Pil 2313
Pil 2313
Pil 2313
Saxenda® 6 mg/ml
Solution for injection in pre-filled pen
liraglutide
Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.
– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor, pharmacist or nurse.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
– If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
What Saxenda® is
Saxenda® is a weight loss medicine that contains the active substance liraglutide. It is similar to a
natural occurring hormone called glucagon-like peptide-1 (GLP-1) that is released from the intestine
after a meal. Saxenda® works by acting on receptors in the brain that control your appetite, causing
you to feel fuller and less hungry. This may help you eat less food and reduce your body weight.
You should only continue using Saxenda® if you have lost at least 5% of your initial body weight
after 12 weeks on the 3.0 mg/day dose (see section 3). Consult your doctor before you continue.
Saxenda can be used as an adjunct to a healthy nutrition and increased physical activity for weight
management in adolescents from the age of 12 years and above who have:
You should only continue using Saxenda if you have lost at least 4% of your BMI after 12 weeks on
the 3.0 mg/day dose or maximum tolerated dose (see section 3). Consult your doctor before you
continue.
Diet and exercise
Your doctor will start you on a diet and exercise programme. Stay on this programme while you are
using Saxenda®.
The use of Saxenda® is not recommended if you have severe heart failure.
There is little experience with this medicine in patients of 75 years and older. It is not recommended if
you are 75 years or older.
There is little experience with this medicine in patients with kidney problems. If you have kidney
disease or are on dialysis, consult your doctor.
There is little experience with this medicine in patients with liver problems. If you have liver
problems, consult your doctor.
This medicine is not recommended if you have a severe stomach or gut problem which results in
delayed stomach emptying (called gastroparesis), or if you have an inflammatory bowel disease.
Thyroid disease
If you have thyroid disease, including thyroid nodules and enlargement of the thyroid gland, consult
your doctor.
Heart rate
Talk to your doctor if you have palpitations (you feel aware of your heartbeat) or if you have feelings
of a racing heartbeat while at rest during Saxenda® treatment.
Do not breast-feed if you are using Saxenda®. This is because it is not known if Saxenda® passes
into breast milk.
Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or
nurse if you are not sure.
Your doctor will start you on a diet and exercise programme. Stay on this programme while you are
using Saxenda®.
Adults
Your treatment will start at a low dose which will be gradually increased over the first five weeks of
treatment.
• When you first start using Saxenda®, the starting dose is 0.6 mg once a day, for at least one
week.
• Your doctor will instruct you to gradually increase your dose by 0.6 mg usually each week until
you reach the recommended dose of 3.0 mg once a day.
Your doctor will tell you how much Saxenda® to use each week. Usually, you will be told to follow
the table below.
Dose injected
Week
Once you reach the recommended dose of 3.0 mg in week 5 of treatment, keep using this dose until
your treatment period ends. Do not increase your dose further.
Adolescents (≥ 12 years)
For adolescents from the age of 12 to below 18 years old a similar dose escalation schedule as for
adults should be applied (see above table for adults). The dose should be increased until 3.0 mg
(maintenance dose) or maximum tolerated dose has been reached. Daily doses higher than 3.0 mg are
not recommended.
Where to inject
Saxenda® is given as an injection under the skin (subcutaneous injection).
• The best places to inject are the front of your waist (abdomen), the front of your thighs or your
upper arm.
• Do not inject into a vein or muscle.
Detailed instructions for use are provided on the other side of this leaflet.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some severe allergic reactions (anaphylaxis) have been reported rarely in patients using Saxenda®.
You should see your doctor straight away if you get symptoms such as breathing problems, swelling
of face and throat and a fast heartbeat.
Cases of inflammation of the pancreas (pancreatitis) have been reported uncommonly in patients using
Saxenda®. Pancreatitis is a serious, potentially life-threatening medical condition.
Stop taking Saxenda® and contact a doctor immediately if you notice any of the following serious
side effects:
• Severe and persistent pain in the abdomen (stomach area) which might reach through to your
back, as well as nausea and vomiting, as it could be a sign of an inflamed pancreas
(pancreatitis).
Great Britain:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or
Apple App Store
By reporting side effects, you can help provide more information on the safety of this medicine.
Do not use Saxenda® after the expiry date which is stated on the pen label and carton after ‘EXP’.
The expiry date refers to the last day of that month.
When you are not using the pen, keep the pen cap on in order to protect it from light.
Do not use this medicine if the solution is not clear and colourless or almost colourless.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.
Saxenda® is available in pack sizes containing 1, 3 or 5 pens. Not all pack sizes may be marketed.
Detailed information on this medicine is available on the European Medicines Agency website:
http://www.ema.europa.eu.
Saxenda®, NovoFine® and NovoTwist® are trademarks owned by Novo Nordisk A/S,
Denmark
© 2021
Novo Nordisk A/S
Instructions on how to use Saxenda® 6 mg/ml solution for injection in pre-
filled pen
Please read these instructions carefully before using your Saxenda® pre-
filled pen.
Do not use the pen without proper training from your doctor or nurse.
Start by checking your pen to make sure that it contains Saxenda® 6 mg/ml,
then look at the illustrations below to get to know the different parts of your
pen and needle.
If you are blind or have poor eyesight and cannot read the dose counter on
the pen, do not use this pen without help. Get help from a person with good
eyesight who is trained to use the Saxenda® pre-filled pen.
Your pen is a pre-filled dial-a-dose pen. It contains 18 mg of liraglutide and
delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg and 3.0 mg. Your pen is
designed to be used with NovoFine® or NovoTwist® disposable needles up to
a length of 8 mm and as thin as 32 G.
Needles are not included in the pack.
Pay special attention to these notes as they are important for safe use of the pen.
Saxenda® pre-filled pen and
needle (example)
Outer
Pen cap needle cap
Inner
needle cap
Needle
Paper tab
Pen scale
Pen window
Saxenda
Pen label
Dose counter
Dose pointer Flow
check
symbol
Dose selector
Dose button
1 Prepare your pen with a new needle A
• Check the name and coloured label of your pen, to make sure that it
contains Saxenda®. This is especially important if you take more than
one type of injectable medicine. Using the wrong medicine could be
harmful to your health.
• Pull off the pen cap.
• Check that the solution in your pen is clear and colourless. Look B
through the pen window. If the solution looks cloudy, do not use the pen.
• Push the needle straight onto the pen. Turn until it is on tight. D
• Pull off the outer needle cap and keep it for later. You will need it E
after the injection, to safely remove the needle from the pen.
• Pull off the inner needle cap and throw it away. If you try to put it F
back on, you may accidentally stick yourself with the needle.
A drop of solution may appear at the needle tip. This is normal, but you
must still check the flow if you use a new pen for the first time.
Do not attach a new needle to your pen until you are ready to take your
injection.
• Before your first injection with each new pen, check the flow. If your
pen is already in use, go to step 3 ‘Select your dose’.
Flow check
symbol
selected
• Hold the pen with the needle pointing up. B
Press and hold in the dose button until the dose counter returns to 0.
The 0 must line up with the dose pointer.
A drop of solution should appear at the needle tip.
A small drop may remain at the needle tip, but it will not be injected.
If no drop appears, repeat step 2 ‘Check the flow’ up to 6 times. If there
is still no drop, change the needle and repeat step 2 ‘Check the flow’
once more.
If a drop still does not appear, dispose of the pen and use a new one.
If no drop appears, you will not inject any medicine, even though the
dose counter may move. This may indicate a blocked or damaged
needle.
If you do not check the flow before your first injection with each new
pen, you may not get the prescribed dose and the intended effect of
Saxenda®.
3 Select your dose A
• Turn the dose selector until the dose counter shows your dose
(0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg or 3.0 mg).
If you select the wrong dose, you can turn the dose selector forward or
backwards to the correct dose.
The pen can dial up to a maximum of 3.0 mg. Example
0.6 mg
The dose selector changes the dose. Only the dose counter and dose selected
pointer will show how many mg you select per dose.
You can select up to 3.0 mg per dose. When your pen contains less than
3.0 mg the dose counter stops before 3.0 is shown.
The dose selector clicks differently when turned forward, backwards or
past the number of mg left. Do not count the pen clicks.
• The pen scale shows you approximately how much solution is left in A Approx.
your pen. how much
solution is
left
• To see precisely how much solution is left, use the dose counter: B
Turn the dose selector until the dose counter stops.
If it shows 3.0, at least 3.0 mg are left in your pen. If the dose counter
stops before 3.0 mg, there is not enough solution left for a full dose of
3.0 mg.
Example
If you need more medicine than what is left in your pen
Only if trained or advised by your doctor or nurse, you may split your dose Dose counter
between your current pen and a new pen. Use a calculator to plan the doses as stopped:
2.4 mg left
instructed by your doctor or nurse.
If you are not sure how to split your dose using two pens, then select and
inject the dose you need with a new pen.
4 Inject your dose A
• Insert the needle into your skin as your doctor or nurse has shown you.
• Make sure you can see the dose counter. Do not cover it with your
fingers. This could interrupt the injection.
• Press and hold down the dose button until the dose counter shows 0. B
The 0 must line up with the dose pointer. You may then hear or feel a
click.
• Keep the needle in your skin after the dose counter has returned to 0 C Count slowly:
and count slowly to 6.
• If the needle is removed earlier, you may see a stream of solution coming 1-2-3-4-5-6
from the needle tip. If so, the full dose will not be delivered.
You may see a drop of solution at the needle tip after injecting. This is
normal and does not affect your dose.
Never touch the dose counter when you inject. This can interrupt the
injection.
5 After your injection A
• Lead the needle tip into the outer needle cap on a flat surface without
touching the needle or the outer needle cap.
• Once the needle is covered, carefully push the outer needle cap B
completely on.
• Unscrew the needle and dispose of it carefully.
• Put the pen cap on your pen after each use to protect the solution from C
light.
• Always keep your pen and needles out of sight and reach of others,
especially children.
• Never share your pen or your needles with other people.
• Caregivers must be very careful when handling used needles - to
prevent needle injury and cross-infection.
Caring for your pen
• Do not leave the pen in a car or other place where it can get too hot or
too cold.
• Do not inject Saxenda® which has been frozen. If you do that, you
may not get the intended effect of this medicine.
• Do not expose your pen to dust, dirt or liquid.
• Do not wash, soak or lubricate your pen. If necessary, clean it with a
mild detergent on a moistened cloth.
• Do not drop your pen or knock it against hard surfaces. If you drop it or
suspect a problem, attach a new needle and check the flow before you
inject.
• Do not try to refill your pen. Once empty, it must be disposed of.
• Do not try to repair your pen or pull it apart.