ropeginterferon alfa-2b njft (Besremi)

Indications

• treatment of adults with polycythemia vera

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

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

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

• drug interaction(s) of methotrexate with biological response modifier

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

More general terms

• peginterferon alfa 2b (Pegintron)

Additional terms

• polycythemia rubra vera (PRV, PV, erythremia)