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Overview: Rytelo is used to treat certain people with myelodysplastic syndromes (MDS). Tiredness, headache, and muscle or joint pain are common side effects. Get all the bloodwork that your health care provider orders for you. This medicine can cause dangerous side effects that can be picked up by blood tests. Tell your health care provider right away if you think that you may have an infection or get any unusual bleeding or bruising.

Uses

What is Rytelo used for?

Rytelo (imetelstat) is commonly used for certain people with myelodysplastic syndromes (MDS).

Rytelo may also be used for other conditions as determined by your health care provider.

How does Rytelo work (mechanism of action)?

Rytelo blocks an enzyme whose activity is increased in certain cells, such as cancerous cells in your bone marrow. This medicine lowers the ability of these cancerous cells to multiply and also causes their death.

How is Rytelo supplied (dosage forms)?

Rytelo is available in an injectable form that is given by a healthcare provider.

How should I store Rytelo?

Rytelo is usually given by a health care provider in a hospital or clinic. You will not store it at home.

Side Effects

What are the most common side effects of Rytelo?

The most common side effects of Rytelo are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Low platelet levels (see below)
  • Low neutrophil levels (see below)
  • Tiredness
  • Muscle, joint, or bone pain
  • Headache
  • High liver enzymes

There may be other side effects of Rytelo that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Rytelo?

While less common, the most serious side effects of Rytelo are described below, along with what to do if they happen.

Severe Allergic Reactions. Rytelo may cause allergic reactions, which can be serious. Get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Low Platelet Levels. Rytelo can cause you to have a severely low number of platelets in your blood, also called thrombocytopenia. Platelets help to form blood clots. Having a low level of platelets may increase your risk of bleeding. Keep all appointments to have your blood checked. Tell your health care provider if you have any of the following symptoms of low platelet levels.

  • Easy bruising or bleeding
  • Bleeding that does not stop
  • Nosebleeds
  • Blood in your pee (urine), poop (stool), or vomit

Low Neutrophil Levels (Neutropenia). Rytelo may cause low levels of a type of white blood cell (called neutrophils), which is known as neutropenia. Neutrophils help prevent infection. Having a low level of neutrophils may increase your risk of infection, including life-threatening infections. Keep all appointments to have your blood checked. Tell your health care provider right away if you have any of the following symptoms of low neutrophil levels.

  • Fever, chills, or sweats
  • Tiredness
  • Sore throat, cough, or shortness of breath
  • Mouth or throat sores
  • Swollen lymph nodes
  • Pain or a burning feeling when you pee

Infusion Reactions. Rytelo can cause reactions that can be serious when it is given to you. Take any medicines your health care provider may give you to take before each infusion. Your infusion may need to be slowed or stopped if you have these reactions. Tell your health care provider right away if you have any of the following symptoms when you get your infusion or within the hour after each dose. 

  • Headache
  • High blood pressure
  • Joint, back, or bone pain
  • Redness of your face and neck
  • Not feeling well, tiredness, or weakness
  • Chest pain
  • Itching or hives
  • Stomach pain or diarrhea

Warnings & Precautions

Who should not use Rytelo?

Allergies to Ingredients. People who are allergic to any of the following should not use Rytelo.

  • Imetelstat
  • Rytelo
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Rytelo.

What should I know about Rytelo before using it?

Rytelo is usually given by a health care provider in a hospital or clinic. 

If you are given medicines to take before each infusion of Rytelo, make sure that you take them as prescribed. If you forget to take them, tell your health care provider before getting this medicine. Make sure that you tell your health care provider if you have any unusual symptoms or just do not feel well when you get this medicine or within about an hour after your infusion is done. You will likely be watched for about an hour after each dose of Rytelo.

This medicine can cause serious side effects. Get all the blood work that is ordered for you. Your blood may take longer to form a clot when using Rytelo. However, this may also be caused by a low level of platelets. Tell your health care provider right away if you get bleeding that lasts a long time.

Rytelo may make it hard for you to get pregnant. If you have concerns, talk to your health care provider.

What should I tell my health care provider before using Rytelo?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Rytelo is right for you.

In particular, make sure that you discuss any of the following.

Other Medicines and Supplements. Rytelo may interact with other medicines and supplements. Before using Rytelo, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. Rytelo may harm an unborn baby. Your health care provider may test you for pregnancy before giving you this medicine. If you can become pregnant, use effective birth control during your treatment with Rytelo and for 1 week after your last dose. Tell your health care provider right away if you are pregnant, think you may be pregnant, or plan to become pregnant. 

Breastfeeding. It is not known if Rytelo passes into breast milk. Do not breastfeed during your treatment with Rytelo and for 1 week after your last dose. Tell your health care provider if you are breastfeeding or plan to breastfeed. 

How can I get more information about Rytelo?

For more information about Rytelo, you can visit the drugmaker’s website at www.rytelo.com or call them at 866-471-0921.

Interactions

Does Rytelo interact with foods or drinks?

There are no known interactions between Rytelo and foods or drinks.

It is unknown if drinking alcohol will affect Rytelo, but both Rytelo and alcohol can increase your risk of bleeding. Heavy drinking can slow your immune response and make it harder for your body to fight infections and cancer. It is best to limit the amount of alcohol you drink.

Does Rytelo interact with other medicines (drug interactions)?

Rytelo may interact with certain medicines. Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Rytelo?

If you or someone else has used too much Rytelo, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Rytelo?

Rytelo is usually given by a health care provider in a hospital. Your health care provider will make sure you are receiving Rytelo as scheduled.

If you miss an appointment to get your Rytelo dose, call to make another appointment as soon as possible.