Vilobelimab: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: March 17, 2026🚩 Report this page

Vilobelimab

Complement Inhibitors

Sold as Gohibic

EU EMA

Drug class: Complement Inhibitors
Availability: See label
Markets covered: 1
Products on record: 1

Overview

Vilobelimab is an active pharmaceutical ingredient in the Complement Inhibitors group (L04AJ). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
EU European Union	EMA	1	March 17, 2026

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised March 17, 2026[1]

Gohibic is indicated for the treatment of adult patients with SARS-CoV2-induced acute respiratory distress syndrome (ARDS) who are receiving systemic corticosteroids as part of Standard of Care and receiving invasive mechanical ventilation (IMV) (with or without extracorporeal membrane oxygenation (ECMO)).

How to take

Sources & citations

[1]European Medicines Agency · EMEA/H/C/006123 · revised March 17, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

EUOfficial regulatory label· Adverse reactions· revised March 17, 2026[1]

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).
5 Table 1. Adverse reactions System organ class Frequency Adverse reactions Infections and infestations very common pneumonia common sepsis, bronchopulmonary aspergillosis, herpes simplex Blood and lymphatic system disorders common thrombocytopenia Cardiac disorders common supraventricular tachycardia Skin and subcutaneous tissue disorders common rash 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.

EUOfficial regulatory label· Warnings and precautions· revised March 17, 2026[1]

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. 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). 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.

This is not medical advice. Consult a qualified healthcare professional.

Overview

Regulatory status by market

EUEuropean Union· EMA

Drugs in the same class

Sources & citations