Incruse Ellipta ®(Umeclidinium) | Tudorza Pressair ®() |
|---|---|
Prescription Only | Prescription Only |
| Dosage & Administration | Dosage & Administration comparison data |
Administration | |
Inhalation. Learn more. | Inhalation. Learn more. |
Dosing | |
Maintenance treatment of COPD: 1 inhalation of INCRUSE ELLIPTA once daily. Learn more. | One inhalation of TUDORZA PRESSAIR 400 mcg twice daily.. Learn more. |
Latin Shorthand | |
Maintenance treatment of COPD: 1 inhalation qd. Learn more. | One inhalation (400 mcg) bid.. Learn more. |
| Financial Assistance | Financial Assistance comparison data |
Out-Of-Pocket Costs With Copay Card | |
$0. Learn more. | |
Annual Cap | |
Assistance Expiration | |
Generics | |
Lower-cost generic available | No lower-cost generic available |
| Physician Advisory | Physician Advisory comparison data |
Adverse Reactions | |
Most common adverse reactions (incidence ≥2% and more common than
placebo) include nasopharyngitis, upper respiratory tract infection, cough,
arthralgia.. Learn more. | Most common adverse reactions (≥3% incidence and greater than placebo) are headache, nasopharyngitis and cough.. Learn more. |
Mechanism of Actions (MoA) | |
Anticholinergics. Learn more. | Anticholinergics. Learn more. |
Special Populations | |
8.1 Pregnancy Risk Summary 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. 8.2 Lactation Risk Summary 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. 8.4 Pediatric Use 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. 8.5 Geriatric Use 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. 8.6 Hepatic Impairment Revefenacin exposure remains unchanged in subjects with hepatic impairment, while the active metabolite's exposure increases. YUPELRI's safety has not been evaluated in COPD patients with hepatic impairment and is not recommended for patients with any degree of hepatic impairment. 8.7 Renal Impairment No dosage adjustment is necessary for patients with renal impairment. However, COPD patients with severe renal impairment should be monitored for systemic antimuscarinic side effects. | 8.1 Pregnancy Risk Summary 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. 8.2 Lactation Risk Summary 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. 8.4 Pediatric Use 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. 8.5 Geriatric Use 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. 8.6 Renal Impairment 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. 8.7 Hepatic Impairment The effects of hepatic impairment on the pharmacokinetics of TUDORZA PRESSAIR have not been studied. |