Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Hypersensitivity reactions, including anaphylaxis, have been reported with administration of sotrovimab (see section 4.8). 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.
Infusion-related reactions (IRRs) have been observed with intravenous administration of monoclonal antibodies (see section 4.8). These reactions may be severe or life threatening. If an IRR occurs, the infusion may be interrupted, slowed or stopped.
No interaction studies have been performed. Sotrovimab is not renally excreted or metabolised by cytochrome P450 (CYP) enzymes; therefore, interactions with medicinal products that are renally excreted or that are substrates, inducers, or inhibitors of CYP enzymes are unlikely.
In vitro pharmacodynamic studies showed no antagonism between sotrovimab and remdesivir or bamlanivimab.
There are no data from the use of sotrovimab in pregnant women. Animal studies have not been evaluated with respect to reproductive toxicity (see section 5.3). 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.
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.
Xevudy has no or negligible influence on the ability to drive and use machines.
The most common adverse reactions were hypersensitivity reactions (2%) and infusion-related reactions (1%). The most serious adverse reaction was anaphylaxis (0.05%).
The adverse reactions in Table 1 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).
Table 1. Tabulated list of adverse reactions:
| System organ class | Adverse reaction | Frequency |
|---|---|---|
| Immune system disorders | Hypersensitivity reactionsa Anaphylaxis | Common Rare |
| Respiratory, thoracic and mediastinal disorders | Dyspnoea | Uncommon |
| Injury, poisoning and procedural complications | Infusion-related reactions | Common |
a Such as rash and bronchospasm. Pruritus may also be seen as a manifestation of hypersensitivity reactions.
IRRs may be severe or life threatening (see section 4.4). 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.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
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