Regdanvimab

Hypersensitivity reactions, including infusion-related and anaphylactic reactions, have been observed during and following administration of regdanvimab.

Reproductive and developmental studies have not been performed with regdanvimab.

Nonclinical reproductive toxicity studies have not been conducted with regdanvimab. In tissue cross-reactivity (TCR) studies with regdanvimab using human foetal and neonatal tissues, no binding of clinical concern was detected in the foetal tissues. Human immunoglobulin G1 (IgG1) antibodies are known to cross the placental barrier; therefore, regdanvimab has the potential to be transferred from the mother to the developing foetus. It is unknown whether the potential transfer of regdanvimab provides any treatment benefit or risk to the developing foetus.

Regdanvimab 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 regdanvimab is excreted in human milk or absorbed systemically after ingestion. Administration of regdanvimab while breast-feeding can be considered when clinically indicated.

Fertility

No fertility studies have been performed.

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

Summary of the safety profile

Overall, 906 subjects have been exposed to regdanvimab in clinical trials in both healthy subjects and non-hospitalised patients. The safety of regdanvimab is based on exposure of ambulatory (nonhospitalised) patients with COVID-19.

Tabulated list of adverse reactions

Adverse reactions reported with regdanvimab based on experience from clinical trials in healthy subjects and mild to moderate COVID-19 patients as well as adverse reactions reported from post-marketing experience are listed in the following table 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). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

¹ Infusion-related reaction (IRR) includes hypersensitivity and anaphylaxis, and symptoms reported as IRRs are described below in ‘Infusion-related reactions’. Anaphylaxis was identified from postmarketing experience.

Description of selected adverse reactions

Infusion-related reactions

Immediate infusion-related reactions were noted for 0.6% of regdanvimab-treated patients and 1.2% of placebo-treated patients. Reported events of fever, pruritus, hypertension and dyspnoea were mild with two cases of fever being moderate and one case of hypertension being severe and palpitation, presyncope and urticaria were moderate in the regdanvimab-treated patients. All patients in the regdanvimab treatment group recovered from the events.

In post-marketing experience, one case of anaphylaxis was reported during infusion of regdanvimab with symptoms of dyspnoea, chest discomfort and cough.