Active ingredient: Each hard capsule contains fedratinib dihydrochloride monohydrate equivalent to 100 mg fedratinib.

Excipients: Capsule content: Silicified microcrystalline cellulose (contains microcrystalline cellulose (E460) and colloidal anhydrous silica colloidal anhydrous (E551)), sodium stearyl fumarate; Capsule cover: Gelatin (E441) (bovine origin), titanium dioxide (E171), red iron oxide (E172), Printing ink: Shellac (E904), titanium dioxide (E171), polypropylene glycol (E1520)

▼This drug is subject to additional monitoring. This triangle will enable rapid identification of new safety information. You can help by reporting any side effects that occur. You can see the end of Chapter 4 to learn how to report side effects.

Before using this medicine, read this INSTRUCTIONS FOR USE carefully because it contains important information for you.

INREBIC are reddish brown capsules, 21.4-22 mm in size, with “FEDR” printed on the cap and “100 mg” printed in white ink on the body. The capsules are presented in rectangular bottles and each bottle is in cardboard packaging containing 120 capsules.

INREBIC, which belongs to a class of drugs known as ‘protein kinase inhibitors’, contains fedratinib as the active ingredient.

INREBIC is a prescription medicine used to treat adults with certain types of myelofibrosis (MF).

It is not known whether INREBIC is safe and effective in children.

Always use this medicine as directed by your doctor or pharmacist. If you are not sure, consult your doctor and pharmacist.

Instructions for proper use and dosage/frequency of administration

The recommended dose is 400 mg taken orally once daily (four INREBIC 100 mg capsules).

You will need to have blood tests before and while using this medication to monitor your progress. If you experience certain side effects while using INREBIC (see Section 4.-Possible side effects), your doctor may reduce your dose or interrupt or stop your treatment.

You should continue taking INREBIC as long as your doctor tells you to take it. This is a long-term treatment.

Like all medicines, INREBIC may have side effects in people who are sensitive to its ingredients.

If you notice any of the following side effects, talk to your doctor:

Side effects are described as shown in the categories below

If any of the following occur, stop using INREBIC and IMMEDIATELY inform your doctor or go to the emergency department of your nearest hospital:

If you notice any of the following, which may be a sign of a serious condition affecting the brain called encephalopathy (including Wernicke’s encephalopathy);

⚠️ Disclaimer: The information provided on this website is for informational purposes only and does not substitute professional medical advice. Always consult a healthcare provider before using any medication.