ORDERING GAMIFANT®
(emapalumab-lzsg)
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
- Data on file. Sobi, Inc. 2023. Commercial and Medicaid Covered Lives. 04.12.2024.
- Data on file. Sobi, Inc. 2023. Derived from CMS Medicaid Managed Care Enrollment and Program Characteristics Reports. Access undetermined in PA, TN, and GA.
- Gamifant (emapalumab-lszg) prescribing information. Stockholm, Sweden: Sobi, Inc. 2022.
- 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
- 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
99.4% of patients on commercial plans1
and
95.7% of patients on Medicaid Fee-for-Service plans have Gamifant coverage2
THE ORDERING PROCESS STARTS HERE
A Sobi Health Systems Director (HSD) will be there to assist you through every step of the ordering process. We understand that primary hemophagocytic lymphohistiocytosis (HLH) requires an urgent response. That's why we're committed to doing everything we can to ensure all orders are delivered to your facility as quickly as possible.
For any ordering or product information questions, contact a Sobi HSD.
There are 2 pathways to access Gamifant
Keep in mind that your institution and the patient's insurance will dictate how Gamifant should be ordered.
DRG=diagnosis-related
group.
ONCE GAMIFANT IS ON THE WAY: HOW TO PREPARE FOR YOUR PATIENT’S INFUSION
Check to ensure you have the proper supplies on hand3:
- Gamifant single-dose vials
- Gamma-irradiated, or ethylene oxide-sterilized, latex-free, polyvinyl chloride (PVC)-free syringe
- Non-PVC polyolefin infusion bag (dependent on volume needed)
- 0.9% sodium chloride for injection, USP
- Intravenous line with sterile, non-pyrogenic, low–protein binding, 0.2-μm in-line filter
Learn more about dosing and administration and download the Gamifant Dosing and Administration Guide.
For questions on access or reimbursement, Gamifant Patient Services can help