Ropeginterferon Alfa-2b

Interferon alfa belongs to the class of type I interferons, which exhibit their cellular effects in polycythemia vera in the bone marrow by binding to a transmembrane receptor termed interferon alfa receptor (IFNAR). Binding to IFNAR initiates a downstream signaling cascade through the activation of kinases, in particular Janus kinase 1 (JAK1) and tyrosine kinase 2 (TYK2) and activator of transcription (STAT) proteins.

• BESREMi is indicated for the treatment of adults with polycythemia vera.

• BESREMi is contraindicated in patients with: Existence of, or history of severe psychiatric disorders, particularly severe depression, suicidal ideation, or suicide attempt Hypersensitivity to interferons including interferon alfa-2b or any of the inactive ingredients of BESREMi Moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment History or presence of active serious or untreated autoimmune disease History of transplantation and receiving immunosuppressant agents.contraindicated

2.1 Pre-Treatment Testing Obtain a pregnancy test in females of reproductive potential prior to initiating treatment with BESREMi [see Use in Specific Populations (8.3)]. 2.2 Recommended Dosage Patients Not Already on Hydroxyurea: The recommended BESREMi starting dosage for patients not on hydroxyurea is 100 mcg by subcutaneous injection every two weeks. Increase the dose by 50 mcg every two weeks (up to a maximum of 500 mcg), until the hematological parameters are stabilized (hematocrit less than 45%, platelets less than 400 x 109/L, and leukocytes less than 10 x 109/L). Patients Transitioning from Hydroxyurea: When transitioning to BESREMi from hydroxyurea, start BESREMi at 50 mcg by subcutaneous injection every two weeks in combination with hydroxyurea. Gradually taper off the hydroxyurea by reducing the total biweekly dose by 20-40% every two weeks during Weeks 3-12. Increase the dose of BESREMi by 50 mcg every two weeks (up to a maximum of 500 mcg), until the hematological parameters are stabilized (hematocrit less than 45%, platelets less than 400 x 109/L, and leukocytes less than 10 x 109/L). Discontinue hydroxyurea by Week 13. Maintain the two-week dosing interval of BESREMi at which hematological stability is achieved for at least 1 year. After achievement of hematological stability for at least 1 year on a stable dose of BESREMi, the dosing interval may be expanded to every 4 weeks. Monitor patients closely especially during the titration phase.

5.1 Depression and Suicide Life-threatening or fatal neuropsychiatric reactions have occurred in patients receiving interferon alfa products, including BESREMi. These reactions may occur in patients with and without previous psychiatric illness. Serious neuropsychiatric reactions have been observed in 3% of patients treated with BESREMi during the clinical development program. Among the 178 patients in the clinical development program of BESREMi, 17 cases of depression, depressive symptoms, depressed mood, and listlessness occurred. Of these seventeen cases, 3.4% of the patients recovered with temporary drug interruption and 2.8% stopped BESREMi treatment. Other central nervous system effects, including suicidal ideation, attempted suicide, aggression, bipolar disorder, mania and confusion have been observed with other interferon alfa products. BESREMi is contraindicated in patients with a history of severe psychiatric disorders, particularly severe depression, suicidal ideation, or suicide attempt [see Contraindications (4) ]. Closely monitor patients for any symptoms of psychiatric disorders and consider psychiatric consultation and treatment if such symptoms emerge. If psychiatric symptoms worsen, it is recommended to discontinue BESREMi therapy. 5.2 Endocrine Toxicity Endocrine toxicity has occurred in patients receiving interferon alfa products, including BESREMi. These toxicities may include worsening hypothyroidism and hyperthyroidism.

The following clinically significant adverse reactions are described elsewhere in the labeling. Depression and Suicide [see Warnings and Precautions (5.1)] Endocrine Toxicity [see Warnings and Precautions (5.2)] Cardiovascular Toxicity [see Warnings and Precautions (5.3)] Decreased Peripheral Blood Counts [see Warnings and Precautions (5.4)] Hypersensitivity Reactions [see Warnings and Precautions (5.5)] Pancreatitis [see Warnings and Precautions (5.6)] Colitis [see Warnings and Precautions (5.7)] Pulmonary Toxicity [see Warnings and Precautions (5.8)] Ophthalmologic Toxicity [see Warnings and Precautions (5.9)] Hyperlipidemia [see Warnings and Precautions (5.10)] Hepatotoxicity [see Warnings and Precautions (5.11)] Renal Toxicity [see Warnings and Precautions (5.12)] Dental and Periodontal Toxicity [see Warnings and Precautions (5.13)] Dermatologic Toxicity [see Warnings and Precautions (5.14)] Driving and Operating Machinery [see Warnings and Precautions (5.15)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The pooled safety population described in the Warnings and Precautions section reflects exposure to BESREMi as monotherapy for the treatment of polycythemia vera dosed every two to four weeks in 178 patients in two open-label trials [PEGINVERA, PROUD/CONTINUATION PV].

8.1 Pregnancy Risk Summary Available human data with BESREMi use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. An abortifacient effect was reported in cynomolgus monkeys receiving ropeginterferon alfa-2b (see Data). Based on mechanism of action and the role of interferon alfa in pregnancy and fetal development, BESREMi may cause fetal harm and should be assumed to have abortifacient potential when administered to a pregnant woman. There are adverse effects on maternal and fetal outcomes associated with polycythemia vera in pregnancy (see Clinical Considerations ). Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage is 2-4% and 15-20%, respectively. Data Animal Data In an embryo-fetal development study, pregnant cynomolgus monkeys received subcutaneous injection of ropeginterferon alfa-2b twice weekly during the period of organogenesis (Gestation Days 20-48).

Metabolism

In patients with polycythemia vera, the estimated steady state C max , C min and area under the curve (AUC) after a two-week dosing interval of BESREMi over a dose range of 100 mcg to 500 mcg ranged from 4.4 – 31 ng/mL, 1.4 – 12 ng/mL, and 1011 – 7809 ng×h/mL, respectively. The estimated steady state C max occurs between 2 to 5 days.

Overdosage of BESREMi may result in influenza-like symptoms or other adverse reactions. There is no antidote to BESREMi overdosage. In case of an overdose, frequently monitor signs and symptoms for adverse reactions.

• Nov 12, 2021BLABLA761166Pharmaessentia Corp

1. 1Fatigue32519%
2. 2Off Label Use25315%
3. 3Pruritus1639.7%
4. 4Headache1458.7%
5. 5Product Dose Omission Issue1116.6%
6. 6Influenza Like Illness1076.4%
7. 7Inappropriate Schedule Of Product Administration1056.3%
8. 8Nausea1046.2%
9. 9Arthralgia985.9%
10. 10Diarrhoea955.7%
11. 11Pain935.6%
12. 12Haematocrit Increased905.4%
13. 13Platelet Count Increased865.1%
14. 14Dizziness804.8%
15. 15Injection Site Erythema704.2%

The 10 most recently updated of 33 ClinicalTrials.gov registrations naming Ropeginterferon Alfa-2b as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Phase II Study Assessing the Safety and Efficacy of Dasatinib in Combination With Ropeginterferon in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
  Not yet recruiting · Phase 2 · Interventional · 40 enrolled · M.D. Anderson Cancer Center
  NCT07269470updated 2026-06-11
• The Safety and Efficacy of Sequential Treatment of Ropeginterferon Alfa-2b (P1101) and Anti-PD1 in Interferon-Naive Adults With Chronic Hepatitis B or D Infection
  Completed · Phase 1 · Interventional · 20 enrolled · PharmaEssentia
  NCT04638439updated 2026-06-10
• A Phase 3 Study of INCA033989 Versus Best Available Therapy in Participants With Essential Thrombocythemia
  Not yet recruiting · Phase 3 · Interventional · 426 enrolled · Incyte Corporation
  NCT07623200updated 2026-06-09
• Ropeginterferon Alfa-2b for the Treatment of Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes and Chronic Myelomonocytic Leukemia
  Not yet recruiting · Phase 2 · Interventional · 35 enrolled · Jonsson Comprehensive Cancer Center
  NCT07468916updated 2026-05-06
• Tolerability of Ropeginterferon Alfa-2b Add-on to Ongoing Ruxolitinib Therapy in Myelofibrosis (RopeRux in Myelofibrosis)
  Not yet recruiting · Phase 1 · Interventional · 15 enrolled · University of Utah
  NCT07521046updated 2026-04-17
• Ropeginterferon in Patients w/Cutaneous T-Cell Lymphoma (CTCL)
  Recruiting · Phase 1 · Interventional · 38 enrolled · H. Lee Moffitt Cancer Center and Research Institute
  NCT07047885updated 2026-04-01
• Ropeginterferon Alfa-2b in Patients With Polycythemia Vera (PV) Without Symptomatic Splenomegaly
  Recruiting · Observational · 200 enrolled · iOMEDICO AG
  NCT06743035updated 2026-01-09
• LOW-PV Continuation
  Recruiting · Observational · 36 enrolled · FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
  NCT06752941updated 2025-12-26
• Observational Study on the Use of Ropeginterferon Alfa-2b in Polycythemia Vera (ROPEG-PV)
  Active not recruiting · Observational · 319 enrolled · FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
  NCT06506084updated 2025-12-26
• Evaluation of Real-World Data on Ropeginterferon Alfa-2b in Patients With Polycythemia Vera: Insights From a Multicenter Study
  Not yet recruiting · Observational · 150 enrolled · Federico II University
  NCT07282132updated 2025-12-15

Frequently asked questions

How does Ropeginterferon Alfa-2b work?

Interferon alfa belongs to the class of type I interferons, which exhibit their cellular effects in polycythemia vera in the bone marrow by binding to a transmembrane receptor termed interferon alfa receptor (IFNAR). Binding to IFNAR initiates a downstream signaling cascade through the activation of kinases, in particular Janus kinase 1 (JAK1) and tyrosine kinase 2 (TYK2) and activator of transcription (STAT) proteins.

What is Ropeginterferon Alfa-2b used for?

According to FDA labeling, Ropeginterferon Alfa-2b carries indications including: BESREMi is indicated for the treatment of adults with polycythemia vera.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Ropeginterferon Alfa-2b?

Ropeginterferon Alfa-2b is classified as Interferons, Interferon alfa-2b, Interferon Receptor Interactions, Hemic/Lymphatic Activity Alteration.

What are the brand names for Ropeginterferon Alfa-2b?

Ropeginterferon Alfa-2b is marketed under brand names including Besremi.

What are the contraindications for Ropeginterferon Alfa-2b?

Ropeginterferon Alfa-2b labeling lists contraindications including: BESREMi is contraindicated in patients with: Existence of, or history of severe psychiatric disorders, particularly severe depression, suicidal ideation, or suicide attempt Hypersensitivity to interferons including interferon alfa-2b or any of the inactive ingredients of BESREMi Moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment History or presence of active serious or untreated autoimmune disease History of transplantation and receiving immunosuppressant agents.. Always consult the full prescribing information and a clinician.