Compare drug alternatives
Incruse Ellipta ® Alternatives
Incruse Ellipta ®(Umeclidinium) | Tudorza Pressair ®() |
|---|---|
Prescription Only | Prescription Only |
| Dosage & Administration | Dosage & Administration comparison data |
Administration | |
Dosing | |
Latin Shorthand | |
| 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 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). 8.2 Lactation Risk Summary 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. 8.4 Pediatric Use INCRUSE ELLIPTA is not approved for use in children, and its safety and efficacy in pediatric patients have not been established. 8.5 Geriatric Use 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. 8.6 Hepatic Impairment 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. 8.7 Renal Impairment 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. | 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. |