Generic Name and Formulations:
Emicizumab-kxwh 30mg/mL, 60mg/0.4mL, 105mg/0.7mL, 150mg/mL; per vial; soln for SC inj; preservative-free.
Indications for HEMLIBRA:
Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A with or without factor VIII inhibitors.
Adults and Children:
Do not inj into moles, scars, tender skin, bruised, red, hard or not intact skin areas. Give by SC inj into upper outer arms, thighs, or any abdomen quadrant; rotate inj sites. 3mg/kg once weekly for first 4 weeks, then 1.5mg/kg once weekly, or 3mg/kg once every 2 weeks, or 6mg/kg once every 4 weeks. Discontinue prophylactic use of bypassing agents the day before starting therapy; may continue FVIII prophylaxis during first week of Hemlibra.
Thrombotic microangiopathy and thromboembolism.
Thrombotic microangiopathy and thromboembolism can occur when average cumulative of >100U/kg per 24hrs of activated prothrombin complex concentrate (aPCC) was given for ≥24hrs. Females of reproductive potential should use effective contraception during treatment. Pregnancy. Nursing mothers.
Bispecific factor IXa- and factor X-directed antibody.
Risk of thrombotic microangiopathy and thromboembolism with concomitant aPCC; monitor and immediately discontinue if occurs. May interfere with coagulation lab tests (eg, ACT, aPTT, aPTT-based assays, Bethesda assays [clotting-based] for FVIII inhibitor titers).
Inj site reactions, headache, arthralgia, pyrexia, diarrhea; thrombotic microangiopathy, thromboembolism.
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