Vilobelimab

There are no data from the use of vilobelimab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of vilobelimab during pregnancy.

It is unknown whether vilobelimab is excreted in human milk. Human IgGs are known to be excreted in breast milk during the first few days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to the breast-fed infant cannot be excluded during this short period. Afterwards, vilobelimab could be used during breast-feeding if clinically needed.

Fertility

Non-clinical data do not suggest any effect on male or female fertility under treatment with vilobelimab.

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

Summary of the safety profile

The most common adverse reactions are pneumonia (21.7%), herpes simplex (6.3%), bronchopulmonary aspergillosis (5.7%), and sepsis (5.1%).

Tabulated list of adverse reactions

The safety of vilobelimab has been evaluated in a placebo-controlled, randomised study in which 175 patients receiving invasive mechanical ventilation with or without extracorporeal membrane oxygenation were treated. However, the very small number of patients who received extracorporeal membrane oxygenation in the clinical trial (7 in the vilobelimab group and 9 in the placebo group) represents a limitation for the characterisation of the safety of vilobelimab in this subset of patients. Adverse reactions are listed below by MedDRA system organ class and by 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), not known (cannot be estimated from the available data).

Adverse reactions: