Brand Name
Gamifant
Generic Name
Emapalumab-Lzsg
View Brand Information FDA approval date: May 17, 2019
Classification: Interferon gamma Blocker
Form: Injection
What is Gamifant (Emapalumab-Lzsg)?
GAMIFANT is indicated for the treatment of: adult and pediatric patients with primary hemophagocytic lymphohistiocytosis with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. adult and pediatric patients with HLH/macrophage activation syndrome in known or suspected Still’s disease, including systemic Juvenile Idiopathic Arthritis , with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS. GAMIFANT is an interferon gamma neutralizing antibody indicated for the treatment of: adult and pediatric patients with primary hemophagocytic lymphohistiocytosis with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. adult and pediatric patients with HLH/macrophage activation syndrome in known or suspected Still’s disease, including systemic Juvenile Idiopathic Arthritis , with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS.
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Brand Information
GAMIFANT (emapalumab-lzsg)
1INDICATIONS AND USAGE
GAMIFANT is 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.
- adult and pediatric (
2DOSAGE FORMS AND STRENGTHS
GAMIFANT is a clear to slightly opalescent, colorless to slightly yellow preservative-free solution available as:
Injection:
• 10 mg/2 mL (5 mg/mL) in a single-dose vial
• 50 mg/10 mL (5 mg/mL) in a single-dose vial
• 100 mg/20 mL (5 mg/mL) in a single-dose vial
• 50 mg/2 mL (25 mg/mL) in a single-dose vial
• 100 mg/4 mL (25 mg/mL) in a single-dose vial
• 250 mg/10 mL (25 mg/mL) in a single-dose vial
• 500 mg/20 mL (25 mg/mL) in a single-dose vial
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The following adverse reactions are described elsewhere in the labeling:
- Infections
- Increased Risk of Infection with Use of Live Vaccines
- Infusion-Related Reactions
4.1Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Primary HLH
The safety data described in this section reflect exposure to GAMIFANT in which 34 patients with untreated primary HLH and previously treated patients with primary HLH (
The median age of study population was 1 year (range: 0.1 to 13 years), 53% were female, and 65% were Caucasian.
Serious adverse reactions were reported in 53% of patients. The most common serious adverse reactions (≥3%) included infections, gastrointestinal hemorrhage, and multiple organ dysfunction. Fatal adverse reactions occurred in two (6%) of patients and included septic shock and gastrointestinal hemorrhage.
Disseminated histoplasmosis led to drug discontinuation in one patient. The most commonly reported adverse reactions (≥20%) were infections, hypertension, infusion-related reactions, and pyrexia. Adverse reactions reported in ≥10% of patients during treatment with GAMIFANT are presented in Table 4.
Table 4: Adverse Reactions Reported in 10% of Patients with Primary HLH
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
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, gastro-intestinal hemorrhage, epistaxis, and peripheral edema.
HLH/MAS
The safety of GAMIFANT was evaluated in two open-label clinical studies in patients with HLH/MAS in Stills disease, including sJIA
The pooled safety data from these two studies included 39 patients who received an initial dose of 6 mg/kg followed by 3 mg/kg every 3 days until Day 16, and then twice weekly thereafter. The median duration of treatment with GAMIFANT was 29 days (range: 7 to 220 days) and the median cumulative dose was 33 mg/kg (range: 12 to 175 mg/kg).
Serious adverse reactions were reported in 12 patients (31%), with the most common serious adverse reaction being pneumonia (5%). Fatal adverse reactions occurred in two patients (5%) and included multiple organ dysfunction and circulatory shock.
Pneumonia led to drug discontinuation in one patient (3%). The most common adverse reactions (≥20%) were viral infections, including cytomegalovirus infection or reactivation, and rash. Adverse reactions reported in ≥ 10% of patients in the pooled safety analysis up to Week 8 during treatment with GAMIFANT are presented in Table 5.
Table 5: Adverse Reactions Reported in ≥10% of Patients with HLH/MAS in Stills disease
aIncludes: Cytomegalovirus infection reactivation, Cytomegalovirus infection, Adenovirus test positive, Cytomegalovirus test positive, BK polyomavirus test positive, Respirovirus test positive, Parainfluenzae virus infection, COVID-19, Rhinovirus infection, gastroenteritis Rotavirus, Adenovirus infection, Human herpesvirus 6 infection reactivation, Adenovirus reactivation
bIncludes: rash maculo-papular, rash erythematous, rash pruritic, urticaria
cIncludes: anemia macrocytic, and hypochromic anemia
dIncludes: granulocytopenia, neutropenia
eInfusion-related reactions were defined as any event reported to have occurred within 24 hours after the start of infusion and assessed as related to study treatment
5OVERDOSAGE
Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
6DESCRIPTION
Emapalumab-lzsg is an interferon gamma (IFNγ) neutralizing antibody. Emapalumab-lzsg is produced in Chinese Hamster Ovary cells by recombinant DNA technology. Emapalumab-lzsg is an IgG1 immunoglobulin with a molecular weight of approximately 148 kDa.
GAMIFANT (emapalumab-lzsg) injection for intravenous use is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution provided in single-dose vials that require dilution prior to intravenous infusion.
7HOW SUPPLIED/STORAGE AND HANDLING
GAMIFANT (emapalumab-lzsg) injection is a sterile, clear to slightly opalescent, colorless to slightly yellow solution supplied in the following packaging configuration:
NDC 66658-501-01 – containing one 10 mg/2 mL (5 mg/mL) single-dose vial
NDC 66658-505-01 – containing one 50 mg/10 mL (5 mg/mL) single-dose vial
NDC 66658-510-01 – containing one 100 mg/20 mL (5 mg/mL) single-dose vial
NDC 66658-522-01 – containing one 50 mg/2 mL (25 mg/mL) single-dose vial
NDC 66658-523-01 – containing one 100 mg/4 mL (25 mg/mL) single-dose vial
NDC 66658-524-01 – containing one 250 mg/10 mL (25 mg/mL) single-dose vial
NDC 66658-525-01 – containing one 500 mg/20 mL (25 mg/mL) single-dose vial
Store GAMIFANT in a refrigerator at 2ºC to 8ºC (36ºF to 46ºF) in original carton to protect from light. Do not freeze or shake. This product contains no preservative.
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (