Indication and Usage
Gamifant® (emapalumab-lzsg) is an interferon gamma
(IFNγ)–blocking antibody indicated for the treatment of
adult and pediatric (newborn and older) patients with primary
hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent,
or progressive disease or intolerance with conventional HLH therapy.
Important Safety Information
Before initiating Gamifant, patients should be evaluated for infection,
including latent tuberculosis (TB). Prophylaxis for TB should be
administered to patients who are at risk for TB or known to have a
positive purified protein derivative (PPD) test result or positive
IFNγ release assay.
During Gamifant treatment, patients should be monitored for TB,
adenovirus, Epstein-Barr virus (EBV), and cytomegalovirus (CMV) every 2
weeks and as clinically indicated.
Patients should be administered prophylaxis for herpes zoster,
Pneumocystis jirovecii, and fungal infections prior to Gamifant
Do not administer live or live attenuated vaccines to patients receiving
Gamifant and for at least 4 weeks after the last dose of Gamifant. The
safety of immunization with live vaccines during or following Gamifant
therapy has not been studied.
Infusion-related reactions, including drug eruption, pyrexia, rash,
erythema, and hyperhidrosis, were reported with Gamifant treatment in
27% of patients. In one-third of these patients, the infusion-related
reaction occurred during the first infusion.
In the pivotal trial, the most commonly reported adverse reactions
(≥10%) for Gamifant included infection (56%), hypertension (41%),
infusion-related reactions (27%), pyrexia (24%), hypokalemia (15%),
constipation (15%), rash (12%), abdominal pain (12%), CMV infection
(12%), diarrhea (12%), lymphocytosis (12%), cough (12%), irritability
(12%), tachycardia (12%), and tachypnea (12%).
Additional selected adverse reactions (all grades) that were reported in
less than 10% of patients treated with Gamifant included vomiting, acute
kidney injury, asthenia, bradycardia, dyspnea, gastrointestinal
hemorrhage, epistaxis, and peripheral edema.
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