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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)
|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|
- Overall response rate (ORR) was defined as achievement of either complete or partial response or HLH improvement.1
- Median time to response was 8 days and responses were generally maintained.4
- Median duration of first response, defined as time from achievement of first response to loss of first response, was not reached.1
Primary endpoint: ORR at end of treatment1
ORR was evaluated using an algorithm of objective clinical and laboratory parameters:
- Central nervous system symptoms
- Complete blood count
- Fibrinogen and/or D-dimer
- Soluble CD25 (also referred to as soluble interleukin-2 receptor) levels
- 70% of patients (19/27) proceeded to hematopoietic stem cell transplantation (HSCT).1
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
Learn more about the pivotal trial
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.
- The recommended starting dose for Gamifant is 1 mg/kg given as an intravenous infusion over 1 hour twice per week.
- Gamifant should be given concomitantly with dexamethasone at a starting daily dose (for the steroid) of at least 5 to 10 mg/m2 and can be tapered according to the judgment of the treating physician.
- Administer Gamifant using a non-polyvinyl chloride (PVC) polyolefin infusion bag or a gamma-irradiated, latex-free, PVC-free syringe only. Do not use with ethylene oxide-sterilized syringes.
- Dose may be increased to 3 mg/kg at day 3, then to 6 mg/kg at day 6, and up to a maximum of 10 mg/kg after day 9, depending on clinical conditions.
Gamifant offers flexibility of dosing1
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 is available in 10 mg/2 mL and 50 mg/10 mL vials
Get more information on dosing and administration
Download the dosing guide
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