GOHIBIC Concentrate for solution for infusion Ref.[114620] Active ingredients: Vilobelimab

Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

Hypersensitivity, including anaphylaxis and infusion-related reactions

There is a possibility for hypersensitivity, including anaphylaxis and infusion-related reactions, to occur as the product is a monoclonal antibody. Signs and symptoms may include hypotension, hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnoea, wheezing, angioedema, rash, nausea, vomiting, diaphoresis and shivering.

If symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, administration should be discontinued immediately and appropriate medical treatment and/or supportive care should be initiated.

Appropriate medical treatment and/or supportive care should be administered if an infusion-related reaction occurs.

Infections other than COVID-19

Cases of infections have been reported while using vilobelimab (see section 4.8).

A patient who develops a new infection during treatment with vilobelimab should undergo diagnostic investigations. Appropriate treatment should be initiated and the patient should be closely monitored.

The risk of vilobelimab-associated infections may be higher in elderly patients (>65 years).

Sodium

This medicinal product contains 296.8 mg sodium per dose of 4 vials, equivalent to 15% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

No interaction studies have been performed. Vilobelimab is not renally excreted or metabolised by cytochrome P450 enzymes; therefore, interactions with concomitant medicinal products that are renally excreted or that are substrates, inducers, or inhibitors of cytochrome P450 enzymes are unlikely.

Pregnancy

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 (see section 5.3).

As a precautionary measure, it is preferable to avoid the use of vilobelimab during pregnancy.

Breast-feeding

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 (see section 5.3).

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).

Table 1. Adverse reactions:

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.