Omacetaxine

Generic name: Omacetaxine
Brand names: Synribo
Dosage form: subcutaneous powder for injection (3.5 mg)
Drug class: Miscellaneous antineoplastics

Usage of Omacetaxine

Omacetaxine is used to treat chronic myeloid leukemia (CML).

Omacetaxine is given after at least two other cancer treatments did not work or have stopped working.

Omacetaxine may also be used for purposes not listed in this medication guide.

Omacetaxine side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Omacetaxine may cause serious side effects. Call your doctor at once if you have:

  • ongoing nausea, stomach pain, or diarrhea;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum);
  • confusion, vision changes, slurred speech;
  • blood in your urine, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • severe skin rash or itching;
  • low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet;
  • high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor; or
  • signs of infection--fever, chills, tiredness, body aches, feeling short of breath.

    • Common side effects of omacetaxine may include:

  • fever, low blood cell counts;
  • feeling weak or tired;
  • diarrhea;
  • nausea; or
  • pain, swelling, or redness where the medicine was injected.

    • This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Before taking Omacetaxine

    You should not use omacetaxine if you are allergic to it.

    Tell your doctor if you have ever had:

  • diabetes (in you or a family member); or
  • bleeding problems.

    • Omacetaxine can harm an unborn baby or cause birth defects if the mother or the father is using omacetaxine.

  • If you are a woman, do not use omacetaxine if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.
  • If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.
  • Tell your doctor right away if a pregnancy occurs while either the mother or the father is using omacetaxine.

    • This medicine may affect fertility (ability to have children) in men. However, it is important to use birth control to prevent pregnancy because omacetaxine can harm an unborn baby.

    Do not breastfeed while using this medicine, and for at least 2 weeks after your last dose.

    Relate drugs

    How to use Omacetaxine

    Usual Adult Dose for Chronic Myelogenous Leukemia:

    Induction dose: 1.25 mg/m2 suBCUTAneously twice daily for 14 consecutive days of a 28 day cycle.Maintenance dose: 1.25 mg/m2 subcutaneously twice daily for 7 consecutive days of a 28 day cycle.Use: Chronic or accelerated phase CML with resistance and/or intolerance to two or more tyrosine kinase inhibitors.Comments: There are no trials verifying an improvement in disease-related symptoms or increased survival with omacetaxine.

    Warnings

    Omacetaxine can increase your risk of bleeding or infection. Call your doctor if you have unusual bruising or bleeding, blood in your urine or stools, confusion, problems with vision or speech, or new signs of infection (fever, chills, tiredness, body aches, feeling short of breath).

    What other drugs will affect Omacetaxine

    Other drugs may affect omacetaxine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

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