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Gamifant® (emapalumab-lzsg) is the first FDA-approved treatment specifically developed for primary hemophagocytic lymphohistiocytosis (HLH), targeting interferon gamma (IFNγ) overexpression.1

Download Prescribing Information View Product Fact Sheet How to Order Gamifant

Learn more about the role of IFNγ overexpression in HLH and how Gamifant may help.

How to access Gamifant for your patients

Gamifant is supplied in 10 mg/2 mL and 50 mg/10 mL single-use glass vials.

NDC Numbers:

Gamifant is available for order via our specialty pharmacy or through one of our two specialty distributors. Please note that the patient's insurance coverage may dictate how Gamifant should be ordered. To better understand your patient's benefits please contact
Sobi Patient Services at 833.597.6530.

Specialty pharmacy:
Biologics
Phone: 800.850.4306

Specialty distributors:
McKesson Plasma and Biologics
Phone: 877.625.2566
Fax: 888.752.7626
Email: mpborders@mckesson.com
Online: connect.mckesson.com

McKesson Specialty Health
Phone: 855.477.9800
Online: mckessonspecialtyhealth.com

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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.

Reference: 1. Gamifant [Prescribing Information]. Stockholm, Sweden: Biovitrum AB; 2018.