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Sotatercept Injection (SOTATERCEPT - INJECTION)

For high blood pressure in the lungs.

Brand Name(s): Winrevair

Generic Name: Sotatercept-csrk

Instructions

This medicine is injected into the skin. Ask your doctor, nurse, or pharmacist where on your body this medicine can be injected and how to inject it.

Read and make sure you understand the instructions for measuring dose and using syringe. If you have any questions, talk to your doctor, nurse, or pharmacist.

Dilute the powder with the liquid provided. Gently swirl the vial until the medicine is completely dissolved. Do not shake the vial.

Always inspect the medicine before using.

The liquid should be clear and colorless to light yellow-brown.

Do not use the medicine if it contains any particles or if it has changed color.

Keep medicine in refrigerator. Do not freeze. Protect from light.

Keep the medicine in its original container.

Take the medicine out of the refrigerator about 15 minutes before use to warm to room temperature.

Discard unused medicine after 24 hours at room temperature.

Never use any medicine that has expired.

Discard any unused, mixed medicine after 4 hours.

Wash your hands before and after handling this medicine.

Do not inject into skin that is bruised, tender, red, hard or has scars or stretch marks.

Avoid injecting the medicine within 2 inches around the navel.

Change the location of the injection each time. Choose a location at least 1 inch from the last injection.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you miss a dose, contact your doctor for instructions.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Do not use the medication any more than instructed.

Your ability to stay alert or to react quickly may be impaired by this medicine. Do not drive or operate machinery until you know how this medicine will affect you.

Please check with your doctor before drinking alcohol while on this medicine.

Do not breastfeed while on this medicine. You may safely start breastfeeding 4 months after stopping treatment.

This medicine can hurt a new baby in the womb. If you become pregnant while on this medicine, tell your doctor immediately. Your doctor may switch you to a different medicine.

Women of childbearing age should have a negative pregnancy test before starting this medicine.

Women must use reliable forms of birth control while using this medicine and for 4 months after stopping to prevent pregnancy.

Ask your doctor, nurse or pharmacist how to safely discard unused medicines, needles and syringes.

Do not share this medicine with anyone who has not been prescribed this medicine.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

  • diarrhea
  • dizziness
  • nosebleeds
  • headaches
  • pain, redness, swelling near injection

Call your doctor or get medical help right away if you notice any of these more serious side effects:

  • bleeding or bruising
  • coughing up blood or vomit that looks like coffee grounds
  • bloody or dark, tarry stools

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.

Please speak with your doctor, nurse, or pharmacist if you have any questions about this medicine.