Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about getting this medicine,
speak to your healthcare professional (doctor, nurse or pharmacist).
This medicine is new. Please report side effects that you may experience with this
medicine. See the full CMI for further details.
1. Why am I using WINREVAIR?
WINREVAIR contains the active ingredient sotatercept. WINREVAIR is used to treat adults
with pulmonary arterial hypertension (PAH). PAH is a type of high blood pressure in
the arteries of your lungs.
2. What should I know before I use WINREVAIR?
Do not use if you have had an allergic reaction to WINREVAIR or any of the ingredients
listed at the end of the CMI.
If your healthcare professional decides that you or a caregiver can give the injections
of WINREVAIR at home, you or your caregiver should receive training from your healthcare
professional on the right way to prepare and inject WINREVAIR.
Talk to your healthcare professional if you have any other medical conditions, take
any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with WINREVAIR and affect how it works.
4. How do I use WINREVAIR?
You will use WINREVAIR every 3 weeks as an injection just under your skin (subcutaneous).
Your dose of WINREVAIR depends on your body weight and blood tests.
Before your first dose and regularly while using WINREVAIR, your healthcare professional
will do blood tests. These are done so that your healthcare professional can monitor
you and find the best dose for you.
Your healthcare professional may adjust your dose, delay treatment, or stop treatment
depending on how you respond to WINREVAIR.
5. What should I know while using WINREVAIR?
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Things you should do
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Remind any healthcare professional you visit that you are using WINREVAIR.
Check with your healthcare professional if you are pregnant or intend to become pregnant.
Talk to your healthcare professional if you are breastfeeding or intend to breastfeed.
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Things you should not do
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Do not change your dose or stop taking WINREVAIR without talking to your healthcare
professional.
Do not use WINREVAIR more often than your healthcare professional tells you to.
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Looking after your medicine
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Store WINREVAIR in the refrigerator at 2°C to 8°C. Do not freeze.
Store in the original carton to help protect from light.
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6. Are there any side effects?
Common side effects: headache, nose bleeds (epistaxis), telangiectasia (also called
spider veins or tiny blood vessels that look like pink or red lines on the skin),
diarrhea, dizziness, rash, increased blood pressure, redness.
Serious side effects: high level of haemoglobin, low number of platelets, serious
bleeding, decreased fertility.
This medicine is subject to additional monitoring. This will allow quick identification
of new safety information. You can help by reporting any side effects you may get.
You can report side effects to your healthcare professional (doctor, nurse or pharmacist)
or directly at www.tga.gov.au/reporting-problems .
Active ingredient:
Sotatercept
Full Consumer Medicine Information (CMI)
This leaflet provides important information about WINREVAIR. You should also speak to your healthcare professional if you would like further information
or if you have any concerns or questions about using WINREVAIR.
Where to find information in this leaflet:
1. Why am I using WINREVAIR?
WINREVAIR contains the active ingredient sotatercept.
WINREVAIR is a prescription medicine used to treat adults with pulmonary arterial
hypertension (PAH).
PAH is a type of high blood pressure in the arteries of your lungs. WINREVAIR can
improve your ability to be physically active by lowering the blood pressure in your
lungs.
It can also relieve symptoms of PAH and slow down the progression of your disease.
WINREVAIR is an activin receptor type IIA-Fc (ActRIIA-Fc) fusion protein which works
to lower the blood pressure in your lungs.
2. What should I know before I use WINREVAIR?
Warnings
Please read this information carefully before you start to use your medicine, even
if you have just refilled your prescription. Some of the information may have changed.
Remember that your doctor has prescribed this medicine only for you. Never give it
to anyone else.
Do not use WINREVAIR if:
you are allergic to sotatercept, or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can use this medicine.
If your healthcare professional decides that you or a caregiver can give the injections
of WINREVAIR at home, you or your caregiver should receive training from your healthcare
professional on the right way to prepare and inject WINREVAIR. Do not try to inject
WINREVAIR until you have been shown the right way by your healthcare professional.
Your doctor will do a blood test before your first 5 doses of WINREVAIR, longer if
needed, and then from time to time to check your levels of haemoglobin (a protein
in red blood cells that carries oxygen) and platelets (blood cells that help blood
clot). After each of these blood tests, your healthcare provider may delay treatment
or change your dose if needed.
Check with your healthcare professional if you:
have any other medical conditions
take any medicines for any other condition
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Children
It is not known if WINREVAIR is safe and effective in children under 18 years of age.
Pregnancy and breastfeeding
Check with your healthcare professional if you are pregnant or intend to become pregnant.
WINREVAIR may harm your unborn baby.
Tell your healthcare professional right away if you become pregnant or think you may
be pregnant while using WINREVAIR.
Your healthcare professional should do a pregnancy test before you start using WINREVAIR.
You should use effective birth control when using WINREVAIR.
You should continue using effective birth control for at least 4 months after your
last dose if you stop using WINREVAIR. Ask your healthcare professional about birth
control methods that would work well for you.
Talk to your healthcare professional if you are breastfeeding or intend to breastfeed.
It is not known if WINREVAIR passes into breast milk.
Do not breastfeed while using WINREVAIR.
Do not breastfeed for at least 4 months after your last dose if you stop using WINREVAIR.
Talk to your healthcare professional about the best way to feed your baby.
3. What if I am taking other medicines?
Tell your healthcare professional if you are taking any other medicines, including
any medicines, vitamins or supplements that you buy without a prescription from your
pharmacy, supermarket or health food shop.
Know the medicines you take. Keep a list of them and show the list to your healthcare
professional when you get a new medicine.
Some medicines may interfere with WINREVAIR and affect how it works.
Check with your healthcare professional if you are not sure about what medicines,
vitamins or supplements you are taking and if these affect WINREVAIR.
4. How do I use WINREVAIR?
Inject WINREVAIR only after you have been shown the right way by your healthcare professional.
Read the separate “Instructions for Use” booklet that comes with WINREVAIR.
How much to use
Your dose of WINREVAIR depends on your body weight and blood tests.
Your healthcare professional will tell you how much WINREVAIR to use and when to use
it.
Do not change your dose or stop using WINREVAIR without talking to your healthcare
professional.
Do not use WINREVAIR more often than your doctor tells you to. If you are not sure
when to use WINREVAIR, call your healthcare professional.
When to use WINREVAIR
You will use or be given WINREVAIR every 3 weeks as an injection just under your skin
(subcutaneous) only in these injection sites:
stomach (abdomen) - at least 2 inches away from the belly button, or
upper thigh
upper arm (only if given by your healthcare professional)
Use WINREVAIR exactly as your healthcare professional tells you to.
You should inject WINREVAIR right away and after mixing the medicine powder with the
sterile water, but no later than 4 hours after mixing.
Your healthcare professional will monitor your dose
Your dose of WINREVAIR depends on your body weight and blood tests.
Before your first dose and regularly while using WINREVAIR, your healthcare professional
will do blood tests. These are done so that your healthcare professional can monitor
you and find the best dose for you.
Your healthcare professional may adjust your dose, delay treatment, or stop treatment
depending on how you respond to WINREVAIR.
If you forget to use WINREVAIR
WINREVAIR should be used every 3 weeks. If you miss your dose at the usual time, use
it within 3 days and follow your original schedule for your next dose. If not used
within 3 days, call your healthcare professional for guidance.
If your miss your appointment to be given WINREVAIR, call your healthcare professional
immediately to reschedule your appointment.
If you use too much WINREVAIR
If you think that you have used too much WINREVAIR, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26), or
contact your healthcare professional, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using WINREVAIR?
Driving or using machines
It is unlikely that this medicine will affect your ability to drive and use machines.
Drinking alcohol
Tell your healthcare professional if you drink alcohol.
Looking after your medicine
Store WINREVAIR in the refrigerator at 2°C to 8°C. Do not freeze.
Store in the original carton to help protect from light.
Contact your healthcare professional if the unused vial has been out of the refrigerator
for an extended period of time.
Follow the instructions on the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children and pets cannot reach it.
How long should I keep my medicine?
Contact your healthcare professional, nurse or pharmacist if the unused injection
pack has been out of the refrigerator for an extended period of time.
After you mix the medicine powder with the sterile water (provided in the pack), it
is recommended that you inject it right away.
Getting rid of any unwanted medicine
It is unlikely you will be asked to dispose of WINREVAIR. However, if you no longer
need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.
Do not get this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your healthcare professional if
you have any further questions about side effects.
Common side effects
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Common side effects
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What to do
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headaches
nose bleeds (epistaxis)
telangiectasia (also called spider veins or tiny blood vessels that look like pink
or red lines on the skin)
diarrhea
dizziness
rash
increased blood pressure
redness
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Speak to your healthcare professional if you have any of these common side effects
and they worry you
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Serious side effects
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Serious side effects
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What to do
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High level of haemoglobin (a protein in red blood cells that carries oxygen
This can raise the chance of a blood clot forming that can block a blood vessel. Your
healthcare professional will do blood tests to check your haemoglobin levels before
starting and regularly during treatment with WINREVAIR.
Low number of platelets (blood cells that help blood clot)
This can cause symptoms such as easy bruising, continued bleeding from cuts, and nosebleeds.
Your healthcare professional will do blood tests to check your platelet level before
starting and regularly during treatment with WINREVAIR.
Serious bleeding - Signs and symptoms:
Persistent headache, nausea, weakness, black or tarry stool, blood in your stool,
bright red blood from vomiting or coughing, persistent abdominal cramps, severe back
pain, or abnormally heavy menstrual bleeding.
These are signs and symptoms of serious bleeding that can happen if you use WINREVAIR
and are more likely to happen if you use WINREVAIR with certain medicines. Your doctor
will inform you on how to recognise them. Talk to your doctor if you notice any of
these signs or symptoms.
Decreased Fertility
WINREVAIR may decrease female and male fertility.
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Call your healthcare professional straight away if you notice any of these serious
side effects.
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Tell your healthcare professional if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your healthcare professional or pharmacist before you
decide to stop using any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What WINREVAIR contains
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Active ingredient
(main ingredient)
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sotatercept
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Other ingredients
(inactive ingredients)
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citric acid monohydrate
polysorbate 80
sucrose
sodium citrate dihydrate
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Do not get this medicine if you are allergic to any of these ingredients.
What WINREVAIR looks like
WINREVAIR medicine powder is a white to off-white lyophilized powder and may be supplied
in the following single-use packaging configurations:
Vial only
Carton containing 1 or 2 vials of WINREVAIR 45 mg powder for injection (AUST R 433670)
Carton containing 1 or 2 vials of WINREVAIR 60 mg powder for injection (AUST R 433671)
Administration Pack
WINREVAIR 45 mg pack contains:
1 or 2 vials of medicine powder, 1 or 2 prefilled syringes with sterile water, 1 or
2 vial adaptors, 1 empty dosing syringe, 1 needle, 4 or 8 alcohol wipes
WINREVAIR 60 mg pack contains:
1 or 2 vials of medicine powder, 1 or 2 prefilled syringes with sterile water, 1 or
2 vial adaptors, 1 empty dosing syringe, 1 needle, 4 or 8 alcohol wipes
Not all presentations may be supplied.
None of the components contain natural rubber latex.
Who distributes WINREVAIR
Merck Sharp & Dohme (Australia) Pty Limited
Level 1, Building A, 26 Talavera Road
Macquarie Park NSW 2113
http://www.msd-australia.com.au
Tel: 1800 818 553
This leaflet was prepared in December 2024.
S-CCPPI-MK7962-I-062024
RCN: 000025703-AU
RCN: 000027094-AU
RCN: 000027270-AU
Copyright © 2024 Merck & Co., Inc., Rahway, NJ, USA, and its affiliates. All rights
reserved.