Sotrovimab dosage, side effects

Sotrovimab dosage, side effects:

Sotrovimab is a monoclonal antibody (mAb) developed for the treatment of mild-to-moderate COVID-19 in high-risk patients. Below is a comprehensive overview of its key details, including brand names, mechanism of action, indications, and more.

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• Xevudy (used in the EU, UK, and other regions)
• Sotrovimab (generic name, used in the US and elsewhere)

Sotrovimab was developed by GlaxoSmithKline (GSK) in collaboration with Vir Biotechnology.

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Sotrovimab is a neutralizing monoclonal antibody that targets the spike protein of SARS-CoV-2 (the virus causing COVID-19). It binds to a conserved epitope on the spike protein, blocking viral entry into human cells and reducing viral replication.

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• Approved for:
  • Treatment of mild-to-moderate COVID-19 in adults and adolescents (≥12 years, ≥40 kg)
  • High-risk patients (those at risk of progression to severe COVID-19, hospitalization, or death)
• Not authorized for:
  • Severe or critical COVID-19 requiring oxygen
  • Post-exposure prophylaxis

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• Single-dose intravenous (IV) infusion (500 mg over 30 minutes)
• Should be given as early as possible after symptom onset (within 5–7 days)

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• Demonstrated 85% reduction in hospitalization/death in high-risk patients (COMET-ICE trial)
• Initially effective against earlier variants (Alpha, Beta, Delta)
• Less effective against Omicron subvariants (BA.2, BA.5, XBB)—led to deprioritization by regulatory agencies

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• FDA Emergency Use Authorization (EUA): Granted (May 2021) but revoked (April 2022) due to ineffectiveness against Omicron.
• EMA (EU): Conditional approval (Dec 2021), but later restricted (2022).
• Other countries: Availability varies based on circulating variants.

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Mostly mild, including:

• Infusion-related reactions (rash, fever, chills)
• Hypersensitivity reactions
• Rare: Worsening of COVID-19 symptoms

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• No longer recommended in the US and several other countries due to lack of efficacy against dominant variants.
• Replaced by newer monoclonal antibodies (e.g., Bebtelovimab) or antiviral drugs (Paxlovid, Remdesivir).

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• Brand name: Xevudy (primary brand outside the US).
• Developed by: GSK & Vir Biotechnology.
• Best for: Early-stage COVID-19 in high-risk individuals (when active against circulating variants).
• Limitations: Ineffective against later Omicron subvariants.