GAMIFANT Solution for injection (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

NovImmune SA

Λέξεις κλειδιά

72171-501 72171-505

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1. Indications 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 ...

2. Dosage and Administration

2.1 Recommended Dosing The recommended starting dose of GAMIFANT is 1 mg/kg given as an intravenous infusion over 1 hour twice per week (every three to four days). Doses subsequent to the initial dose ...

3. Dosage 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 ...

4. Contraindications

None.

5. Warnings and Precautions

5.1 Infections GAMIFANT may increase the risk of fatal and serious infections to include specific pathogens favored by IFNγ neutralization, including mycobacteria, Herpes Zoster virus, and Histoplasma ...

6. Adverse Reactions

The following adverse reactions are described elsewhere in the labeling: Infections [see Warnings and Precautions (5.1)] Infusion-Related Reactions [see Warnings and Precautions (5.3)] ...

6.1. Clinical Trials 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 ...

6.2. Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed ...

7. Drug Interactions

7.1 Effect of GAMIFANT on Cytochrome P450 Substrates The formation of CYP450 enzymes may be suppressed by increased levels of cytokines (such as IFNγ) during chronic inflammation. By neutralizing IFNγ, ...

8.1. Pregnancy

Risk Summary There are no available data on GAMIFANT use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. In an animal reproduction study, a murine surrogate anti-mouse ...

8.2. Lactation

Risk Summary There is no information regarding the presence of emapalumab-lzsg in human milk, the effects on the breastfed child, or the effects on milk production. Published data suggest that only limited ...

8.4. Pediatric Use

Safety and effectiveness of GAMIFANT have been established in pediatric patients, newborn and older, with primary HLH that is reactivated or refractory to conventional therapies. Use of GAMIFANT is supported ...

8.5. Geriatric Use

Clinical studies of GAMIFANT did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has ...

11. Description

Emapalumab-lzsg is an interferon gamma (IFNγ) blocking antibody. Emapalumab-lzsg is produced in Chinese Hamster Ovary cells by recombinant DNA technology. Emapalumab-lzsg is an IgG1 immunoglobulin with ...

12.1. Mechanism of Action

Emapalumab-lzsg is a monoclonal antibody that binds to and neutralizes interferon gamma (IFNγ). Nonclinical data suggest that IFNγ plays a pivotal role in the pathogenesis of HLH by being hypersecreted. ...

12.2. Pharmacodynamics

IFNγ Inhibition Emapalumab-lzsg reduces the plasma concentrations of CXCL9, a chemokine induced by IFNγ. Cardiac Electrophysiology At a dose of 3 mg/kg GAMIFANT does not prolong the QT interval to any ...

12.3. Pharmacokinetics

The pharmacokinetics of emapalumab-lzsg were evaluated in healthy adult subjects and in patients with primary HLH. Following a 1 mg/kg emapalumab-lzsg dose, median steady state peak concentration was 44 ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

No carcinogenicity or genotoxicity studies have been conducted with emapalumab-lzsg. No studies have been conducted to evaluate the effects of emapalumab-lzsg on fertility; however, no adverse effects ...

14. Clinical Studies

The efficacy of GAMIFANT was evaluated in a multicenter, open-label, single-arm trial NI-0501-04 (NCT01818492) in 27 pediatric patients with suspected or confirmed primary HLH with either refractory, recurrent, ...

16.1. How Supplied

GAMIFANT (emapalumab-lzsg) injection is a sterile, clear to slightly opalescent, colorless to slightly yellow solution supplied in the following packaging configuration: NDC 72171-501-01 containing one ...

16.2. Storage and Handling

Store GAMIFANT in a refrigerator at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze or shake. This product contains no preservative.

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Infections Inform patients and their caregivers of the risk of developing infections during treatment with GAMIFANT, ...