GOHIBIC 10 mg/mL
vilobelimab · INJECTION · InflaRx GmbH
GOHIBIC is a injection containing vilobelimab at 10 mg/mL, taken intravenous. Manufactured by InflaRx GmbH.
Key Facts
- Brand Name
- GOHIBIC
- Generic Name
- vilobelimab
- NDC Code (Product)
83000-110- Manufacturer
- InflaRx GmbH
- Strength
- 10 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Marketing Start
- 04/04/2023
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage The recommended dosage of GOHIBIC for the treatment of adults with COVID-19 is 800 mg administered by intravenous infusion after dilution [see Dosage and Administration (2.2) ] for a maximum of 6 (six) doses over the treatment period as described below. Treatment should be started within 48 hours of intubation (Day 1) followed by administration on Days 2, 4, 8, 15 and 22 as long as the patient is hospitalized (even if discharged from ICU). 2.2 Preparation and Administration Preparation Using aseptic technique, dilute and prepare GOHIBIC for intravenous infusion before administration. For the recommended dose of 800 mg GOHIBIC, dilute 80 mL of GOHIBIC in 170 mL of 0.9% Sodium Chloride at room temperature. Use a 250 mL infusion bag of 0.9% Sodium Chloride solution USP and the follow steps below: Withdraw 80 mL of 0.9% Sodium Chloride solution USP from the infusion bag and discard. Withdraw the 80 mL of GOHIBIC from the vials and add slowly to the 0.9% Sodium Chloride solution USP infusion bag to a final concentration of 3.2 mg/mL. To mix the solution, gently invert the bag to avoid foaming. Storage of Diluted GOHIBIC Diluted GOHIBIC …
Contraindications
4 CONTRAINDICATIONS No contraindications have been identified based on the limited available data for the emergency use of GOHIBIC under this EUA.
Drug Interactions
7 DRUG INTERACTIONS No drug interaction studies have been conducted with GOHIBIC.
Adverse Reactions
6 ADVERSE REACTIONS 6.1 Clinical Trial Experience The following adverse reactions have been observed in the clinical studies of GOHIBIC that supported the EUA. The adverse reaction rates observed in these clinical studies cannot be directly compared to rates in the clinical studies of other products and may not reflect the rates observed in clinical practice. The safety of GOHIBIC is based on PANAMO, a Phase 3 randomized, placebo-controlled trial in COVID-19 patients requiring IMV or ECMO [see Clinical Studies (14) ] . The analysis of adverse reactions included a total of 364 adult patients who received at least one dose of either GOHIBIC (n=175) or placebo (n=189) plus standard of care. Patients received GOHIBIC 800 mg administered by intravenous infusion on Days 1, 2, 4, 8, 15 and 22 or placebo. During the study, there were 62 deaths in the GOHIBIC arm and 85 deaths in the placebo arm [see Clinical Studies (14) ] . Fatal infections occurred in more placebo patients. Nonfatal serious infections occurred in 58 patients (33.1%) in the GOHIBIC arm and in 55 patients (29.1%) in the placebo arm. The most commonly reported nonfatal serious infections with GOHIBIC were pneumonia (18.9% v…
Frequently Asked Questions
What is GOHIBIC used for?
GOHIBIC contains vilobelimab. It is a injection taken intravenous. Consult your doctor for specific uses.
Is GOHIBIC a controlled substance?
GOHIBIC is not classified as a controlled substance by the DEA.
What is the generic name for GOHIBIC?
The generic name for GOHIBIC is vilobelimab. There are no other listed brand versions of vilobelimab.
What is the NDC code for GOHIBIC 10 mg/mL?
The NDC (National Drug Code) for GOHIBIC 10 mg/mL is 83000-110, listed by InflaRx GmbH.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)