GOHIBIC
6a571038-1f6c-4e66-937c-ddf6e2a4e30a
HUMAN PRESCRIPTION DRUG LABEL
May 16, 2023
InflaRx GmbH
DUNS: 312681962
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
vilobelimab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (5)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 200 mg/20 mL Vial Carton
NDC 83000-110-04
Rx-only
GOHIBIC
(vilobelimab)
injection
200 mg/20 mL
(10 mg/mL)
For intravenous infusion after dilution
For use under Emergency Use Authorization
4 x 20 mL single-dose vials-Discard unused portion
WARNINGS AND PRECAUTIONS SECTION
5 WARNINGS AND PRECAUTIONS
There are limited clinical data available for GOHIBIC. Serious and unexpected adverse events (AEs) may occur that have not been previously reported with GOHIBIC use.
5.1 Serious Infections
Serious infections due to bacterial, fungal, and viral pathogens have been reported in patients with COVID-19 receiving GOHIBIC. In patients with COVID-19, monitor for signs and symptoms of new infections during and after treatment with GOHIBIC. There is limited information regarding the use of GOHIBIC in patients with COVID-19 and concomitant active serious infections. The risks and benefits of treatment with GOHIBIC in COVID-19 patients with other concurrent infections should be considered [see Adverse Reactions (6)].
5.2 Hypersensitivity Reactions
Hypersensitivity reactions have been observed with GOHIBIC. If a severe hypersensitivity reaction occurs, administration of GOHIBIC should be discontinued and appropriate therapy initiated.
NONCLINICAL TOXICOLOGY SECTION
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Animal studies have not been conducted to evaluate the carcinogenic potential of GOHIBIC. The malignancy risk in humans from an antibody that binds C5a, such as GOHIBIC, is currently unknown.
Male and female fertility parameters were evaluated as part of the 13-week and 26-week repeat-dose toxicity studies, respectively. There were no treatment- related changes to sperm morphology, count, or motility in male monkeys administered GOHIBIC for 13-weeks at intravenous doses up to 50.6 mg/kg/week (approximately 2.5 times the MRHD on a mg/kg basis). Following 26-weeks intravenous administration of GOHIBIC, there were no effects on female fertility including menstrual cyclicity identified at doses up to 50 mg/kg/week (approximately 2.5 time the MRHD on a mg/kg basis).
HOW SUPPLIED SECTION
16 HOW SUPPLIED/STORAGE AND HANDLING
How supplied
GOHIBIC (vilobelimab) 200 mg/20 mL (10 mg/mL) injection is a clear to slightly opalescent, colorless solution in a single-dose vial (NDC 83000-110-04).
Storage and Handling
Store unopened vials refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake.