Casirivimab and imdevimab

There are no or limited amount of data from the use of casirivimab and imdevimab in pregnant women. Animal studies have not been performed with respect to reproductive toxicity. Human immunoglobulin G1 (IgG1) antibodies are known to cross the placenta. It is unknown whether the potential transfer of casirivimab and imdevimab provides any treatment benefit or risk to the developing foetus. However, as casirivimab and imdevimab directly target the spike protein of SARSCoV-2 and in view of lack of cross reactivity with reproductive or foetal tissues in the tissue cross reactivity studies, negative effects on developing foetus are not expected. Casirivimab/imdevimab combination should be used during pregnancy only if the potential benefit justifies the potential risk for the mother and the foetus considering all associated health factors. If a woman becomes pregnant while taking this medicine, the individual should be informed that any potential risk to the foetus is unknown.

It is unknown whether casirivimab and imdevimab are excreted in human milk, but maternal IgG is known to be transferred to milk during the first days after birth. As casirivimab and imdevimab directly target the spike protein of SARS-CoV-2 and in view of low systemic absorption after oral ingestion of antibodies, administration of casirivimab/imdevimab whilst breast-feeding can be considered when clinically indicated.

Fertility

No fertility studies have been performed.

Casirivimab/imdevimab combination has no or negligible influence on the ability to drive and use machines.

Summary of the safety profile

Overall, 8 596 subjects (6 173 via intravenous administration and 2 423 via subcutaneous administration) have been treated with casirivimab and imdevimab in clinical trials.

The most frequently reported adverse drug reactions are hypersensitivity reactions, which include infusion related reactions (IRRs) and injection site reactions (ISRs).

Tabulated summary of adverse reactions

The adverse reactions in table are listed below by system organ class and frequency. Frequencies are defined as 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 identified from clinical trials and post-marketing:

¹ ISRs include erythema, pruritus, ecchymosis, oedema, pain, tenderness, urticaria, and convulsive syncope
^* In some cases, symptoms of IRRs and ISRs have been reported as individual ADRs

Paediatric population

Intravenous administration

In the RECOVERY study, 4 adolescents ≥12 and <18 years old received treatment with casirivimab and imdevimab. The safety profile observed in this limited population was similar to that in adult patients.

Subcutaneous administration

In study COV-2069, 66 adolescents ≥12 and <18 years old received treatment with casirivimab and imdevimab. The safety profile observed was similar to that in adult patients.