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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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (0)

              Serious - Use Alternative (3)

              • glucagon

                glucagon increases toxicity of umeclidinium bromide by Other (see comment). Avoid or Use Alternate Drug. Comment: Coadministration of anticholinergic drugs and glucagon increase the risk of gastrointestinal adverse reactions due to additive effects on inhibition of gastrointestinal motility. .

              • glucagon intranasal

                glucagon intranasal increases toxicity of umeclidinium bromide by Other (see comment). Avoid or Use Alternate Drug. Comment: Coadministration of anticholinergic drugs and glucagon increase the risk of gastrointestinal adverse reactions due to additive effects on inhibition of gastrointestinal motility. .

              • revefenacin

                revefenacin and umeclidinium bromide both decrease cholinergic effects/transmission. Avoid or Use Alternate Drug. Coadministration may cause additive anticholinergic effects.

              Monitor Closely (28)

              • abobotulinumtoxinA

                abobotulinumtoxinA increases effects of umeclidinium bromide by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects. .

              • acetylcholine

                acetylcholine increases and umeclidinium bromide decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor. Monitor when umeclidinium bromide is coadministered with cholinergic agents.

              • aclidinium

                umeclidinium bromide and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor. If possible, avoid coadministration of additional anticholinergic agents

              • amantadine

                umeclidinium bromide, amantadine. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Potential for increased anticholinergic adverse effects.

              • atropine

                umeclidinium bromide and atropine both decrease cholinergic effects/transmission. Use Caution/Monitor. If possible, avoid coadministration of additional anticholinergic agents

              • atropine IV/IM

                umeclidinium bromide and atropine IV/IM both decrease cholinergic effects/transmission. Use Caution/Monitor. If possible, avoid coadministration of additional anticholinergic agents

              • atropine ophthalmic

                umeclidinium bromide and atropine ophthalmic both decrease cholinergic effects/transmission. Use Caution/Monitor. If possible, avoid coadministration of additional anticholinergic agents

              • belladonna alkaloids

                umeclidinium bromide and belladonna alkaloids both decrease cholinergic effects/transmission. Use Caution/Monitor. If possible, avoid coadministration of additional anticholinergic agents

              • bethanechol

                bethanechol increases and umeclidinium bromide decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor. Monitor when umeclidinium bromide is coadministered with cholinergic agents.

              • carbachol

                carbachol increases and umeclidinium bromide decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor. Monitor when umeclidinium bromide is coadministered with cholinergic agents.

              • dicyclomine

                umeclidinium bromide and dicyclomine both decrease cholinergic effects/transmission. Use Caution/Monitor. If possible, avoid coadministration of additional anticholinergic agents

              • echothiophate iodide

                echothiophate iodide increases and umeclidinium bromide decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor. Monitor when umeclidinium bromide is coadministered with cholinergic agents.

              • glycopyrrolate

                umeclidinium bromide and glycopyrrolate both decrease cholinergic effects/transmission. Use Caution/Monitor. If possible, avoid coadministration of additional anticholinergic agents

              • glycopyrrolate inhaled

                umeclidinium bromide and glycopyrrolate inhaled both decrease cholinergic effects/transmission. Use Caution/Monitor. If possible, avoid coadministration of additional anticholinergic agents

              • glycopyrronium tosylate topical

                glycopyrronium tosylate topical, umeclidinium bromide. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.

              • homatropine

                umeclidinium bromide and homatropine both decrease cholinergic effects/transmission. Use Caution/Monitor. If possible, avoid coadministration of additional anticholinergic agents

              • hyoscyamine

                umeclidinium bromide and hyoscyamine both decrease cholinergic effects/transmission. Use Caution/Monitor. If possible, avoid coadministration of additional anticholinergic agents

              • hyoscyamine spray

                umeclidinium bromide and hyoscyamine spray both decrease cholinergic effects/transmission. Use Caution/Monitor. If possible, avoid coadministration of additional anticholinergic agents

              • ipratropium

                umeclidinium bromide and ipratropium both decrease cholinergic effects/transmission. Use Caution/Monitor. If possible, avoid coadministration of additional anticholinergic agents

              • methscopolamine

                umeclidinium bromide and methscopolamine both decrease cholinergic effects/transmission. Use Caution/Monitor. If possible, avoid coadministration of additional anticholinergic agents

              • neostigmine

                neostigmine increases and umeclidinium bromide decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor. Monitor when umeclidinium bromide is coadministered with cholinergic agents.

              • physostigmine

                physostigmine increases and umeclidinium bromide decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor. Monitor when umeclidinium bromide is coadministered with cholinergic agents.

              • pilocarpine

                pilocarpine increases and umeclidinium bromide decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor. Monitor when umeclidinium bromide is coadministered with cholinergic agents.

              • pilocarpine ophthalmic

                pilocarpine ophthalmic increases and umeclidinium bromide decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor. Monitor when umeclidinium bromide is coadministered with cholinergic agents.

              • propantheline

                umeclidinium bromide and propantheline both decrease cholinergic effects/transmission. Use Caution/Monitor. If possible, avoid coadministration of additional anticholinergic agents

              • pyridostigmine

                pyridostigmine increases and umeclidinium bromide decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor. Monitor when umeclidinium bromide is coadministered with cholinergic agents.

              • scopolamine

                umeclidinium bromide and scopolamine both decrease cholinergic effects/transmission. Use Caution/Monitor. If possible, avoid coadministration of additional anticholinergic agents

              • tiotropium

                umeclidinium bromide and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor. If possible, avoid coadministration of additional anticholinergic agents

              Minor (0)

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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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                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                Incruse Ellipta inhalation
                -
                62.5 mcg/actuation aerosol
                Incruse Ellipta inhalation
                -
                62.5 mcg/actuation aerosol

                Copyright © 2010 First DataBank, Inc.

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                Patient Handout

                Patient Education
                umeclidinium inhalation

                UMECLIDINIUM POWDER INHALER - ORAL INHALATION

                (ue-ME-kli-DIN-ee-um)

                COMMON BRAND NAME(S): Incruse Ellipta

                USES: Umeclidinium is used to control and prevent symptoms (such as wheezing, shortness of breath) caused by ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes bronchitis and emphysema). It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Umeclidinium belongs to a class of drugs known as anticholinergics. Controlling symptoms of breathing problems can decrease time lost from work or school.This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden shortness of breath. If wheezing or sudden shortness of breath occurs, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed.

                HOW TO USE: Read the Patient Information Leaflet and Instructions for Use Leaflet for directions on the proper use of this medication. If you have any questions, ask your doctor or pharmacist.Inhale this medication by mouth as directed by your doctor, usually once daily. Do not open the cover of the inhaler until you are ready to use it. Each time you open the cover, you prepare a dose of the medication. If you open and close the cover without inhaling the medication, you will lose the dose. To avoid wasting a dose, do not close the cover until after you have inhaled the medication. You may or may not taste/feel the drug when you inhale. Do not exhale into the device.Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time every day. Do not use it more than one time each day.Do not increase your dose, use this medication more often, or stop using it without first consulting your doctor. Your condition will not improve any faster, and your risk of side effects will increase.If you are using other inhalers at the same time, wait at least 1 minute between the use of each medication.Learn which of your inhalers you should use every day and which you should use if your breathing suddenly worsens (quick-relief drugs). Ask your doctor ahead of time what you should do if you have new or worsening cough or shortness of breath, wheezing, increased sputum, waking up at night with trouble breathing, if you use your quick-relief inhaler more often, or if your quick-relief inhaler does not seem to be working well. Learn when you can treat sudden breathing problems by yourself and when you must get medical help right away.Tell your doctor if your condition does not improve or if it worsens.

                SIDE EFFECTS: Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: difficult/painful urination.Rarely, this medication may cause sudden severe wheezing/trouble breathing right after use. If this occurs, use your quick-relief inhaler and get medical help right away.Get medical help right away if you have any very serious side effects, including: eye pain/swelling/redness, vision changes (such as seeing rainbows around lights at night, blurred vision).A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

                PRECAUTIONS: Before using umeclidinium, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as milk proteins), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: personal or family history of glaucoma (angle-closure type), difficulty urinating (such as due to an enlarged prostate).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

                DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: other anticholinergics (such as ipratropium, atropine).

                OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

                NOTES: Do not share this medication with others.Avoid smoking and other things that can worsen breathing problems. Because the flu virus can also worsen breathing problems, ask your doctor or pharmacist if you should have a flu shot every year.

                MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up. Do not use more than one dose each day.

                STORAGE: Store at room temperature away from light, heat, and moisture. Do not store in the bathroom. Do not open the sealed tray that the inhaler comes in until you are ready to use the new inhaler. Throw away the inhaler 6 weeks after first removing it from the tray or when the dose counter reads zero, whichever comes first. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

                MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

                Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

                IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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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.