Rytelo 188 mg intravenous solution

Generic name:
Imetelstat - injection

Pronunciation
(IM-e-TEL-stat)

Brand name(s)
Rytelo

This medication is used to treat anemia in patients with a group of blood/bone marrow disorders (myelodysplastic syndromes-MDS). Imetelstat works by slowing or stopping the growth of cancer cells. This effect may help reduce the need for blood transfusions.

Read the Medication Guide provided by your pharmacist before you start using imetelstat and each time you get a treatment. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection into a vein by a health care professional. It is given as directed by your doctor, usually once every 4 weeks. It is injected slowly into a vein over 2 hours. The dosage is based on your weight and response to treatment.

Infusion reactions may happen during the infusion of this drug and for some time afterward. Your doctor may prescribe other medications (such as diphenhydramine, hydrocortisone) before each treatment to help prevent these side effects. Tell your doctor right away if you have any symptoms of infusion reactions such as stomach pain, headache, joint pain, weakness, tiredness, back/bone pain, chest pain, diarrhea, itching, redness, or hives. Your doctor may give you other medications to help with these side effects or may slow down or stop your treatment for some time.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

Tell your doctor if your condition gets worse.

Tiredness, headache, or joint/bone/muscle pain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may cause a low number of platelets and white blood cells. This can cause easy bruising/bleeding or decrease your body's ability to fight an infection. Tell your doctor right away if you have any of the following symptoms:

• new/worsening bruising/bleeding
• signs of infection (such as sore throat that doesn't go away, fever, chills, burning/painful urination)

Get medical help right away if you have any very serious side effects, including:

• black/bloody stools
• vomit that looks like coffee grounds

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using imetelstat, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• liver problems

Imetelstat can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using imetelstat before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using imetelstat. Imetelstat may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Ask about reliable forms of birth control while using this medication and for 1 week after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug and for 1 week after the last dose. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as complete blood count, liver function) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.