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Indication

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
Infections

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.

Indication

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

Infections

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.

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, 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.

Click here for full Prescribing Information for Gamifant.

You may also contact Sobi at medinfo.us@sobi.com or 866-773-5274.

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.
Gamifant Cares logo

Gamifant Cares offers access and reimbursement support to help patients access Gamifant. Gamifant Cares provides information regarding patient healthcare coverage options and financial assistance information that may be available to help patients with financial needs.

GAMIFANT CARES CAN:

Health icon Evaluate a patient’s insurance coverage, including benefits investigation, prior authorization, and appeal support
Search icon Identify potential financial assistance options that may be available to help patients with financial needs
Wallet icon Provide a benefit investigation summary and, if applicable, any prior authorization requirements
Medication icon Answer logistical questions and provide information and confirmation around the specialty pharmacy fulfillment process

Financial assistance options

The Gamifant Copay Assistance Program*

is for eligible patients who have commercial prescription insurance. Patients may pay as little as $0 per prescription and may receive up to a maximum of $10,000 per calendar year

The Patient Assistance Program

provides Gamifant at no cost to patients who meet eligibility requirements

*In order to participate in the Gamifant Copay Assistance Program (Program), a patient must have commercial insurance for Gamifant. The Program is not valid for patients whose prescription claims are reimbursed, in whole or in part, by any state or federal government program, including, but not limited to Medicaid, Medicare, Medigap, Department of Defense (DoD), Veterans Affairs (VA), TRICARE, Puerto Rico Government Insurance, or any state patient or pharmaceutical assistance program. This offer is not valid for cash paying patients. The Program is void where prohibited by law. Certain rules and restrictions apply. Sobi reserves the right to revoke, rescind, or amend this offer without notice. This Program is not insurance.

Program subject to eligibility requirement and program terms and conditions.

Enroll your patient

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View an enrollment form for your patients

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Contact us at: 1-833-597-6530

Fax: 1-866-895-7204

Email: GamifantCares@pharmacord.com

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GAMIFANT PATIENT ENROLLMENT FORM

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GAMIFANT CARES BROCHURE

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GAMIFANT CONSENT FORM

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