Generic Medicine Info
Indications and Dosage
Prophylaxis of haemorrhage in haemophilia A
Adult: In patients with or without factor VIII inhibitors: Initially, 3 mg/kg once weekly for the 1st 4 weeks. Maintenance: Either 1.5 mg/kg once weekly, 3 mg/kg every 2 weeks, or 6 mg/kg every 4 weeks.
Child: Same as adult dose.
Special Precautions
Patient with risk factors for thrombotic microangiopathy. Discontinue treatment (including prophylactic use) with bypassing agents the day prior to initiation of emicizumab. Children. Pregnancy and lactation.
Adverse Reactions
Significant: Thrombotic microangiopathy, thromboembolism, antibody formation.
Gastrointestinal disorders: Diarrhoea.
General disorders and administration site conditions: Inj site reactions (e.g. erythema, pain, pruritus, haematoma), pyrexia.
Musculoskeletal and connective tissue disorders: Arthralgia, myalgia.
Nervous system disorders: Headache.
Skin and subcutaneous tissue disorders: Skin necrosis.
Vascular disorders: Thrombophlebitis superficial, cavernous sinus thrombosis.
Patient Counseling Information
Women of childbearing potential must use effective birth control methods during therapy and for at least 6 months after stopping the treatment.
Monitoring Parameters
Monitor coagulation parameters using single factor assays utilising chromogenic or immune-based methods. Assess for thrombotic microangiopathy and thrombotic events in patients receiving activated prothrombin complex concentrate (aPCC).
Drug Interactions
Increased risk of thrombotic microangiopathy and thromboembolism with aPCC.
Lab Interference
May affect the results of intrinsic pathway clotting-based laboratory tests, including activated clotting time, aPTT, Bethesda assays (clotting-based) for FVIII inhibitor titres, one-stage aPTT-based single-factor assays, and aPTT-based activated protein C resistance.
Mechanism of Action: Emicizumab, a humanised monoclonal modified IgG4 antibody with a bispecific antibody structure, links activated factor IX and factor X to restore the function of missing activated factor VIII, which is necessary for effective haemostasis.
Absorption: Bioavailability: 80.4-93.1%.
Distribution: Volume of distribution: 10.4 L.
Excretion: Elimination half-life: 26.9 ± 9.1 days.
Store between 2-8°C. Do not freeze. Do not shake. Protect from light. Unopened vials may also be stored below 30°C for up to 7 days.
MIMS Class
ATC Classification
B02BX06 - emicizumab ; Belongs to the class of other systemic hemostatics. Used in the treatment of hemorrhage.
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Hemlibra 30 mg/mL, 150 mg/mL Solution for Injection (Roche [Malaysia] Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 07/11/2022.

Hemlibra Injection, Solution (Genentech, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 07/11/2022.

Joint Formulary Committee. Emicizumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/11/2022.

Roche Products (New Zealand) Limited. Hemlibra 30 mg/1 mL, 60 mg/0.4 mL, 105 mg/0.7 mL, 150 mg/1 mL Solution for Injection data sheet 1 February 2022. Medsafe. http://www.medsafe.govt.nz. Accessed 08/11/2022.

Disclaimer: This information is independently developed by MIMS based on Emicizumab from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by MIMS.com
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