Gamifant
(emapalumab-lzsg)Gamifant 10 MG in 2 ML InjectionGamifant 50 MG in 10 ML Injection
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Gamifant FAQs
What is the drug-associated risk of adverse developmental outcomes in pregnant women using GAMIFANT?Limited data on the use of GAMIFANT in pregnant women do not identify a concern for specific adverse developmental outcomes. An animal reproduction study using a murine surrogate anti-mouse IFNγ antibody administered to pregnant mice throughout gestation did not show any fetal harm. However, the estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
What is the estimated background risk of major birth defects and miscarriage in the general population?In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Is emapalumab-lzsg present in human milk?There is no information regarding the presence of emapalumab-lzsg in human milk. Published data suggest that only limited amounts of therapeutic antibodies are found in breast milk and they do not enter the neonatal and infant circulations in substantial amounts.
Is GAMIFANT safe and effective for use in pediatric patients?GAMIFANT has been established as safe and effective in pediatric patients with primary HLH that is reactivated or refractory to conventional therapies. Use of GAMIFANT is supported by a single-arm trial in 27 pediatric patients with reactivated or refractory primary HLH, including patients from newborn to 13 years of age.
Is there clinical data available on the use of GAMIFANT in geriatric patients?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 not identified differences in responses between the elderly and younger patients.
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