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.
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
- Jordan MB, Allen CE, Weitzman S, Filipovich AH, McClain KL. How I treat hemophagocytic lymphohistiocytosis. Blood. 2011;118(15):4041-4052. doi: https://doi.org/10.1182/blood-2011-03-278127.
- Marsh RA, Haddad E. How I treat primary haemophagocytic lymphohistiocytosis. Br J Haematol. 2018;182(2):185-199. doi: 10.1111/bjh.15274.
- Sepulveda F, de Saint Basile G. Hemophagocytic syndrome: primary forms and predisposing conditions. Curr Opin Immunol. 2017; 49:20-26. http://dx.doi.org/10.1016/j.coi.2017.08.004.
- Lehmberg K, Nichols KE, Henter J-I, et al. Consensus recommendations for the diagnosis and management of hemophagocytic lymphohistiocytosis associated with malignancies. Haematologica. 2015:100(8):997-1004.
- Gamifant [prescribing information]. Stockholm, Sweden: Swedish Orphan Biovitrum AB.
GAMIFANT CARES IS HERE TO HELP
Each patient's insurance coverage for Gamifant is unique. Because of this, each patient has a dedicated Care Manager to assist you in understanding your patient's coverage options. This dedicated Care Manager can provide education regarding billing, coding, and the reimbursement pathway as specified by your patient's insurance company.
If you have questions about access or reimbursement for Gamifant, contact a Care Manager. If you would like assistance in understanding a patient's benefits, fill out the Prescription and Enrollment Form and fax it to 1-866-895-7204.
Enroll your patient in Gamifant Cares
Gamifant Cares offers patient support programs, created by Sobi, to offer personalized support and resources to help your patients and their families throughout treatment with Gamifant. Gamifant Cares can help your patients with insurance questions, financial support information, educational materials, and assist in the coordination of care, including:
- Confirming your patient’s insurance coverage and help with navigating and understanding the insurance process
- Providing educational materials and nursing support through the Sobi Nurse Case Manager program
- Providing financial assistance information for eligible patients
Click below to download the Prescription and Enrollment Form. Once you have completed the form, fax it along with a copy of the patient's insurance and pharmacy benefit cards to Gamifant Cares at 1-866-895-7204.
Once Gamifant Cares receives the Enrollment Form, a Care Manager can provide resources and assistance, including help understanding your patient's insurance benefits and providing financial assistance information for eligible patients, while you get your patient started with Gamifant treatment. You can also request to enroll your patients in the Nursing Support Program using this form.
Should you have questions at any point during the process, reach out directly to your Care Manager or email GamifantCares@rxallcare.com.
Additional Resources
WHERE TO BEGIN
Prescription and Enrollment Form
Upon receipt of the completed form, a team member will contact you regarding next steps specified by your patient's insurance company
DOWNLOADGAMIFANT PRODUCT FACT SHEET
A high-level overview of Gamifant, including relevant product codes
DOWNLOADACCESS AND REIMBURSEMENT
SAMPLE LETTER OF MEDICAL NECESSITY
A downloadable sample letter that can be tailored to your patient and submitted to health insurance plans to request approval for Gamifant
DOWNLOAD