Evusheld

Evusheld

Manufacturer:

Samsung Biologics

Distributor:

Zuellig

Marketer:

AstraZeneca
Concise Prescribing Info
Contents
Tixagevimab, cilgavimab
Indications/Uses
Pre-exposure prophylaxis of COVID-19 in adults & adolescents ≥12 yr weighing at least 40 kg.
Dosage/Direction for Use
Adult & adolescent ≥12 yr weighing at least 40 kg 150 mg tixagevimab & 150 mg cilgavimab, administered as 2 separate sequential IM inj.
Contraindications
Special Precautions
Immediately discontinue administration if signs & symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur. Consider risks & benefits prior to administration in individuals at high risk for CV or thrombo-embolic events. Give w/ caution to patients w/ thrombocytopenia or any coagulation disorder. Risk of antiviral resistance. Not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended. Pregnancy. Safety & efficacy in childn <12 yr have not yet been established.
Adverse Reactions
Hypersensitivity; inj site reactions.
MIMS Class
Vaccines, Antisera & Immunologicals / Antivirals
ATC Classification
J06BD03 - tixagevimab and cilgavimab ; Belongs to the class of antiviral monoclonal antibodies. Used in passive immunizations.
Additional Information
The product is conditionally approved with limited safety, efficacy, and quality data for public health emergency to satisfy local unmet medical need and the registration status is subjected to be reviewed by the Pharmacy and Poisons (Registration of Pharmaceutical Products and Substances: Certification of Clinical Trial/Medicinal Test) Committee. The product can only be supplied to institutions or registered medical practitioners. (Drug Office, Department of Health HK)
Presentation/Packing
Form
Evusheld soln for inj 150 mg/1.5 mL + 150 mg/1.5 mL
Packing/Price
2's
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