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 Inj on abdomen, upper outer arm or thighs. Recommended loading dose: 3 mg/kg once wkly for the 1st 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
Not to be administered into areas where skin is red, bruised, tender or hard, or areas w/ moles or scars. Discontinue treatment w/ bypassing agents the day before starting therapy. Thrombotic microangiopathy & thromboembolism associated w/ treatment & activated prothrombin complex conc. Immunogenicity. Lab coagulation test interference eg, aPTT, Bethesda assays (clotting-based) for FVIII inhibitor titers, 1-stage, aPTT-based, single-factor assays (eg, FVIII activity), aPTT-based activated protein C resistance, activated clotting time. 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 30 mg/mL
Packing/Price
1's
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