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ropeginterferon alfa-2b njft (Besremi)
Indications:
- treatment of adults with polycythemia vera
Dosage:
- recommended starting dose:
- 100 ug SC every 2 weeks (50 ug if receiving hydroxyurea)
- increase dose by 50 ug every 2 weeks (up to a maximum of 500 ug) until hematological parameters are stabilized
Injection: 500 ug/mL solution in a single-dose prefilled syringe
Contraindications:
- history of severe psychiatric disorders
- severe depression, suicidal ideation or suicide attempt
- hepatic impairment (Child-Pugh B or C)
- serious or untreated autoimmune disease
- Immunosuppressed transplant recipients
Monitor:
- monitor serum triglycerides before BESREMi treatment & intermittently during therapy
- monitor liver function tests at baseline & during treatment
- monitor serum creatinine at baseline & during therapy
Adverse effects:
- common (> 40%)
- influenza-like illness,
- arthralgia
- fatigue
- pruritus
- nasopharyngitis,
- musculoskeletal pain
- urinary tract infection
- depression
- transient ischemic attack
Drug interactions:
- avoid use with narcotics, hypnotics or sedatives
Mechanism of action:
- binding to interferon alfa receptor (IFNAR) initiating a downstream signaling cascade through the activation of kinases, in particular Janus kinase 1 (JAK1) & tyrosine kinase 2 (TYK2) & activator of transcription (STAT) proteins
- nuclear translocation of STAT proteins controls distinct gene-expression programs & exhibits various cellular effects
- actions involved in the therapeutic effects of interferon alfa in polycythemia vera are not fully elucidated [2]
Related
polycythemia rubra vera (PRV, PV, erythremia)
General
peginterferon alfa 2b (Pegintron)
References
- FDA News Release. Nov 12, 2021
FDA Approves Treatment for Rare Blood Disease
https://www.fda.gov/news-events/press-announcements/fda-approves-treatment-rare-blood-disease
- HIGHLIGHTS OF PRESCRIBING INFORMATION
Besremi (ropeginterferon alfa-2b-njft) injection, for subcutaneous use
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761166s000lbl.pdf