Tudorza

Question 1

8.1 Pregnancy Risk Summary

Accepted Answer

There are no adequate and well-controlled studies of TUDORZA PRESSAIR in pregnant women to inform drug-associated risks. While no adverse developmental effects were observed in pregnant rats and rabbits during organogenesis when exposed to aclidinium bromide, reduced pup weights were seen in pregnant rats continuing inhalation administration through lactation. Adverse developmental effects occurred in rabbits dosed orally at high levels. The estimated background risk of major birth defects and miscarriage in the general U.S. population is 2% to 4% and 15% to 20%, respectively.

Question 2

8.2 Lactation Risk Summary

Accepted Answer

There are no available data on the effects of TUDORZA PRESSAIR or aclidinium bromide on the breastfed child or on milk production or presence in human milk. Aclidinium bromide was found in the milk of lactating female rats, suggesting a likelihood of its presence in human milk. The benefits of breastfeeding should be weighed against any potential risks to the breastfed child from TUDORZA PRESSAIR or the underlying maternal condition.

Question 3

8.4 Pediatric Use

Accepted Answer

TUDORZA PRESSAIR is approved for use in the maintenance treatment of bronchospasm associated with COPD. Since COPD is uncommon in children, the safety and effectiveness of TUDORZA PRESSAIR in pediatric patients have not been established.

Question 4

8.5 Geriatric Use

Accepted Answer

Studies in COPD patients of different age groups showed no overall differences in safety or effectiveness between elderly subjects and younger subjects. While there were no identified differences in responses between the elderly and younger patients, sensitivity of some older individuals cannot be ruled out. No dosage adjustment in geriatric patients is warranted based on available data for TUDORZA PRESSAIR.

Question 5

8.6 Renal Impairment

Accepted Answer

Pharmacokinetic studies in subjects with varying degrees of renal impairment showed no clinically significant differences in aclidinium pharmacokinetics. No dosage adjustment in renally impaired subjects is warranted based on available data for TUDORZA PRESSAIR.

Question 6

8.7 Hepatic Impairment

Accepted Answer

The effects of hepatic impairment on the pharmacokinetics of TUDORZA PRESSAIR have not been studied.

Tudorza Pressair