COPD: Most common adverse reactions (incidence ≥1%) are upper respiratory tract infection, pneumonia, bronchitis, oral candidiasis, headache, back pain, arthralgia, influenza, sinusitis, pharyngitis, rhinitis, dysgeusia, constipation, urinary tract infection, diarrhea, gastroenteritis, oropharyngeal pain, cough, and dysphonia. (6.1) Asthma: Most common adverse reactions (incidence ≥2%) are pharyngitis/nasopharyngitis, upper respiratory tract infection/viral upper respiratory tract infection, bronchitis, respiratory tract infection/viral respiratory tract infection, sinusitis/acute sinusitis, urinary tract infection, rhinitis, influenza, headache, and back pain.. Learn more.

Most common adverse reactions (incidence greater than or equal to 2% and more common than placebo) include cough, nasopharyngitis, upper respiratory tract infection, headache, and back pain.. Learn more.

Anticholinergics . Learn more.

Anticholinergics. Learn more.

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.

Trelegy Ellipta ®(Fluticasone Furoate, Umeclidinium Bromide And Vilanterol Trifenatate)	Yupelri ®(Revefenacin)

Prescription Only TRELEGY ELLIPTA is a combination of fluticasone furoate, an inhaled corticosteroid (ICS); umeclidinium, an anticholinergic; and vilanterol, a long-acting beta2-adrenergic agonist...	Prescription Only Yupelri is classified as an anticholinergic medication, which plays a role in maintaining relaxation in the muscles surrounding the airways within your lungs. This prescription...
Dosage & Administration	Dosage & Administration comparison data
Administration
Inhalation. Learn more.	Inhalation. Learn more.
Dosing
Maintenance treatment of COPD: 1 actuation of TRELEGY ELLIPTA 100/62.5/25 mcg once daily administered by oral inhalation.. Learn more.	One 175 mcg vial (3 mL) once daily.. Learn more.
Latin Shorthand
1 actuation qd. Learn more.	One 175 mcg vial qd.. Learn more.
Financial Assistance	Financial Assistance comparison data
Out-Of-Pocket Costs With Copay Card
$0. Learn more.	$0. Learn more.
Annual Cap
Learn more.	$6,660. Learn more.
Assistance Expiration
12/31/2023. Learn more.	Calendar year. Learn more.
Generics
No lower-cost generic available	No lower-cost generic available
Physician Advisory	Physician Advisory comparison data
Adverse Reactions
COPD: Most common adverse reactions (incidence ≥1%) are upper respiratory tract infection, pneumonia, bronchitis, oral candidiasis, headache, back pain, arthralgia, influenza, sinusitis, pharyngitis, rhinitis, dysgeusia, constipation, urinary tract infection, diarrhea, gastroenteritis, oropharyngeal pain, cough, and dysphonia. (6.1) Asthma: Most common adverse reactions (incidence ≥2%) are pharyngitis/nasopharyngitis, upper respiratory tract infection/viral upper respiratory tract infection, bronchitis, respiratory tract infection/viral respiratory tract infection, sinusitis/acute sinusitis, urinary tract infection, rhinitis, influenza, headache, and back pain.. Learn more.	Most common adverse reactions (incidence greater than or equal to 2% and more common than placebo) include cough, nasopharyngitis, upper respiratory tract infection, headache, and back pain.. 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 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.

Trelegy Ellipta ® Alternatives