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INDICATIONS

Gamifant (emapalumab-lzsg) is an interferon gamma (IFNγ)-neutralizing 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.
  • HLH/macrophage activation syndrome (MAS) in known or suspected Still’s disease, including systemic Juvenile Idiopathic Arthritis (sJIA), with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS.
IMPORTANT SAFETY INFORMATION
Infections

Gamifant may increase the risk of fatal and serious infections with pathogens including mycobacteria, herpes zoster virus... and histoplasma capsulatum. Do not administer Gamifant in patients with these infections until appropriate treatment has been initiated.

INDICATIONS

Gamifant (emapalumab-lzsg) is an interferon gamma (IFNγ)-neutralizing 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.
  • HLH/macrophage activation syndrome (MAS) in known or suspected Still’s disease, including systemic Juvenile Idiopathic Arthritis (sJIA), with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS.

IMPORTANT SAFETY INFORMATION

Infections

Gamifant may increase the risk of fatal and serious infections with pathogens including mycobacteria, herpes zoster virus, and histoplasma capsulatum. Do not administer Gamifant in patients with these infections until appropriate treatment has been initiated.

In patients with primary HLH receiving Gamifant in clinical trials, serious infections such as sepsis, pneumonia, bacteremia, disseminated histoplasmosis, necrotizing fasciitis, viral infections, and perforated appendicitis were observed in 32% of patients.

In patients with HLH/MAS in Still’s disease receiving Gamifant in clinical trials, serious infections such as pneumonia, cytomegalovirus infection, cytomegalovirus infection reactivation, and sepsis were observed in 13% of patients.

Evaluate patients for tuberculosis risk factors and test for latent infection prior to initiating Gamifant. Administer tuberculosis prophylaxis to patients at risk for tuberculosis or known to have a positive purified protein derivative (PPD) test result.

Consider prophylaxis for herpes zoster, Pneumocystis jirovecii, and fungal infection while receiving Gamifant. Employ surveillance testing during treatment with Gamifant.

Closely monitor patients receiving Gamifant for signs or symptoms of infection, promptly initiate a complete diagnostic workup appropriate for an immunocompromised patient, and initiate appropriate antimicrobial therapy.

Increased Risk of Infection With Use of Live Vaccines

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 in patients with primary HLH, 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.

Infusion-related reactions in patients with HLH/MAS in Still’s disease, including pyrexia, headache, paresthesia, bone pain, pruritic rash, and peripheral coldness, were reported with Gamifant treatment in 13% of patients. Infusion-related reactions were reported as mild in 8% of patients and as moderate in 5% of patients.

Monitor patients for infusion-related reactions, which can be severe. Interrupt the infusion for infusion reactions and institute appropriate medical management before continuing infusion at a slower rate.

Adverse Reactions

Primary HLH

Serious adverse reactions were reported in 53% of patients. The most common serious adverse reactions (≥3%) included infections, gastrointestinal hemorrhage, and multiple organ dysfunction. Fatal adverse reactions occurred in 2 (6%) of patients and included septic shock and gastrointestinal hemorrhage.

The most common adverse reactions were (≥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%).

HLH/MAS

Serious adverse reactions were reported in 12 patients (31%), with the most common serious adverse reaction being pneumonia (5%). Fatal adverse reactions occurred in two patients (5%) and included multiple organ dysfunction and circulatory shock.

The most common adverse reactions (≥10%) for Gamifant included viral infection (44%), rash (21%), anemia (18%), leukopenia (15%), thrombosis (15%), bacterial infections (13%), headache (13%), hyperglycemia (13%), infusion-related reactions (13%), abdominal pain (10%), hypertension (10%), pyrexia (10%), and thrombocytopenia (10%).

References

  1. Jordan MB, Allen CE, Weitzman S, Filipovich AH, McClain KL. How I treat hemophagocytic lymphohistiocytosis. Blood. 2011;118(15):4041-4052. doi:10.1182/blood-2011-03-278127
  2. Sepulveda FE, de Saint Basile G. Hemophagocytic syndrome: primary forms and predisposing conditions. Curr Opin Immunol. 2017;49:20-26. doi:10.1016/j.coi.2017.08.004
  3. Gamifant (emapalumab-lszg) prescribing information. Stockholm, Sweden: Sobi, Inc. 2022.

Resources for You and Your Patients

Help guide your patients and their caregivers along the treatment journey with these tools and resources.

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Learn more about Gamifant and primary HLH with the Investigating HLH: Gamifant pivotal trial podcast

Adam Narloch speaks with Dr Michael B. Jordan to talk about his hemophagocytic lymphohistiocytosis (HLH) research and Gamifant. Dr Jordan is a pediatric hematologist-oncologist at Cincinnati Children's Hospital, and a professor in the Department of Pediatrics at the University of Cincinnati. Hear from Dr Jordan about his work exploring the pathology of HLH using mouse models and a walkthrough of the background, methods, and results from the Gamifant pivotal trial.

On your phone, open your podcast app and search "Investigating HLH."

Also available on:

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All trademarks used are the property of their respective owners, and their use here does not imply endorsement.

PRIMARY HEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH)

CXCL9 testing brochure

Information about the relationship between IFNγ and CXCL9 and the value of CXCL9 testing

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GAMIFANT® (emapalumab-lzsg)

Gamifant Full Prescribing Information

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Dosing and Administration Guide

Information about dose titration, preparation, and administration of Gamifant

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Clinical Overview

A guide to Gamifant pivotal trial data

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Gamifant Brochure

A brief overview of primary HLH, Gamifant pivotal trial data, and information for getting started

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ACCESS GAMIFANT

Product Information

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Gamifant Start Form

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Summary of Relevant Codes

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Guide to Requesting Medical Exception

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Letter of Medical Necessity

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Medical vs Pharmacy Benefits Brochure

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Tips for Completing a Benefits Investigation

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Guide to Prior Authorization Submission

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Advocacy Groups

The mission of The Matthew and Andrew Akin Foundation is to inform, inspire, and invest in families affected by hemophagocytic lymphohistiocytosis.

matthewandandrew.org

Founded by the mother of an HLH survivor, the goal of this program is to support and connect others struggling with the disease. In addition to hosting an active Facebook support group, HLH Support holds events like the Marsh Family Annual Toy Drive to raise money for HLH.

Hannah, the HLH survivor who inspired the program, also sells handmade blue Swarovski crystal bracelets to spread awareness and fund HLH research.

hlhsupport.org

Histiocytosis Association provides educational materials, peer/physician networking opportunities, and a physician directory for treatment/second opinions. The organization also offers staff to assist families with awareness, advocacy, and programs to raise funds for research.

histio.org

Liam’s Lighthouse Foundation (LLF) is a nonprofit, tax exempt organization established to increase awareness of HLH and other histiocytic disorders. The organization focuses on bringing the families affected together, offering support through a variety of programs, and raising much-needed funds for continued research and education at leading medical institutions.

liamslighthousefoundation.org

Founded in 1980, the Immune Deficiency Foundation (IDF) is a national nonprofit patient organization dedicated to improving the diagnosis, treatment, and quality of life of persons with primary immunodeficiency (PI) diseases through advocacy, education, and research. IDF provides accurate and timely information and valuable resources for patients and families living with PI, including HLH.

primaryimmune.org

Transplant Resources

BMT InfoNet is an organization for bone marrow, stem cell, and cord blood transplant patients. It empowers patients and caregivers with knowledge through its website, video learning library, patient books, and symposiums. BMT InfoNet also provides personal guidance and a one-on-one peer support program.

bmtinfonet.org

Over the past 30 years, Be The Match®, operated by the National Marrow Donor Program® (NMDP), has managed the largest and most diverse marrow registry in the world. Their team works every day to save lives through transplant.

bethematch.org
Doctor playing with young patient beside Sobi "rare strength" logo

A rare dedication

At Sobi, we focus on ultra-rare diseases, which can affect just hundreds or even dozens of patients. These patients have many critical unmet needs, yet are frequently overlooked by the healthcare industry.

We are dedicated to providing access to innovative treatments that make a significant difference in the lives of individuals with ultra-rare diseases.

We work closely with patients, caregivers, and advocacy organizations to understand and address the challenges they face throughout their journey, from infancy to adulthood. And we keep innovating to meet their evolving needs, serving as a trusted partner for life.