Version October 2024
Chronic obstructive pulmonary disease, maintenance:
Note: Depending on symptoms and exacerbation risk, may use monotherapy long-acting bronchodilator (long-acting beta agonist or long-acting muscarinic antagonist). In patients with more symptoms (eg, Group B), use in combination with long-acting beta agonist. In addition, a short-acting bronchodilator is used for intermittent symptom relief (Ref).
Dry powder inhaler (62.5 mcg/actuation): Oral inhalation: One inhalation once daily.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
No dosage adjustment necessary.
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).
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Cardiovascular: Tachycardia (1%)
Gastrointestinal: Toothache (1%), upper abdominal pain (1%)
Hematologic & oncologic: Bruise (1%)
Neuromuscular & skeletal: Arthralgia (2%), myalgia (1%)
Respiratory: Cough (3%), nasopharyngitis (8%), pharyngitis (1%), upper respiratory tract infection (5%), viral upper respiratory tract infection (1%)
<1%: Cardiovascular: Atrial fibrillation
Postmarketing:
Genitourinary: Dysuria, urinary retention
Hypersensitivity: Hypersensitivity reaction (including anaphylaxis and angioedema)
Nervous system: Voice disorder
Ophthalmic: Blurred vision, eye pain, glaucoma
Respiratory: Oropharyngeal pain
Hypersensitivity to umeclidinium or any component of the formulation; severe hypersensitivity to milk proteins
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.
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.
Incruse Ellipta contains 30 inhalations (30 blisters) or 7 inhalations (7 blisters) in the institutional pack
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]
No
Aerosol powder (Incruse Ellipta Inhalation)
62.5 mcg/ACT (per each): $12.87
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
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]
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.
Chronic obstructive pulmonary disease, maintenance: Maintenance treatment of patients with chronic obstructive pulmonary disease.
Incruse Ellipta may be confused with Anoro Ellipta, Arnuity Ellipta, Breo Ellipta, and Trelegy Ellipta; Ellipta is the inhaler delivery system trademark not a medication.
Substrate of CYP2D6 (minor), P-glycoprotein/ABCB1 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Agents with Clinically Relevant Anticholinergic Effects: Umeclidinium may enhance the anticholinergic effect of Agents with Clinically Relevant Anticholinergic Effects. Risk X: Avoid combination
Inhaled Anticholinergic Agents: May enhance the anticholinergic effect of other Inhaled Anticholinergic Agents. Risk C: Monitor therapy
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. Risk X: Avoid combination
Methacholine: Long-acting muscarinic antagonists (LAMAs) may diminish the therapeutic effect of Methacholine. Management: Hold long-acting muscarinic antagonists (LAMAs) for at least 7 days before methacholine use. Risk D: Consider therapy modification
Adverse events were not observed in animal reproduction studies. Systemic absorption following oral inhalation in negligible.
It is not known if umeclidinium is present in breast milk; however, systemic absorption following oral inhalation in negligible.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
FEV1, peak flow, and/or other pulmonary function tests; signs/symptoms of glaucoma; hypersensitivity reactions; urinary retention
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)
Protein binding: ~89%
Metabolism: Hepatic via CYP2D6 and is a substrate for the P-glycoprotein (P-gp) transporter.
Half-life elimination: 11 hours
Time to peak: 5 to 15 minutes
Excretion: Urine <1%; feces 92% (following oral administration)
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