Class: Biological Therapy
Generic Name: fedratinib
Trade Name: Inrebic®
For which conditions is Inrebic approved for? INREBIC is approved for the treatment of adults with intermediate-2 or high-risk primary or secondary myelofibrosis (MF). The labeling contains a boxed warning to alert healthcare professionals and patients about the potential severe and/or life-threatening side effect of serious and fatal encephalopathy, including Wernicke’s encephalopathy which is a neurologic emergency.
What is the mechanism of action? INREBIC is a JAK2 kinase inhibitor. JAK inhibitors target abnormal cell signaling that is through to contribute to the growth of cells in MF.
How is INREBIC typically given (administered)?
Take INREBIC one time a day exactly as your healthcare provider tells you to take it. Take INREBIC with or without food; taking with a high fat meal may help reduce nausea and vomiting. Do not change your dose or stop INREBIC unless your healthcare provider tells you to do so. If you miss a dose, skip the missed dose and take the next dose at your regular time.
How are patients typically monitored? Before taking INREBIC, discuss any medical conditions with your healthcare provider. Typically, blood will be drawn to check blood counts and your vitamin B1 levels before and during treatment.
What are the common (occur in 20% or more of patients) side effects of treatment with INREBIC?
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects? Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain other medicines may affect how INREBIC works and can cause side effects. Tell your doctor if you have or have had any medical condition, including liver or kidney problems or if you are breastfeeding or plan to breastfeed or are pregnant or plan on becoming pregnant.
Are there any special precautions patients should be aware of before starting treatment? Talk to your healthcare provider about any medicines (prescription and over-the-counter), vitamins or herbal supplements that you are taking.
When should patients notify their physician?
Tell your doctor if you experience any side effects that bother you or don’t go away. Also call your healthcare provider right away if:
- You have diarrhea, nausea or vomiting that does not respond to treatment.
- You experience rapid weight loss.
Get emergency medical help if you develop confusion, memory problems, drowsiness, problems with balance and movement or eye problems.
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
Important Limitations of Use
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