INREBIC Hard capsule (2021)

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Περιεχόμενα

1. Name of the medicinal product

Inrebic 100 mg hard capsules.

2. Qualitative and quantitative composition

Each hard capsule contains fedratinib dihydrochloride monohydrate equivalent to 100 mg fedratinib. For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Hard capsule. Reddish-brown opaque capsules, 21.4-22.0 mm (size 0), printed with FEDR on the cap and 100 mg on the body in white ink.

4.1. Therapeutic indications

Inrebic is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia ...

4.2. Posology and method of administration

Treatment with Inrebic should be initiated and monitored under the supervision of physicians experienced in the use of anti-cancer medicinal products. Posology Patients who are on treatment with ruxolitinib, ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Pregnancy (see section 4.6).

4.4. Special warnings and precautions for use

Encephalopathy, including Wernickes encephalopathy Cases of serious and fatal encephalopathy, including Wernickes, were reported in patients taking Inrebic. Wernickes encephalopathy is a neurologic emergency ...

4.5. Interaction with other medicinal products and other forms of interaction

Effect of other medicinal products on fedratinib Fedratinib is metabolised by multiple CYPs in vitro with the predominant contribution from CYP3A4 and with a lesser contribution from CYP2C19, ...

4.6. Fertility, pregnancy and lactation

Women of childbearing potential / Contraception Females of reproductive potential should be advised to avoid becoming pregnant whilst receiving Inrebic and should use effective contraception during treatment ...

4.7. Effects on ability to drive and use machines

Inrebic has minor influence on the ability to drive and use machines. Patients who experience dizziness after taking Inrebic should refrain from driving or using machines.

4.8. Undesirable effects

Summary of the safety profile The overall safety information of Inrebic was assessed in 608 patients who received continuous doses of Inrebic in Phase 1, 2 and 3 clinical studies. Primary or secondary ...

4.9. Overdose

Experience with overdose of Inrebic is limited. During clinical studies of Inrebic in myelofibrosis patients, doses were escalated up to 600 mg per day including 1 accidental overdose at 800 mg. At doses ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors ATC code: L01EJ02 Mechanism of action Fedratinib is a kinase inhibitor with activity against wild type and mutationally ...

5.2. Pharmacokinetic properties

Absorption Fedratinib at 300 mg to 500 mg once daily (0.75 to 1.25 times the recommended dose of 400 mg) results in a dose proportional increase in geometric mean fedratinib Cmax and the area ...

5.3. Preclinical safety data

Fedratinib has been evaluated in safety pharmacology, repeated dose toxicity, genotoxicity and reproductive toxicity studies and in a carcinogenicity study. Fedratinib was not genotoxic and not carcinogenic ...

6.1. List of excipients

Capsule content: Silicified microcrystalline cellulose (contains microcrystalline cellulose (E460) and silica colloidal anhydrous (E551)). Sodium stearyl fumarate Capsule shell: Gelatin (E441) ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

4 years.

6.4. Special precautions for storage

Keep the bottle tightly closed in order to protect from moisture. This medicinal product does not require any special temperature storage conditions.

6.5. Nature and contents of container

High-density polyethylene (HDPE) bottle with polypropylene child resistant cap and heat induction seal. Each bottle contains 120 hard capsules and is packed in a cardboard carton.

6.6. Special precautions for disposal and other handling

Any unused product or waste material should be returned to the pharmacist for safe disposal in accordance with local requirements.

7. Marketing authorization holder

Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland

8. Marketing authorization number(s)

EU/1/20/1514/001

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 8 February 2021

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