Incruse

Question 1

8.1 Pregnancy Risk Summary

Accepted Answer

Insufficient data are available on the use of umeclidinium in pregnant women to determine a drug-associated risk. Animal studies with pregnant rats and rabbits, exposed to umeclidinium through inhalation or subcutaneous routes, showed no adverse effects on embryofetal development at exposures approximately 50 and 200 times, respectively, the human exposure at the maximum recommended daily inhaled dose (MRHDID).

Question 2

8.2 Lactation Risk Summary

Accepted Answer

There is no information regarding the presence of umeclidinium in human milk, its effects on breastfed infants, or its impact on milk production. Umeclidinium was detected in the plasma of offspring from lactating rats treated with umeclidinium, suggesting its presence in maternal milk. The decision to breastfeed should consider the benefits of breastfeeding along with the clinical need for INCRUSE ELLIPTA, weighing potential effects on the breastfed child from umeclidinium or the maternal condition.

Question 3

8.4 Pediatric Use

Accepted Answer

INCRUSE ELLIPTA is not approved for use in children, and its safety and efficacy in pediatric patients have not been established.

Question 4

8.5 Geriatric Use

Accepted Answer

Available data do not suggest the need for dosage adjustment of INCRUSE ELLIPTA in geriatric patients. However, some older individuals may exhibit greater sensitivity, although no overall differences in safety or effectiveness were observed in clinical trials between elderly and younger subjects.

Question 5

8.6 Hepatic Impairment

Accepted Answer

Patients with moderate hepatic impairment (Child-Pugh score of 7-9) did not show relevant increases in Cmax or AUC, and protein binding did not differ from healthy controls. Studies in subjects with severe hepatic impairment have not been conducted.

Question 6

8.7 Renal Impairment

Accepted Answer

Patients with severe renal impairment (CrCl <30 mL/min) did not exhibit relevant increases in Cmax or AUC, and protein binding did not differ from healthy controls. No dosage adjustment is required for patients with renal impairment.

Incruse Ellipta