Imetelstat

Imetelstat is used in adults to treat myelodysplastic syndromes that come with a certain type of anemia requiring a transfusion, and it is typically given after other treatments have not worked.

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

Follow all directions on your prescription label and read all medication guides or instruction sheets.

Your doctor will perform tests to ensure imetelstat is the right treatment for you.

Imetelstat is given slowly over 2 hours as an infusion into a vein, usually once every 4 weeks. A healthcare provider will administer this injection.

You will need frequent medical tests, and your next dose may be delayed or permanently stopped based on the results.

You may be given other medications to help prevent serious side effects or allergic reactions. Keep taking these medicines for as long as your doctor has prescribed.

Store this medicine in the original container in the refrigerator, away from moisture, heat, and light. Do not freeze.

Imetelstat can increase your risk of bleeding, even from small cuts. Contact your doctor if you have bleeding that does not stop. Internal bleeding may also occur, such as in your stomach, intestines, or brain.

You may be more likely to get infections, including serious or life-threatening ones. Call your doctor if you experience flu-like symptoms, a cough, night sweats, stiff neck, confusion, or vision issues.

Tell your doctor if you have or have ever had:

• easy bruising, unusual bleeding; or
• an active or chronic infection.

May cause pregnancy problems such as miscarriage or harm an unborn baby. You may need a pregnancy test to make sure you are not pregnant. Use effective birth control while using imetelstat and for at least 1 week after your last dose. Tell your doctor if you become pregnant.

It may be harder for you to get pregnant while you are using imetelstat. You should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

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

Some side effects may occur during the injection. Tell your medical caregiver if you feel dizzy, nauseous, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Tell your medical caregivers right away if you have:

• bruising, unusual bleeding;
• nosebleeds, any bleeding that will not stop;
• pain or burning when you urinate;
• blood in your vomit;
• bloody or tarry stools;
• diarrhea, stomach pain;
• bone or joint pain;
• redness;
• high blood pressure;
• chest pain not related to your heart; or
• fever, cough, chills, not feeling well, tiredness, weakness.

Your imetelstat treatments may be changed, delayed, or permanently stopped if you have certain side effects.

Common side effects of imetelstat may include:

• abnormal lab results;
• headache;
• muscle, joint, or bone pain;
• tiredness; or
• bacterial or viral infection.

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 the FDA at 1-800-FDA-1088.

Usual Adult Dose for Myelodysplastic Syndrome:

7.1 mg/kg IV every 4 weeksDuration of therapy: Discontinue if patient does not experience a decreased RBC transfusion burden after 24 weeks of treatment (i.e., 6 doses), or if unacceptable toxicity occursComments:-Administer as an IV infusion over 2 hours; monitor patient for at least 1 hour after infusion completion. -Pretreatment medications are recommended to reduce or prevent infusion-related reactions. -Assess CBC and liver function tests prior to administration, and then as recommended. Use: For the treatment of low- to intermediate-1 risk myelodysplastic syndromes with transfusion-dependent anemia requiring 4 or more red blood cell units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents

Call your doctor for instructions if you miss your appointment for the imetelstat injection.

In a medical setting, an overdose would be treated quickly.

Follow your doctor's instructions regarding any limits on food, drinks, or activities.

Other drugs may affect imetelstat, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are using.