Incruse Ellipta (umeclidinium) Disease Interactions

Some inhaled anticholinergic bronchodilators such as aclidinium and umeclidinium are contraindicated in patients with severe hypersensitivity to milk proteins. There have been reports of anaphylactic reactions on these patients after inhalation of other powder products containing lactose, therefore patients with severe milk protein allergy should not use these products.

Aclidinium, ipratropium, umeclidinium, and tiotropium are anticholinergic agents. Although systemic effects are uncommon due to the poor absorption of quaternary ammonium compounds from gastrointestinal and nasal mucosa, worsening of urinary retention or angle-closure glaucoma has been reported. Increased intraocular pressure and precipitation or exacerbation of angle-closure glaucoma may also occur due to inadvertent contact of the eye with aerosolized or nebulized drug. Accordingly, therapy with quaternary ammonium compounds should be administered cautiously in patients with urinary retention/obstruction or angle-closure glaucoma. Measures should be taken whenever possible to minimize ocular exposure to these drugs, such as keeping eyes closed during oral inhalation or use of a mouthpiece rather than face mask during nebulization. Patients should be advised to contact their physician if they experience urinary difficulty (especially in patients with prostatic hyperplasia or bladder neck obstruction); or signs and symptoms of angle-closure glaucoma (e.g., eye pain or discomfort; blurred vision; visual halos; colored images in association with red eyes from conjunctival congestion or corneal edema).

Patients with moderate hepatic impairment showed no relevant increases in Cmax or AUC when using umeclidinium, when compared with healthy subjects. However, studies have not been performed in patients with severe hepatic impairment.