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
- Gamifant (emapalumab-lszg) prescribing information. Stockholm, Sweden: Sobi, Inc. 2022.
- Locatelli F, Jordan MB, Allen C, et al. Emapalumab in children with primary hemophagocytic lymphohistiocytosis. N Engl J Med. 2020;382(19):1811-1822. doi:10.1056/NEJMoa1911326
- Data on file. Stockholm, Sweden: Swedish Orphan Biovitrum AB. 2018.
- 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
Serious adverse reactions were reported in 53% of patients. The most common serious adverse reactions (≥3%) included infections, gastrointestinal hemorrhage, and multiple organ dysfunction.1
- Serious infections such as sepsis, pneumonia, bacteremia, disseminated histoplasmosis, necrotizing fasciitis, viral infections, and perforated appendicitis were seen in 32% of patients taking Gamifant in clinical trials1
- Fatal adverse reactions occurred in 2 (6%) patients and included septic shock and gastrointestinal hemorrhage1
- Disseminated histoplasmosis led to drug discontinuation in 1 patient1
Most commonly reported adverse reactions (≥10%)1
The most commonly reported adverse reactions (≥10%) in the Gamifant pivotal trial included:
| Adverse reactions | Gamifant (N=34) | Adverse reactions | Gamifant (N=34) |
|---|---|---|---|
| Infectionsa | 56% | Cytomegalovirus infection | 12% |
| Hypertensionb | 41% | Diarrhea | 12% |
| Infusion-related reactionsc | 27% | Lymphocytosis | 12% |
| Pyrexia | 24% | Cough | 12% |
| Hypokalemia | 15% | Irritability | 12% |
| Constipation | 15% | Tachycardia | 12% |
| Rash | 12% | Tachypnea | 12% |
| Abdominal pain | 12% | ||
| Cytomegalovirus infection | 12% | ||
| Diarrhea | 12% | ||
| Lymphocytosis | 12% | ||
| Cough | 12% | ||
| Irritability | 12% | ||
| Tachycardia | 12% | ||
| Tachypnea | 12% |
- aIncludes viral, bacterial, fungal, and infections in which no pathogen was identified.
- bIncludes secondary hypertension.
- cIncludes events of drug eruption, pyrexia, rash, erythema, and hyperhidrosis.
- 35% of patients entered the study with ongoing infections or positive microbiological results2
- No contraindications associated with administration of concomitant medications 1
- No increase of adverse reaction frequency with increased dosage of Gamifant observed in the pivotal trial3