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Established safety profile1

The most commonly reported adverse reactions (≥10%) in the Gamifant® (emapalumab-lzsg) pivotal trial included:

Adverse reactions Gamifant (N=34) Adverse reactions Gamifant (N=34)
Infectionsa 56%* Cytomegalovirus infection 12%
Hypertensionb 41% Diarrhea 12%
Infusion-related reactionsc 27% Lymphocytosis 12%
Pyrexia 24% Cough 12%
Hypokalemia 15% Irritability 12%
Constipation 15% Tachycardia 12%
Rash 12% Tachypnea 12%
Abdominal pain 12%
Cytomegalovirus infection 12%
Diarrhea 12%
Lymphocytosis 12%
Cough 12%
Irritability 12%
Tachycardia 12%
Tachypnea 12%
  • aIncludes viral, bacterial, fungal, and infections in which no pathogen was identified.
  • bIncludes secondary hypertension.
  • cIncludes events of drug eruption, pyrexia, rash, erythema, and hyperhidrosis.
*Thirteen of 34 patients (38%) entered the study with ongoing infections or positive microbiological results.2
  • Disseminated histoplasmosis led to drug discontinuation in 1 patient1
  • Serious infections such as sepsis, pneumonia, bacteremia, disseminated histoplasmosis, necrotizing fasciitis, viral infections, and perforated appendicitis were seen in 32% of patients taking Gamifant in clinical trials1
  • Additional selected adverse reactions (all grades) reported in <10% of patients treated with Gamifant included vomiting, acute kidney injury, asthenia, bradycardia, dyspnea, gastrointestinal hemorrhage, epistaxis, and peripheral edema1