Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: AOP Orphan Pharmaceuticals GmbH, Leopold-Ungar-Platz 2, 1190 Vienna, Austria
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.
| Pharmaceutical Form |
|---|
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Solution for injection in pre-filled pen (injection). Clear, colourless to pale yellow solution. |
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, corresponding to 500 micrograms/mL.
Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen: Each pre-filled pen of 0.5 mL solution contains 500 micrograms of ropeginterferon alfa-2b as measured on a protein basis, corresponding to 1.000 micrograms/mL.
The strength indicates the quantity of the interferon alpha-2b moiety of ropeginterferon alfa-2b without consideration of the pegylation.
Ropeginterferon alfa-2b is a covalent conjugate of the protein interferon alpha-2b, produced in Escherichia coli cells by recombinant DNA technology, with a methoxypolyethylene glycol (mPEG) moiety.
The potency of this medicinal product should not be compared to that of another pegylated or nonpegylated protein of the same therapeutic class (see section 5.1).
Excipient with known effect: Each pre-filled pen contains 10 mg benzyl alcohol per mL.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ropeginterferon alfa-2b |
Ropeginterferon alfa-2b is a recombinant interferon alfa-2b conjugated with a two-arm mPEG at a degree of substitution of 1 mole of polymer/mole of protein. Interferon alfa belongs to the class of type I interferons which exhibit their cellular effects by binding to a transmembrane receptor termed interferon alfa receptor (IFNAR). Binding to IFNAR initiates a downstream signalling cascade through the activation of kinases, particularly Janus kinase 1 (JAK1) and tyrosine kinase 2 (TYK2) and signal transducer and activator of transcription (STAT) proteins. Interferon alfa was shown to have an inhibitory effect on the proliferation of hematopoietic and bone marrow fibroblast progenitor cells and antagonised the action of growth factors and other cytokines that have a role in the development of myelofibrosis. These actions may be involved in the therapeutic effects of interferon alfa in polycythaemia vera. |
| List of Excipients |
|---|
|
Sodium chloride |
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 grey on the label. It delivers doses of 50 μg, 100 μg, 150 μg, 200 μg and 250 μg.
Besremi 250 micrograms/0.5 mL solution for injection in pre-filled pen is available in 2 pack-sizes:
Besremi 500 micrograms/0.5 mL solution for injection in pre-filled pen:
The pre-filled pen is made of white polypropylene, with a blue push button and the strength “500 mcg/0.5 mL” highlighted in blue on the label. It delivers doses of 50 μg, 100 μg, 150 μg, 200 μg, 250 μg, 300 μg, 350 μg, 400 μg, 450 μg and 500 μg.
Each pack of Besremi 500 micrograms/0.5 mL solution for in pre-filled pen contains:
Each pre-filled pen contains a cartridge (type 1 colourless glass) with a grey plunger (bromobutyl rubber) and a flanged cap (aluminium) with a stopper (bromobutyl rubber). The cartridge is sealed in a pen injector. Each cartridge contains 0.5 mL of solution.
AOP Orphan Pharmaceuticals GmbH, Leopold-Ungar-Platz 2, 1190 Vienna, Austria
EU/1/18/1352/001
EU/1/18/1352/002
EU/1/18/1352/003
Date of first authorisation: 15 February 2019
| Drug | Countries | |
|---|---|---|
| BESREMI | Austria, Estonia, Finland, Croatia, Ireland, Israel, Japan, Lithuania, Poland, Romania, United Kingdom, United States |
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