BESREMI Solution for injection (2024)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen. Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen.

2. Qualitative and quantitative composition

Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen: Each pre-filled pen of 0.5 mL solution contains 250 micrograms of ropeginterferon alfa-2b as measured on a protein basis, ...

3. Pharmaceutical form

Solution for injection in pre-filled pen (injection). Clear, colourless to pale yellow solution.

4.1. Therapeutic indications

Besremi is indicated as monotherapy in adults for the treatment of polycythaemia vera without symptomatic splenomegaly.

4.2. Posology and method of administration

Treatment should be initiated under supervision of a physician experienced in the management of the disease. Posology Titration phase The dose is titrated individually with a recommended starting dose ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Pre-existing thyroid disease unless it can be controlled with conventional treatment. Existence of, or history ...

4.4. Special warnings and precautions for use

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Dose titration phase The recommended ...

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

Enzymes of the protein catabolism are considered to be involved in the metabolism of ropeginterferon alfa-2b. The involvement of transport proteins in absorption, distribution and elimination of ropeginterferon ...

4.6. Fertility, pregnancy and lactation

Women of childbearing potential/Contraception in females Women of childbearing potential must use effective contraception during the treatment with ropeginterferon alfa-2b, unless otherwise discussed with ...

4.7. Effects on ability to drive and use machines

Besremi has minor influence on the ability to drive and use machines. Patients who experience dizziness, somnolence or hallucination (see section 4.8) during Besremi therapy should avoid driving or using ...

4.8. Undesirable effects

Summary of the safety profile The most common adverse reactions are leukopenia (20.2%), thrombocytopenia (18.5%), arthralgia (13.5%), fatigue (12.4%), increased gamma-glutamyltransferase (11.2%), influenza-like ...

4.9. Overdose

During the clinical study program, one accidental case of overdose has been reported with ropeginterferon alfa-2b. The patient received a 10-time higher starting dose as recommended and developed flu-like ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Immunostimulants, interferons ATC code: L03AB15 Ropeginterferon alfa-2b is a recombinant interferon alfa-2b conjugated with a two-arm mPEG at a degree of substitution ...

5.2. Pharmacokinetic properties

Absorption The absorption of ropeginterferon alfa-2b is sustained in patients with peak serum concentrations reached after 3 to 6 days. The absolute bioavailability of subcutaneous administered ropeginterferon ...

5.3. Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity. Reproductive and developmental studies were not performed ...

6.1. List of excipients

Sodium chloride Sodium acetate, anhydrous Acetic acid, glacial Benzyl alcohol Polysorbate 80 Water for injections

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen: 3 years. Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen: 3 years. After first use: The ...

6.4. Special precautions for storage

Store in a refrigerator (2°C-8°C). Do not freeze. Keep the pre-filled pen in the outer carton in order to protect from light. For storage conditions after first opening of the medicinal product, see section ...

6.5. Nature and contents of container

Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen: The pre-filled pen is made of white polypropylene, with a grey push button and the strength 250 mcg/0.5 mL highlighted in ...

6.6. Special precautions for disposal and other handling

Before use, the pre-filled pen should be brought to room temperature (15°C-25°C) for up to 15 minutes. Since Besremi is a solution, it does not require resuspension before use. Inspect the solution before ...

7. Marketing authorization holder

AOP Orphan Pharmaceuticals GmbH, Leopold-Ungar-Platz 2, 1190 Vienna, Austria

8. Marketing authorization number(s)

EU/1/18/1352/001 EU/1/18/1352/002 EU/1/18/1352/003

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 15 February 2019

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