How Gamifant® (emapalumab-lzsg) works
For questions about Gamifant or the ordering process, connect with a Sobi Health Systems Director today.
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.
Click here for full Prescribing Information for Gamifant.
You may also contact Sobi at medinfo.us@sobi.com or 866-773-5274.
Gamifant is the only treatment specifically designed to target and neutralize interferon gamma (IFNγ), a key upstream mediator of the proinflammatory cytokine storm associated with primary hemophagocytic lymphohistiocytosis (HLH).1-4
Gamifant is a monoclonal antibody that binds to soluble and receptor-bound forms of IFNγ. Binding to IFNγ neutralizes its activity, blocking its intracellular signaling to inhibit macrophage activation and the downstream release of proinflammatory cytokines.1,4-8
Click through to see how Gamifant blocks IFNγ and subdues the cytokine storm at its center.
Although the chemokine CXCL9 is not recommended as a diagnostic marker, nor is it needed to begin treatment or for follow-up monitoring, it is a recognized marker for IFNγ activity. In a clinical trial, sustained and consistent reductions in the plasma concentrations of CXCL9 showed that IFNγ was effectively neutralized by Gamifant.1,6
See the dataCXCL9 is 1 of 3 chemokines in the CXC subfamily predominantly induced by IFNγ. CXCL9 helps regulate immune responses, hematopoietic development, and cell-to-cell communication by acting as a mediator and modulator.10-14
In primary HLH, CXCL9 is produced by IFNγ-activated macrophages. CXCL9 is also a chemoattractant for activated T cells, especially the Th1 cells that produce IFNγ. Thus, higher levels of CXCL9 can indicate IFNγ activity.13