Brand Name
Inrebic
Generic Name
Fedratinib
View Brand Information FDA approval date: August 16, 2019
Form: Capsule
What is Inrebic (Fedratinib)?
INREBIC ® is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary myelofibrosis . INREBIC is a kinase inhibitor indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary myelofibrosis .
Approved To Treat
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Brand Information
Inrebic (Fedratinib Hydrochloride)
WARNING: ENCEPHALOPATHY INCLUDING WERNICKE'S
Serious and fatal encephalopathy, including Wernicke's, has occurred in patients treated with INREBIC. Wernicke's encephalopathy is a neurologic emergency. Assess thiamine levels in all patients prior to starting INREBIC. Do not start INREBIC in patients with thiamine deficiency; replete thiamine prior to treatment initiation. While on treatment all patients should receive prophylaxis with daily oral thiamine and should have thiamine levels assessed as clinically indicated. If encephalopathy is suspected, immediately discontinue INREBIC and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize
1INDICATIONS AND USAGE
INREBIC
2DOSAGE FORMS AND STRENGTHS
Capsules: 100 mg, reddish brown, opaque size 0, printed with "FEDR 100 mg" in white ink.
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Encephalopathy, including Wernicke's
- Anemia and Thrombocytopenia
- Gastrointestinal Toxicity
- Hepatic Toxicity
- Amylase and Lipase Elevation
- Uveitis
- Major Adverse Cardiac Events
- Thrombosis
- Secondary Malignancies
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data in the WARNINGS AND PRECAUTIONS Section 5.1 Encephalopathy, including Wernicke's, reflect exposure to INREBIC as a single agent in 608 patients who received more than one dose (ranging from 30 mg to 800 mg) in Studies JAKARTA, ARD11936, JAKARTA2, ARD12042, ARD12888, TED12037/TED12015, INT12497, and TES13519, of whom 459 were patients with myelofibrosis, including 97 patients previously treated with ruxolitinib. Among the 608 patients receiving INREBIC, the median drug exposure was 37 weeks and the median number of cycles initiated was 9 cycles. Fifty-nine percent of 608 patients were exposed for 6 months or longer and 39% were exposed for 12 months or longer.
Using the dataset described above, the most common adverse reactions in >20% of patients (N=608) were diarrhea, nausea, anemia, vomiting, fatigue, thrombocytopenia, and constipation.
4.2Postmarketing Experience
The following adverse reactions have been identified during post approval use of INREBIC. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Eye Disorders: Uveitis
5OVERDOSAGE
Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
6DESCRIPTION
INREBIC (fedratinib) is a kinase inhibitor with the chemical name N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino]benzenesulfonamide dihydrochloride monohydrate. Its empirical formula is C
INREBIC (fedratinib) is available as 100-mg (equivalent to 117.3 mg of fedratinib dihydrochloride monohydrate) hard gelatin capsules for oral administration. Each capsule contains inactive ingredients of silicified microcrystalline cellulose and sodium stearyl fumarate. The capsule shell contains gelatin, red iron oxide, titanium dioxide and white ink.
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Discuss the following with patients prior to and during treatment with INREBIC.
8PRINCIPAL DISPLAY PANEL - 100 mg Capsule Bottle Label
NDC 59572-720-12
INREBIC
100 mg
Dispense the accompanying Medication Guide to each patient.
Rx only
