Quick answers
- What is Ropeginterferon ALFA-2B used for?
- The FDA-approved label (BESREMi, PharmaEssentia USA, August 25, 2026) says: “BESREMi is an interferon alfa-2b indicated for: • The treatment of adults with essential thrombocythemia. • The treatment of adults with polycythemia vera. 1.1 Essential Thrombocythemia BESREMi is indicated for the treatment of adults with essential thrombocythemia. 1.2 Polycythemia Vera BESREMi is indicated for the treatment of adults with polycythemia vera.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ropeginterferon ALFA-2B have a boxed warning?
- Yes. The FDA label for BESREMi has a boxed warning (“WARNING: RISK OF SERIOUS DISORDERS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Ropeginterferon ALFA-2B?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Ropeginterferon ALFA-2B been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Ropeginterferon ALFA-2B?
- 1 company lists prescription products of Ropeginterferon ALFA-2B in the FDA NDC Directory, including PharmaEssentia USA.
What Ropeginterferon ALFA-2B is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
BESREMi is an interferon alfa-2b indicated for: • The treatment of adults with essential thrombocythemia. • The treatment of adults with polycythemia vera. 1.1 Essential Thrombocythemia BESREMi is indicated for the treatment of adults with essential thrombocythemia. 1.2 Polycythemia Vera BESREMi is indicated for the treatment of adults with polycythemia vera.
— FDA label: BESREMi, PharmaEssentia USA, effective August 25, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: RISK OF SERIOUS DISORDERS
. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection · Injection, solution |
|---|---|
| Route | Subcutaneous |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Besremi, Besremi Pen |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- PharmaEssentia USA2 products
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA761166 BESREMI | Pharmaessentia Corp | November 12, 2021 | 4, latest August 28, 2026 2026: Efficacy · 2026: Labeling · 2024: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2587064, 2587070, 2748665, 2748670 |
|---|---|
| SPL set ID of the quoted label | 9583405d-53a0-49dc-88eb-5e6384ebabcb |
| FDA labels (SPL) | 1 |
| FDA applications | BLA761166 |
| Active ingredients (FDA) | ROPEGINTERFERON ALFA-2B |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — BESREMi, PharmaEssentia USA, effective August 25, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →