Tixagevimab and Cilgavimab interacts in the following cases:
As with any other intramuscular injections, tixagevimab and cilgavimab should be given with caution to patients with thrombocytopenia or any coagulation disorder.
There are no or limited data from the use of tixagevimab and cilgavimab in pregnant women.
Non-clinical reproductive toxicity studies have not been performed with tixagevimab and cilgavimab. In tissue cross reactivity studies with tixagevimab and cilgavimab using human foetal tissues no binding of clinical concern was detected. Human immunoglobulin G1 (IgG1) antibodies are known to cross the placenta therefore tixagevimab and cilgavimab have the potential to be transferred from the mother to the developing foetus. The potential treatment benefit or risk of placental transfer of tixagevimab and cilgavimab to the developing foetus is not known.
Tixagevimab/cilgavimab should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the foetus.
It is not known whether tixagevimab and cilgavimab are excreted in human milk but maternal IgG is known to be transferred to milk during the first days after birth.
As tixagevimab and cilgavimab directly target the spike protein of SARS-CoV-2, and in view of low systemic absorption after oral ingestion of antibodies, administration of tixagevimab/cilgavimab whilst breastfeeding can be considered when clinically indicated.
There are no data on the effects of tixagevimab and cilgavimab on human fertility. Effects on male and female fertility have not been evaluated in animal studies.
Tixagevimab/cilgavimab has no or negligible influence on the ability to drive and use machines.
The most common adverse reactions were injection site reactions (1.3%) and hypersensitivity (1.0%).
A total of 4,210 adult participants have received 150 mg tixagevimab and 150 mg cilgavimab, via intramuscular injection, in Phase III prophylaxis studies.
The adverse reactions in the following table are listed by MedDRA 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) and not known (cannot be estimated from available data).
Tabulated list of adverse reactions:
| MedDRA system organ class | Adverse reaction | Frequency |
|---|---|---|
| Immune system disorders | Hypersensitivitya | Common |
| General disorders and administration site conditions | Injection related reactionb | Uncommon |
| Injury, poisoning and procedural complications | Injection site reactionc | Common |
a Including the preferred terms Rash and Urticaria.
b Description of events reported under the preferred term Injection related reaction include headache, chills and redness, discomfort or soreness near where the injection was given.
c Including the preferred terms Injection site pain, Injection site erythema, Injection site pruritus, Injection site reaction and Injection site induration.
No data are available for paediatric patients <18 years old.
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