Garetosmab-grts Injection

Garetosmab-grts injection is used to reduce formation of new lesions and flare-ups in patients with fibrodysplasia ossificans progressiva (FOP; genetic disorder where muscles, tendons, ligaments and other connective tissue are replaced by bone). Garetosmab-grts is in a class of medications called activin signaling inhibitors. It works by stopping the formation and progression of bony lesions.

Garetosmab-grts injection comes as a solution to be given intravenously (into the vein) by a doctor or nurse at a hospital or clinic. It is given over 60 minutes once every 4 weeks.

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

Before receiving garetosmab-grts injection,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are receiving garetosmab-grts. You may have to take a pregnancy test before starting treatment and during treatment. You should use effective birth control to prevent pregnancy during your treatment and for 6 months after your final dose. Talk to your doctor about the best birth control method for you. If you become pregnant while receiving garetosmab-grts, call your doctor immediately. Garetosmab-grts may harm the fetus.
• do not breastfeed during treatment and for 6 months after your final dose of garetosmab-grts.
• you should know that garetosmab-grts injection may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving garetosmab-grts injection.
• garetosmab-grts injection may cause nosebleeds, including severe nosebleeds that last a long time. If you experience a nosebleed that lasts longer than 20 minutes and does not stop with first-aid procedures, you should seek medical care.

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

If you miss a scheduled dose of garetosmab-grts injection, call your doctor or clinic right away to schedule a new dose. Your next 4 week dose will be scheduled from that date.

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

• acne
• increased hair growth
• eyebrow or eyelash hair loss
• ulcers on mouth, lips or tongue
• infections of the nail or nailbed
• rash

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

• fever; swelling or pain or redness of skin; painful swollen lump under the skin

Garetosmab-grts injection 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 all appointments with your doctor.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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