Sotatercept-csrk Injection

Sotatercept-csrk is used to treat pulmonary arterial hypertension (PAH; high blood pressure in the vessels carrying blood to the lungs, causing shortness of breath, dizziness, and tiredness) in adults. Sotatercept-csrk may improve the ability to exercise and slow the worsening of symptoms in individuals with PAH. Sotatercept-csrk is in a class of medications called activin signaling inhibitors. It works by blocking certain substances to slow or stop the tissue changes that happen with PAH.

Sotatercept-csrk comes as a solution (liquid) to inject subcutaneously (just under the skin). It is usually given once every 3 weeks. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use sotatercept-csrk exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Your doctor will may start you on a low dose of sotatercept-csrk and gradually increase your dose, not more than once every 3 weeks. Your dose may be changed or treatment delayed for at least 3 weeks or stopped based on the results of your lab tests.

Sotatercept-csrk controls PAH but does not cure it. Continue to use sotatercept-csrk even if you feel well. Do not stop using sotatercept-csrk without talking to your doctor. If you suddenly stop using sotatercept-csrk, your PAH will become worse.

Your doctor or nurse will show you or a caregiver how to mix and inject a dose of sotatercept-csrk injection at home. Before you use sotatercept-csrk injection for the first time, you or the person who will be giving the injections should read the manufacturer's information for the patient that comes with it. These instructions describe how to mix and inject a dose of sotatercept-csrk. Be sure that you understand these directions. Ask your healthcare provider if you have any questions about when you should use the medication, where on your body you should inject the medication, how to give the injection, or what type of syringe and needle to use.

To use the injection, follow these steps:

1. Remove your medication from the refrigerator and wait 15 minutes before injecting your dose.
2. Wash your hands before preparing and injecting the medication.
3. Follow the manufacturer's information for mixing and preparing the syringe for your dose.
4. Select a place for injection on the abdomen (stomach area) at least 2 inches away from your navel, or your upper thigh. Make sure this place is not scarred, tender, or bruised.
5. Clean the place for injection with a new alcohol wipe.
6. Gently pinch and hold a fold of skin where you will inject the medication. Insert the needle at a 45 to 90 degree angle.
7. Push the plunger with slow, steady pressure all the way down until the dosing syringe is empty.
8. Dispose of the syringe and used items in the appropriate container.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before using sotatercept-csrk,

• tell your doctor and pharmacist if you are allergic to sotatercept-csrk, any other medications, or any of the ingredients in the solution. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while using sotatercept-csrk. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had any medical conditions.
• tell your doctor if you are pregnant, plan to become pregnant. You should not become pregnant while you are receiving sotatercept-csrk injection. If you are a woman who is able to become pregnant, you must take a pregnancy test before starting treatment and use effective birth control during your treatment and for 4 months after your final dose. Talk to your doctor about birth control methods that will work for you. If you become pregnant while taking sotatercept-csrk, call your doctor.
• tell your doctor if you are breastfeeding. You should not breastfeed while you are receiving sotatercept-csrk injection and for 4 months after your final dose.
• you should know that this medication has caused decreased fertility in males and females based on animal studies.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking sotatercept-csr.

Unless your doctor tells you otherwise, continue your normal diet.

If it is within 3 days of your scheduled dose, use the missed dose as soon as you remember it. If it is greater than 3 days, give the dose and adjust your schedule to maintain a 3 weeks between doses. Do not use a double dose to make up for a missed one.

Sotatercept-csrk may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• nose bleeds
• rash or redness on the skin
• tiny blood vessels that look like pink or red lines on the skin (spider veins)
• bruising easily
• diarrhea
• dizziness

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• vomiting blood or your vomit looks like coffee-grounds
• pink or brown urine
• red or black stools that look like tar
• coughing up blood or blood clots
• dizziness or feeling weak
• persistent abdominal cramps
• severe back pain
• heavy menstrual bleeding

Sotatercept-csrk may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it in the refrigerator and do not freeze. Unused medication may be kept out of the refrigerator for up to 24 hours.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• high levels of red blood cells

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to sotatercept-csrk.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking sotatercept-csrk.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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