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Umeclidinium

Medically reviewed on Dec 30, 2018

Pronunciation

See also: Stiolto

(ue me kli DIN ee um)

Index Terms

  • Umeclidinium Bromide

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Aerosol Powder Breath Activated, Inhalation:

Incruse Ellipta: 62.5 mcg/inhalation (7 ea, 30 ea) [contains lactose monohydrate]

Brand Names: U.S.

  • Incruse Ellipta

Pharmacologic Category

  • Anticholinergic Agent
  • Anticholinergic Agent, Long-Acting

Pharmacology

Competitively and reversibly inhibits the action of acetylcholine at type 3 muscarinic (M3) receptors in bronchial smooth muscle causing bronchodilation.

Absorption

Lung; minimum contribution from oral absorption.

Distribution

Vd: 86 L (following IV administration)

Metabolism

Hepatic via CYP2D6 and is a substrate for the P-glycoprotein (P-gp) transporter.

Excretion

Urine <1%; feces 92% (following oral administration)

Time to Peak

5 to 15 minutes

Half-Life Elimination

11 hours

Protein Binding

~89%

Use: Labeled Indications

COPD: Maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema.

Contraindications

Hypersensitivity to umeclidinium or any component of the formulation; severe hypersensitivity to milk proteins

Dosing: Adult

COPD: Oral inhalation: Dry powder inhaler: One inhalation (62.5 mcg) once daily (maximum dose: 1 inhalation/day)

Dosing: Geriatric

Refer to adult dosing.

Administration

Oral inhalation: Dry powder inhaler: For oral inhalation only; administer at the same time each day; there is no need to shake the inhaler. Remove inhaler from sealed pouch immediately prior to first use. Each time the cover of the inhaler is opened, a “click” should be heard and the counter will count down by 1 number; dose is ready to be inhaled. If the counter does not count down as the “click” is heard, the inhaler will not deliver the medicine. Only open inhaler cover when ready for administration; opening and closing the device without inhaling will result in a lost dose; do not close inhaler cover until dose has been inhaled. Refer to product labeling for additional administration instructions.

Storage

Store between 68°F and 77°F (20°C and 25°C); excursions are permitted between 59°F and 86°F (15°C and 30°C). Protect from moisture, heat or sunlight. Remove inhaler from tray immediately prior to initial use. Discard inhaler 6 weeks after opening the foil tray or after the labeled number of inhalations have reached zero, whichever comes first.

Drug Interactions

Acetylcholinesterase Inhibitors: Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Acetylcholinesterase Inhibitors may diminish the therapeutic effect of Anticholinergic Agents. Monitor therapy

Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Amantadine: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy

Anticholinergic Agents: Umeclidinium may enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Botulinum Toxin-Containing Products: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy

Cannabinoid-Containing Products: Anticholinergic Agents may enhance the tachycardic effect of Cannabinoid-Containing Products. Exceptions: Cannabidiol. Monitor therapy

Chloral Betaine: May enhance the adverse/toxic effect of Anticholinergic Agents. Monitor therapy

Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Avoid combination

Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Avoid combination

Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Monitor therapy

Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Monitor therapy

Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Avoid combination

Glycopyrronium (Topical): May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Monitor therapy

Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Avoid combination

Loxapine: Agents to Treat Airway Disease may enhance the adverse/toxic effect of Loxapine. More specifically, the use of Agents to Treat Airway Disease is likely a marker of patients who are likely at a greater risk for experiencing significant bronchospasm from use of inhaled loxapine. Management: This is specific to the Adasuve brand of loxapine, which is an inhaled formulation. This does not apply to non-inhaled formulations of loxapine. Avoid combination

Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy

Mirabegron: Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron. Monitor therapy

Nitroglycerin: Anticholinergic Agents may decrease the absorption of Nitroglycerin. Specifically, anticholinergic agents may decrease the dissolution of sublingual nitroglycerin tablets, possibly impairing or slowing nitroglycerin absorption. Monitor therapy

Opioid Agonists: Anticholinergic Agents may enhance the adverse/toxic effect of Opioid Agonists. Specifically, the risk for constipation and urinary retention may be increased with this combination. Monitor therapy

Oxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Potassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium chloride. Avoid combination

Potassium Citrate: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Citrate. Avoid combination

Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Consider therapy modification

Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Monitor therapy

Revefenacin: Anticholinergic Agents may enhance the anticholinergic effect of Revefenacin. Avoid combination

Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid concomitant use of anticholinergic agents and secretin. Discontinue anticholinergic agents at least 5 half-lives prior to administration of secretin. Consider therapy modification

Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Monitor therapy

Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Avoid combination

Topiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate. Monitor therapy

Adverse Reactions

1% to 10%:

Cardiovascular: Tachycardia (1%)

Gastrointestinal: Toothache (1%), upper abdominal pain (1%)

Hematologic & oncologic: Bruise (1%)

Neuromuscular & skeletal: Arthralgia (2%), myalgia (1%)

Respiratory: Nasopharyngitis (8%), upper respiratory tract infection (5%), cough (3%), pharyngitis (1%), viral upper respiratory tract infection (1%)

<1%, postmarketing, and/or case reports: Anaphylaxis, atrial fibrillation, blurred vision, dysgeusia, dysuria, eye pain, glaucoma, hypersensitivity reaction, urinary retention

Warnings/Precautions

Concerns related to adverse effects:

• Bronchospasm: Paradoxical bronchospasm that may be life-threatening may occur with use of inhaled agents; this should be distinguished from inadequate response. If paradoxical bronchospasm occurs, discontinue use and institute alternative therapy.

• Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, angioedema, pruritus, rash, and urticaria may occur; discontinue immediately if signs/symptoms of a hypersensitivity reaction occur.

Disease-related concerns:

• Glaucoma: Use with caution in patients with narrow angle glaucoma; may increase intraocular pressure.

• Urinary retention: Use with caution in patients with urinary retention. Monitor for signs and symptoms of urinary retention, especially in patients with prostatic hyperplasia or bladder-neck obstruction.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Dosage form specific issues:

• Lactose: Powder for oral inhalation may contain lactose; use is contraindicated in patients with severe milk protein allergy.

Other warnings/precautions:

• Appropriate use: Not indicated for the initial (rescue) treatment of acute episodes of bronchospasm or with acutely deteriorating or potentially life-threatening COPD; after initiation of therapy, patients should use short-acting bronchodilators only on an as needed basis for acute symptoms.

Monitoring Parameters

FEV1, peak flow, and/or other pulmonary function tests; signs/symptoms of glaucoma; hypersensitivity reactions; urinary retention

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies. Systemic absorption following oral inhalation in negligible.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience rhinitis, pharyngitis, rhinorrhea, muscle pain, joint pain, abdominal pain, or toothache. Have patient report immediately to prescriber bruising, angina, tachycardia, arrhythmia, tremors, vision changes, eye pain, severe eye irritation, visual halos around lights, eye redness, urinary retention, change in amount of urine passed, polyuria, painful urination, or difficulty breathing, wheezing, or cough (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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