Sotrovimab

Hypersensitivity reactions, including anaphylaxis, have been reported with administration of sotrovimab. If signs or symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, administration should be discontinued immediately and appropriate medications and/or supportive care should be given.

There are no data from the use of sotrovimab in pregnant women. Animal studies have not been evaluated with respect to reproductive toxicity. In a cross-reactive binding assay using a protein array enriched for human embryofoetal proteins, no off-target binding was detected. Since sotrovimab is a human immunoglobulin G (IgG), it has the potential for placental transfer from the mother to the developing foetus. The potential treatment benefit or risk of placental transfer of sotrovimab to the developing foetus is not known.

Sotrovimab should be used during pregnancy only if the expected benefit to the mother justifies the potential risk to the foetus.

It is not known whether sotrovimab is excreted in human milk or absorbed systemically after ingestion. Administration of sotrovimab while breast-feeding can be considered when clinically indicated.

Fertility

There are no data on the effects of sotrovimab on human male or female fertility. Effects on male and female fertility have not been evaluated in animal studies.

Sotrovimab has no or negligible influence on the ability to drive and use machines.

Summary of the safety profile

The most common adverse reactions were hypersensitivity reactions (2%) and infusion-related reactions (1%). The most serious adverse reaction was anaphylaxis (0.05%).

Tabulated list of adverse reactions

The adverse reactions in the following table are listed by system organ class and frequency. Frequencies are defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).

Tabulated list of adverse reactions:

^a Such as rash and bronchospasm. Pruritus may also be seen as a manifestation of hypersensitivity reactions.

Description of selected adverse reactions

Infusion-related reactions

IRRs may be severe or life threatening. Signs and symptoms of IRRs may include fever, difficulty breathing, reduced oxygen saturation, chills, nausea, arrhythmia (e.g. atrial fibrillation), tachycardia, bradycardia, chest pain or discomfort, weakness, altered mental status, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, dizziness, fatigue and diaphoresis.