Indacaterol and glycopyrrolate
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Allison Tu [2]
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Black Box Warning
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ASTHMA-RELATED DEATH
See full prescribing information for complete Boxed Warning.
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Overview
Indacaterol and glycopyrrolate is a combination of a long-acting beta2-adrenergic agonist and an anticholinergic that is FDA approved for the treatment of airflow obstruction in patients with chronic obstructive pulmonary disease. There is a Black Box Warning for this drug as shown here. Common adverse reactions include cough.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indacaterol and glycopyrrolate is indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. UTIBRON NEOHALER is NOT indicated for the relief of acute bronchospasm or for the treatment of asthma.
Dosing Information
- The recommended dosage of UTIBRON NEOHALER is the inhalation of the contents of one UTIBRON capsule twice-daily using the NEOHALER device.
- No dosage adjustment is required for geriatric patients, patients with mild and moderate hepatic impairment, or patients with mild to moderate renal impairment.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of indacaterol and glycopyrrolate in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of indacaterol and glycopyrrolate in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Indacaterol and glycopyrrolate FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Indacaterol and glycopyrrolate in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Indacaterol and glycopyrrolate in pediatric patients.
Contraindications
- All LABAs are contraindicated in patients with asthma without use of a long-term asthma control medication.
- UTIBRON NEOHALER is not indicated for the treatment of asthma.
- UTIBRON NEOHALER is contraindicated in patients who have demonstrated hypersensitivity to indacaterol, glycopyrrolate, or to any of the ingredients.
Warnings
|
ASTHMA-RELATED DEATH
See full prescribing information for complete Boxed Warning.
|
- Asthma-Related Death
- Data from a large, placebo-controlled U.S. study in asthma patients showed that LABAs may increase the risk of asthma-related death.
- Data are not available to determine whether the rate of death in patients with COPD is increased by LABAs.
- A 28-week, placebo-controlled U.S. study comparing the safety of another LABA (salmeterol) with placebo, each added to usual asthma therapy, showed an increase in asthma-related deaths in patients receiving salmeterol (13/13,176 in patients treated with salmeterol versus 3/13,179 in patients treated with placebo; RR 4.37, 95% CI 1.25, 15.34).
- The increased risk of asthma-related death is considered a class effect of the LABAs, including indacaterol, one of the ingredients in UTIBRON NEOHALER.
- No study adequate to determine whether the rate of asthma-related death is increased in patients treated with UTIBRON NEOHALER has been conducted. The safety and efficacy of UTIBRON NEOHALER in patients with asthma have not been established. UTIBRON NEOHALER is not indicated for the treatment of asthma.
- Deterioration of Disease and Acute Episodes
- UTIBRON NEOHALER should not be initiated in patients with acutely deteriorating or potentially life-threatening episodes of COPD. UTIBRON NEOHALER has not been studied in patients with acutely deteriorating COPD. The initiation of UTIBRON NEOHALER in this setting is not appropriate.
- UTIBRON NEOHALER should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. UTIBRON NEOHALER has not been studied in the relief of acute symptoms, and extra doses should not be used for that purpose. Acute symptoms should be treated with an inhaled, short-acting beta2-agonist.
- When beginning UTIBRON NEOHALER, patients who have been taking oral or inhaled, short-acting beta2-agonists on a regular basis (e.g., 4 times a day) should be instructed to discontinue the regular use of these drugs and use them only for symptomatic relief of acute respiratory symptoms.
- When prescribing UTIBRON NEOHALER, the healthcare provider should also prescribe an inhaled, short-acting beta2-agonist and instruct the patient on how it should be used. Increasing inhaled beta2-agonist use is a signal of deteriorating disease for which prompt medical attention is indicated.
- COPD may deteriorate acutely over a period of hours or chronically over several days or longer. If UTIBRON NEOHALER no longer controls the symptoms of bronchoconstriction; the patient’s inhaled, short-acting beta2-agonist becomes less effective; or the patient needs more inhalation of short-acting beta2-agonist than usual, these may be markers of deterioration of disease. In this setting, a re-evaluation of the patient and the COPD treatment regimen should be undertaken at once. Increasing the daily dose of UTIBRON NEOHALER beyond the recommended dose is not appropriate in this situation.
- Excessive Use of UTIBRON NEOHALER and Use with Other Long-Acting Beta2-Adrenergic Agonists
- As with other inhaled drugs containing beta2-adrenergics, UTIBRON NEOHALER should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medications containing LABAs, as an overdose may result.
- Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs.
- Patients using UTIBRON NEOHALER should not use another medicine containing a LABA for any reason.
- Paradoxical Bronchospasm
- As with other inhaled medicines, UTIBRON NEOHALER can produce paradoxical bronchospasm that may be life-threatening.
- If paradoxical bronchospasm occurs following dosing with UTIBRON NEOHALER, it should be treated immediately with an inhaled, short-acting bronchodilator; UTIBRON NEOHALER should be discontinued immediately and alternative therapy instituted.
- Immediate Hypersensitivity Reactions
- Immediate hypersensitivity reactions have been reported after administration of indacaterol or glycopyrrolate, the components of UTIBRON NEOHALER. If signs suggesting allergic reactions occur, in particular, angioedema (including difficulties in breathing or swallowing, swelling of tongue, lips and face), urticaria, or skin rash, UTIBRON NEOHALER should be discontinued immediately and alternative therapy instituted. UTIBRON NEOHALER should be used with caution in patients with severe hypersensitivity to milk proteins.
- Cardiovascular Effects
- Indacaterol, like other beta2-agonists, can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, systolic or diastolic blood pressure, or symptoms. If such effects occur, UTIBRON NEOHALER may need to be discontinued.
- In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T-wave, prolongation of the QTc interval, and ST segment depression, although the clinical significance of these findings is unknown.
- Therefore, UTIBRON NEOHALER should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
- Coexisting Conditions
- UTIBRON NEOHALER, like all medicines containing sympathomimetic amines, should be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to sympathomimetic amines.
- Doses of the related beta2-agonist albuterol, when administered intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.
- Worsening of Narrow-Angle Glaucoma
- UTIBRON NEOHALER should be used with caution in patients with narrow-angle glaucoma. Prescribers and patients should 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 should any of these signs or symptoms develop.
- Worsening of Urinary Retention
- UTIBRON NEOHALER should be used with caution in patients with urinary retention. Prescribers and patients should be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, painful urination), especially in patients with prostatic hyperplasia or bladder-neck obstruction.
- Instruct patients to consult a physician immediately should any of these signs or symptoms develop.
- Hypokalemia and Hyperglycemia
- Beta2-adrenergic agonists may produce significant hypokalemia in some patients, which has the potential to produce adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring supplementation.
- Inhalation of high doses of beta2-adrenergic agonists may produce increases in plasma glucose.
- In patients with severe COPD, hypokalemia may be potentiated by hypoxia and concomitant treatment, which may increase the susceptibility for cardiac arrhythmias.
- In 2 clinical trials of 12-weeks duration evaluating UTIBRON NEOHALER in subjects with COPD, there was no evidence of a treatment effect on serum glucose or potassium.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Indacaterol and glycopyrrolate Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Indacaterol and glycopyrrolate Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Indacaterol and glycopyrrolate Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Indacaterol and glycopyrrolate in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Indacaterol and glycopyrrolate in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Indacaterol and glycopyrrolate during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Indacaterol and glycopyrrolate in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Indacaterol and glycopyrrolate in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Indacaterol and glycopyrrolate in geriatric settings.
Gender
There is no FDA guidance on the use of Indacaterol and glycopyrrolate with respect to specific gender populations.
Race
There is no FDA guidance on the use of Indacaterol and glycopyrrolate with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Indacaterol and glycopyrrolate in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Indacaterol and glycopyrrolate in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Indacaterol and glycopyrrolate in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Indacaterol and glycopyrrolate in patients who are immunocompromised.
Administration and Monitoring
Administration
Indacaterold and glycopyrrolate is for oral inhalation only. Do not swallow UTIBRON capsules, as the intended effects on the lungs will not be obtained. UTIBRON capsules should only be used with the NEOHALER device. UTIBRON NEOHALER should be administered at the same time of the day (1 capsule in the morning and 1 capsule in the evening) every day. More frequent administration or a greater number of inhalations (more than 1 capsule twice-daily) of UTIBRON NEOHALER is not recommended. Store UTIBRON capsules in the blister, and only remove IMMEDIATELY BEFORE USE with the NEOHALER device.
Monitoring
There is limited information regarding Indacaterol and glycopyrrolate Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Indacaterol and glycopyrrolate and IV administrations.
Overdosage
There is limited information regarding Indacaterol and glycopyrrolate overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Indacaterol and glycopyrrolate Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Indacaterol and glycopyrrolate Mechanism of Action in the drug label.
Structure
There is limited information regarding Indacaterol and glycopyrrolate Structure in the drug label.
Pharmacodynamics
There is limited information regarding Indacaterol and glycopyrrolate Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Indacaterol and glycopyrrolate Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Indacaterol and glycopyrrolate Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Indacaterol and glycopyrrolate Clinical Studies in the drug label.
How Supplied
There is limited information regarding Indacaterol and glycopyrrolate How Supplied in the drug label.
Storage
There is limited information regarding Indacaterol and glycopyrrolate Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Indacaterol and glycopyrrolate Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Indacaterol and glycopyrrolate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Indacaterol and glycopyrrolate Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Indacaterol and glycopyrrolate Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.