Umeclidinium
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];
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Black Box Warning
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See full prescribing information for complete Boxed Warning.
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Overview
Umeclidinium is a that is FDA approved for the {{{indicationType}}} of . There is a Black Box Warning for this drug as shown here. Common adverse reactions include .
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
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- Dosing Information
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- Dosing Information
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- Dosing Information
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Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition1
- Developed by:
- Class of Recommendation:
- Strength of Evidence:
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Umeclidinium in adult patients.
Non–Guideline-Supported Use
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Umeclidinium in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding FDA-Labeled Use of Umeclidinium in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
- Developed by:
- Class of Recommendation:
- Strength of Evidence:
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Umeclidinium in pediatric patients.
Non–Guideline-Supported Use
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Umeclidinium in pediatric patients.
Contraindications
- Condition1
Warnings
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See full prescribing information for complete Boxed Warning.
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- Description
Precautions
- Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Umeclidinium in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Umeclidinium in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Drug Interactions
- Drug
- Description
Use in Specific Populations
Pregnancy
- Pregnancy Category
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Umeclidinium in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Umeclidinium during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Umeclidinium with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Umeclidinium with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Umeclidinium with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Umeclidinium with respect to specific gender populations.
Race
There is no FDA guidance on the use of Umeclidinium with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Umeclidinium in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Umeclidinium in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Umeclidinium in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Umeclidinium in patients who are immunocompromised.
Administration and Monitoring
Administration
- Oral
- Intravenous
Monitoring
There is limited information regarding Monitoring of Umeclidinium in the drug label.
- Description
IV Compatibility
There is limited information regarding IV Compatibility of Umeclidinium in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
- Description
Management
- Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Umeclidinium in the drug label.
Pharmacology
There is limited information regarding Umeclidinium Pharmacology in the drug label.
Mechanism of Action
Structure
This image is provided by the National Library of Medicine.
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Umeclidinium in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Umeclidinium in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Umeclidinium in the drug label.
Clinical Studies
- The safety and efficacy of umeclidinium 62.5 mcg were evaluated in 3 dose-ranging trials, 2 placebo-controlled clinical trials (one 12-week trial and one 24-week trial), and a 12-month long-term safety trial. The efficacy of INCRUSE ELLIPTA is based primarily on the dose-ranging trials in 624 subjects with COPD and the 2 placebo-controlled confirmatory trials in 1,738 subjects with COPD.
Dose-Ranging Trials
- Dose selection for umeclidinium in COPD was supported by a 7-day, randomized, double-blind, placebo-controlled, crossover trial evaluating 4 doses of umeclidinium (15.6 to 125 mcg) or placebo dosed once daily in the morning in 163 subjects with COPD. A dose ordering was observed, with the 62.5- and 125-mcg doses demonstrating larger improvements in FEV1 over 24 hours compared with the lower doses of 15.6 and 31.25 mcg (Figure 2).
- The differences in trough FEV1 from baseline after 7 days for placebo and the 15.6-, 31.25-, 62.5-, and 125-mcg doses were -74 mL (95% CI: -118, -31), 38 mL (95% CI: -6, 83), 27 mL (95% CI: -18, 72), 49 mL (95% CI: 6, 93), and 109 mL (95% CI: 65, 152), respectively. Two additional dose-ranging trials in subjects with COPD demonstrated minimal additional benefit at doses above 125 mcg. The dose-ranging results supported the evaluation of 2 doses of umeclidinium, 62.5 and 125 mcg, in the confirmatory COPD trials to further assess dose response.
- Evaluations of dosing interval by comparing once- and twice-daily dosing supported selection of a once-daily dosing interval for further evaluation in the confirmatory COPD trials.
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Confirmatory Trials
- The clinical development program for INCRUSE ELLIPTA included 2 randomized, double-blind, placebo-controlled, parallel-group trials in subjects with COPD designed to evaluate the efficacy of INCRUSE ELLIPTA on lung function. Trial 1 was a 24-week placebo-controlled trial, and Trial 2 was a 12-week placebo-controlled trial. These trials treated subjects that had a clinical diagnosis of COPD, were 40 years of age or older, had a history of smoking greater than or equal to 10 pack-years, had a post-albuterol FEV1 less than or equal to 70% of predicted normal values, had a ratio of FEV1/FVC of less than 0.7, and had a Modified Medical Research Council (mMRC) score greater than or equal to 2. Subjects in Trial 1 had a mean age of 63 years and an average smoking history of 46 pack-years, with 50% identified as current smokers. At screening, the mean post-bronchodilator percent predicted FEV1was 47% (range: 13% to 74%), the mean post-bronchodilator FEV1/FVC ratio was 0.47 (range: 0.20 to 0.74), and the mean percent reversibility was 15% (range: -35% to 109%). Baseline demographics and lung function for subjects in Trial 2 were similar to those in Trial 1.
- Trial 1 evaluated umeclidinium 62.5 mcg and placebo. The primary endpoint was change from baseline in trough (predose) FEV1 at Day 169 (defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous dose on Day 168) compared with placebo. INCRUSE ELLIPTA 62.5 mcg demonstrated a larger increase in mean change from baseline in trough (predose) FEV1 relative to placebo (see Table 2). Similar results were obtained from Trial 2.
How Supplied
- INCRUSE ELLIPTA is supplied as a disposable light grey and light green plastic inhaler containing a double-foil blister strip with 30 blisters. The inhaler is packaged in a moisture-protective foil tray with a desiccant and a peelable lid (NDC 0173-0873-10).
- INCRUSE ELLIPTA is also supplied in an institutional pack of a disposable light grey and light green plastic inhaler containing a double-foil blister strip with 7 blisters. The inhaler is packaged in a moisture-protective foil tray with a desiccant and a peelable lid (NDC 0173-0873-06).
- Store at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) [See USP Controlled Room Temperature]. Store in a dry place away from direct heat or sunlight. Keep out of reach of children.
- INCRUSE ELLIPTA should be stored inside the unopened moisture-protective foil tray and only removed from the tray immediately before initial use. Discard INCRUSE ELLIPTA 6 weeks after opening the foil tray or when the counter reads “0” (after all blisters have been used), whichever comes first. The inhaler is not reusable. Do not attempt to take the inhaler apart.
Storage
There is limited information regarding Umeclidinium Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
- Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
- Not for Acute Symptoms: Inform patients that INCRUSE ELLIPTA is not meant to relieve acute symptoms of COPD and extra doses should not be used for that purpose. Advise them to treat acute symptoms with a rescue inhaler such as albuterol. Provide patients with such medicine and instruct them in how it should be used.
- Instruct patients to seek medical attention immediately if they experience any of the following:
- Symptoms get worse
- Need for more inhalations than usual of their rescue inhaler
- Patients should not stop therapy with INCRUSE ELLIPTA without physician/provider guidance since symptoms may recur after discontinuation.
- Paradoxical Bronchospasm: As with other inhaled medicines, INCRUSE ELLIPTA can cause paradoxical bronchospasm. If paradoxical bronchospasm occurs, instruct patients to discontinue INCRUSE ELLIPTA.
- Worsening of Narrow-Angle Glaucoma: Instruct patients to be alert for signs and symptoms of acute narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema). Instruct patients to consult a physician immediately if any of these signs or symptoms develops.
- Worsening of Urinary Retention: Instruct patients to be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, painful urination). Instruct patients to consult a physician immediately if any of these signs or symptoms develops.
Precautions with Alcohol
- Alcohol-Umeclidinium interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- ®[1]
Look-Alike Drug Names
- A® — B®[2]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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- ↑ "http://www.ismp.org". External link in
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