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Umeclidinium

Pronunciation

(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

Chronic obstructive pulmonary disease: Maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Limitations of use: Not indicated for relief of acutely deteriorating COPD.

Contraindications

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

Dosing: Adult

Chronic obstructive pulmonary disease (COPD): Oral inhalation: 1 inhalation (62.5 mcg) once daily; maximum dose: 1 inhalation (62.5 mcg) once daily

Dosing: Geriatric

Refer to adult dosing

Dosing: Renal Impairment

No dosage adjustment necessary.

Dosing: Hepatic Impairment

Mild to moderate hepatic impairment: No dosage adjustment necessary.

Severe hepatic impairment: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Administration

Inhalation: Administer via oral inhalation once daily at the same time each day; do not use more than 1 inhalation every 24 hours. Do not shake inhaler. Remove from sealed pouch immediately prior to first use. Slide cover of mouthpiece down until a “click” is heard. Prior to inhaling the dose, exhale fully (do not exhale into the inhaler); close lips tightly around the inhaler mouthpiece and inhale (rapidly, steadily, and deeply); do not breathe through nose or block air vent with fingers. Remove inhaler and hold breath for a few seconds then breathe out slowly and gently. Only open inhaler cover when ready for administration; opening and closing the cover without inhaling the medicine will cause a dose to be lost (the lost dose will be securely held inside the inhaler, but it will no longer be available to be inhaled). Do not close inhaler cover until medication has been inhaled.

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

AbobotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of AbobotulinumtoxinA. Monitor therapy

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

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

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

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. Avoid combination

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

OnabotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of OnabotulinumtoxinA. 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

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

RimabotulinumtoxinB: Anticholinergic Agents may enhance the anticholinergic effect of RimabotulinumtoxinB. Monitor therapy

Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid using drugs with substantial anticholinergic effects in patients receiving secretin whenever possible. If such agents must be used in combination, monitor closely for a diminished response to 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% (Limited to important or life-threatening): Atrial fibrillation

Warnings/Precautions

Concerns related to adverse effects:

• Bronchospasm: Paradoxical bronchospasm may occur with the use of inhaled agents, which may be life threatening; discontinue use immediately and consider other therapy if bronchospasm occurs.

• Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, may occur. Use is contraindicated in patients with severe milk protein allergy.

Disease-related concerns:

• Glaucoma: May worsen symptoms of narrow-angle glaucoma; use with caution.

• Prostatic hyperplasia/bladder neck obstruction: May worsen the symptoms of prostatic hyperplasia and/or bladder neck obstruction; use with caution.

Dosage form specific issues:

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

Other warnings/precautions:

• Appropriate use: Do not use for acute episodes of chronic obstructive pulmonary disease (COPD). Do not initiate in patients with significantly worsening or acutely deteriorating COPD. Do not increase the daily dose beyond the recommended dose.

Monitoring Parameters

FEV1, peak flow, and/or other pulmonary function tests; signs and symptoms of narrow angle glaucoma and 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.

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