Buy Besremi (ropeginterferon alfa-2b)

What is Besremi (ropeginterferon alfa-2b) for?

Besremi (ropeginterferon alfa-2b) is an interferon indicated to treat Polycythaemia Vera (PV) in adults who do not have symptoms of an enlarged spleen.^[1]

It is available as a pre-filled pen, each containing 250 micrograms/0.5 mL ropeginterferon alfa-2b solution.^[1]

How does Besremi (ropeginterferon alfa-2b) work?

The active ingredient in Besremi, ropeginterferon alfa-2b, can attach to receptors present on the surface of cells called interferon alfa/beta receptors (IFNAR). This causes various reactions that reduce the capacity of the bone marrow to produce red blood cells.^[2]

Ropeginterferon alfa-2b is a kind of ‘interferon’, a protein naturally produced by the body. Besremi has been designed in a way so that it can stay longer in the body and be given less often, in a process called ‘pegylation’.^[2]

Where has Besremi (ropeginterferon alfa-2b) been approved?

Besremi (ropeginterferon alfa-2b) was approved for the treatment of people with PV by:

• The European Medicines Agency (EMA) on February 15, 2019.3
• The Food and Drug Administration (FDA), USA on November 12, 2021.4

Besremi was granted Orphan Drug designation by the FDA, which is given to encourage drug development for rare diseases.4

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Besremi (ropeginterferon alfa-2b) taken?

The standard dosage is:^[1]

• The usual starting dose of 100 micrograms injected under the skin (subcutaneously) every 2 weeks.

During treatment, your dose will be increased stepwise (titrated) and may be adjusted during treatment.

If you have severe kidney problems, your treating doctor will reduce your starting dose to 50 micrograms.^[1]

Complete information about Besremi (ropeginterferon alfa-2b) dosage (modifications) and administration can be found in the official prescribing information listed in our references section.1

Note: Please consult with your treating doctor for personalised dosing.

Are there any known adverse reactions or side effects of Besremi (ropeginterferon alfa-2b)?

Common adverse reactions

The most common side effects (≥40% of patients) listed in the prescribing information include:^[1]

• Influenza-like illness
• Joint stiffness (arthralgia)
• Tiredness (fatigue)
• Itching (pruritus)
• Cold (nasopharyngitis)
• Bone and muscle (musculoskeletal) pain

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include:^[1]

• Urinary tract infection
• Transient ischemic attack
• Depression

Use in a specific population

The effect of Besremi (ropeginterferon alfa-2b-njft) during pregnancy is not known. It is advised to avoid pregnancy and breastfeeding during treatment with Besremi. Women of childbearing potential should discuss with their doctor if effective birth control should be used during treatment.^[1]

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.^[1]

References

1. Full prescribing information [EMA]: Besremi (ropeginterferon alfa-2b) [PDF]
AOP Orphan, Feb 2019

2. Besremi product information
EMA, Feb 2019

3. AOP Orphan announces EU Marketing Authorization for BESREMi® (Ropeginterferon alfa-2b) for rare blood cancer (PV)
AOP Orphan, Feb 2019

4. FDA Approves Treatment for Rare Blood Disease
FDA, Nov 2021