Hemlibra

Hemlibra

emicizumab

Manufacturer:

Roche

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Emicizumab
Indications/Uses
Routine prophylaxis of bleeding episodes in patients w/ haemophilia A w/ factor VIII (FVIII) inhibitors & severe haemophilia A w/o factor VIII inhibitors.
Dosage/Direction for Use
Recommended loading dose: 3 mg/kg SC inj once wkly for 1st 4 wk, followed by maintenance dose: 1.5 mg/kg SC inj once wkly, 3 mg/kg every 2 wk or 6 mg/kg every 4 wk.
Contraindications
Hypersensitivity to emicizumab or L-arginine, L-histidine, L-aspartic acid, poloxamer 188.
Special Precautions
Thrombotic microangiopathy (TMA). Discontinue treatment w/ bypassing agents 1 day prior to initiation. Misinterpretation of intrinsic pathway clotting-based laboratory tests results eg, activated clotting time, activated partial thromboplastin time may lead to under-treatment of patients experiencing bleeding episodes. Possible hypercoagulability w/ recombinant activated clotting factor VII (rFVIIa) or FVIII. Concomitant use of anti-fibrinolytics w/ activated prothrombin complex concentration (aPCC) or rFVIIa. Women of childbearing potential should use effective contraception during & for at least 6 mth after cessation of treatment. Pregnancy & lactation.
Adverse Reactions
TMA, thrombotic events; inj site reaction, arthralgia, headache.
Drug Interactions
Possible hypercoagulability w/ rFVIIa or FVIII. Possible thrombotic events when systemic anti-fibrinolytics are used in combination w/ aPCC or rFVIIa.
MIMS Class
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
Form
Hemlibra soln for inj 60 mg/0.4 mL
Packing/Price
1's
Form
Hemlibra soln for inj 150 mg/mL
Packing/Price
1's
Form
Hemlibra soln for inj 105 mg/0.7 mL
Packing/Price
1's
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