YUPELRI® INHALATION SOLUTION 175MCG/3ML

1 INDICATIONS AND USAGE

YUPELRI inhalation solution is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

4 CONTRAINDICATIONS

YUPELRI is contraindicated in patients with hypersensitivity to revefenacin or any component of this product.

2 DOSAGE AND ADMINISTRATION

The recommended dose of YUPELRI inhalation solution is one 175 mcg unit-dose vial administered once daily by nebulizer using a mouthpiece.

YUPELRI should be administered by the orally inhaled route via a standard jet nebulizer connected to an air compressor (See Patient Information – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The safety and efficacy of YUPELRI have been established in clinical trials when administered using the PARI LC® Sprint nebulizer with a mouthpiece and the PARI Trek® S compressor. The safety and efficacy of YUPELRI delivered from non-compressor-based nebulizer systems have not been established.

The YUPELRI unit-dose vial should only be removed from the foil pouch and opened IMMEDIATELY BEFORE USE. The vial and any residual content should be discarded after use.

No dosage adjustment is required for geriatric patients, or patients with renal impairment [see sections 8.5, 8.7, Clinical Pharmacology (12.3) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information ].

The drug compatibility (physical and chemical), efficacy, and safety of YUPELRI when mixed with other drugs in a nebulizer have not been established.