Patient Leaflet Updated 02-Jun-2025 | Merck Sharp & Dohme (UK) Limited
Winrevair 45 mg & 60 mg powder and solvent for solution for injection
Winrevair® 45 mg powder and solvent for solution for injection
Winrevair® 60 mg powder and solvent for solution for injection
sotatercept
▼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. See the end of section 4 for how to report side effects.
1. What Winrevair is and what it is used for
2. What you need to know before you use Winrevair
3. How to use Winrevair
4. Possible side effects
5. How to store Winrevair
6. Contents of the pack and other information
Winrevair contains the active substance sotatercept.
It is used with other therapies to treat pulmonary arterial hypertension (PAH) in adults. PAH is a type of high blood pressure in the arteries of your lungs. In PAH, these arteries get narrower, which makes it harder for the heart to pump blood through these vessels, and leads to symptoms like fatigue, dizziness, and difficulty breathing.
Winrevair acts on the causes of PAH responsible for the narrowing of the arteries of your lungs. This makes it easier for the heart to pump blood to your lungs and improves your ability to be physically active.
Winrevair can increase the levels of haemoglobin in your blood, decrease the number of platelets in your blood, or increase the risk of serious bleeding.
Talk to your doctor or pharmacist before and while using Winrevair if you have:
This can increase the chance of a blood clot forming that can block a blood vessel. Your doctor will check haemoglobin levels with regular blood tests before each of your first 5 doses of Winrevair, or longer before each dose if needed, and regularly while you are using this medicine.
These are signs and symptoms of serious bleeding that can happen if you take Winrevair and are more likely to happen if you take Winrevair with certain medicines. Your doctor will inform you on how to recognize them. Talk to your doctor if you notice any of these signs or symptoms. Serious bleeding could lead to hospitalisation, need for blood transfusion or other treatments, and could be life-threatening.
Do not give this medicine to children and adolescents below the age of 18 years. It is not known if this medicine is safe and works in people under 18 years of age.
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy:
Winrevair may harm your unborn baby.
This medicine is not recommended during pregnancy. Your doctor should do a pregnancy test before you start your treatment and you should use effective birth control (contraception) during your treatment and for at least 4 months after the last dose of Winrevair. Ask your doctor or pharmacist about birth control methods that would work well for you.
Tell your doctor immediately if you become pregnant or think you may be pregnant while using this medicine.
Breast-feeding:
It is not known whether Winrevair passes into breast milk. Do not breastfeed during your treatment and for at least 4 months after the last dose of Winrevair. Talk to your doctor or pharmacist about the best way to feed your baby.
Fertility:
Winrevair may decrease female and male fertility.
It is unlikely that this medicine will affect your ability to drive and use machines.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium free’.
This medicine contains 0.20 mg of polysorbate 80 in each mL of reconstituted solution. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.
Always use this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.
The recommended dosing schedule is one injection every 3 weeks.
You will take Winrevair, as an injection just under your skin (subcutaneous (SC)) only in these injection sites:
Note: In case your doctor or nurse is giving you the injection, they may also use your upper arm as injection site as they have received training in how to do it properly.
If you use less or more Winrevair than you should, talk to your doctor or pharmacist.
If you miss your prescribed dose of Winrevair and it is within 3 days of when you should have taken it, take it immediately and follow your original schedule for your next dose. If you miss your prescribed dose of Winrevair and it is more than 3 days of when you should have taken it, your injection schedule has to be changed, talk to your doctor or pharmacist for guidance.
Do not change your dose or stop taking Winrevair without talking to your doctor.
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.
Talk to your doctor or pharmacist immediately if you notice:
In addition, your doctor will do regular blood tests to notice whether you have:
The serious side effects above may affect more than 1 in 10 people.
Talk to your doctor or pharmacist if you notice any of the following:
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at 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.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the vial and the carton after “EXP”. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze. Store in the original package in order to protect from light.
You should inject this medicine right away after mixing the medicine powder with the sterile water for injection, but no later than 4 hours after mixing.
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.
Winrevair is a powder and solvent for solution for injection (powder for injection). The white to off-white powder comes in a 2 mL glass vial containing 45 mg or 60 mg of sotatercept. The solvent is a clear and colourless water for injections in a prefilled syringe of 1 mL or 1.3 mL.
Winrevair 45 mg is available in:
Winrevair 60 mg is available in:
Marketing Authorisation Holder:
Manufacturer:
For any information about this medicine, please contact:
This leaflet was last revised in September 2024.
© 2024 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved.
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