Hemlibra

Hemlibra

emicizumab

Manufacturer:

Roche

Distributor:

DKSH
Concise Prescribing Info
Contents
Emicizumab
Indications/Uses
Routine prophylaxis to prevent bleeding or reduce frequency of bleeding episodes in adults & childn w/ hemophilia A (congenital factor VIII deficiency) w/ or w/o factor VIII inhibitors.
Dosage/Direction for Use
SC Recommended loading dose: 3 mg/kg once wkly for the first 4 wk, followed by maintenance dose of either 1.5 mg/kg once wkly, or 3 mg/kg every 2 wk, or 6 mg/kg every 4 wk.
Contraindications
Special Precautions
Monitor for development of thrombotic microangiopathy (TMA) & thromboembolism when administering activated prothrombin complex concentrate (aPCC) in patients receiving Hemlibra prophylaxis. Immediately discontinue aPCC & interrupt therapy if TMA & thrombotic events occur. Discontinue treatment w/ bypassing agents the day before the start of Hemlibra therapy. May increase coagulation potential. Initial dose should not exceed 50 U/kg in patients indicated w/ aPCC during Hemlibra therapy. May affect results of activated partial thromboplastin time (aPTT), Bethesda assays for FVIII inhibitor titers, 1-stage, aPTT-based, single factor assays (eg, FVIII activity), aPTT-based activated protein C resistance (APC-R), & activated clotting time (ACT). Women of childbearing potential should use effective contraception during & for at least 6 mth after cessation of treatment. Pregnancy & lactation.
Adverse Reactions
Inj site reactions; headache; arthralgia. Pyrexia, diarrhea, myalgia.
MIMS Class
Haemostatics
ATC Classification
B02BX06 - emicizumab ; Belongs to the class of other systemic hemostatics. Used in the treatment of hemorrhage.
Presentation/Packing
Form
Hemlibra soln for inj 105 mg/0.7 mL
Packing/Price
1's
Form
Hemlibra soln for inj 150 mg/mL
Packing/Price
1's
Form
Hemlibra soln for inj 30 mg/mL
Packing/Price
1's
Form
Hemlibra soln for inj 60 m/0.4 mL
Packing/Price
1's
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