Description and Brand Names

Drug information provided by: Merative, Micromedex®

US Brand Name

  1. Rytelo

Descriptions


Imetelstat injection is used to treat low to intermediate-1 risk myelodysplastic syndrome (MDS) in patients with anemia who need blood transfusions and who did not respond, have stopped responding, or cannot receive other medicines (eg, erythropoiesis stimulating agent (ESA)).

This medicine is to be given only by or under the immediate supervision of your doctor.

This product is available in the following dosage forms:

  • Powder for Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of imetelstat injection in the pediatric population.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of imetelstat injection in the elderly.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through an IV catheter that is placed in one of your veins. It must be given slowly, so the IV should remain in place for at least 2 hours.

You may also receive other medicines (eg, allergy medicine, steroid) 30 minutes before starting treatment with this medicine to help prevent infusion-related reactions.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have questions.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests are needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before giving you this medicine. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for 1 week after the last dose. If you think you have become pregnant while receiving this medicine, tell your doctor right away.

This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, dizziness, trouble breathing, itching or rash, or lightheadedness or fainting after receiving this medicine.

Some female patients who receive this medicine have become infertile (unable to have children). Talk with your doctor if you plan to have children.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

  1. Arm or leg pain
  2. back pain
  3. black, tarry stools
  4. bladder pain
  5. bleeding gums
  6. blood in the urine or stools
  7. bloody or cloudy urine
  8. bone pain
  9. chills
  10. collection of blood under the skin
  11. cough or hoarseness
  12. deep, dark purple bruise
  13. diarrhea
  14. difficult, burning, or painful urination
  15. difficulty in moving
  16. dizziness
  17. enlarged pupils
  18. facial swelling
  19. fainting
  20. falls
  21. fast or slow heartbeat
  22. fever
  23. fracture
  24. frequent urge to urinate
  25. headache
  26. increased sensitivity of the eyes to light
  27. increased sweating, possibly with fever or cold, clammy skin
  28. itching, pain, redness, or swelling
  29. joint pain
  30. lower back or side pain
  31. muscle or body aches
  32. muscle stiffness
  33. nausea
  34. nervousness
  35. new loss of taste or smell
  36. painful or difficult urination
  37. pale skin
  38. pinpoint red spots on the skin
  39. pounding in the ears
  40. severe chest pain
  41. sore throat
  42. stiff or sore neck
  43. stomach pain
  44. stuffy or runny nose
  45. trouble breathing
  46. ulcers, sores, or white spots in the mouth
  47. unusual bleeding or bruising
  48. unusual tiredness or weakness
  49. vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  1. Itching skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.