Trelegy Ellipta (fluticasone furoate)
TRELEGY ELLIPTA 100 MCG / 62.5 MCG / 25 MCG Dry Powder Inhaler, 14 Blisters
NO BOXED WARNING
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Trelegy Ellipta FAQs
8.1 Pregnancy Risk SummaryInsufficient data are available on the use of TRELEGY ELLIPTA or its individual components (fluticasone furoate, umeclidinium, and vilanterol) in pregnant women to determine a drug-associated risk. Animal studies showed no adverse effects on embryofetal development for these components at exposures approximately 4.5 to 200 times the maximum recommended daily inhalation doses in adults.
8.2 Lactation Risk SummaryNo information is available on the presence of these components in human milk, their effects on the breastfed child, or milk production. Umeclidinium was detected in the plasma of offspring of lactating rats treated with umeclidinium, suggesting its presence in maternal milk.
8.4 Pediatric UseTRELEGY ELLIPTA is not approved for use in pediatric patients, and its safety and efficacy in pediatric patients have not been established.
8.5 Geriatric UseNo dosage adjustment is necessary for geriatric patients, but greater sensitivity in some older individuals cannot be ruled out.
8.6 Hepatic ImpairmentTRELEGY ELLIPTA has not been studied in subjects with hepatic impairment. Information on the individual components is provided.
8.7 Renal ImpairmentTRELEGY ELLIPTA has not been studied in subjects with renal impairment. Information on the individual components is provided.
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