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Besremi (ropeginterferon alfa-2b-njft)
ropeginterferon alfa-2b
Black Box Warnings .
Serious Disorders
alpha-interferons can cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders; closely monitor w/ clinical and lab eval.; D/C tx if persistently severe or worsening s/sx of these conditions; disorders resolve in many but not all cases after D/C tx
Adult Dosing .
Dosage forms: INJ (pre-filled syringe): 500 mcg per mL
Special Note
- [formulation clarification]
- Info: nonproprietary name = ropeginterferon alfa-2b-njft
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing incl. toxicity-related dose adjustments
polycythemia vera
- [pts not on hydroxyurea]
- Dose: 100-500 mcg SC q2wk; Start: 100 mcg SC q2wk; Max: 500 mcg/dose; Info: incr. dose by 50 mcg q2wk until Hct <45%, Plt <400,000, and leukocytes <10,000, then cont. same dose q2wk for at least 1yr, then may extend dosing interval to q4wk
- [pts transitioning from hydroxyurea]
- Dose: 50-500 mcg SC q2wk; Start: 50 mcg SC q2wk; Max: 500 mcg/dose; Info: incr. dose by 50 mcg q2wk until Hct <45%, Plt <400,000, and leukocytes <10,000, then cont. same dose q2wk for at least 1yr, then may extend dosing interval to q4wk; decr. hydroxyurea total biweekly dose by 20-40% q2wk on wk 3-12, then D/C hydroxyurea by wk 13
renal dosing
- [see below]
- eGFR <30: avoid use
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class B or C: contraindicated
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.