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About Gamifant® (emapalumab-lzsg)

Gamifant targets interferon gamma (IFNγ)

Gamifant is specifically designed to neutralize IFNγ, a pivotal cytokine in the pathogenesis of primary HLH.1

How Gamifant works

Gamifant is a monoclonal antibody that binds to and neutralizes IFNγ.1 IFNγ plays a pivotal role in the pathogenesis of HLH by being hypersecreted, with consequent downstream effects of hypercytokinemia and inflammation.1-3 Gamifant was shown to neutralize IFNγ by a rapid and sustained reduction in the plasma concentrations of CXCL9, a chemokine induced by IFNγ.1

Learn about the role of IFNγ in primary HLH, and how Gamifant may help.

An important milestone in the treatment of primary HLH

In the pivotal trial, Gamifant was shown to be effective treatment for primary HLH in patients with refractory, recurrent, or progressive disease or who were intolerant of conventional treatment.1

Pivotal trial details

Type: Multi-center, open-label, single-arm study

No. of patients: 34

Median age: 1 year (range 0.1-13 years)

Median no. of prior agents: 3

Prior regimens included combinations of: Dexamethasone, etoposide, cyclosporine A, anti-thymocyte globulin

Median duration of Gamifant treatment: 59 days (range 4-245 days)

  Evaluation   Safety   Efficacy  
  No. of patients   34 of 34   27 of 34  
  Disease   Primary HLH   Confirmed (82%) or suspected (18%) primary HLH  
  Received conventional treatment   27 of 34   27 of 34  
Gamifant ORR chart

Primary endpoint: ORR at end of treatment1

ORR was evaluated using an algorithm of objective clinical and laboratory parameters:

70% to HSCT chart

Open-label extension study1

Patients enrolled: 81% of pivotal study patients

Duration: Monitored patients for up to 1 year after HSCT or last Gamifant infusion

Gamifant clinical trial overview

Learn more about the pivotal trial

Download the clinical overview

Download the clinical overview

Gamifant is a twice-weekly infusion1

Administer Gamifant® (emapalumab-lzsg) as an intravenous infusion twice a week (every 3 to 4 days) until HSCT is performed.

Gamifant offers flexibility of dosing1

Gamifant dosing chart

Gamifant can be incrementally titrated upward or downward according to the clinician's assessment of patient response.

After the patient's clinical condition is stabilized, decrease the dose to the previous level to maintain clinical response until HSCT.

Gamifant 10mg/2mL 50mg/10mL

Gamifant is available in 10 mg/2 mL and 50 mg/10 mL vials

Gamifant dosing guide

Get more information on dosing and administration

Download the dosing guide

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Accessing Gamifant

Gamifant 10mg/2mL 50mg/10mL Gamifant 10mg/2mL 50mg/10mL

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 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

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.

Adverse Reactions

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.

Please see full Prescribing Information for Gamifant.

You may also contact Sobi at medinfo.us@sobi.com or 866-773-5274.