umeclidinium bromide (Rx)

Brand and Other Names:Incruse Ellipta
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for inhalation

  • 62.5mcg/actuation

Chronic Obstructive Pulmonary Disease

Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema

62.5 mcg (1 actuation) inhaled PO qDay

Dosage Modifications

Renal impairment (including severe [CrCl <30 mL/min]): No dosage adjustment required

Moderate hepatic impairment (Child-Pugh 7-9): No dosage adjustment required

Severe hepatic impairment: Unknown, not evaluated

Geriatric patients: No dosage adjustment required

Administration

Inhaler is not reusable

Store at room temperature between 68-77°F (20-25°C); excursions permitted from 59-86°F (15-30°C)

Store in a dry place away from direct heat or sunlight

Before the inhaler is used for the first time, the counter should show the number 30 (7 if a sample or institutional pack); this is the number of doses in the inhaler

See prescribing information for detailed description regarding how to administer

Safety and efficacy not established

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Interactions

Interaction Checker

and umeclidinium bromide

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Nasopharyngitis (8%)

            Upper respiratory tract infection (5%)

            Cough (3%)

            Arthralgia (2%

            Toothache (1%)

            Pharyngitis (1%)

            Viral upper respiratory tract infection (1%)

            Tachycardia (1%)

            <1%

            Atrial fibrillation

            Postmarketing Reports

            Hypersensitivity reactions, including anaphylaxis, angioedema, pruritus, rash, and urticaria

            Eye disorders: Eye pain, glaucoma, vision blurred

            Renal and urinary disorders: Dysuria, urinary retention

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            Warnings

            Contraindications

            Severe hypersensitivity to milk proteins

            Demonstrated hypersensitivity to umeclidinium or any of the excipients

            Cautions

            Anaphylactic reactions reported in patients with severe milk protein allergy after inhalation of other powder products containing lactose (see Contraindications)

            Hypersensitivity reactions such as anaphylaxis, angioedema, pruritus, rash, and urticaria may occur; discontinue if reactions occur

            Do not initiate in patients during rapidly deteriorating or potentially life-threatening episodes of COPD; not be used for the relief of acute symptoms (ie, as rescue inhaler) from acute episodes of bronchospasm

            Paradoxical bronchospasm reported; discontinue and treat immediately with an inhaled, prompt-acting bronchodilator (eg, albuterol)

            Worsening of narrow-angle glaucoma may occur

            Worsening of urinary retention may occur; caution in patients with prostatic hyperplasia or bladder-neck obstruction

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            Pregnancy & Lactation

            Pregnancy

            There are insufficient data on use in pregnant women to inform a drug-associated risk

            Animal data

            • Administered via inhalation or subcutaneously to pregnant rats and rabbits was not associated with adverse effect on embryofetal development at exposures approximately 50 and 200 times, respectively, the human exposure at maximum recommended human daily inhaled dose (MRHDID)

            Lactation

            There is no information available on presence of drug in human milk, effects on breastfed child, or on milk production; the drug was detected in plasma of offspring of lactating rats treated with umeclidinium suggesting its presence in maternal milk; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from umeclidinium or from underlying maternal condition

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Long-acting muscarinic antagonist (LAMA) often referred to as an anticholinergic; blocks action of acetylcholine at muscarinic receptors (M1 to M5) in the bronchial airways (M3) by preventing increase in intracellular calcium concentration, leading to relaxation of airway smooth muscle, improved lung function, and decreased mucus secretion; dissociates slowly from M3 muscarinic receptors extending its duration of action

            Absorption

            Plasma levels not predictive of therapeutic effect

            Peak plasma time: 5-15 minutes

            Distribution

            Following IV administration

            Protein bound: 89% (umeclidinium)

            Vd: 86 L (umeclidinium)

            Metabolism

            Primarily metabolized by CYP2D6 and is a substrate for the P-gp transporter

            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

            Systemic exposure to the metabolites is low

            Elimination

            Half-life: 11 hr

            Umeclidinium (IV): 58% feces; 22% urine

            Umeclidinium (PO): 92% feces; <1% urine

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.