Sotatercept-csrk (soe-TAT-er-sept - csrk)

Treats pulmonary arterial hypertension.

Brand Name(s):

Winrevair

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. It is usually given in the stomach, thigh, or upper arm.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• Allow 15 minutes for the kit to warm up to room temperature.
• Check the powder in the vial. It should be white to off-white. Do not use if it is damaged, discolored, or has particles in it.
• This powder medicine must be mixed with the liquid provided in your dose kit. Mix the medicine only when you are ready to use it. Check the mixed liquid in the vial. It should be clear to slightly pearly and colorless to slightly brownish-yellow. Do not use if it has clumps or powder in it.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into skin areas that are bruised, damaged, sore, tender, or has red patches.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If you miss a dose, and it has been less than 3 days, use it as soon as possible then go back to your regular dosing schedule for the next dose. If you miss a dose, and it has been more than 3 days, ask your doctor for instructions.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. You may store the kit at room temperature for up to 24 hours. You may use the mixed medicine right away. Throw away unused medicine if it has been more than 4 hours after mixing.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this treatment. Use an effective form of birth control during treatment with this medicine and for 4 months after the last dose to keep from getting pregnant.
• Do not breastfeed during treatment and for 4 months after the last dose.
• This medicine may cause the following problems:
  • Erythrocytosis (high amount of red blood cells)
  • Serious bleeding problems (including stomach or bowel bleeding, intracranial hemorrhage)
• This medicine lowers the number of certain blood cells, so you may bleed or bruise more easily. Be careful to avoid injuries.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Black, tarry stools, vomiting of blood or material that looks like coffee grounds
• Confusion, headache, nausea, vomiting
• Dizziness, fainting, trouble breathing, uneven heartbeat
• Raised, dark red, wart-like spots on skin
• Nosebleeds, unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Diarrhea
• Redness, pain, itching, swelling, or skin changes where the shot is given

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088