Vials contain no preservative discard any residual solution remaining in the vial after administration of the single dose. To minimize risk of flu-like syndrome, administer at bedtime and/or give acetaminophen to prevent or partially alleviate fever and headache. Optimum sites for sub-Q injection include right and left deltoid and anterior thigh. If home use is prescribed, carefully instruct patients and/or their caregivers in appropriate use provide a puncture-resistant container for proper, safe disposal of used syringes and needles.Īdminister by sub-Q injection 3 times weekly (e.g., Monday, Wednesday, Friday). Related/similar drugs Ofev, nintedanib, pirfenidone, Esbriet, methoxsalen, romidepsin, bexarotene Interferon Gamma Dosage and Administration General
Copay assistance interferon gamma 1b trial#
FDA suggests that health-care professionals should discuss the results of this trial with their patients receiving the drug for IPF and carefully consider whether they should continue to receive treatment with interferon gamma-1b. Interferon gamma-1b is not approved for use in patients with IPF. Interim analysis also indicated that 14.5% of patients receiving interferon gamma 1-b died compared with 12.7% of those receiving placebo. Interferon gamma-1b was investigated in patients with idiopathic pulmonary fibrosis † (IPF) with mild-to-moderate lung function impairment in the INSPIRE study the study was terminated early when interim data analysis indicated lack of benefit in patients receiving the drug. Treatment to delay the time to disease progression in patients with severe, malignant osteopetrosis (designated an orphan drug by FDA for this use). Reduction of the frequency and severity of serious infections in patients with chronic granulomatous disease (designated an orphan drug by FDA for this use). Uses for Interferon Gamma Chronic Granulomatous Disease Written by ASHP.īiologic response modifier biosynthetic (recombinant DNA origin) form of endogenous human interferon gamma. Any interferon in breastmilk is probably destroyed in the infant GI tract and not absorbed, except perhaps in neonates.Chemical name: N2-l-Methionyl-1-139-interferonγ (human lymphocyte protein moiety reduced) No data are available on the use of exogenous interferon gamma 1b during breastfeeding however, the amounts of the similar drugs, interferon alfa and interferon beta-1a, excreted into milk are very low. Interferon gamma is a normal component of human milk. The effects in the nursing infant are unknown. See references Interferon gamma-1b Breastfeeding WarningsĮxcreted into animal milk: Data not available Based on the information available, it cannot be excluded that the presence of higher levels of interferon gamma may impair male and female fertility. Risk Summary: Animal studies at comparative human doses showed no evidence of maternal toxicity, embryotoxicity, fetotoxicity, or teratogenicity. This drug should be used during pregnancy only if the benefit outweighs the risk. Pregnancy categories A, B, C, D and X are being phased out. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.ĪU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. There are no controlled data in human pregnancy. For lower doses, there is no evidence of maternal toxicity, embryotoxicity, fetotoxicity, or teratogenicity in animal studies. This drug has shown an increased incidence of abortions in primates when given from gestation day 20 to 80 in doses approximately 100 times the human dose. Interferon gamma-1b Pregnancy and Breastfeeding Warnings
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