Brand Name
BESREMi
Generic Name
Ropeginterferon alfa-2B
View Brand Information FDA approval date: November 12, 2021
Classification: Interferon alfa-2b
Form: Injection
What is BESREMi (Ropeginterferon alfa-2B)?
BESREMi is indicated for the treatment of adults with polycythemia vera. BESREMi is an interferon alfa-2b indicated for the treatment of adults with polycythemia vera
Approved To Treat
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Brand Information
BESREMi (ROPEGINTERFERON ALFA-2B)
These highlights do not include all the information needed to use BESREMi safely and effectively. See full prescribing information for BESREMi. BESREMi (ropeginterferon alfa-2b-njft) injection, for subcutaneous use Initial U.S. Approval: 2021 WARNING: RISK OF SERIOUS DISORDERS
Risk of Serious Disorders: Interferon alfa products may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping therapy [
1INDICATIONS AND USAGE
BESREMi is indicated for the treatment of adults with polycythemia vera.
2DOSAGE FORMS AND STRENGTHS
Injection: 500 mcg/mL clear and colorless to slightly yellowish solution in a single-dose prefilled syringe.
3CONTRAINDICATIONS
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
- Immunosuppressed transplant recipients
4OVERDOSAGE
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.
5DESCRIPTION
Ropeginterferon alfa-2b-njft, an interferon alfa-2b, is an N-terminal monopegylated covalent conjugate of proline interferon alfa-2b, produced in
BESREMi (ropeginterferon alfa-2b-njft) injection is a sterile, preservative-free, clear and colorless to slightly yellowish solution for subcutaneous use supplied in a single dose prefilled syringe.
Each prefilled syringe delivers 1 mL of solution containing 500 mcg of ropeginterferon alfa-2b-njft and benzyl alcohol (10 mg), glacial acetic acid (0.05 mg), polysorbate 80 (0.05 mg), sodium acetate (1.58 mg), sodium chloride (8 mg), and Water for Injection, USP. The pH is approximately 6.
6CLINICAL STUDIES
The efficacy and safety of BESREMi were evaluated in the PEGINVERA study, a prospective, multicenter, single-arm trial of 7.5 years duration. The study included 51 adults with polycythemia vera. The mean age at baseline was 56 years (range 35-82 years) with 20 (39%) women and 31 (61%) men. All patients had the JAK2V617F mutation with 16% of subjects being newly diagnosed; 84% had known disease with a median duration of 2.2 years. One-third (33%) of patients were undergoing treatment with hydroxyurea (HU) upon study entry. At baseline, the mean ± SD hematocrit, platelets, and leukocytes were 45% ± 4.0%, 457 ×10
In stage I, the maximum tolerated dose, defined as the highest administered dose without dose-limiting toxicities was determined to be 540 mcg. In stage II, an intra-patient dose escalation began at 150 mcg, or 100 mcg if titrating from hydroxyurea, or at the highest dose achieved in those patients enrolled during stage I. Titration with BESREMi occurred every two-weeks at doses of 225 mcg, 300 mcg, 400 mcg and 450 mcg with dose escalation stopping when hematological parameters were stabilized. For patients transitioning from hydroxyurea, the hydroxyurea dose was tapered off over the first 12 weeks of treatment to avoid toxicity. After at least one year on therapy and at a median time of 21.5 months, 28 eligible patients in the PEGINVERA study increased the dosing interval to once every 4 weeks. Because of formulation changes, the recommended starting dose, titration amounts, and maximum dose of BESREMi differ slightly from those used in the trial
The median duration of treatment exposure was 61 months and 53% of patients completed at least 60 months of treatment. Thirty-six patients completed one year of treatment with eleven patients discontinuing after one year of treatment mainly due to treatment emergent adverse events. The mean dose of BESREMi was 237 mcg (± 110) during the treatment period.
The efficacy of BESREMi was evaluated in the PEGINVERA study by assessing complete hematological response (CHR) defined as hematocrit <45% and no phlebotomy in the preceding 2 months, platelets ≤400 × 10
The CHR in the treated population during the treatment period was 61% (31/51) (95% CI: 46, 74). The median duration of response was 14.3 months (95% CI: 5.5, 30.1).
Among the patients in the treated population who achieved a CHR, the median time to response was 7.8 months of treatment with BESREMi. It required 1.2 years of treatment with BESREMi for 50% of patients (hydroxyurea-naïve) to achieve a CHR and 1.4 years for 50% of patients with prior hydroxyurea use to achieve a CHR.
A hematological response based only on hematocrit, platelets, and leukocytes was achieved among 80% of patients treated with BESREMi (41/51) (95% CI: 67, 90). The median duration of this response was 20.8 months (95% CI: 13.0, 43.8).
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
8PRINCIPAL DISPLAY PANEL - 500 mcg/mL Syringe Label
BESREMi
500 mcg/mL
LOT:
Rx Only
9PRINCIPAL DISPLAY PANEL - 500 mcg/mL Syringe Carton
BESREMi
500 mcg/mL
One Single-Dose Prefilled Syringe
CAUTION: Prefilled syringe contains more medication than your
ATTENTION: Dispense the Enclosed Medication Guide to Each Patient.
NDC 73536-500-01
Contains:
- One Single-Dose
- One Injection
- Full Prescribing
- Instructions for Use
- Medication Guide
PharmaEssentia™
