Winrevair 60 mg subcutaneous kit

Generic name:
Sotatercept - injection

Pronunciation
(soe-TAT-er-sept)

Brand name(s)
Winrevair

This medication is used to treat high blood pressure in the lungs (pulmonary arterial hypertension-PAH). Sotatercept helps to improve your ability to exercise and to slow down worsening of PAH.

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using sotatercept and each time you get a refill. Ask your health care professional how to prepare and use this medication. If you have any questions, ask your doctor or pharmacist.

Inject this medication under the skin as directed by your doctor, usually once every 3 weeks. The injection is given in the upper thigh or abdomen (at least 2 inches from your belly button). The dosage is based on your medical condition, labs, weight, and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.

Take the carton containing the medication and the solution used to mix the medication out of the refrigerator 15 minutes before you mix the product to allow it to reach room temperature. After mixing, gently swirl to completely dissolve the powder. Do not shake. Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Use the mixed medication as soon as possible, but no later than 4 hours after mixing. Before injecting each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into skin that is tender, bruised, or red. To lessen bruising, do not rub the injection site after a shot. Learn how to store and discard medical supplies safely.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

Tell your doctor if your condition does not get better or if it gets worse.

Pain/redness/swelling at the injection site, headache, diarrhea, nosebleeds, spider veins (telangiectasia), or dizziness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• easy bruising/bleeding
• bloody/black stools
• vomit that looks like coffee grounds

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using sotatercept, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• bleeding problems
• blood disorders

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using sotatercept. Sotatercept may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Ask about reliable forms of birth control while using this medication and for 4 months after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication and for 4 months after the last dose. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Keep all regular medical and lab appointments.

Lab and/or medical tests (such as complete blood count) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose and it is within 3 days after the missed dose, use it as soon as you remember and then use your next dose at the regular time. If it is more than 3 days after the missed dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

Store in the refrigerator. Do not freeze. Keep the medication in the original packaging to protect from light. If the medication is taken out of the refrigerator, discard after 24 hours. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.