Imetelstat

Who should not take RYTELO?
Before taking RYTELO, tell your healthcare provider about all your medical conditions, including if you:

• are pregnant or plan to become pregnant. RYTELO may harm your unborn baby and may cause loss of pregnancy. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with RYTELO.
• are breastfeeding or plan to breastfeed. It is not known if RYTELO passes into breastmilk. Do not breastfeed during treatment with RYTELO or for 1 week after the last dose.

Females who are able to become pregnant:

• your healthcare provider will perform a pregnancy test before you start RYTELO
• you should use effective birth control during treatment with RYTELO and for 1 week after your last dose

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist pharmacist: A highly trained and licensed professional whose job concerns the preparation, distribution, and use of prescription drugs. A pharmacist also advises patients, as well as physicians and other health practitioners, on the selection, dosages, interactions, and side effects of medications. when you get a new medicine.

How will I take RYTELO?

• RYTELO will be given as an intravenous infusion intravenous infusion: A method of getting fluids or medicines directly into the bloodstream over a period of time. Also called IV infusion. into your vein over a period of 2 hours by a healthcare provider.
• RYTELO is usually given every 4 weeks.
• Your healthcare provider will prescribe RYTELO in a dose that is right for you and may change your dose, change dosage schedule or stop treatment based upon how you respond to RYTELO.
• During treatment with RYTELO, your healthcare provider will do certain blood tests to check for side effects and to see how well you are responding to treatment.
• Your healthcare team will help to decide how long you are treated with RYTELO.

What are the possible side effects of RYTELO?
RTYELO may cause serious cause side effects, including:

• low platelet platelet: The smallest type of blood cell. Platelets help the blood to clot and stop bleeding. Also called a thrombocyte. count
• low neutrophil neutrophil: (NOO-truh-fil) The most numerous of the white blood cells, important for helping the body fight infections (particularly bacterial and fungal infections. count

Your healthcare provider will do blood tests to check your platelet and neutrophil counts before you start treatment, at least weekly for the first 2 cycles, before you receive each additional cycle and as needed during treatment. Treatment may be delayed, decrease in dosage or stopped if you develop thrombocytopenia thrombocytopenia: (throm-buh-sie-tuh-PEE-nee-uh) A condition in which there is a shortage of platelets in the bloodstream. This results in a low platelet count. Bleeding and bruising often occur with thrombocytopenia. (low platelets) or neutropenia neutropenia: (noo-truh-PEE-nee-uh) A condition in which there is a shortage of neutrophils in the bloodstream. Neutrophils are a type of white blood cell. This results in a low white blood cell count. (low neutropenia).

• Infusion related reactions – these can occur during or after treatment that can be severe which include a sudden increase in blood pressure called hypertensive crisis. Your healthcare team will give you medicine before treatment to prevent or lessen infusion related reactions and watch you for 1 hour after your RYTELO infusion.

The most common side effects of RYTELO are:

• decreased white cell blood count, neutrophil count and platelet count
• increased liver enzymes
• tiredness
• abnormal blood coagulation tests
• joint, muscle and bone pain
• COVID 19 infections
• headache 

RYTELO can cause fertility problems in females and could affect your ability to get pregnant. Talk to your healthcare provider if this is a concern for you.
Tell your healthcare provider about any side effects that bother you or that do not go away.

These are not all the possible side effects of RYTELO.

Call your doctor for medical advice about side effects.

What are the ingredients in RYTELO?
Active ingredient: Imetelstat

Inactive ingredients:

•  47 mg: sodium carbonate anhydrous or hydrochloric acid may be added during manufacturing to adjust the pH
• 188 mg: sodium carbonate monohydrate or hydrochloric acid may be added during manufacturing to adjust the pH