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Gamifant® (emapalumab-lzsg)

Now Available

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

How to access Gamifant for your patients

Gamifant is available for order via our specialty pharmacy or through one of our two specialty distributors.

Specialty pharmacy

Biologics

Phone: 800.850.4306

Specialty distributors

McKesson Plasma and Biologics
Phone: 877.625.2566
Fax: 888.752.7626
mpborders@mckesson.com

McKesson Specialty Health

Phone: 855.477.9800

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

Please note that the patient's insurance coverage may dictate how Gamifant should be ordered.

NDC 72171-501-01
10 mg/2 mL (5 mg/mL)
single-use vial

NDC 72171-505-01
50 mg/10 mL (5 mg/mL)
single-use vial.

To better understand your patient's benefits please contact Sobi Patient Services at 833.597.6530.

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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: Swedish Orphan Biovitrum AB; 2018.