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Anti-SARS-CoV-2 spike monoclonal antibody Pregnancy: SPC section 4.6: there are no data from the use of sotrovimab in pregnant women. As a human IgG it has the potential for placental transfer; the potential treatment benefit or risk of placental transfer to the developing foetus is not known. Sotrovimab may be used during pregnancy where the expected benefit to the mother justifies the risk to the foetus. Breast-feeding: there are no data on excretion in human milk; decide whether to breastfeed during treatment or abstain from sotrovimab therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Fertility: no data on effects on human male or female fertility.

Sotrovimab

Brand names: Xevudy

Sotrovimab is a recombinant human monoclonal antibody used for treatment of COVID-19 in eligible high-risk patients.

Adult dose

Dose: Treatment of symptomatic adults with acute covid-19 infection who do not require oxygen supplementation and who are at increased risk of progressing to severe covid infection: a single 500 mg intravenous infusion administered following dilution (each vial contains 500 mg of sotrovimab in 8 mL, 62.5 mg/mL); recommended to be administered within 5 days of onset of symptoms of COVID-19
Route: Intravenous infusion (diluted; with a 0.2-μm in-line filter)
Frequency: Single dose; infuse over 15 minutes (50 mL infusion bag) or over 30 minutes (100 mL infusion bag); not as an intravenous push or bolus
The pinned product is XEVUDY 500 MG CONCENTRATE FOR SOLUTION FOR INFUSION (PLGB194940301, GlaxoSmithKline UK Limited); section 4.1: 'For the treatment of symptomatic adults and adolescents (aged 12 years and over and weighing at least 40 kg) with acute covid-19 infection who do not require oxygen supplementation and who are at increased risk of progressing to severe covid infection'. Section 4.2: 'Xevudy should only be administered by a qualified healthcare provider. Administration should be under conditions where management of severe hypersensitivity reactions, such as anaphylaxis, is possible. Individuals should be monitored during and post intravenous infusion in accordance with local guidelines.' Consideration should be given to official guidance on the appropriate use of Xevudy. The product must be diluted prior to administration (instructions in section 6.6, which was not retrieved). Prime the infusion set and administer as a single IV infusion at room temperature. Section 4.4: record the name and batch number of the administered product; hypersensitivity reactions (including anaphylaxis) typically occur within 24 hours of infusion; consider known SARS-CoV-2 variant susceptibility to sotrovimab when deciding on use. Elderly, renal impairment and hepatic impairment: no dose adjustment is required. Adolescents aged 12 years and over and weighing at least 40 kg: see paedDose. NOT PRINTED, so not written: any maximum dose beyond the single 500 mg dose, any repeat dose, and the dilution volumes (section 6.6 not retrieved).

Paediatric dose

Dose: Adolescents aged 12 years and over and weighing at least 40 kg: the same single 500 mg intravenous infusion administered following dilution (section 4.2 'Adults and adolescents (from 12 years and 40 kg body weight)'); no dosage adjustment is recommended in paediatric individuals 12 years of age and over and weighing 40 kg or more
Route: Intravenous infusion (diluted)
Frequency: Single dose
This is the SPC's own printed figure for the 12 years and 40 kg group, not a scaled dose. Children under 12 years old or weighing less than 40 kg: the safety and efficacy have not yet been established; currently available data are described in sections 4.8 and 5.2 but no recommendation on posology can be made. Use a children's formulary / specialist advice for these children.

Dose adjustments

Renal

SPC section 4.2: no dose adjustment is required in patients with renal impairment (see section 5.2).

Hepatic

SPC section 4.2: no dose adjustment is required in patients with hepatic impairment (see section 5.2).

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via MHRA Products — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients

Side effects

  • Hypersensitivity reactions (common) - includes rash, contact dermatitis, skin reaction, hypersensitivity, multiple allergies, infusion-related reaction and bronchospasm; the most common adverse reactions
  • Anaphylaxis (rare) - the most serious adverse reaction
  • Hypersensitivity reactions typically occur within 24 hours of infusion; signs and symptoms may include nausea, chills, dizziness (or syncope), rash, urticaria and flushing
  • In COMET-ICE the hypersensitivity reactions reported were grade 1 (mild) or grade 2 (moderate); none led to discontinuation of the infusions

Interactions

  • No interaction studies have been performed; sotrovimab is not renally excreted or metabolised by cytochrome P450 enzymes, so interactions with renally excreted drugs or CYP substrates, inducers or inhibitors are unlikely
  • COVID-19 vaccines - concomitant administration has not been studied; refer to local/national guidelines for vaccine administration

Monitoring

  • Monitor individuals during and after the intravenous infusion in accordance with local guidelines; give only where severe hypersensitivity reactions such as anaphylaxis can be managed
  • If signs and symptoms of severe hypersensitivity occur, discontinue administration immediately and start appropriate treatment and/or supportive care; for mild to moderate reactions consider slowing or stopping the infusion with supportive care
  • Record the name and batch number of the administered product (traceability)
  • Consider circulating SARS-CoV-2 variant characteristics and sotrovimab susceptibility data (molecular testing or sequencing where available)
  • Recipients are advised to self-isolate in accordance with national covid-19 guidelines
  • Contains 4.8 mg of polysorbate 80 in each 500 mg dose; polysorbates may cause allergic reactions

Clinical monograph

How it works

It binds a conserved epitope on the SARS-CoV-2 spike protein, neutralising the virus and limiting its ability to infect host cells.

Prescribing in practice

  • Infusion-related and hypersensitivity reactions, including anaphylaxis, can occur, so give by intravenous infusion with monitoring and resuscitation facilities available.
  • Activity depends on the circulating variant, so use should follow current national recommendations on susceptibility.
  • It is reserved for patients meeting national high-risk eligibility criteria.

Monitoring

Observe the patient during and for a period after the infusion for hypersensitivity or infusion reactions.

Counselling the patient

  • This treatment is given as a single drip in a monitored setting.
  • Report any rash, breathlessness, dizziness or chest tightness during or after the infusion.
  • It is offered to people at higher risk of severe COVID-19.

Evidence & guidelines

Sotrovimab use is guided by MHRA authorisation and national recommendations, with effectiveness dependent on circulating SARS-CoV-2 variants.

Reference: NICE TA878; UKHSA; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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