Imetelstat Injection

Imetelstat injection is used to treat certain types of myelodysplastic syndrome (MDS) with transfusion-dependent anemia that have not responded to or cannot receive other therapies used for MDS. Imetelstat is in a class of medications called telomerase inhibitors. It works by stopping the production of unhealthy red blood cells.

Imetelstat comes as a powder to be mixed with a liquid and given intravenously (into the vein) by a doctor or nurse at a healthcare clinic or hospital. It is usually given over 2 hours every 4 weeks. You will be given other medicines prior to receiving your imetelstat infusion to help keep you from having side effects. Your doctor or nurse will watch you for one hour after your infusion is complete. It is important you tell your doctor or nurse how you are feeling during and after your imetelstat infusion.

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

Before receiving imetelstat,

• tell your doctor and pharmacist if you are allergic to imetelstat, any other medications, or any of the ingredients in imetelstat injection. Ask your pharmacist or check the Medication Guide 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.
• tell your doctor if you are pregnant or plan to become pregnant. You will need to have a pregnancy test before you receive this medication. You should not become pregnant during your treatment with imetelstat and for at least 1 week after your final dose. Talk to your doctor about types of birth control that will work for you. If you become pregnant while using imetelstat, call your doctor immediately. Imetelstat may harm the fetus.
• tell your doctor if you are breastfeeding. Do not breastfeed while receiving imetelstat and for at least 1 week after your final dose.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking imetelstat.
• do not have any vaccinations without talking to your doctor.

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

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

• tiredness
• joint, bone and muscle pain
• runny nose, congestion, sore throat, or cough
• headache

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

• unusual bleeding or bruising, bleeding that lasts a long time, nosebleeds, bleeding gums, vomiting or coughing up blood, or blood in your stool or having dark, tarry stools
• fever, shortness of breath, cough, chills, or pain or burning when urinating

Imetelstat 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 and the laboratory. Your doctor will order certain lab tests to check your body's response to imetelstat. If you miss a scheduled imetelstat infusion, call your doctor right away.

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

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.

• Rytelo^®