Treating primary HLH
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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.
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.
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 administration.
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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For patients with primary hemophagocytic lymphohistiocytosis (HLH), a successful hematopoietic stem cell transplantation (HSCT) is the ultimate goal. Meanwhile, keeping inflammatory symptoms under control with the proper treatment is crucial.1-3
Immediately bring the cytokine storm under control to prevent irreversible organ damage. Subsequent treatment depends on symptom presentation and confirmation of diagnosis.1-3
Condition the patient for HSCT in a way that optimizes their long-term prognosis.1
Data show that 50% of patients fail to reach HSCT due to inadequate response to conventional treatments.4
Over the past 25 years, few advancements have been made in targeted HLH therapy.5
Conventional treatments—which were not specifically developed for primary HLH and which are not FDA approved for the condition—are aimed at immune suppression.1,6
When a patient responds unsatisfactorily to conventional treatment, cannot tolerate it, or relapses, there has been no standard alternative. HSCT is always the goal, but physicians may have little choice but to rush poorly conditioned patients into the procedure, or forgo transplant altogether.1,5,7
Gamifant® (emapalumab-lzsg) is the first and only treatment designed specifically for primary HLH. It works by targeting IFNγ, a central and upstream cytokine in the pathogenesis of the disease.1-3
See how it works