Winrevair

Pronunciation: WIN-reh-vair
Generic name: sotatercept
Dosage form: injection for subcutaneous use

Medically reviewed by Carmen Pope, BPharm. Last updated on Apr 16, 2024.

What is Winrevair?

Winrevair (sotatercept) is an injectable activin signaling inhibitor that can be self-administered subcutaneously (under the skin) and may be used to treat adults with pulmonary arterial hypertension (PAH, WHO Group 1). Winrevair can improve your ability to exercise, improve your ability to perform normal activities with fewer symptoms and reduce the risk of your physical condition and symptoms worsening.

Winrevair (sotatercept) works by binding to activin A (a cytokine that is involved in inflammation, fibrosis, and wound repair that promotes atherosclerotic plaque formation). It also binds to other TGF- β superfamily ligands, many of which act on cardiac cells. This action improves the signaling balance and modulates vascular proliferation (the uncontrolled duplication of immature cells), reducing inflammation, and slowing down or reversing the structural tissue changes that happen with PAH.

Winrevair was FDA-approved on 26 March 2024.

What are the side effects of Winrevair?

Winrevair may cause serious side effects including:

High levels of hemoglobin in your blood, which may increase your risk for blood clots. Your healthcare provider will do blood tests to check your hemoglobin levels before starting and regularly during treatment
Severely low number of platelets in your blood. Your healthcare provider will do blood tests to check your platelet levels before starting and regularly during treatment. Tell your healthcare provider if you develop easy bruising or bleeding, bleeding that does not stop, or nosebleeds.
Serious bleeding. Tell your healthcare provider if you develop any signs or symptoms of bleeding, including:

vomiting blood or your vomit looks like coffee-grounds
nausea
dizziness or feeling weak
pink or brown urine
persistent abdominal cramps
red or black stools that look like tar
severe back pain
coughing up blood or blood clots
abnormally heavy menstrual bleeding
persistent headaches.

Decreased fertility: Winrevair may affect female and male fertility, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.

The most common side effects of Winrevair affecting 10% or more patients include:

headache
nose bleeds
rash
tiny blood vessels that look like pink or red lines on the skin (spider veins)
diarrhea
dizziness
redness.

These are not all the possible side effects of Winrevair. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA1088.

Warnings and serious effects

May increase red blood cell concentrations (erythrocytosis), which, if severe, may increase the risk of thromboembolic events (such as a stroke) or hyperviscosity syndrome. Your healthcare provider will monitor your hemoglobin levels before and after each dose for the first 5 doses, or longer if these are unstable, and periodically thereafter.

May cause severe low platelet counts ( thrombocytopenia) which may increase the risk of bleeding. Your healthcare provider will monitor your platelets before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter.

Serious bleeding events have been reported and were more likely with certain other medications, such as prostacyclin or antithrombotic agents (eg, iloprost, dabigatran, or clopidogrel) or with low platelet counts. Your healthcare provider will not administer Winrevair if you are experiencing serious bleeding.

May cause harm to an unborn baby. If you are a female of reproductive potential you should use effective contraception. May also reduce female and male fertility.

It is not known if Winrevair is safe and effective in children under 18 years of age.

Before taking

What should I tell my healthcare provider before taking Winrevair?

Tell your healthcare provider:

About all of your medical conditions and all of the medicines you take, including prescriptions, over-the-counter medicines, vitamins, and herbal supplements
If you are pregnant or plan to become pregnant
If you are breastfeeding or plan to breastfeed.

If your healthcare provider decides that you or a caregiver can give your injections of Winrevair at home, you or your caregiver should receive training from your healthcare provider on the right way to prepare and inject it. Do not try to inject it until you have been shown how to do so by your healthcare provider.

Your healthcare provider 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 hemoglobin (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.

Pregnancy

Winrevair may harm your unborn baby. Your healthcare provider should do a pregnancy test before you start taking Winrevair and you should use effective birth control during treatment and for at least 4 months after your final dose. Ask your healthcare provider about birth control methods that may be right for you.

Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Winrevair. You or your healthcare provider should report any exposure during pregnancy by calling 1-877-888-4231.

Breastfeeding

It is not known if Winrevair passes into breast milk. Do not breastfeed during treatment with Winrevair and for 4 months after your final dose. Talk to your healthcare provider about the best way to feed your baby.

You or your healthcare provider should report any exposure during breastfeeding by calling 1-877-888-4231.

How should I administer Winrevair?

Use Winrevair exactly as your healthcare provider tells you to. Your healthcare provider will work out the dosage that is right for you because this depends on your body weight and blood tests.

Winrevair is usually given every 3 weeks as an injection just under your skin (subcutaneous) in your:

stomach (abdomen) at least 2 inches away from the belly button, or
upper thigh.

Winrevair is supplied in a kit that requires premixing before use.

See the package instructions for detailed information about mixing the medicine powder with the sterile water and administering Winrevair.
Once mixed, Winrevair should be injected right away, but no later than 4 hours after mixing.
Do not change your dose, take it more often, or stop taking Winrevair without talking to your healthcare provider.

What if I miss a dose?

If you miss your dose of Winrevair and it has been 3 days or fewer, give it as soon as possible. You can then follow your usual schedule for your next dose.

If it has been more than 3 days, call your healthcare provider for what to do.

What if I overdose or take the wrong dose?

If you give more or less than your prescribed dose, call your healthcare provider right away.

What other drugs will affect Winrevair?

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking Winrevair with certain other medicines may affect how each medicine works or increase the risk of side effects, for example, taking it with prostacyclins or anticoagulants may increase the risk of bleeding.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. See the prescribing information for a full list of interactions.