whether or not you’ve had a baby
• Can be removed by your healthcare professional any time
in case your plans change

DID YOU KNOW?

Mirena is the #1 prescribed IUD in the U.S.*

IMPORTANT SAFETY INFORMATION

• If you have an untreated genital infection, get infections
easily, or have certain cancers, don’t use Mirena. Less
than 1% of users get a serious pelvic infection called
pelvic inflammatory disease (PID).
• If you have persistent pelvic or stomach pain, or
excessive bleeding after placement, tell your healthcare
professional (HCP). If Mirena comes out, call your HCP
and avoid intercourse or use non-hormonal back-up birth
control (such as condoms or spermicide). Mirena may
go into or through the wall of the uterus and cause other
problems.

*Supported by 2017–2019 SHS data.

For additional Important Safety

Information, please see throughout
brochure. Please see Important
Facts on pages 20–23 and the full
Prescribing Information here. 3
 A closer look at Mirena
• Small and T-shaped
• Made of soft, flexible plastic
• Placed in your uterus by a healthcare professional who
can remove it at any time

IMPORTANT SAFETY INFORMATION

• Pregnancy while using Mirena® is uncommon but can be
life threatening and may result in loss of pregnancy or
fertility.
• Ovarian cysts may occur but usually disappear.

DID YOU KNOW?

Mirena is 1.26” — about the same height as a

set of stacked dice.

Actual size

For additional Important Safety

Information, please see throughout
brochure. Please see Important
Facts on pages 20–23 and the full
Prescribing Information here.
4 For more information, visit Mirena.com.
 More
Effective:
Greater Than 99%

Implants IUDs Injections Sterilization

The Pill Patch Vaginal Ring

Condoms Diaphragm

Spermicides Withdrawal

Less Effective:
Approx. 70%

DID YOU KNOW?

IUDs are considered one of the most effective

forms of birth control by the American College
of Obstetricians and Gynecologists (ACOG).

IMPORTANT SAFETY INFORMATION

• Bleeding and spotting may increase in the first 3 to 6

months and remain irregular. Periods over time usually
become shorter, lighter, or may stop.
Mirena® does not protect against HIV or STIs.
Only you and your HCP can decide if Mirena is right for
you. Mirena is available by prescription only.
You are encouraged to report negative side effects of
prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088. 5
 Mirena works in
the uterus
• Mirena® is placed in the uterus by a healthcare
professional
• It works by giving you a continuous dose of a hormone
called progestin
• Because Mirena releases hormones locally in the
uterus at a slow rate, only small amounts enter the
bloodstream

Ovary

Common side effects include:

• Pain, bleeding or dizziness during and after

placement. If these symptoms do not stop 30 minutes
after placement, Mirena may not have been placed
correctly. Your healthcare professional will examine you to
see if Mirena needs to be removed or replaced.

6 For more information, visit Mirena.com.

How does Mirena
prevent pregnancy?
Mirena® prevents pregnancy most likely by:
• Thickening the mucus in the cervix, preventing sperm
from entering the uterus
• Inhibiting sperm from reaching and fertilizing the egg
• Thinning the uterine lining

It is not known exactly how these actions work together

to prevent pregnancy.

Fallopian tube

Ovary
Ovary
Inhibits sperm
Thins uterine from reaching/
lining fertilizing egg

Mirena

Thickens cervical mucus to prevent

sperm from entering uterus

Cervix

Soft threads

Vagina

Common side effects include:

• Changes in bleeding. You may have bleeding and

spotting between menstrual periods, especially during the
first 3 to 6 months. Sometimes the bleeding is heavier
than usual at first. However, the bleeding usually becomes
lighter than usual and may be irregular. Call your healthcare
professional if the bleeding remains heavier than usual or
increases after it has been light for a while.

For additional Important Safety

Information, please see throughout
brochure. Please see Important
Facts on pages 20–23 and the full
Prescribing Information here. 7
 What is Heavy Menstrual
Bleeding (HMB)?
Heavy menstrual bleeding, also known as HMB, is
excessive menstrual blood loss (≥ 80 mL, or about 6
tablespoons) during a single cycle. You may have HMB if
you:

• Need to double up on pads to control your menstrual

flow
• Have menstrual periods lasting more than 7 days
• Need to change pads or tampons during the night

If you have any of these symptoms, talk to your healthcare

professional.

8 For more information, visit Mirena.com.

With Mirena, your heavy
periods may change
Mirena® rapidly reduces heavy periods. In a clinical trial
of Mirena in women with heavy periods, the majority
experienced:

80%
reduction
> 90%
reduction
in bleeding in bleeding

after 3 months after 6 months

Mirena may also affect heavy periods

in other ways
The number of spotting and bleeding days may initially
increase but then typically decrease in the months that
follow. Bleeding may also continue to be irregular.

Call your healthcare professional if bleeding remains heavier

than usual or you do not have a period for 6 weeks during
Mirena use.

Other common side effects include:

• Missed menstrual periods. About 2 out of 10 women

stop having periods after 1 year of Mirena use. If you
have any concerns that you may be pregnant while using
Mirena, do a urine pregnancy test and call your healthcare
professional. If you do not have a period for 6 weeks
during Mirena use, call your healthcare professional.
When Mirena is removed, your menstrual periods
should return.

For additional Important Safety

Information, please see throughout
brochure. Please see Important
Facts on pages 20–23 and the full
Prescribing Information here. 9
 What to expect when
getting Mirena
• Mirena® is inserted in the uterus by your healthcare
professional
• Mirena is a non-surgical procedure and can be placed
during an in-office visit or immediately after giving birth
• After 4–6 weeks, you should return for a follow-up visit
• After placement, your healthcare professional will show
you how to perform a monthly thread check to ensure
Mirena is still in your uterus
• If you can’t locate the threads, contact your healthcare
professional. Your IUD may not be in the right position
and may not prevent pregnancy. Avoid intercourse or use
non-hormonal back-up birth control (such as condoms
or spermicide) and ask your healthcare professional to
check that Mirena is still in the right place.

DID YOU KNOW?

Mirena is reversible any time in case your plans

change. Once your healthcare professional
removes Mirena, you can try to get pregnant
right away.

Other common side effects include:

• Cysts on the ovary. Some women using Mirena develop

a painful cyst on the ovary. These cysts usually disappear
on their own in 2 to 3 months. However, cysts can cause
pain and sometimes cysts will need surgery.

For additional Important Safety

Information, please see throughout
brochure. Please see Important
Facts on pages 20–23 and the full
Prescribing Information here.
10 For more information, visit Mirena.com.
What to expect during
placement
• Common side effects experienced by women are pain,
bleeding, or dizziness during or after placement
• If your symptoms do not pass within 30 minutes after
placement, Mirena may not have been placed correctly
• Your healthcare professional will examine you to see if
Mirena needs to be removed or replaced

If pain is a concern for you, ask your healthcare

professional about taking over-the-counter pain medication
before the procedure to help minimize any discomfort.

Other common side effects include:

• abdominal or pelvic pain

• inflammation or infection of the outer part of your vagina
(vulvovaginitis)
• headache or migraine
• vaginal discharge
These are not all of the possible side effects with Mirena.
For more information, ask your healthcare professional.
11
 How Mirena may affect
your period
For the first 3 to 6 months, your period may

3– 6
become irregular and the number of bleeding
days may increase. You may also have frequent
months
spotting or light bleeding, and some women
have heavy bleeding during this time. You may
also have cramping during the first few weeks.
Call your healthcare professional (HCP) if the
bleeding remains heavier than usual or increases
after it has been light for a while.

After you have used Mirena for a while, the

number of bleeding and spotting days is likely
to lessen. For some women, periods will stop
altogether. When Mirena is removed, your
menstrual periods should return. This is because
the hormone in Mirena reduces the monthly
thickening of your uterine lining.

By the end of year one, about 20% of users

1
year
have no period at all. If you have any concerns
that you may be pregnant while using Mirena, do
a urine pregnancy test and call your HCP. If you
do not have a period for 6 weeks during Mirena
use, call your HCP. Your periods will return once
Mirena is removed.

In some women with heavy bleeding, the total blood loss

per cycle progressively decreases with continued use. The
number of spotting and bleeding days may initially increase
but then typically decreases in the months that follow.

Some serious risk considerations about Mirena

• Call your healthcare professional right away if you

think you may be pregnant. If possible, also do a urine
pregnancy test. If you get pregnant while using Mirena,
you may have an ectopic pregnancy. This means that the
pregnancy is not in the uterus. Unusual vaginal bleeding
or abdominal pain, especially with missed periods, may
be a sign of ectopic pregnancy.
• Ectopic pregnancy is a medical emergency that often
requires surgery. Ectopic pregnancy can cause internal
bleeding, infertility, and even death.
12
 DID YOU KNOW?

You can still use tampons or menstrual cups

while using Mirena®.

Because Mirena is in your uterus, not your vagina:

• You and your partner should not feel Mirena during sex
• Sometimes your partner may feel the threads; if this
occurs or if you or your partner experiences pain during
sex, talk with your healthcare professional

Some serious risk considerations about Mirena

• There are also risks if you get pregnant while using

Mirena and the pregnancy is in the uterus. Severe
infection, miscarriage, premature delivery, and even
death can occur with pregnancies that continue with an
intrauterine device (IUD). Because of this, your healthcare
professional may try to remove Mirena, even though
removing it may cause a miscarriage. If Mirena cannot
be removed, talk with your healthcare professional about
the benefits and risks of continuing the pregnancy and
possible effects of the hormone on your unborn baby.
• If you continue your pregnancy, see your healthcare
professional regularly. Call your healthcare professional
right away if you get flu-like symptoms, fever, chills,
cramping, pain, bleeding, vaginal discharge, or fluid
leaking from your vagina. These may be signs of
infection.

For additional Important Safety

Information, please see throughout
brochure. Please see Important
Facts on pages 20–23 and the full
Prescribing Information here.
For more information, visit Mirena.com. 13
 Check if Mirena is covered
by your insurance
1. Call the number on the back of your insurance card and
tell them that Mirena® is a healthcare professional-
administered method of birth control.
2. Ask them to check if Mirena is covered at no cost.
3. Provide them with the J code for Mirena:
J7298; and the Current Procedural Terminology
(CPT) code for Mirena placement: 58300.
4. Ask if you will have any out-of-pocket costs if Mirena is
only partially covered under your plan.

If you need help understanding your insurance coverage,

visit CoverHer.org.

DID YOU KNOW?

You may be able to get Mirena with no

out-of-pocket cost. Call your insurance company.

Other serious risk considerations about Mirena

• Ectopic pregnancy and intrauterine pregnancy risks.

There are risks if you become pregnant while using
Mirena (see “What if I become pregnant while using
Mirena?”) on page 21.
• Life-threatening infection. Life-threatening infection can
occur within the first few days after Mirena is placed. Call
your healthcare professional immediately if you develop
severe pain or fever shortly after Mirena is placed.
• Pelvic inflammatory disease (PID). Some IUD users
get a serious pelvic infection called pelvic inflammatory
disease. PID is usually sexually transmitted. You have a
higher chance of getting PID if you or your partner has
sex with other partners. PID can cause serious problems
such as infertility, ectopic pregnancy or pelvic pain that
does not go away. PID is usually treated with antibiotics.
More serious cases of PID may require surgery including
removal of the uterus (hysterectomy). In rare cases,
infections that start as PID can even cause death.
Tell your healthcare professional right away if you have
any of these signs of PID: long-lasting or heavy bleeding,
unusual vaginal discharge, low abdominal (stomach area)
pain, painful sex, chills, fever, genital lesions or sores.

14
No insurance? Bayer may
be able to help
The Bayer US Patient Assistance Foundation is a charitable
organization that helps eligible patients get Bayer
prescription medicine at no cost.

Please contact the program at 1-866-2BUSPAF (228-7723)

Monday–Friday, 8:30 am–5:00 pm ET, or visit the foundation
website at patientassistance.bayer.us for information.
Apply online and see if you may qualify for assistance.

LEARN MORE

at Mirena.com or call 1-866-647-3646

Other serious risk considerations about Mirena

• Perforation. Mirena may go into the wall of the uterus

(become embedded) or go through the wall of the uterus.
This is called perforation. If this occurs, Mirena may no
longer prevent pregnancy. If perforation occurs, Mirena
may move outside the uterus and can cause internal
scarring, infection, or damage to other organs and you
may need surgery to have Mirena removed. Excessive
pain or vaginal bleeding during placement of Mirena, pain
or bleeding that gets worse after placement, or not being
able to feel the threads may happen with perforation. The
risk of perforation is increased if Mirena is inserted while
you are breastfeeding, or if you have recently given birth.
• Expulsion. Mirena may come out by itself. This is called
expulsion. Expulsion occurs in about 4 out of 100 women.
Excessive pain or vaginal bleeding during placement of
Mirena, pain or bleeding that gets worse after placement,
or not being able to feel the threads may happen with
expulsion. You may become pregnant if Mirena comes
out. If you think that Mirena has come out, avoid
intercourse or use a non-hormonal back-up birth control
(such as condoms or spermicide) and call your healthcare
professional. The risk of expulsion is increased with
insertion right after delivery or second-trimester abortion.

For additional Important Safety

Information, please see throughout
brochure. Please see Important
Facts on pages 20–23 and the full
Prescribing Information here.
For more information, visit Mirena.com. 15
 If you’re a new mom considering Mirena®:

• You may use Mirena when you are breastfeeding.

• Mirena is not likely to affect the quality or amount of your
breast milk or the health of your nursing baby.
• However, isolated cases of decreased milk production
have been reported.

Also consider this:

• The risk of Mirena going into the wall of the uterus

(become embedded) or going through the wall of the
uterus (called perforation) is increased when Mirena is
placed in breastfeeding women.

Mirena is not right for everyone. Do not use Mirena

if you:

• a re or might be pregnant; Mirena cannot be used as an

emergency contraceptive
• have a serious pelvic infection called pelvic
inflammatory disease (PID) or have had PID in the past
unless you have had a normal pregnancy after the
infection went away
• have an untreated genital infection now
For additional Important Safety
Information, please see throughout
brochure. Please see Important
Facts on pages 20–23 and the full
Prescribing Information here.
16 For more information, visit Mirena.com.
 Is Mirena right for me?
I’m looking for birth control that:

Is highly effective

Helps alleviate my heavy periods

Is reversible if my plans for my family change

I can use while breastfeeding

Is helpful in planning the time in between my

pregnancies

Only you and your healthcare professional can decide

if Mirena is right for you. If you checked any of the
boxes above, ask your healthcare professional about
Mirena today.

Mirena is not right for everyone. Do not use Mirena

if you:

• have had a serious pelvic infection in the past 3 months

after a pregnancy
• can get infections easily. For example, if you:
- have multiple sexual partners or your partner has
multiple sexual partners
- have problems with your immune system
- use or abuse intravenous drugs
• have or suspect you might have cancer of the uterus or
cervix
• have bleeding from the vagina that has not been
explained
• have liver disease or a liver tumor
• have breast cancer or any other cancer that is sensitive to
progestin (a female hormone), now or in the past
• have an intrauterine device in your uterus already
• have a condition of the uterus that changes the shape of
the uterine cavity, such as large fibroid tumors
• are allergic to levonorgestrel, silicone, polyethylene, silica,
barium sulfate, or iron oxide

You are encouraged to report negative side effects of

prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
17
 Looking for birth control,
but don’t have HMB?
Meet Kyleena® (levonorgestrel-releasing intrauterine
system) 19.5 mg — the smallest, lowest-hormone
5-year IUD approved to prevent pregnancy:

• Over 99% effective at preventing pregnancy for each

year of use, and 98.6% effective over 5 years
• The lowest hormone-dose available in a 5-year IUD
• Can be used whether or not you’ve had a baby
• Can be removed by your healthcare professional
any time in case your plans change

Kyleena and Mirena® Important Safety Information

• If you have an untreated genital infection, get infections
easily, or have certain cancers, don’t use Kyleena or
Mirena. Less than 1% of users get a serious pelvic
infection called pelvic inflammatory disease (PID).

Please see Important Safety Information throughout brochure.

Please see Important Facts on pages 20–23 and the full
Prescribing Information here.
18 For more information, visit Kyleena.com.
Which IUD birth control is
right for me?

I want an IUD that I want a 5-year IUD

will also help with my with the lowest dose
heavy periods of hormones

Ask your HCP about Ask your HCP about

Mirena® (levonorgestrel- Kyleena® (levonorgestrel-
releasing intrauterine releasing intrauterine
system) 52 mg, a hormone- system) 19.5 mg, a
releasing IUD that prevents hormone-releasing IUD
pregnancy for up to 7 years. that prevents pregnancy
Mirena also treats heavy for up to 5 years.
periods for up to 5 years
in women who choose
intrauterine contraception.

Kyleena and Mirena Important Safety Information

• If you have persistent pelvic or stomach pain, or
excessive bleeding after placement, tell your healthcare
professional (HCP). If Kyleena or Mirena comes out, call
your HCP and avoid intercourse or use non-hormonal
back-up birth control (such as condoms or spermicide).
Kyleena or Mirena may go into or through the wall of the
uterus and cause other problems.
• Pregnancy while using Kyleena or Mirena is uncommon
but can be life threatening and may result in loss of
pregnancy or fertility.
• Ovarian cysts may occur but usually disappear.
• Bleeding and spotting may increase in the first 3 to 6
months and remain irregular. Periods over time usually
become shorter, lighter, or may stop.

Kyleena or Mirena do not protect against HIV or STIs.

Only you and your HCP can decide if Kyleena or Mirena

is right for you. Kyleena and Mirena are available by
prescription only. You are encouraged to report negative
side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
19
IMPORTANT FACTS ABOUT MIRENA® (LEVONORGESTREL-
RELEASING INTRAUTERINE SYSTEM) 52 MG AND KYLEENA®
(LEVONORGESTREL-RELEASING INTRAUTERINE SYSTEM) 19.5 MG
Mirena and Kyleena do not protect against HIV infection (AIDS)
and other sexually transmitted infections (STIs).
This information does not take the place of talking with your gynecologist
or other healthcare professional (HCP) who specializes in women’s health.
If you have any questions about Mirena or Kyleena, ask your HCP.
INDICATIONS FOR MIRENA
Mirena is a hormone-releasing IUD that prevents pregnancy for up to 7
years. Mirena also treats heavy periods for up to 5 years in women who
choose intrauterine contraception.
INDICATION FOR KYLEENA
Kyleena is a hormone-releasing intrauterine device (IUD) that prevents
pregnancy for up to 5 years.
Who might use Mirena or Kyleena?
You might choose Mirena or Kyleena if you:
• want long-term birth control that provides a low chance of getting
pregnant (less than 1 in 100)
• want birth control that works continuously for up 7 years for Mirena,
or 5 years for Kyleena
• want birth control that is reversible
• want a birth control method that you do not need to take daily
• are willing to use a birth control method that is placed in the uterus
• want birth control that does not contain estrogen
Do not use Mirena or Kyleena if you:
• are or might be pregnant; Mirena or Kyleena cannot be used as an
emergency contraceptive
• have a serious pelvic infection called pelvic inflammatory disease (PID) or
have had PID in the past unless you have had a normal pregnancy after the
infection went away
• have an untreated genital infection now
• have had a serious pelvic infection in the past 3 months after a
pregnancy
• can get infections easily. For example, if you:
- or your partner has multiple sexual partners
- have problems with your immune system
- use or abuse intravenous drugs
• have or suspect you might have cancer of the uterus or cervix
• have bleeding from the vagina that has not been explained
• have liver disease or a liver tumor
• have breast cancer or any other cancer that is sensitive to progestin (a
female hormone), now or in the past
• have an intrauterine device in your uterus already
• have a condition of the uterus that changes the shape of the uterine
cavity, such as large fibroid tumors
• are allergic to these ingredients:
- do not use Mirena if you’re allergic to levonorgestrel, silicone,
polyethylene, silica, barium sulfate, or iron oxide
- do not use Kyleena if you’re allergic to levonorgestrel, silicone,
polyethylene, silver, silica, barium sulfate, polypropylene, or copper
phthalocyanine
Before having Mirena or Kyleena placed, tell your HCP about all
of your medical conditions including if you:
• have any of the conditions • have had a heart attack
listed above • have had a stroke

20
• were born with heart disease • recently had a baby or are
or have problems with your breastfeeding
heart valves • have severe headaches or
• have problems with blood migraine headaches
clotting or take medicine to • have AIDS, HIV, or any other
reduce clotting sexually transmitted infection
• have high blood pressure
Tell your HCP about all of the medicines you take, including prescription
and over-the-counter medicines, vitamins, and herbal supplements.
Should I check that Mirena or Kyleena is in place?
Yes, you should check that Mirena or Kyleena is in proper position by
feeling the removal threads. It is a good habit to do this 1 time a month.
If you feel more than just the threads or if you cannot feel the threads, be
sure to call your HCP and avoid intercourse or use non-hormonal back-up
birth control, as Mirena or Kyleena may not be in the right position and
may not prevent pregnancy.
How soon after placement should I return to my HCP?
Call your HCP if you have questions or concerns (see “After placement, when
should I call my HCP?”). Otherwise, return for a follow-up 4-6 weeks after
placement to make sure Mirena or Kyleena is in the right position.
Can I use tampons or menstrual cups with Mirena or Kyleena?
Yes, tampons or menstrual cups may be used with Mirena or Kyleena.
Change tampons or menstrual cups with care to avoid pulling the threads of
Mirena or Kyleena. If you think you may have pulled Mirena or Kyleena out of
place, avoid intercourse or use a non-hormonal back-up birth control (such as
condoms or spermicide), and contact your healthcare professional.
What if I become pregnant while using Mirena or Kyleena?
Call your HCP right away if you think you may be pregnant. If possible,
also do a urine pregnancy test. If you get pregnant while using Mirena
or Kyleena, you may have an ectopic pregnancy. This means that the
pregnancy is not in the uterus. Unusual vaginal bleeding or abdominal
pain, especially with missed periods may be a sign of ectopic pregnancy.
Ectopic pregnancy is a medical emergency that often requires surgery.
Ectopic pregnancy can cause internal bleeding, infertility, and even death.
There are also risks if you get pregnant while using Mirena or Kyleena
and the pregnancy is in the uterus. Severe infection, miscarriage,
premature delivery, and even death can occur with pregnancies that
continue with an intrauterine device (IUD). Because of this, your HCP may
try to remove Mirena or Kyleena, even though removing it may cause a
miscarriage. If Mirena or Kyleena cannot be removed, talk with your HCP
about the benefits and risks of continuing the pregnancy and possible
effects of the hormone on your unborn baby.
If you continue your pregnancy, see your HCP regularly. Call your HCP
right away if you get flu-like symptoms, fever, chills, cramping, pain,
bleeding, vaginal discharge, or fluid leaking from your vagina. These may
be signs of infection.
How will Mirena or Kyleena change my periods?
For the first 3 to 6 months, your period may become irregular and the
number of bleeding days may increase. You may also have frequent
spotting or light bleeding, and some women have heavy bleeding during
this time. You may also have cramping during the first few weeks. After
you have used Mirena or Kyleena for a while, the number of bleeding
and spotting days is likely to lessen. For some women, periods will stop
altogether. When Mirena or Kyleena is removed, your menstrual periods
should return.

Important Facts continued on next page. 21

IMPORTANT FACTS ABOUT MIRENA® (LEVONORGESTREL-RELEASING
INTRAUTERINE SYSTEM) 52 MG AND KYLEENA® (LEVONORGESTREL-
RELEASING INTRAUTERINE SYSTEM) 19.5 MG (CONT.)
In some women with heavy bleeding who are using Mirena, the total blood
loss per cycle progressively decreases with continued use. The number
of spotting and bleeding days may initially increase but then typically
decreases in the months that follow.
Is it safe to breastfeed while using Mirena or Kyleena?
You may use Mirena or Kyleena when you are breastfeeding. Mirena or Kyleena
is not likely to affect the quality or amount of your breast milk or the health of
your nursing baby. However, isolated cases of decreased milk production have
been reported. The risk of Mirena or Kyleena going into the wall of the uterus
(becoming embedded) or going through the wall of the uterus is increased if Mirena
or Kyleena is inserted while you are breastfeeding.
Will Mirena or Kyleena interfere with sexual intercourse?
You and your partner should not feel Mirena or Kyleena during intercourse.
Mirena or Kyleena is placed in the uterus, not in the vagina. Sometimes
your partner may feel the threads. If this occurs, or if you or your partner
experience pain during sex, talk with your HCP.
Can I have an MRI with Kyleena in place?
Kyleena can be safely scanned with MRI only under specific conditions.
Before you have an MRI, tell your HCP that you have Kyleena, an IUD, in place.
What are the possible serious side effects of Mirena or Kyleena?
• Ectopic pregnancy and intrauterine pregnancy risks. There are risks
if you become pregnant while using Mirena or Kyleena (see “What if I
become pregnant while using Mirena or Kyleena?”).
• Life-threatening infection. Life-threatening infection can occur within
the first few days after placement. Call your HCP immediately if you
develop severe pain or fever shortly after placement.
• Pelvic inflammatory disease (PID). Some IUD users get a serious pelvic
infection called pelvic inflammatory disease. PID is usually sexually transmitted.
You have a higher chance of getting PID if you or your partner has sex with
other partners. PID can cause serious problems such as infertility, ectopic
pregnancy or pelvic pain that does not go away. PID is usually treated with
antibiotics. More serious cases of PID may require surgery, including removal
of the uterus (hysterectomy). In rare cases, infections that start as PID can
even cause death. Tell your HCP right away if you have any of these signs of
PID: long-lasting or heavy bleeding, unusual vaginal discharge, low abdominal
(stomach area) pain, painful sex, chills, fever, genital lesions or sores.
• Perforation. Mirena or Kyleena may go into the wall of the uterus (become
embedded) or go through the wall of the uterus. This is called perforation.
If this occurs, Mirena or Kyleena may no longer prevent pregnancy. If
perforation occurs, Mirena or Kyleena may move outside the uterus and can
cause internal scarring, infection, or damage to other organs and you may
need surgery to have Mirena or Kyleena removed. Excessive pain or vaginal
bleeding during placement of Mirena or Kyleena, pain or bleeding that gets
worse after placement, or not being able to feel the threads may happen
with perforation. The risk of perforation is increased if Mirena or Kyleena is
inserted while you are breastfeeding, or if you have recently given birth.
• Expulsion. Mirena or Kyleena may come out by itself. This is called expulsion.
Expulsion occurs in about 4 out of 100 women. Excessive pain or vaginal
bleeding during placement of Mirena or Kyleena, pain or bleeding that gets
worse after placement, or not being able to feel the threads may happen with
expulsion. You may become pregnant if Mirena or Kyleena comes out. If you
think that Mirena or Kyleena has come out, avoid intercourse or use a
non-hormonal back-up birth control (such as condoms or spermicide) and call
your healthcare professional. The risk of expulsion is increased with insertion
right after delivery or second-trimester abortion.
22
Common side effects of Mirena or Kyleena include:
• Pain, bleeding or dizziness during and after placement. If these
symptoms do not stop 30 minutes after placement, Mirena or Kyleena
may not have been placed correctly. Your HCP will examine you to see if
Mirena or Kyleena needs to be removed or replaced.
• Changes in bleeding. You may have bleeding and spotting between
menstrual periods, especially during the first 3-6 months. Sometimes the
bleeding is heavier than usual at first. However, the bleeding usually becomes
lighter than usual and may be irregular. Call your HCP if the bleeding remains
heavier than usual or increases after it has been light for a while.
• Missed menstrual periods. About 2 out of 10 women stop having
periods after 1 year of Mirena use. About 12 out of 100 women stop
having periods after 1 year of Kyleena use. If you have any concerns that
you may be pregnant while using Mirena or Kyleena, do a urine pregnancy
test and call your HCP. Your periods may stop after 1 year of Mirena or
Kyleena use. If you do not have a period for 6 weeks during Mirena or
Kyleena use, call your HCP. When Mirena or Kyleena is removed, your
menstrual periods should return.
• Cysts on the ovary. Some women develop painful cysts on the ovary.
These cysts usually disappear on their own in 2-3 months. However, cysts
can cause pain and sometimes cysts will need surgery.
Other common side effects for Mirena include:
• abdominal or pelvic pain • headache or migraine
• inflammation or infection of • vaginal discharge
the outer part of your vagina
(vulvovaginitis)
Other common side effects for Kyleena include:
• inflammation or infection of • headache or migraine
the outer part of your vagina • acne or greasy skin
(vulvovaginitis) • painful periods
• abdominal or pelvic pain • sore or painful breasts
These are not all of the possible side effects with Mirena or Kyleena.
For more information, ask your HCP. Tell your HCP if you have any side effect
that bothers you or does not go away.
Call your HCP for medical advice about side effects. You may report side effects
to FDA at 1-800-FDA-1088. You may also report side effects to Bayer Healthcare
Pharmaceuticals at 1-888-842-2937, or www.fda.gov/medwatch.
After placement, when should I call my HCP?
If Mirena or Kyleena is accidentally removed and you had vaginal intercourse
within the preceding week, you may be at risk of pregnancy, and you should
talk to a HCP. Call your HCP if you have any concerns about Mirena or
Kyleena. Be sure to call if you:
• think you are pregnant
• have pelvic pain, abdominal pain, or pain during sex
• have unusual vaginal discharge or genital sores
• have unexplained fever, flu-like symptoms or chills
• might be exposed to sexually transmitted infections (STIs)
• are concerned that Mirena or Kyleena may have been expelled (came out)
• cannot feel Mirena's or Kyleena's threads
• develop very severe or migraine headaches
• have yellowing of the skin or whites of the eyes. These may be signs of
liver problems
• have had a stroke or heart attack
• become HIV positive or your partner becomes HIV positive
• have severe vaginal bleeding, bleeding that lasts a long time or concerns you
To learn more, talk about Mirena or Kyleena with your HCP and see the
FDA-approved Full Prescribing Information found on www.mirena.com or
www.kyleena.com, or call 1-866-647-3646.
23
 Learn more at Mirena.com

Scan the QR code with

your phone’s camera to
visit Mirena.com

If you have any questions about Mirena® 52 mg or

Kyleena® (levonorgestrel-releasing intrauterine system)
19.5 mg, you should ask your healthcare professional.
You should also learn about other birth control methods,
and choose the one that is right for you.

Please see Important Safety Information throughout brochure.

Please see Important Facts on pages 20–23 and the full
Prescribing Information here.

Models used for illustrative purposes only.

BAYER, the Bayer Cross, Mirena, and Kyleena are registered trademarks of Bayer.
© 2021 Bayer. Whippany, NJ 07981
All rights reserved. PP-PF-WHC-IUS-US-1399-1 USA/August 2021