Imetelstat (im-e-TEL-stat)

Treats myelodysplastic syndromes (MDS) in patients with anemia.

Brand Name(s):

Rytelo

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein. This must be given slowly, so the IV should remain in place for at least 2 hours.
• A nurse or other health provider will give you this medicine.
• You may also receive other medicines (including allergy medicine, steroid) 30 minutes before starting treatment with this medicine to help prevent infusion-related reactions.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before giving you this medicine. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for 1 week after the last dose.
• Do not breastfeed during treatment with this medicine and for 1 week after the last dose.
• Tell your doctor if you have kidney disease or liver disease.
• This medicine may cause infusion-related reactions.
• Some female patients who receive this medicine have become infertile (unable to have children). Talk with your doctor if you plan to have children.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Back or chest pain
• Bone, muscle, or joint pain
• Blurred vision, headache, fast or slow heartbeat, nervousness, pounding in the ears
• Fever, chills, cough, sore throat, body aches
• Diarrhea, stomach pain
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088