![]() Any interferon in breastmilk is probably destroyed in the infant GI tract and not absorbed, except perhaps in neonates. Identificar una dosis máxima tolerada de monocitos autólogos intraperitoneales y Sylatron(R) (peginterferón alfa-2b) y Actimmune(R) (interferón gamma-1b). 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. A Phase 1 trial of autologous monocytes stimulated ex vivo with Sylatron ® (Peginterferon alfa-2b) and Actimmune ® (Interferon gamma-1b) for intra-peritoneal administration in recurrent ovarian cancer. Interferon gamma is a normal component of human milk. Actimmune injection subcutaneous (interferon gamma-1b) Eligibility Requirements : Insurance Status: Must have insurance: Those with Part D Eligible Not specified: Income: At or below 500 of FPL: Diagnosis/Medical Criteria: FDA-approved diagnosis: US Residency Required Yes and have social security number : Application: Obtaining: Call. ![]() 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. ACTIMMUNE (Interferon gamma-1b), an interferon gamma, is a single-chain. Pregnancy categories A, B, C, D and X are being phased out. Some Actimmune side effects do not require medical assistance. 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. HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist. 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. Adding more interferon may help your body fight off serious infections. 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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