Ropeginterferon alfa-2b
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
| ID | DRUG-ROPEGINTERFERON-ALFA-2B |
|---|---|
| Type | Drug |
| Aliases | BesremiРопегінтерферон альфа-2b |
| Status | reviewed 2026-04-25 | pending_clinical_signoff |
| Diseases | DIS-PV |
| Sources | SRC-ESMO-MPN-2015 SRC-NCCN-MPN-2025 |
Drug Facts
| Class | Mono-pegylated long-acting interferon alfa-2b |
|---|---|
| Mechanism | Mono-PEGylated proline-conjugated interferon alfa-2b with prolonged half-life enabling biweekly to monthly SC dosing. Direct antiproliferative + immunomodulatory effect on JAK2-V617F clone; achieves molecular response (V617F allele burden reduction) in a subset of patients — the only currently-approved cytoreductive therapy with disease-modifying potential in PV. Approved 1L regardless of HU exposure on basis of PROUD-PV / CONTINUATION-PV. |
| Typical dosing | Initial 100 µg SC q2wk (50 µg if combined with HU); titrate by 50 µg every 2 weeks based on hematologic response + tolerance, to maximum 500 µg q2wk. After hematologic response sustained ≥1 year, may extend interval to q4wk. Continue indefinitely. |
| Ukraine registered | False |
| NSZU reimbursed | False |
| Ukraine last verified | 2026-04-27 |
Warnings
- Neuropsychiatric (depression, suicidality, mania) — discontinue if severe
- Autoimmune (thyroiditis, hepatitis, hemolytic anemia) — discontinue if severe
- Ischemic / cardiovascular events
- Infectious disorders
Notes
Pivotal: PROUD-PV / CONTINUATION-PV (Gisslinger et al., Lancet Haematol 2020) — phase-3 ropeginterferon vs HU in newly-dx PV age <60 (non-high-thrombosis-risk). Complete hematologic response ~71% vs ~51% at 36 months; 36-month JAK2-V617F allele burden reduction substantially greater. FDA approval Nov 2021, EMA Feb 2019. Disease-modifying potential (V617F allele burden reduction) distinct from HU and ruxolitinib. Ukraine: NOT registered — access via named-patient import / EAP AOP Health / cross-border. PROUD-PV / CONTINUATION-PV (Gisslinger Lancet Haematol 2020) is the principal evidence base.
Used By
Regimens
REG-ROPEGINTERFERON-PV- Ropeginterferon alfa-2b (Besremi) for PV — 1L cytoreductive