Is Fedratinib approved by the FDA?

Yes, Fedratinib, marketed under the brand name Inrebic, is FDA approved. The U.S. Food and Drug Administration (FDA) granted approval for Fedratinib on August 16, 2019.

What is Fedratinib?

Fedratinib is a multikinase inhibitor used to treat myelofibrosis in adults. Myelofibrosis is a rare type of bone marrow cancer that disrupts the body's ability to produce blood cells. The drug works by inhibiting specific enzymes involved in the disease's progression.

Approved Use

Fedratinib is approved for the treatment of patients with intermediate-2 or high-risk primary or secondary myelofibrosis, including post-polycythemia vera and post-essential thrombocythemia myelofibrosis. This designation helps manage the symptoms and progression of this challenging condition.

Dosage and Administration

Fedratinib is available in oral capsule form with a dosage of 100 mg. The typical dosing regimen for adults is as follows:

• Standard Dose: 400 mg orally once a day.
• Administration: The medication can be taken with or without food, but taking it with a high-fat meal may help reduce nausea and vomiting.
• Monitoring: Patients need to have their thiamine (vitamin B1) levels and nutritional status assessed before starting treatment, periodically during therapy, and as indicated. A vitamin B1 supplement may be necessary.

Side Effects

Common Side Effects

• Nausea
• Vomiting
• Diarrhea
• Anemia

Serious Side Effects

• Vitamin B1 Deficiency: This can lead to serious and sometimes fatal brain damage. Symptoms include drowsiness, confusion, memory problems, vision problems, unusual eye movements, and coordination issues.
• Low Blood Cell Counts: Symptoms include easy bruising, unusual bleeding, pale skin, tiredness, shortness of breath, and cold hands and feet.
• Liver Function Issues: Regular blood tests are necessary to monitor liver function.
• Severe Nausea, Vomiting, or Diarrhea: Even while taking medication to prevent these effects.

Warnings and Precautions

• Vitamin B1 Levels: Patients should be monitored for vitamin B1 deficiency, which can cause serious neurological damage.
• Blood Cell Counts and Liver Function: Regular testing is required.
• Pregnancy and Breastfeeding: It is not known if fedratinib will harm an unborn baby. Pregnant women should inform their doctor, and breastfeeding is not recommended while using this medication and for at least one month after the last dose.

How to Take Fedratinib

• Dosage: Follow the doctor's prescription strictly and do not adjust the dose without medical advice.
• Vomiting and Diarrhea: Call your doctor if you experience these symptoms, as they can lead to malnutrition and low vitamin B1 levels.
• Storage: Store at room temperature away from moisture and heat.

Drug Interactions

Fedratinib can interact with various medications, including prescription, over-the-counter drugs, vitamins, and herbal products. It's essential to inform your doctor about all medications you are currently taking to avoid adverse interactions.

Conclusion

Fedratinib (Inrebic) received FDA approval on August 16, 2019, for the treatment of intermediate-2 or high-risk myelofibrosis. This medication offers a significant therapeutic option for managing this rare bone marrow cancer, but it requires careful monitoring due to potential side effects and the need for vitamin B1 supplementation. Always consult with your healthcare provider for personalized medical advice and follow their instructions meticulously.

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