Winrevair, also known as sotatercept-csrk, is a medicine used to treat pulmonary arterial hypertension (PAH), which causes high blood pressure in the arteries that go from your heart to your lungs.
Winrevair is available as an injection given by a health care provider or by you or your caregiver after getting trained on the injection technique.
Below you’ll find common questions and answers about Winrevair.
What Type of Pulmonary Arterial Hypertension Is Winrevair Used For?
Pulmonary arterial hypertension is categorized into groups by the World Health Organization based on the cause of the symptoms. Winrevair is approved for the treatment of people who have Group 1 pulmonary arterial hypertension, which is caused by narrowness, thickening, or stiffness in the arteries in the lungs.
Pulmonary arterial hypertension is also categorized by functional class based on the types of physical activity people are able to perform. These are known as functional classes and they include I, II, III, and IV.
- If your pulmonary arterial hypertension is classified as I, this means there is no limitation on your physical activity. You are able to participate in ordinary physical activity without being short of breath, tired, or having chest pain or fainting.
- If your pulmonary arterial hypertension is classified as II, you may be comfortable when resting, but ordinary physical activity may cause shortness of breath, tiredness, chest pain, or near fainting.
- If your pulmonary arterial hypertension is classified as III, you may be comfortable at rest, but less than ordinary physical activity may cause shortness of breath, tiredness, chest pain, or near fainting.
- If your pulmonary arterial hypertension is classified as IV, you are unable to carry out any physical activity without having symptoms. You may have shortness of breath and tiredness at rest. Any type of physical activity can cause discomfort and fainting.
How Does Winrevair Work for Pulmonary Arterial Hypertension?
In people with pulmonary arterial hypertension, there is high blood pressure in the arteries that go from your heart to your lungs. This can cause your heart to work harder to pump blood through the arteries, which can cause your heart to become weaker over time. Over time, this may cause heart failure. Winrevair is the first medicine in a new class of medicines used in people with pulmonary arterial hypertension. It can open up narrowed blood vessels, which can help blood flow through more easily. As a result, you may be able to exercise more or perform ordinary activities with less symptoms.
How Is Winrevair Given?
Winrevair is an injection given subcutaneously, meaning just below the skin. It comes in a kit that contains the medicine in the form of a powder, a prefilled syringe that contains sterile water for injection, and supplies needed to mix and give the injection.
Your health care provider may give this medicine to you, or it can be given by yourself or a caregiver. Your health care provider will determine which option is best. If you or a caregiver will be giving the medicine, you will be trained on the proper way to mix and give the medicine. Follow all instructions that your health care provider gives you.
You will need to have blood taken for some lab tests before you receive your first five doses, and occasionally after that. Your health care provider will decide when you need to have your blood tested.
You will receive or give yourself this medicine every three weeks. The dose is based on your weight and may also be based on the results of laboratory tests. It can be given in the stomach (at least 2 inches from your belly button), the upper thigh, or the upper arm. Your health care provider will decide how often you will get treatment and what the dose will be.
How Was Winrevair Studied?
Winrevair was studied in a trial that included over 300 people who had pulmonary arterial hypertension that was classified as Group 1, functional class II or III, by the World Health Organization. All people were receiving treatment for their pulmonary arterial hypertension for at least 90 days before starting the trial. They were allowed to continue this treatment during the trial. About half of the people in this trial received Winrevair and about half received a placebo injection, which did not contain any medicine.
The people who received Winrevair in this trial received 0.3 milligrams per kilogram of their weight for the first dose. Starting with the second dose, people received 0.7 milligrams per kilogram, which was continued unless the dose needed to be reduced.
The six-minute walk distance was used to determine the effects of Winrevair. This test measures how far you can walk in six minutes. This distance was measured for each person at the beginning of the trial and after 24 weeks to see if there was any improvement.
What Types of People Were in These Studies?
Here are some characteristics of people who participated in these studies.
- The average age was 47.9.
- About 79% of people in these studies were female.
- Most people were White (89%), with 2% Black/African American, 2% Asian, 0.3% American Indian or Alaska Native, 0.3% Native Hawaiian, and 6% Missing/Other.
- About half were in functional class II (48.6%) and half in functional class III (51.4%).
- About 40% were taking epoprostenol or treprostinil for their pulmonary arterial hypertension.
- Most were using three medicines for their pulmonary arterial hypertension (61.3%) and about a third were using two medicines (34.7%). A small percentage were only using one medicine for their pulmonary arterial hypertension (4%).
- At the start of the trial, people were able to walk about 400 meters on the six-minute walk distance test (401.1 meters).
What Benefits Were Seen in These Studies?
People who were treated with Winrevair were able to walk about 34.4 more meters at the end of the 24-week trial compared to only 1 more meter for those who received the placebo injection.
The number of people who died or had a clinical worsening event was compared in this study. Clinical worsening event meant any symptom that led to patients becoming sicker, such as the need for a lung or heart transplant, the need for other medicines, the need for higher doses of medicine, hospitalization, surgery, or worsening of pulmonary arterial hypertension, for example.
The total number of people in this study who died or had at least one clinical worsening event was lower for people who received Winrevair than those who received the placebo injections. A total of nine people who received Winrevair died or experienced a clinical worsening event compared to 42 who received a placebo injection.
Two people died who were receiving Winrevair compared to seven who were receiving the placebo injections.
More people who received placebo injections had to add a new medicine or increase their dose compared to those who received Winrevair.
Placebo | Winrevair |
10.6% | 1.2% |
More people who received a placebo had a hospital stay of at least a day for their pulmonary arterial hypertension compared to those who received Winrevair.
Placebo | Winrevair |
5% | 0% |
More people who received placebo had their pulmonary arterial hypertension get worse compared to those who received Winrevair.
Placebo | Winrevair |
9.4% | 2.5% |
What Are the Side Effects of Winrevair, and How Can I Manage Them?
The most common side effects seen with Winrevair were headache, nosebleeds, rash, spider veins, diarrhea, dizziness, or skin redness.
To help prevent headaches, be sure to get enough sleep at night, exercise regularly, eat regular meals, drink plenty of water, and limit stress.
If you get a nosebleed, stay calm. Try not to lie down but lean a little forward to help keep the blood from draining down your throat. Pinch your nostrils to close them and hold for 5 to 10 minutes. You will need to breathe through your mouth. After the bleeding has stopped, gently blow your nose to remove any clots.
Compression stockings and physical exercise may help with spider veins. In addition, try not to stand or wear high heels for long periods of time. Elevate your legs when possible, and try not to cross them.
If you get diarrhea, you can try the BRAT diet – bananas, rice, applesauce and toast. Try to avoid foods that are spicy, fried, fatty, citrus, or vegetables that can cause gas (beans, cabbage, Brussels sprouts). Also avoid dairy and foods and drinks that are high in sugar or caffeine.
Contact your pharmacist or health care provider if you are experiencing dizziness. Be sure you are getting enough fluids and eating enough. Do not drive while you are feeling dizzy.
Winrevair may increase your hemoglobin levels or decrease your platelet levels. You may have to have your blood taken before your dose to measure your hemoglobin and platelets.
Winrevair may cause serious bleeding. Call your health care provider right away if you have any of the following signs of severe bleeding while taking 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
Do not take Winrevir if you are pregnant, as it can cause harm to a fetus. Talk to your health care provider if you are pregnant, planning to get pregnant, or become pregnant while using Winrevair. You should use effective birth control while taking Winrevair and for at least four months after your last dose.
Winrevair may affect your ability to get pregnant. Talk to your health care provider if this is an important concern for you.
These are not all of the possible side effects of Winrevair. Talk with your health care provider if you are having symptoms that bother you. If you experience anything that you think may be caused by Winrevair, you can also report side effects to the FDA at 800-FDA-1088 (800-332-1088).
How Do I Get Winrevair?
Winrevair can be obtained from specialty pharmacies that will ship the medicine directly to you. The specialty pharmacy will work directly with you and your health care team. It is important to answer all calls that you receive from your specialty pharmacy.
Is There Any Cost Assistance Available?
There may be cost assistance to help you afford Winrevair. You may have options even if you do not have health insurance. The Merck Access Program provides insurance support during treatment and helps eligible people with financial assistance, if eligible. Your health care provider will help you get started. Call 888-637-2502 for more information.
