Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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% vs 13.8% in placebo), sepsis (14.9% versus 7.4% in placebo), and septic shock (9.1% versus 7.4% in placebo).
Discontinuation of study treatment due to an adverse reaction occurred in 2.9% of the GOHIBIC group and 1.6% of the placebo group.
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.
Like all medications, Gohibic can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: