Sotatercept

Sotatercept is used in adults to treat pulmonary arterial hypertension (PAH). sotatercept helps you exercise better, allows you to do everyday activities more easily, and can help stop your condition from getting worse.

Sotatercept may also be used for reasons not mentioned in this medication guide.

Follow all instructions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Sotatercept is injected under the skin, usually once every 3 weeks. A healthcare provider may give you this injection or may teach you how to properly use this medicine by yourself.

Do not use this medicine more often than prescribed.

Your blood will need to be tested before your first 5 doses of sotatercept and longer if needed. Your treatment schedule may be delayed or changed based on the results.

Doses are based on weight. Your dose may change if you gain or lose weight.

Your dose should be given as 1 or 2 injections under the skin to receive the full dose. Do not inject into the same place two times in a row. Do not give an injection into skin that is scarred, bruised, or tender.

Read and carefully follow any Instructions for Use before preparing and giving your first dose. Prepare an injection only when you are ready to give it. Ask your doctor or pharmacist if you do not understand these instructions.

Be sure you understand how to properly mix and store this medicine with a liquid (diluent) and how to store the mixture. Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it.

Take the medicine out of the refrigerator and let it reach room temperature for 15 minutes before using. Do not leave the medicine out for longer than 24 hours.

Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

You should not change your dose or stop using sotatercept suddenly. Follow your doctor's instructions.

Sotatercept can make it easier for you to bleed, even from a minor injury. Call your doctor if you have bruising or any bleeding that will not stop.

Store the medicine in the original container in the refrigerator. Protect from light and do not freeze.

Use only as directed. Inform your doctor if you are taking any other medicines or have other medical conditions or allergies.

Tell your doctor if you have or have ever had:

• active or uncontrolled bleeding;
• a history of low levels of platelets in your blood; or
• any other medical condition or take any medicine.

Sotatercept may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using sotatercept.

It may harm an unborn baby. You may need a pregnancy test to confirm you are not pregnant. Use effective birth control while using sotatercept and for at least 4 months after your last dose. Tell your doctor if you become pregnant or plan to become pregnant.

Do not breastfeed while using this medicine, and for at least 4 months after your last dose.

If you use sotatercept during pregnancy or while breastfeeding, your name may be listed on a drug exposure registry to track the effects of sotatercept on the baby.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Sotatercept can raise your hemoglobin levels, which can increase your risk of blood clots. Seek emergency medical help if you have:

• signs of a blood clot in the lung--chest pain, sudden cough or shortness of breath, dizziness, coughing up blood; or
• signs of a blood clot deep in the body--pain, swelling, or warmth in one leg.

Sotatercept may cause serious side effects. Call your doctor at once if you have:

• easy bruising, bleeding that will not stop, purple or red spots under your skin;
• sudden weakness (especially on one side of the body), severe headache, problems with speech or vision, pounding in your neck or ears; or
• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Your treatment may be permanently discontinued if you have certain side effects.

Common side effects of sotatercept may include:

• headache, dizziness;
• nosebleed;
• skin rash, skin redness;
• small, visible blood vessels on the skin (spider veins); or
• diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Pulmonary Hypertension:

Initial dose: 0.3 mg/kg subcutaneously every 3 weeksMaintenance target dose: 0.7 mg/kg subcutaneously every 3 weeksComments:-Obtain hemoglobin and platelet count prior to the first dose; do not initiate treatment if platelet count is less than 50,000/mm3 (less than 50 x 10[9]/L).-Increase to maintenance dose only after verifying acceptable hemoglobin and platelet count.-Injection volume equals patient body weight (kg) multiplied by dose (mg/kg), then divided by 50 mg/mL; round volume to nearest 0.1 mL.-Consult the manufacturer product information for dose calculation examples and kit type recommendations.Use: For the treatment of pulmonary arterial hypertension (PAH, Group 1 pulmonary hypertension) to improve exercise capacity and WHO functional class, and reduce the risk of clinical worsening events, including hospitalization for PAH, lung transplantation, and death

Use the medicine as soon as you remember, and then return to your regular schedule. Do not take two doses at the same time.

Contact your doctor for guidance if you are more than 3 days late for the dose or if you are uncertain whether the correct dose was taken.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid activities that may increase your risk of bleeding or injury. Use extra care while shaving or brushing your teeth.

Many drugs may increase the risk of bleeding when taken with sotatercept. Inform your doctor about all your other medicines, especially:

• medicines used to prevent blood clots--alteplase, clopidogrel, dipyridamole, ticlopidine, and others; or
• any other medicines to treat pulmonary arterial hypertension.

This list is not complete. Other drugs may affect sotatercept, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.