Reviews Overview: Winrevair is an injectable medicine that is used to treat pulmonary arterial hypertension (PAH). It works by binding to certain substances and blocking signals in the body that may contribute to the worsening of PAH. Common side effects include infections, nosebleeds, rash or skin redness, diarrhea, headache, and dizziness. Tell your health care provider right away if you have any unusual bleeding or bruising, including if you are coughing up blood, have pink or red pee, or have red or black stools. Talk with your health care provider about how to properly prepare your dose of Winrevair and inject it under the skin.
Uses
What is Winrevair used for?
Winrevair (sotatercept-csrk) is commonly used to treat pulmonary arterial hypertension (PAH). PAH is high blood pressure in the blood vessels (pulmonary arteries) that go to your lungs from your heart. The arteries may be narrowed or blocked, which makes it harder for your heart to pump blood through them.
Learn more about Winrevair for pulmonary arterial hypertension.
Winrevair may also be used for other conditions as determined by your health care provider.
How does Winrevair work (mechanism of action)?
Winrevair binds to certain substances and blocks signals in the body that may contribute to the progression of pulmonary arterial hypertension. Winrevair may help improve your ability to exercise, reduce the severity of PAH, and lower your risk of having certain problems or worsening symptoms from PAH.
How is Winrevair supplied (dosage forms)?
Brands and other names
- Winrevair
Dosage forms and strengths
- 45 mg injection kit
- 60 mg injection kit
- 90 mg injection kit (2 x 45 mg vials)
- 120 mg injection kit (2 x 60 mg vials)
How should I store Winrevair?
Winrevair should be stored in the refrigerator, between 36 F and 46 F (2 C and 8 C). Do not freeze. Keep it in the original carton to protect it from light.
When you are ready to use Winrevair, you may keep it out of the refrigerator at a temperature of up to 77 F (25 C) for up to 24 hours.
Side Effects
What are the most common side effects of Winrevair?
The most common side effects of Winrevair are listed below. Tell your health care provider if you have any of these side effects that bother you.
- Infections
- Nosebleed
- Spider veins on the skin
- Diarrhea
- Headache
- Rash
- Dizziness
- Skin redness
- Bleeding gums
There may be other side effects of Winrevair that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Winrevair?
While less common, the most serious side effects of Winrevair are described below, along with what to do if they happen.
Severe Allergic Reactions. Winrevair may cause allergic reactions, which can be serious. Stop using Winrevair and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching or skin rash
- Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Increased Red Blood Cells. Winrevair may increase levels of red blood cells, also called erythrocytosis. This can increase the amount of hemoglobin, which is a protein in red blood cells that carries oxygen. In severe cases, it may increase your risk for blood clots. Keep all appointments to have your blood checked, and tell your health care provider right away if you have any of the following symptoms of erythrocytosis.
- Blurred vision
- Headaches
- Confusion
- Itching
- Weakness or tiredness
Severely Low Platelet Levels. Winrevair can cause you to have a severely low number of platelets in your blood, also called thrombocytopenia. Platelets help to form blood clots. Having a low level of platelets may increase your risk of bleeding. Keep all appointments to have your blood checked, and tell your health care provider if you have any of the following symptoms of low platelet levels.
- Easy bruising or bleeding
- Bleeding that does not stop
- Nosebleeds
Severe Bleeding. Winrevair can increase your risk of severe bleeding that can lead to death. Some people with serious bleeding may need a blood transfusion or surgery. The risk of bleeding may be higher if you are using certain medicines. Call your health care provider right away if you have any of the following signs of severe bleeding while using Winrevair.
- Pink, red, or brown urine (pee)
- Vomit with blood that looks like coffee grounds
- Red or black stools (looks like tar)
- Coughing up blood or blood clots
- Abnormally heavy menstrual periods
- Persistent headaches or severe back pain
- Nausea, dizziness, or weakness
- Persistent stomach pain
Fertility Problems. Winrevair may impair fertility, which may affect you or your partner’s ability to become pregnant. Talk to your health care provider if you have concerns about this.
Warnings & Precautions
Who should not use Winrevair?
Allergies to Ingredients. People who are allergic to any of the following should not use Winrevair.
- Sotatercept
- Winrevair
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Winrevair.
What should I know about Winrevair before using it?
Do not use Winrevair unless it has been prescribed to you by a health care provider. Use it as prescribed.
Do not share Winrevair with other people, even if they have the same condition as you. It may harm them.
Keep Winrevair out of the reach of children.
Winrevair can cause dizziness. Do not drive or do other activities that require alertness or coordination until you know how Winrevair affects you.
Winrevair is injected under the skin (subcutaneously). See the “Instructions for Use” booklet that comes with your prescription for details about how to prepare and inject your dose. Ask your health care provider if you are not sure how to prepare Winrevair, measure your dose, select an injection site, or inject Winrevair under your skin. Do not inject Winrevair if more than 4 hours have passed since you prepared it.
You will need to have blood tests before starting Winrevair and regularly during treatment. Keep all appointments to have your blood checked. Your dose of Winrevair may be adjusted based on these tests.
What should I tell my health care provider before using Winrevair?
Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Winrevair is right for you.
In particular, make sure that you discuss any of the following.
Blood Disorders. Tell your health care provider if you have had any blood disorders or abnormal blood test results. Keep all appointments for blood work before and during treatment with Winrevair. Tell your health care provider if you have any unusual bruising or bleeding before starting or while using Winrevair.
Pregnancy. Winrevair may cause harm to a fetus. Tell your health care provider right away if you are pregnant, think you might be pregnant, or plan to become pregnant. Your health care provider should do a pregnancy test before starting Winrevair. You will need to use an effective form of birth control while using Winrevair and for at least 4 months after your last dose. Ask your health care provider about effective forms of birth control. Tell your health care provider right away if you have unprotected sex or if you think your birth control has failed. If you have used Winrevair while pregnant, call 877-888-4231. This helps collect safety information about the use of Winrevair during pregnancy.
Breastfeeding. It is not known if Winrevair passes into breast milk. Do not breastfeed while you are using Winrevair and for 4 months after your last dose. Tell your health care provider if you are breastfeeding or plan to breastfeed. If you have used Winrevair while breastfeeding, call 877-888-4231. This helps collect safety information about the use of Winrevair while breastfeeding.
Other Medicines and Supplements. Winrevair may interact with other medicines and supplements. Before using Winrevair, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
How can I get more information about Winrevair?
For more information about Winrevair, you can visit the drugmaker's website at www.winrevair.com or call them at 877-888-4231.
Interactions
Does Winrevair interact with foods or drinks?
There are no known interactions between Winrevair and foods or drinks.
It is unknown if drinking alcohol will affect Winrevair. The risk of dizziness may be increased if you drink alcohol while using Winrevair. Both Winrevair and alcohol may also increase your risk of bleeding. It is best to limit the amount of alcohol you drink.
Does Winrevair interact with other medicines (drug interactions)?
Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
In particular, make sure that you discuss if you are using any of the following before using Winrevair.
- A blood thinner, which is a medicine used to treat or prevent blood clots
- A prostacyclin, such as epoprostenol (Flolan, Veletri), iloprost (Ventavis), or treprostinil (Orenitram, Remodulin, Tyvaso), which is used to treat pulmonary arterial hypertension
This may not be a complete list of medicines that can interact with Winrevair. Always check with your health care provider.
Overdose/Missed Dose
What should I do if I accidentally use too much Winrevair?
If you or someone else has used too much Winrevair, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Winrevair?
If you miss a dose of Winrevair and it is within 3 days of your scheduled dose, use it as soon as you remember. You can keep your original dosing schedule for the next dose. Do not use double or extra doses.
If you miss your dose and it has been more than 3 days since your scheduled dose, call your health care provider. You may need to adjust your dosing schedule.
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