Fedratinib

What is Fedratinib?

• Fedratinib (Inrebic) is a kinase inhibitor used to treat adults with certain types of myelofibrosis (MF).

What are the uses of this medicine?

• This medicine is used for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF).

How does this medicine work?

• An orally bioavailable, small-molecule, ATP-competitive inhibitor of Janus-associated kinase 2 (JAK2) with potential antineoplastic activity. Fedratinib competes with JAK2 as well as the mutated form AK2V617F for ATP binding, which may result in inhibition of JAK2 activation, inhibition of the JAK-STAT signaling pathway, and the induction of tumor cell apoptosis.
• JAK2 is the most common mutated gene in bcr-abl-negative myeloproliferative disorders (MPDs); the mutated form JAK2V617F has a valine-to-phenylalanine modification at position 617 and plays a key role in tumor cell proliferation and survival.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Coadministration of Inrebic with a strong CYP3A4 inhibitor increases fedratinib exposure. Consider alternative therapies that do not strongly inhibit CYP3A4 activity. Alternatively, reduce the dose of Inrebic when administering with a strong CYP3A4 inhibitor.
• Avoid Inrebic with strong and moderate CYP3A4 inducers.
• Avoid Inrebic with dual CYP3A4 and CYP2C19 inhibitor.
• Coadministration of Inrebic with drugs that are CYP3A4 substrates, CYP2C19 substrates, or CYP2D6 substrates increases the concentrations of these drugs, which may increase the risk of adverse reactions of these drugs.

Is this medicine FDA approved?

• It was approved for use in the United States in 2019.

How should this medicine be used?

• Conduct baseline testing of thiamine (Vitamin B1) levels prior to initiation of Inrebic.

Recommended Dosage

• 400 mg orally once daily with or without food for patients with a baseline platelet count of greater than or equal to 50 × 109/L

Dose Modifications with Concomitant Use of Strong CYP3A4 Inhibitors

• Reduce Inrebic dose when administering with strong CYP3A4 inhibitors to 200 mg once daily.

Dose Modifications for Severe Renal Impairment

• Reduce Inrebic dose to 200 mg once daily in patients with severe renal impairment

Administration

• Take Inrebic exactly as your healthcare provider tells you to. Do not change your dose or stop taking Inrebic unless your healthcare provider tells you to.
• Take Inrebic 1 time each day.
• Take Inrebic with or without food. Taking Inrebic with a high fat meal may help to reduce nausea and vomiting symptoms.
• If you miss a dose of Inrebic, skip the missed dose and take your next dose at your regular time. Do not take 2 doses to make up for the missed dose.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Capsules: 100 mg

This medicine is available in fallowing brand namesː

• Inrebic

What side effects can this medication cause?

The most common side effects of this medicine include:

• diarrhea
• nausea
• low red blood cell counts (anemia)
• vomiting

Inrebic can cause serious side effects, including:

• Low blood cell counts
• Nausea, vomiting, and diarrhea
• Liver problems
• Amylase and lipase increases

What special precautions should I follow?

• Treatment with Inrebic can cause anemia and thrombocytopenia. Manage by dose reduction, interruption, or transfusion.
• Gastrointestinal toxicities are the most frequent adverse reactions in Inrebic-treated patients. Manage by dose reduction or interruption if patient develops severe diarrhea, nausea, or vomiting. Prophylaxis with anti-emetics and treatment with anti-diarrhea medications are recommended.
• This medicine can cause hepatic Toxicity. Manage by dose reduction or interruption.
• This medicine may cause amylase and lipase elevation. Manage by dose reduction or interruption.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no available data on Inrebic use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

Can this medicine be used in children?

• The safety and effectiveness of Inrebic in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: fedratinib
• Inactive ingredients: silicified microcrystalline cellulose and sodium stearyl fumarate. The capsule shell contains gelatin, red iron oxide, titanium dioxide and white ink.

Who manufactures and distributes this medicine?

• Manufactured for and marketed by:

Celgene Corporation, Summit, NJ 07901

What should I know about storage and disposal of this medication?

• Store below 86°F (30°C).

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