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Jivi (antihemophilic factor (factor VIII, recombinant), pegylated-aucl)
antihemophilic factor (factor VIII, recombinant), pegylated
Adult Dosing .
Dosage forms: INJ
Special Note
- [drug name clarification]
- Info: nonproprietary name = antihemophilic factor (factor VIII, recombinant), pegylated-aucl
- [dosing clarification]
- Info: 1 unit/kg will incr. factor VIII level approx. 2%; dose, duration varies by site/severity of bleeding, severity of deficiency, and presence of inhibitors
hemophilia A
- [bleeding episode, minor]
- Dose: 10-20 unit/kg/dose IV q24-48h until hemostasis; Max: 6000 units/dose; Info: estimated dose (units) = [wt (kg) x desired factor VIII level (%) x 0.5] where desired factor VIII level = 20-40%; not 1st line tx
- [bleeding episode, moderate]
- Dose: 15-30 unit/kg/dose IV q24-48h until hemostasis; Max: 6000 units/dose; Info: estimated dose (units) = [wt (kg) x desired factor VIII level (%) x 0.5] where desired factor VIII level = 30-60%; not 1st line tx
- [bleeding episode, major]
- Dose: 30-50 unit/kg/dose IV q8-24h until hemostasis; Max: 6000 units/dose; Info: estimated dose (units) = [wt (kg) x desired factor VIII level (%) x 0.5] where desired factor VIII level = 60-100%; not 1st line tx
- [bleeding prophylaxis, minor surgery]
- Dose: 15-30 unit/kg/dose IV q24h for at least 24h until healing achieved; Max: 6000 units/dose; Info: estimated dose (units) = [wt (kg) x desired factor VIII level (%) x 0.5] where desired factor VIII level = 30-60%; not 1st line tx
- [bleeding prophylaxis, major surgery]
- Dose: 40-50 unit/kg/dose IV q12-24h until at least 7 days after adequate wound healing; Max: 6000 units/dose; Info: estimated dose (units) = [wt (kg) x desired factor VIII level (%) x 0.5] where desired factor VIII level = 80-100% until healing complete, then 30-60% for at least 7 days; not 1st line tx
- [routine bleeding prophylaxis]
- Dose: 30-40 units/kg/dose IV 2x/wk; Alt: 45-60 units/kg/dose q5 days
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: INJ
Special Note
- [drug name clarification]
- Info: nonproprietary name = antihemophilic factor (factor VIII, recombinant), pegylated-aucl
- [dosing clarification]
- Info: 1 unit/kg will incr. factor VIII level approx. 2%; dose, duration varies by site/severity of bleeding, severity of deficiency, and presence of inhibitors
hemophilia A
- [bleeding episode, minor, 7 yo and older]
- Dose: 10-20 unit/kg/dose IV q24-48h until hemostasis; Max: 6000 units/dose; Info: estimated dose (units) = [wt (kg) x desired factor VIII level (%) x 0.5] where desired factor VIII level = 20-40%; not 1st line tx
- [bleeding episode, moderate, 7 yo and older]
- Dose: 15-30 unit/kg/dose IV q24-48h until hemostasis; Max: 6000 units/dose; Info: estimated dose (units) = [wt (kg) x desired factor VIII level (%) x 0.5] where desired factor VIII level = 30-60%; not 1st line tx
- [bleeding episode, major, 7 yo and older]
- Dose: 30-50 unit/kg/dose IV q8-24h until hemostasis; Max: 6000 units/dose; Info: estimated dose (units) = [wt (kg) x desired factor VIII level (%) x 0.5] where desired factor VIII level = 60-100%; not 1st line tx
- [bleeding prophylaxis, minor surgery, 7 yo and older]
- Dose: 15-30 unit/kg/dose IV q24h for at least 24h until healing achieved; Max: 6000 units/dose; Info: estimated dose (units) = [wt (kg) x desired factor VIII level (%) x 0.5] where desired factor VIII level = 30-60%; not 1st line tx
- [bleeding prophylaxis, major surgery, 7 yo and older]
- Dose: 40-50 unit/kg/dose IV q12-24h until at least 7 days after adequate wound healing; Max: 6000 units/dose; Info: estimated dose (units) = [wt (kg) x desired factor VIII level (%) x 0.5] where desired factor VIII level = 80-100% until healing complete, then 30-60% for at least 7 days; not 1st line tx
- [routine bleeding prophylaxis, 7-11 yo]
- Dose: 60 units/kg/dose IV 2x/wk
- [routine bleeding prophylaxis, 12 yo and older]
- Dose: 30-40 units/kg/dose IV 2x/wk; Alt: 45-60 units/kg/dose q5 days
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- hypersensitivity to murine protein
- hypersensitivity to hamster protein
Drug Interactions .
Overview
antihemophilic factor (factor VIII)
coagulation factor/cofactor
-
None
Avoid/Use Alternative
- efgartigimod alfa
- rozanolixizumab
Monitor/Modify Tx
- concizumab
Adverse Reactions .
Serious Reactions
- hypersensitivity rxn
Common Reactions
- headache
- cough
- fever
- nausea
- vomiting
- abdominal pain
- insomnia
- dizziness
- rash
- hypersensitivity rxn
Safety/Monitoring .
Monitoring Parameters
no routine tests recommended
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; inadequate human or animal data available
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available, though risk of infant harm not expected based on drug properties; no human data available to assess effects on milk production
Pharmacology .
Metabolism: other; CYP450: unknown
Excretion: other; Half-life: 17.4-21.4h
Subclass: Hemostasis: Coagulation Factors/Cofactors
Mechanism of Action
supplies factor VIII, promoting coagulation
Formulary .
No Formulary Selected
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