Asthma/COPD:

Indications for: INCRUSE ELLIPTA

Maintenance treatment of COPD.

Adult Dosage:

Take at same time every day. 1 inhalation every 24hrs.

Children Dosage:

Not established.

INCRUSE ELLIPTA Contraindications:

Severe hypersensitivity to milk proteins.

INCRUSE ELLIPTA Warnings/Precautions:

Not indicated for relief of acute bronchospasm. Do not initiate in rapidly or acutely deteriorating COPD. Do not exceed recommended dose. Reevaluate periodically. Prescribe a short-acting, inhaled β2-agonist for acute symptoms; monitor for increased need. Discontinue if paradoxical bronchospasm (use alternatives) or hypersensitivity reactions occur. Narrow-angle glaucoma. Urinary retention. Prostatic hyperplasia. Bladder-neck obstruction. Severe hepatic impairment. Pregnancy. Nursing mothers.

INCRUSE ELLIPTA Classification:

Anticholinergic.

INCRUSE ELLIPTA Interactions:

Additive effects with concomitant other anticholinergic-containing drugs; avoid.

Adverse Reactions:

Nasopharyngitis, URTI, cough, arthralgia; visual disturbances, paradoxical bronchospasm.

Metabolism:

Umeclidinium is primarily metabolized by the enzyme cytochrome P450 2D6 (CYP2D6) and is a substrate for the P-glycoprotein (P-gp) transporter. The primary metabolic routes for umeclidinium are oxidative (hydroxylation, O-dealkylation) followed by conjugation (eg, glucuronidation), resulting in a range of metabolites with either reduced
pharmacological activity or for which the pharmacological activity has not been established. 

Drug Elimination:

The effective half-life of umeclidinium after once-daily inhaled dosing is 11 hours. Following intravenous dosing with radiolabeled umeclidinium, mass balance showed 58% of the radiolabel in the feces and 22% in the urine. The excretion of the drug-related material in the feces following intravenous dosing indicated elimination in the bile. Following oral dosing to healthy male patients, radiolabel recovered in feces was 92% of the total dose and that in urine was <1% of the total dose, suggesting negligible oral absorption. 

Generic Drug Availability:

NO

How Supplied:

Dry pwd inhaler—30 doses