
Etesevimab Injection
Brand Name: 埃特司韦单抗®
Generic Name: Etesevimab
Strength: 700mg/20mL (35mg/mL) per single-dose vial
Manufacturer: Eli Lilly and Company
Marketing Authorization Holder: Eli Lilly and Company
Approval Date in China: Not officially approved for marketing in China (only obtained US FDA Emergency Use Authorization, no NMPA domestic marketing approval)
Registration Number: No domestic import registration number in China
Storage: Store refrigerated at 2°C ~ 8°C, keep in original carton to avoid light exposure. Do not freeze, do not shake violently. After dilution for intravenous infusion, the diluted solution can be stored at 2°C~8°C for up to 24 hours, keep away from children.
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1. Indications and Usage
Etesevimab, in combination with bamlanivimab, was indicated for the treatment of mild to moderate COVID-19 in patients aged 12 years and older weighing at least 40 kg, who tested positive for SARS-CoV-2 and were at high risk for progression to severe COVID-19 or hospitalization.
2. Dosage and Administration
Route of Administration:
Intravenous Infusion ONLY. Do not administer as an IV push or bolus.
Recommended Dosage:
Dose: 280 mg (2 mL) of Etesevimab administered intravenously.
Timing: Administered in combination with bamlanivimab (700 mg) as soon as possible within 10 days of symptom onset.
3. Mechanism of Action
SARS-CoV-2 Spike Protein Binding:
Etesevimab is a neutralizing human IgG1 monoclonal antibody directed against the spike (S) protein of SARS-CoV-2.
Inhibition of Viral Entry:
It binds to the receptor-binding domain (RBD) of the S protein and blocks the interaction between the virus and the ACE2 receptor on host cells, thereby inhibiting viral entry and replication.
4. Safety and Warnings
Hypersensitivity and Infusion-Related Reactions:
Hypersensitivity reactions, including anaphylaxis, and infusion-related reactions (e.g., dyspnea, bronchospasm, urticaria, hypotension) can occur. Monitor patients during infusion.
Immunosuppression:
Use of this product may interfere with the immune response to live viral vaccines.
5. Adverse Reactions
Most Common:
Infusion-related reactions, hypersensitivity reactions, nausea, dizziness, and headache.
6. Drug Interactions
Live Viral Vaccines:
The use of live viral vaccines is not recommended during treatment and for a certain period after the last dose (specific duration depends on drug clearance).
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Etesevimab.
Storage:
Store in a refrigerator at 2-8°C. Do not freeze or shake.
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