Leukemias, lymphomas, and other hematologic cancers:
Indications for: BESREMI
Polycythemia vera.
Clinical Trials:
The efficacy and safety of ropeginterferon alfa-2b-njft were evaluated in the prospective, multicenter, single-arm PEGINVERA trial in 51 adults with polycythemia vera for a duration of 7.5 years. 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.
Findings showed that 61% (n=31/51; 95% CI, 46-74) of patients treated with ropeginterferon alfa-2b-njft achieved complete hematological response (CHR; defined as hematocrit less than 45% and no phlebotomy in the preceding 2 months, platelets 400 x 109/L or greater, leukocytes 10 x 109/L or greater, and normal spleen size). The median duration of response was 14.3 months (95% CI, 5.5-30.1).
Among patients who achieved CHR, the median time to response was 7.8 months of treatment with ropeginterferon alfa-2b-njft. It required 1.2 years of treatment with ropeginterferon alfa-2b-njft 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 ropeginterferon alfa-2b-njft (n=41/51) (95% CI, 67-90). The median duration of this response was 20.8 months (95% CI, 13.0-43.8).
Adult Dosage:
Not already on hydroxyurea: Initially 100mcg by SC inj every 2 weeks. Transitioning from hydroxyurea: Initially 50mcg by SC inj every 2 weeks in combination with hydroxyurea; gradually taper off hydroxyurea by reducing the total biweekly dose by 20–40% every 2 weeks during weeks 3–12 and discontinue hydroxyurea by week 13. Both: Increase Besremi dose by 50mcg every 2 weeks (up to max 500mcg) until hematological parameters are stabilized (hematocrit <45%, platelets <400×109/L, and leukocytes <10×109/L). Dosing interval may be expanded to every 4 weeks after achieving hematological stability for at least 1 year on a stable Besremi dose. Dose modifications for adverse reactions: see full labeling.
Children Dosage:
Not established.
BESREMI Contraindications:
Existence of, or history of severe psychiatric disorders, particularly severe depression, suicidal ideation or suicide attempt. Moderate or severe hepatic impairment (Child-Pugh B or C). History or presence of active serious or untreated autoimmune disease. Immunosuppressed transplant recipients.
Boxed Warning:
Risk of serious disorders.
BESREMI Warnings/Precautions:
May cause or exacerbate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, or infectious disorders: monitor closely, discontinue if they worsen. Avoid use in active serious or untreated endocrine disorders associated with autoimmune disease, severe or unstable cardiovascular disease (eg, uncontrolled hypertension, CHF [≥ NYHA class 2], serious cardiac arrhythmia, significant coronary artery stenosis, unstable angina), recent stroke or MI, or eGFR <30mL/min. Uncontrolled thyroid abnormalities. Diabetes. History of cardiovascular disorders; monitor closely. Pulmonary disease. Interrupt treatment if pancreatitis is suspected; consider discontinuing if confirmed. Discontinue if colitis, pulmonary infiltrates/dysfunction, new or worsening eye disorders, evidence of hepatic decompensation (eg, jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome, variceal hemorrhage), or severe renal impairment develops. Consider discontinuing if significant dermatologic toxicity occurs. Obtain eye exams before and during therapy, especially in those with retinopathy-associated disease (eg, diabetes, hypertension). Monitor CBCs at baseline, every 2 weeks during titration phase, then every 3–6 months during maintenance phase, and as clinically indicated. Monitor for infection or bleeding. Monitor serum triglycerides, creatinine, thyroid, visual, and liver function at baseline and during therapy. Dental and periodontal disorders. Have regular dental exams. Elderly. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for at least 8 weeks after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 8 weeks after the last dose).
BESREMI Classification:
Interferon.
BESREMI Interactions:
Avoid concomitant myelosuppressive agents, narcotics, hypnotics, or sedatives; if unavoidable, monitor for excessive effects. Concomitant drugs that are CYP450 substrates with a narrow therapeutic index; monitor.
Adverse Reactions:
Influenza-like illness, arthralgia, fatigue, pruritus, nasopharyngitis, musculoskeletal pain, headache, diarrhea, hyperhidrosis, nausea, upper RTI, liver enzyme elevations, leukopenia, neutropenia, thrombocytopenia; depression, suicide, hypersensitivity reactions (discontinue if occurs), pancreatitis, colitis, hyperlipidemia, cardiovascular toxicity, endocrine toxicity, ophthalmologic toxicity, pulmonary toxicity, renal toxicity, hepatotoxicity.
Drug Elimination:
Half-life: ~7 days.
Generic Drug Availability:
NO
How Supplied:
Single-dose prefilled syringe—1 (w. safety needle)
