Fedratinib
Primary Myelofibrosis
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Drug Status
Government Approvals
US(FDA), UK(BNF)
WHO Essential Medicine
NO
Known Teratogen
No
Pharmaceutical Class
NA
Controlled Drug Substance
No
Fedratinib
Summary
Fedratinib is used to treat adults with certain types of myelofibrosis, a cancer of the bone marrow. It's specifically indicated for intermediate-2 or high-risk primary or secondary myelofibrosis, including post-polycythemia vera or post-essential thrombocythemia myelofibrosis.
Fedratinib is a kinase inhibitor. It targets and blocks the action of abnormal proteins, specifically Janus Associated Kinase 2 (JAK2) and FMS-like tyrosine kinase 3 (FLT3), which are involved in the growth and spread of cancer cells. By inhibiting these proteins, it helps slow down or stop the proliferation of cancer cells.
The usual daily dose of Fedratinib for adults is 400 mg taken orally once daily. It can be taken with or without food.
Common side effects of Fedratinib include diarrhea, nausea, vomiting, anemia, and weight gain. Serious adverse effects include encephalopathy, thrombocytopenia, and liver enzyme elevations.
Fedratinib can cause serious and potentially fatal encephalopathy, including Wernicke's encephalopathy. It's contraindicated during pregnancy and breastfeeding. Women of childbearing potential should use effective contraception during treatment and for at least 1 month after the last dose. Patients should not start treatment if they have a thiamine deficiency.
Indications and Purpose
How does Fedratinib work?
Fedratinib is a kinase inhibitor that targets and blocks the action of abnormal proteins, specifically Janus Associated Kinase 2 (JAK2) and FMS-like tyrosine kinase 3 (FLT3), which are involved in the growth and spread of cancer cells. By inhibiting these proteins, Fedratinib helps to slow down or stop the proliferation of cancer cells.
Is Fedratinib effective?
Fedratinib has been shown to be effective in reducing spleen volume and improving symptoms in patients with myelofibrosis. Clinical trials, such as the JAKARTA study, demonstrated that a significant proportion of patients achieved a 35% or greater reduction in spleen volume, indicating its efficacy in treating this condition.
What is Fedratinib?
Fedratinib is used to treat adults with certain types of myelofibrosis, a cancer of the bone marrow. It works by blocking the action of an abnormal protein that signals cancer cells to multiply, helping to stop or slow the spread of cancer cells. It is a kinase inhibitor that targets specific proteins involved in cell growth.
Directions for Use
For how long do I take Fedratinib?
Fedratinib is typically used for as long as the patient derives clinical benefit from the treatment. The duration can vary based on individual response and tolerance to the medication.
How do I take Fedratinib?
Fedratinib should be taken once daily, with or without food. However, taking it with a high-fat meal may help reduce nausea and vomiting. Patients should talk to their doctor about eating grapefruit or drinking grapefruit juice while on this medication, as it may interact with the drug.
How should I store Fedratinib?
Fedratinib should be stored in its original container, tightly closed, and kept out of reach of children. It should be stored at room temperature, away from excess heat and moisture, and not in the bathroom. Unneeded medication should be disposed of through a take-back program.
What is the usual dose of Fedratinib?
The usual daily dose of Fedratinib for adults is 400 mg taken orally once daily. The safety and effectiveness of Fedratinib in children have not been established, so there is no recommended dose for pediatric patients.
Warnings and Precautions
Can Fedratinib be taken safely while breastfeeding?
It is not known if Fedratinib passes into breast milk, but due to the potential for serious adverse reactions in a breastfed child, breastfeeding is not recommended during treatment and for at least 1 month after the last dose.
Can Fedratinib be taken safely while pregnant?
There is no available data on the use of Fedratinib in pregnant women, and it may cause fetal harm based on its mechanism of action. Women of childbearing potential should use effective contraception during treatment and for at least 1 month after the last dose. It is contraindicated during pregnancy.
Can I take Fedratinib with other prescription drugs?
Fedratinib interacts with strong CYP3A4 inhibitors, which can increase its exposure and risk of adverse reactions. It is advised to avoid these inhibitors or adjust the dose of Fedratinib. Additionally, coadministration with CYP3A4, CYP2C19, or CYP2D6 substrates can increase the concentrations of these drugs, requiring dose adjustments.
Is Fedratinib safe for the elderly?
Elderly patients, especially those over 75, may experience more frequent serious adverse reactions and treatment discontinuations. It is important for healthcare providers to monitor these patients closely and adjust treatment as necessary to ensure safety.
Who should avoid taking Fedratinib?
Important warnings for Fedratinib include the risk of serious and potentially fatal encephalopathy, including Wernicke's encephalopathy. Patients should not start treatment if they have a thiamine deficiency. Other warnings include risks of anemia, thrombocytopenia, gastrointestinal toxicity, and liver enzyme elevations. Patients should be monitored closely for these conditions.
