umeclidinium bromide/vilanterol inhaled (Rx)

Brand and Other Names:Anoro Ellipta
  • Print

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

umeclidinium/vilanterol

powder for inhalation

  • (62.5mcg/25mcg)/actuation
more...

Chronic Obstructive Pulmonary Disease

Combination anticholinergic/long-acting beta2-adrenergic agonist (LABA) indicated for long-term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema

62.5 mcg/25 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 require

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 1st 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

Next:

Interactions

Interaction Checker

and umeclidinium bromide/vilanterol inhaled

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 
            Previous
            Next:

            Adverse Effects

            1-10%

            Pharyngitis (2%)

            Diarrhea (2%)

            Pain in extremity (2%)

            Muscle spasms (1%)

            Neck pain (1%)

            Chest pain (1%)

            Sinusitis (1%)

            Lower respiratory tract infection (1%)

            Constipation (1%)

            <1%

            Productive cough

            Dry mouth

            Dyspepsia

            Abdominal pain

            GERD

            Vomiting

            Musculoskeletal chest pain

            Chest discomfort

            Asthenia

            Atrial fibrillation

            Ventricular extrasystoles

            Supraventricular extrasystoles

            Myocardial infarction

            Pruritus

            Rash

            Conjunctivitis

            Postmarketing reports

            Cardiac Disorders : Palpitations

            Immune System Disorders: Hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria

            Nervous System Disorders: Dysgeusia, tremor

            Psychiatric Disorders: Anxiety

            Previous
            Next:

            Warnings

            Black Box Warnings

            Long-acting beta2-adrenergic agonists (LABAs), such as vilanterol, increase the risk for asthma-related death

            A placebo-controlled trial with another LABA (salmeterol) showed an increase in asthma-related deaths; this finding is considered a class effect of all LABA, including vilanterol

            Safety and efficacy not established in patients with asthma; NOT approved for treatment of asthma

            Contraindications

            Severe hypersensitivity to milk proteins

            Demonstrated hypersensitivity to umeclidinium, vilanterol, 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)

            Not indicated for relief of acute bronchospasm or for the treatment of asthma; data from a large placebo-controlled trial in subjects with asthma showed that LABAs may increase the risk of asthma-related death (see Black Box Warnings)

            Do not initiate in patients during rapidly deteriorating or potentially life-threatening episodes of COPD

            Beta2-agonists can produce clinically significant cardiovascular effects including increased pulse rate or increased systolic or diastolic blood pressure

            Do not exceed recommended dose (ie, 1 actuation once daily) or coadminister with other medicines containing a LABA; may result in overdose

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

            Beta2-agonists should be used with caution with convulsive disorders, thyrotoxicosis, narrow-angle glaucoma, conditions causing urinary retention, and in individuals who are unusually responsive to sympathomimetic amines

            Potential for beta2-agonists to produce significant hypokalemia (possibly through intracellular shunting) and transient hyperglycemia (not observed in clinical trials)

            Caution with coadministration with strong CYP3A4 inhibitors because increased cardiovascular adverse effects may occur

            Use beta2-agonists with extreme caution in patients being treated with MAOIs, TCAs, or drugs known to prolong the QTc interval or within 2 weeks of discontinuation of such agents

            Previous
            Next:

            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: Unknown if distributed in human breast milk

            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.

            more...
            Previous
            Next:

            Pharmacology

            Mechanism of Action

            Umeclidinium bromide: 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 mucous secretion; dissociates slowly from M3 muscarinic receptors extending its duration of action

            Vilanterol: Long-acting selective beta2-adrenergic agonist (LABA); stimulates intracellular adenyl cyclase resulting in increased cAMP levels causing bronchial smooth muscle relaxation; also inhibits release of mediators of immediate hypersensitivity from cells, especially from mast cells

            Absorption

            Plasma levels not predictive of therapeutic effect

            Peak plasma time: 5-15 minutes (umeclidinium/vilanterol)

            Distribution

            Following IV administration of each component

            Protein bound: 89% (umeclidinium); 94% (vilanterol)

            Vd: 86 L (umeclidinium); 165 L (vilanterol)

            Metabolism

            Umeclidinium

            • 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

            Vilanterol

            • Metabolized principally by CYP3A4 and is a substrate for the P-gp transporter
            • Metabolized to a range of metabolites with significantly reduced beta1- and beta2-agonist activity

            Elimination

            Half-life: 11 hr (umeclidinium/vilanterol)

            Excretion

            • Umeclidinium (IV): 58% feces; 22% urine
            • Umeclidinium (PO): 92% feces; <1% urine
            • Vilanterol (PO): 30% feces; 70% urine
            Previous
            Next:

            Images

            Previous
            Next:

            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            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.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
            Additional Offers
            Email to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Email Forms to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Previous