Winrevair
Winrevair (sotatercept or sotatercept-csrk) is an FDA-approved medication used to treat adults with pulmonary arterial hypertension (PAH). It’s an activin signaling inhibitor that helps increase your ability to exercise, improve your daily functioning, and decrease the chances of worsening PAH. Winrevair (sotatercept) is given as an injection under the skin every 3 weeks. It’s given by your PAH specialist at the beginning. But you can give the injection to yourself at home once you or a family member receives training from a healthcare professional. Common side effects include headaches, nose bleeds, and rashes.
What is Winrevair (sotatercept)?
What is Winrevair (sotatercept) used for?
How Winrevair (sotatercept) works
In people with PAH, the walls of the small blood vessels in the lungs grow too thick. Scientists think that people with PAH may have extra activin, a protein that tells the blood vessels to get thicker, in their lungs.
When this happens, it makes the heart work harder to get blood to the lungs for oxygen. As a result, people with PAH have symptoms like shortness of breath, tiredness, dizziness, and chest pain.
Winrevair (sotatercept) is an activin signaling inhibitor, which means it blocks the activity of activin in the body. By balancing signals for blood vessel growth, Winrevair (sotatercept) prevents the blood vessels in the lungs from getting too thick.
Drug facts
Side effects of Winrevair (sotatercept)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Headache (25%)
- Nose bleeds (22%)
- Rash (20%)
- Spider veins (17%)
- Diarrhea (15%)
- Dizziness (15%)
- Skin redness (14%)
Winrevair (sotatercept) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Signs or symptoms of a blood clot: redness or swelling of the legs, chest pain, difficulty breathing, weakness of the face, sudden confusion
- Severe bleeding: blood in the urine, stool that appears black and sticky, vomit that looks like coffee grounds, bruises that keep getting bigger
The following Winrevair (sotatercept) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
- Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Diarrhea
- Headache
- Nosebleed
Pros and cons of Winrevair (sotatercept)
Pros
- Only taken once every three weeks
- Can inject at home once your PAH specialist knows how you react to the medication
- Can use along with other medications for PAH
Cons
- Must be given as an injection
- Requires regular blood work to make sure your blood cell count is normal
- Shouldn’t take while pregnant or breastfeeding
Pharmacist tips for Winrevair (sotatercept)
- Winrevair (sotatercept) is given as an injection under the skin every 3 weeks by your PAH specialist. Eventually, your PAH specialist may train you or a family member to inject the medication at home. If this is the case, you’ll no longer need to come into the clinic to receive your injection.
- Your PAH specialist will check your blood cell count before each of your first 5 doses and every so often during treatment. These blood tests help make sure Winrevair (sotatercept) is safe for you. Treatment raises the risk of having extra red blood cells, which can lead to blood clots. It can also put you at risk for having too few platelets, which can raise the risk for bleeding.
- If you can get pregnant, make sure to use effective birth control while you’re taking Winrevair (sotatercept) and for at least 4 months after your last dose. This medication can be harmful to an unborn baby.
How to use Winrevair (sotatercept) at home:
- Carefully review the instructions for use or watch the instructional video before you prepare and inject Winrevair (sotatercept) at home. If you have questions about how to use the medication, contact your PAH specialist or ask a pharmacist.
- Each Winrevair (sotatercept) kit has everything you need for one dose. Don't save or reuse any of the materials in the kit for future use. Each kit is for a one-time use only.
- Before you prepare Winrevair (sotatercept) for your injection, remove the kit from the refrigerator and wait 15 minutes for it to reach room temperature (injecting cold medication can be more uncomfortable). Don’t warm up Winrevair (sotatercept) in any other way, since that can damage the medication. As you wait, look at the vials and prefilled syringes to check for damage, leaks, or visible particles inside. If you find any damage, don’t use the kit and call the pharmacy to ask what to do next.
- To prepare Winrevair (sotatercept), attach the prefilled syringe to the vial using the vial adapter. Then, slowly add all of the sterile water to the vial and swirl gently until the powder fully dissolves (don’t shake). Let the vial sit for 3 minutes to get rid of large bubbles. The solution should appear colorless to slightly brownish-yellow. Use the solution within 4 hours. If your kit contains 2 vials, repeat these steps with the second vial.
- Follow your PAH specialist’s instructions to draw up your prescribed Winrevair (sotatercept) dose with the empty syringe and safety needle from the bottom tray. Remove any air bubbles or extra medication from the syringe, if needed.
- To inject Winrevair (sotatercept), swab an area of skin on your belly or upper thigh with an alcohol wipe. Then, pinch the skin and insert the needle at a 45 to 90 degree (diagonal to vertical) angle. Slowly push the plunger all the way down to inject the medication.
- Choose an area of skin to inject Winrevair (sotatercept) into that’s different from your most recent injection. Using different injection sites each time helps prevent skin irritation from repeated injections.
- After each Winrevair (sotatercept) injection, put used needles, syringes, and anything else you used in a red sharps container to prevent injuries to yourself or others. Get rid of the sharps container as recommended in your area.
Common questions about Winrevair (sotatercept)
No, there’s currently no cure for PAH. But there are medications available to help you feel better day-to-day. Winrevair (sotatercept) is one of the medications that can help make it easier for you to exercise and prevent your PAH from getting worse. Some people with very severe PAH whose condition hasn’t improved with medication may qualify for treatment with a lung transplant. Contact your PAH specialist if you have questions about your treatment options.
The Winrevair (sotatercept) kit should be kept in the refrigerator until you’re ready to use it. If needed, unused kits can be outside of the refrigerator at room temperature for up to 24 hours. Don’t store your medication in the freezer.
In a clinical study, people who took Winrevair (sotatercept) for about 6 months had improvements in their PAH, notably in their ability to exercise. At the end of the study, they were able to walk further than people who didn’t take Winrevair (sotatercept). People who took Winrevair (sotatercept) also had a lowered risk of worsening PAH or death than those who didn’t take this medication. Keep in mind that the people in the study were already taking 2 to 3 other medications for PAH, and nearly half were receiving prostacyclin infusions. Follow up with your PAH specialist about your symptoms while taking Winrevair (sotatercept). Be sure to let them know if you feel your symptoms are getting worse.
When your PAH specialist gives you the Winrevair (sotatercept) injection, they can inject it under the skin of your upper arm, upper thigh, or belly (at least 2 inches away from the belly button). When you inject Winrevair (sotatercept) at home, only inject it under the skin of either your belly or upper thigh. Follow your PAH specialist's instructions from training to decide where to inject. Use a different place each time you inject the medication, and choose areas of skin that aren't scarred, tender, bruised, or tattooed. These tips help lessen the risk for skin irritation from repeated injections.
Winrevair (sotatercept) should be given every 3 weeks. If you miss an appointment for your dose, try to schedule a new appointment within 3 days of when you were supposed to get your injection. Similarly, if you’re injecting Winrevair (sotatercept) at home and you miss a dose, give yourself your medication within 3 days of when you were supposed to take it. Setting an alert on your phone or writing down the day you should take your Winrevair (sotatercept) on your calendar can help you remember to take your medication on time. If you haven’t taken Winrevair (sotatercept) within 3 days of your planned date, call your PAH specialist for instructions.
You shouldn’t take Winrevair (sotatercept) while pregnant. Animal studies suggest that the medication can be harmful to your baby. If you’re pregnant or trying to become pregnant, talk to your PAH specialist or obstetrician-gynecologist (OB-GYN) about alternative treatments for your PAH. If you become pregnant while taking Winrevair (sotatercept), call the makers of the medication, Merck Sharp & Dohme, at 1-877-888-4231 to report your pregnancy. Researchers will monitor you to help them find out more about the effects of Winrevair (sotatercept) on pregnancy.
It’s recommended to avoid breastfeeding while you’re taking Winrevair (sotatercept) and for 4 months following your last dose. Scientists don’t know how this medication would affect a breastfed baby. If you’re considering breastfeeding, talk to your PAH specialist or obstetrician-gynecologist (OB-GYN) about other treatments for your PAH or alternatives to breastfeeding, such as baby formula. If you end up breastfeeding while you’re taking Winrevair (sotatercept), contact the makers of the medication, Merck Sharp & Dohme, at 1-877-888-4231 to report it. Researchers at the company can monitor you and your baby to learn more about the effects of Winrevair (sotatercept) on breastfeeding.
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Risks and warnings for Winrevair (sotatercept)
Winrevair (sotatercept) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk for blood clots
Taking Winrevair (sotatercept) can raise the number of red blood cells in your body. Large increases in the number of red blood cells in your body can make you more likely to have a blood clot. It can also make your blood thicker so it doesn’t flow as freely.
Your PAH specialist will check your blood cell count before each Winrevair (sotatercept) injection for at least the first five doses. But they may continue to monitor your blood cell count from time to time during treatment. Based on your lab results, your PAH specialist will let you know whether you need to pause your Winrevair (sotatercept) injections.
Go to the emergency room right away if you experience symptoms of a blood clot, including redness or swelling of the legs, chest pain, difficulty breathing, or weakness of the face.
Risk for serious bleeding
- Risk factors: Low platelet levels | Also receiving prostacyclin therapy | Taking blood thinners
Taking Winrevair (sotatercept) can decrease the number of platelets you have in your body. Because platelets help your blood to clot, having low platelet levels makes you more likely to have serious bleeding.
Your PAH specialist will check your blood cell count before each of your first five doses of Winrevair (sotatercept). But they may continue to monitor your blood cell count every so often during treatment. If your platelet count is too low, your PAH specialist will decide whether you should hold off on your Winrevair dose to lessen your bleeding risk.
Watch out for signs of serious bleeding, such as blood in the urine, stool that appears black and sticky, vomit that looks like coffee grounds, or a bruise that keeps getting bigger. Go to the emergency room right away if you experience any of these symptoms. Additionally, go to the hospital if you fall and hit your head. Tell the care team that you fell so they know to check for any bleeding in the brain, even if you feel okay.
Harmful during pregnancy
Studies in animals showed that Winrevair (sotatercept) can harm an unborn baby if it’s taken during pregnancy. If you’re able to get pregnant, it’s recommended that you take a pregnancy test before starting this medication. Also use effective birth control while taking Winrevair (sotatercept) and for at least four months after your last dose of the medication. If you think you may be pregnant or plan to become pregnant, talk to your PAH specialist or obstetrician-gynecologist (OB-GYN) about alternative treatment options.
Possible difficulty getting pregnant
Studies done in animals found that taking Winrevair (sotatercept) can make it more difficult to get pregnant or to get someone else pregnant. Animal studies showed that the change may be reversible after stopping the medication. Talk to your PAH specialist or OB-GYN about other medication options if you’re interested in having a baby while taking Winrevair (sotatercept).
Winrevair (sotatercept) dosage
Typical dosage for Winrevair (sotatercept)
In general, Winrevair (sotatercept) is injected under the skin every 3 weeks. Your PAH specialist will give injections into your belly, upper thigh, or upper arm. They can also train you to inject the medication on your own (under the skin of either your belly or upper thigh only).
Your dose will be based on your weight in kilograms (kg). The first dose is typically 0.3 mg/kg injected under the skin. Three weeks after that, the typical dose is 0.7 mg/kg injected under the skin every 3 weeks as a maintenance dose.
Note: Since Winrevair (sotatercept) is drawn up into a dosing syringe with milliliter (mL) markings, your PAH specialist will prescribe the medication using mL units.
Your PAH specialist may temporarily pause or adjust your dose depending on your blood test results and your risk for side effects.
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