Fedratinib

Generic name: Fedratinib
Brand names: Inrebic
Dosage form: oral capsule (100 mg)
Drug class: Multikinase inhibitors

Usage of Fedratinib

Fedratinib is used to treat myelofibrosis in adults.

Myelofibrosis is a rare type of bone marrow cancer that affects your body's ability to produce blood cells.

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

Fedratinib 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.

Some people using fedratinib have developed vitamin B1 deficiency that resulted in serious and sometimes fatal brain damage. Seek emergency medical attention if you have symptoms such as:

  • drowsiness, confusion, memory problems;
  • vision problems, unusual eye movements; or
  • problems with coordination and muscle movement.
  • Fedratinib may cause serious side effects. Call your doctor at once if you have:

  • severe or ongoing nausea, vomiting, or diarrhea (even while you are taking medication to prevent these effects);
  • easy bruising, unusual bleeding, purple or red spots under your skin;
  • low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or
  • low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough, trouble breathing.
  • You may need a blood transfusion if your blood counts get too low.

    Common side effects of fedratinib may include:

  • nausea, vomiting;
  • diarrhea; or
  • anemia.
  • 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 Fedratinib

    Tell your doctor if you have ever had:

  • low levels of platelets or red blood cells;
  • liver disease;
  • kidney disease; or
  • if you have been taking ruxolitinib (Jakafi).
  • It is not known whether fedratinib will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

    You should not breastfeed while using this medicine, and for at least 1 month after your last dose.

    Relate drugs

    How to use Fedratinib

    Usual Adult Dose for Myelofibrosis:

    For patients with a baseline platelet count of 50 x 10(9)/L or greater:400 mg orally once a dayComments:-Patients who are taking ruxolitinib: Patients should taper off and discontinue ruxolitinib prior to starting this drug.-Assess thiamine (vitamin B1) levels and nutritional status prior to starting therapy, periodically during therapy, and as indicated.-Administration with a high fat meal may reduce the incidence of nausea and vomiting.-Subsequent doses of this drug are subject to dose adjustments based on the concomitant use of CYP450 3A4 inhibitors, renal function, prior adverse reactions, and/or thiamine levels.Use: For the treatment of patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF)

    Warnings

    Some people using fedratinib have developed vitamin B1 deficiency that resulted in serious and sometimes fatal brain damage. Your vitamin B1 levels will need to be checked before and during treatment, and you may need to take a vitamin B1 supplement.

    Get emergency medical help if you have symptoms such as drowsiness, confusion, memory problems, vision problems, unusual eye movements, or problems with coordination and muscle movement.

    Call your doctor if you are sick with vomiting or diarrhea even while taking medications to prevent these side effects.

    What other drugs will affect Fedratinib

    Sometimes it is not safe to use certain medications at the SAMe time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

    Other drugs may affect fedratinib, 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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