Rebreath

Chronic Obstructive Pulmonary Disease

Do not swallow or inject solution Orally inhale using a standard jet nebulizer connected to air compressor; safety and efficacy not established for administration via noncompressor nebulizer systems Immediately before use, remove unit-dose vial from the foil pouch and open; discard vial and any residual content after use

Chronic Obstructive Pulmonary Disease Indicated for maintenance treatment of chronic obstructive pulmonary disease (COPD) 175 mcg inhaled PO qDay via nebulizer using a mouthpiece Administer at the same time every day Not to exceed 175 mg once daily Hepatic impairment Mild-to-severe: Safety not evaluated; not recommended in patients with any degree of hepatic impairment

Renal impairment Any degree of impairment: No dosage adjustment is required Monitor for systemic antimuscarinic adverse effects in COPD patients with severe renal impairment

Hypersensitivity

Long-acting muscarinic antagonist (LAMA), which is often referred to as an anticholinergic; blocks action of acetylcholine at muscarinic receptors (M1 to M5); in the bronchial airways, it elicits pharmacologic effect by inhibiting M3 at the smooth muscle, leading to bronchodilation

Do not initiate during acutely deteriorating or life-threatening COPD episodes; intended as maintenance treatment and not for relief of acute symptoms Inhalers can produce paradoxical bronchospasm that may be life-threatening; if this occurs, treat immediately with an inhaled, short-acting bronchodilator and discontinue revefenacin Caution with narrow-angle glaucoma; instruct patients to contact physician if symptoms occur (eg, eye pain, blurred vision, visual halos, colored images, red eyes from congestion, corneal edema) May worsen urinary retention, especially with history of prostatic hyperplasia or bladder-neck obstruction Immediate hypersensitivity reported; discontinue drug immediately

1-10% Cough (4%) Nasopharyngitis (4%) Headache (4%) Upper respiratory tract infection (3%) Back pain (2%) Hypertension (1-2%) Dizziness (1-2%) Oropharyngeal pain (1-2%) Bronchitis (1-2%) Frequency Not Defined Paradoxical bronchospasm Worsening narrow-angle glaucoma Worsening urinary retention Immediate hypersensitivity reactions

Pregnancy There are no available data regarding use in pregnant women Advise women to contact their physician if they become pregnant while taking revefenacin Lactation Data are not available regarding presence of revefenacin in human milk, effects on breastfed infant, or effects on milk production Present in milk of lactating rats following dosing during pregnancy and lactation Consider the development and health benefits of breastfeeding along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed child or from the underlying maternal condition

Avoid coadministration with other anticholinergic drugs, owing to additive effects OATP1B1 and OATP1B3 inhibitors may increase systemic exposure of revefenacin’s active metabolite; coadministration not recommended