Romlusevimab Application Scope

Romlusevimab is a fully human IgG1 monoclonal antibody that neutralizes SARS-CoV-2 by binding to the receptor-binding domain (RBD) of the viral spike protein, preventing interaction with the host ACE2 receptor. It is used in combination with Amubarvimab (BRII-196) for the treatment of mild to moderate COVID-19 in adults and adolescents (12–17 years, ≥40 kg) at high risk of disease progression.

Romlusevimab Characteristics

Ingredients: Fully human anti-SARS-CoV-2 monoclonal antibody (IgG1)
Properties: Sterile, clear, colorless solution for intravenous infusion
Packaging Specification: 500mg × 1 vial/box
Storage: 2–8 °C, protect from light, do not freeze or shake
Expiry Date: To be confirmed
Executive Standard: To be confirmed (per NMPA)
Approval Number: To be confirmed (NMPA)
Date of Revision: 2021-12-08 (NMPA emergency approval); 2022-07-07 commercial release
Manufacturer: Tengsheng Huachuang Pharmaceutical Technology (Beijing) Co., Ltd.

Guidelines for the Use of Romlusevimab

Dosage and Administration:
- Recommended Dose: 1000 mg for Romlusevimab per infusion (adults and adolescents ≥40 kg)
- Administration: Dilute with 100 mL saline; infuse at ≤4 mL/min.
- Missed Dose: Administer as soon as possible, following the same infusion guidelines.
Adverse Reactions:
- Common Adverse Reactions: Infusion-related reactions, fever, chills, fatigue, nausea, headache.
- Serious Adverse Reactions: Rare severe hypersensitivity, infusion reactions, worsening COVID-19 symptoms (e.g., hypoxia, respiratory distress).
Contraindications:
- Known hypersensitivity to Romlusevimab or any excipient.
- History of severe infusion-related reactions to monoclonal antibodies.
- Patients with uncontrolled severe allergic conditions should avoid use.
Precautions:
- Closely monitor patients during infusion and for at least 1–2 hours post-infusion for hypersensitivity, anaphylaxis, or infusion-related reactions.
- Limited clinical data for pediatric patients <12 years or weighing <40 kg; use with caution.
- Use during pregnancy and lactation only if potential benefits outweigh potential risks.
- Ensure infusion solution is at room temperature before administration if previously refrigerated; do not freeze.
- Observe for any signs of respiratory distress, fever, or hypotension during and after infusion.

Romlusevimab Interactions

No known pharmacological drug interactions identified.
Co-administration approved only with Amubarvimab (BRII-196®) as per clinical trial and regulatory guidance.
Monitor for additive immune modulation if used with other monoclonal antibodies or immunosuppressive therapies.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.