Sipavibart

As with any other intramuscular injections, sipavibart should be given with caution to patients with thrombocytopenia or any coagulation disorder.

There are no data on the use of sipavibart in pregnant women.

Non-clinical reproductive toxicity studies have not been performed with sipavibart. In a tissue cross reactivity study with sipavibart, no binding was detected to human foetal tissue or reproductive tissues.

Human IgG1 antibodies are known to cross the placenta barrier; therefore, sipavibart has the potential to be transferred from the mother to the developing foetus. It is unknown whether the potential placental transfer of sipavibart provides any treatment benefit or risk to the developing foetus.

Sipavibart should be used during pregnancy only if the potential benefit to the mother outweighs the potential risk to the foetus.

It is unknown whether sipavibart is excreted in human milk. In humans, excretion of IgG antibodies in milk occurs during the first few days after birth, decreasing to low concentrations soon afterwards. Consequently, a risk to the breast-fed infant cannot be excluded during this short period. Afterwards, sipavibart could be used during breast-feeding if clinically needed.

Fertility

There are no data on the effects of sipavibart on human fertility.

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

Summary of the safety profile

In patients receiving sipavibart by intramuscular injection, the most common adverse reaction is injection site reaction (4.1%). In patients receiving sipavibart by intravenous infusion, the most common adverse reactions are infusion site reactions (1.9%) and infusion-related reactions (1.9%).

Tabulated list of adverse reactions

The table below presents the adverse reactions identified from the clinical studies.

The adverse reactions in the following table are listed by MedDRA system organ class (SOC). Within each SOC, preferred terms are arranged by decreasing frequency, and then by decreasing seriousness. Frequencies of occurrence of adverse reactions 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), and not known (cannot be estimated from the available data).

Tabulated list of adverse reactions:

^a Including the following preferred terms: pruritus, erythema, hypersensitivity, urticaria, dermatitis allergic, and drug eruption.
^b Including the following preferred terms: injection site pain, injection site bruising, injection site erythema, injection site haemorrhage, injection site swelling, injection site haematoma, injection site pruritus, injection site paraesthesia, injection site reaction, injection site rash, injection site discolouration, and injection site warmth.
^c Including the following preferred terms: infusion site bruising, infusion site pain, infusion site pruritus, infusion site erythema, infusion site extravasation, and infusion site swelling.
^d Including the following symptoms: nausea, arthralgia, headache, pyrexia, chills, dyspepsia, pain, hypotension, facial flushing, coughing, chest discomfort, dizziness, and shortness of breath.

Description of selected adverse reactions

Hypersensitivity

Hypersensitivity reactions occurred within 14 days post-dose, were mild to moderate in severity, and most resolved within a few days.

Injection site reactions

Injection site reactions occurred within 7 days post-dose, were mild in severity, and most resolved within a few days.

Infusion site reactions

Infusion site reactions occurred within 7 days post-dose, were mild to moderate in severity, and resolved within a few days.

Infusion-related reactions

Infusion-related reactions occurred during or on the same day of infusion, were mild to moderate in severity, and resolved within a few days.

Paediatric population

There are limited safety data available for paediatric patients ≥12 years to <18 years of age (n=8). No data are available for paediatric patients <12 years of age. The safety profile in paediatric participants ≥12 years of age was similar to the safety profile in adults.