Emicizumab


Concise Prescribing Info
Indications/Uses
Treatment and prophylaxis of haemorrhagic episodes in patients with haemophilia A.
Dosage/Direction for Use
Adult : SC Initial: 3 mg/kg once weekly for 4 weeks. Maintenance: Either 1.5 mg/kg once weekly or 3 mg/kg every 2 weeks or 6 mg/kg every 4 weeks.
Dosage Details
Subcutaneous
Treatment and prophylaxis of haemorrhagic episodes in patients with haemophilia A
Adult: Initially, 3 mg/kg once weekly for 4 weeks. Maintenance: Either 1.5 mg/kg once weekly or 3 mg/kg every 2 weeks or 6 mg/kg every 4 weeks.
Child: Same as adult dose.
Special Precautions
Patient with risk of thrombotic microangiopathy and thromboembolism e.g. thrombocytopenia, microangiopathic haemolytic anaemia and acute kidney injury, without severe deficiencies in ADAMTS13. Children. Pregnancy and lactation.
Adverse Reactions
Significant: Thrombotic microangiopathy.
Gastrointestinal disorders: Diarrhoea.
General disorders and administration site conditions: Inj site reactions, pyrexia.
Infections and infestations: Cavernous sinus thrombosis.
Musculoskeletal and connective tissue disorders: Arthralgia, myalgia.
Nervous system disorders: Headache.
Skin and subcutaneous tissue disorders: Skin necrosis.
Vascular disorders: Thrombophlebitis superficial.
MonitoringParameters
Monitor coagulation parameters using single factor assays utilizing chromogenic or immune-based methods. Asses for thrombotic microangiopathy and thrombotic events if activated prothrombin complex concentrate (aPCC) is administered concomitantly.
Drug Interactions
May increase risk of thrombotic microangiopathy with activated prothrombin complex concentrate (aPCC). May enhanced adverse effect of belimumab.
Lab Interference
May interfere with coagulation tests e.g. activated clotting time (ACT), aPTT,  and all assay based on aPTT e.g. Bethesda assays (clotting-based) for FVIII inhibitor titers, one-stage aPTT-based single-factor assays, aPTT-based activated protein C resistance (APC-R).
Action
Description: Emicizumab is a humanized monoclonal modified IgG4 antibody that links activated factor IX and factor X to restore the function of missing activated factor VIII that is needed for effective haemostasis.
Pharmacokinetics:
Absorption: Bioavailability: 80.4-93.1%.
Distribution: Volume of distribution: 10.4 L.
Excretion: Elimination half-life: Approx 26.9 ± 9.1 days.
Storage
Store between 2-8°C. Protect from light. Do not freeze.
MIMS Class
ATC Classification
B02BX06 - emicizumab ; Belongs to the class of other systemic hemostatics. Used in the treatment of hemorrhage.
References
Anon. Emicizumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 19/06/2019.

Buckingham R (ed). Emicizumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 19/06/2019.

Hemlibra Injection, Solution (Genentech, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 19/06/2019.

Joint Formulary Committee. Emicizumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 19/06/2019.

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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in