Gamifant FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 4, 2019.
FDA Approved: Yes (First approved November 20, 2018)
Brand name: Gamifant
Generic name: emapalumab-lzsg
Dosage form: Injection
Company: Novimmune SA
Treatment for: Hemophagocytic Lymphohistiocytosis
Gamifant (emapalumab-lzsg) is an interferon gamma (IFNγ) blocking antibody for the treatment of patients with primary hemophagocytic lymphohistiocytosis (HLH).
DOSAGE AND ADMINISTRATION
For intravenous infusion only:
- Recommended starting dosage: 1 mg/kg as an intravenous infusion over 1 hour twice per week.
- Administer dexamethasone concomitantly with Gamifant.
WARNINGS AND PRECAUTIONS
- 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.
- 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. Patients should be monitored for infusion-related reactions. Interrupt infusion for severe infusion reactions and institute appropriate medical management.
The most common adverse reactions (≥ 20%) were: infections, hypertension, infusion-related reactions, and pyrexia.
Development Timeline for Gamifant
|Nov 20, 2018||Approval FDA Approves Gamifant (emapalumab-lzsg) for Primary Hemophagocytic Lymphohistiocytosis|
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