Adverse reactions1

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

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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 15% Tachypnea 12%
Abdominal pain 15%
  • 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 patient.1
  • Serious infections such as sepsis, pneumonia, bacteremia, disseminated histoplasmosis, necrotizing fasciitis, viral infections, and perforated appendicitis were seen in 32% of patients taking in clinical trials.1
  • Additional selected adverse reactions (all grades) reported in less than 10% of patients treated with included: vomiting, acute kidney injury, asthenia, bradycardia, dyspnea, gastrointestinal hemorrhage, epistaxis, and peripheral edema.1