GOLD Report for COPD | UTIBRON® NEOHALER® (indacaterol/glycopyrrolate)

GOLD Report for COPD

GOLD recommends prescribing a long-acting bronchodilator for maintenance treatment, with a goal to manage symptoms

  • GOLD recommends using long-acting bronchodilators over short-acting bronchodilators except for patients with only occasional dyspnea1
  • Patients may be started on single long-acting bronchodilator or dual bronchodilator therapy. In patients with persistent dyspnea, they should be escalated to two1
  • Short-acting bronchodilators should be prescribed to all patients for immediate symptom relief1

GOLD does not endorse any specific treatments. Refer to the GOLD 2019 Report for complete recommendations.

The Global Initiative for Chronic Obstructive Lung Disease (GOLD) was launched in 1997 in collaboration with the National Heart, Lung, and Blood Institute, the National Institutes of Health, USA, and the World Health Organization. The GOLD Report is shaped by committees made up of leading experts from around the world. Working with health care professionals and public health officials, GOLD seeks to raise awareness and improve prevention and treatment of COPD.

Assess COPD symptoms, exacerbation risk, and patient response to determine initial and follow-up pharmacological treatment

Initial Pharmacological Treatment

Initial and Follow-up Pharmacological Treatment

Initial and Follow-up Pharmacological Treatment

Follow-up Pharmacological Treatment

1. IF RESPONSE TO INITIAL TREATMENT IS APPROPRIATE, MAINTAIN IT

2. IF NOT:

  Consider the predominant treatable trait to target (dyspnea or exacerbations)

  Use exacerbation pathway if both exacerbations and dyspnea need to be targeted

  Place patient in box corresponding to current treatment and follow indications

  Assess response, adjust, and review

  These recommendations do not depend on the ABCD assessment at diagnosis

GOLD Treatment Chart

GOLD Treatment Chart

Consider de-escalation of ICS or switch if pneumonia, inappropriate original indication, or lack of response to ICS.
§ Consider if eos ≥300 or eos ≥100 AND ≥2 moderate exacerbations/1 hospitalization.

GOLD does not endorse any specific treatments. Refer to the GOLD 2019 Report for complete recommendations.

LAMA=long-acting muscarinic antagonist; LABA=long-acting beta2-adrenergic agonist; ICS=inhaled corticosteroid; eos=blood eosinophil count in cells per microliter; mMRC=modified British Medical Research Council Questionnaire; CAT™=COPD Assessment Test™.

© 2019 Global Strategy for Diagnosis, Management, and Prevention of COPD. All rights reserved. Use is by express license from the owner.

 

Following implementation of therapy, reassess patients for attainment of treatment goals

GOLD recommends reviewing symptoms, assessing inhalation device technique, and then adjusting pharmacological treatment as needed.1

Management Cycle

GOLD Management Cycle

GOLD Management Cycle

*Response to escalation should always be reviewed. De-escalation should be considered if there is a lack of clinical benefit and/or side effects.
Including pulmonary rehabilitation and self-management education.

GOLD does not endorse any specific treatments. Refer to the GOLD 2019 Report for complete recommendations.

© 2019 Global Strategy for Diagnosis, Management, and Prevention of COPD. All rights reserved. Use is by express license from the owner.


Reference:
1. Global strategy for the diagnosis, management and prevention of COPD: 2019 report. Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019:1-139.

Important Safety Information & Indication

Important Safety Information

UTIBRON NEOHALER is contraindicated in patients with a history of hypersensitivity to indacaterol, glycopyrrolate, or to any of the ingredients.

Use of a LABA, including UTIBRON NEOHALER, without an inhaled corticosteroid is contraindicated in patients with asthma.

Use of a LABA, including UTIBRON NEOHALER, as monotherapy (without inhaled corticosteroids) for asthma, increases the risk of serious asthma-related events, including hospitalization, intubation and death. No study adequate to determine whether the rate of asthma-related death is increased in patients treated with UTIBRON NEOHALER has been conducted. Available data do not suggest an increased risk of death with use of LABAs in patients with COPD.

UTIBRON NEOHALER should not be initiated in patients with acutely deteriorating or potentially life-threatening episodes of COPD or used as rescue therapy for acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled short-acting beta2-agonist.

UTIBRON NEOHALER should not be used more often, at higher doses than recommended, or in conjunction with other medicines containing LABAs as an overdose may result. Patients who have been taking inhaled short-acting beta2-agonists on a regular basis should be instructed to discontinue their regular use and to use them only for symptomatic relief of acute respiratory symptoms. 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.

Immediate hypersensitivity reactions have been reported with UTIBRON NEOHALER. If signs occur, discontinue immediately and institute alternative therapy. UTIBRON NEOHALER should be used with caution in patients with severe hypersensitivity to milk proteins.

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.

Indacaterol, like other beta2-adrenergic 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. UTIBRON NEOHALER should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Beta2-adrenergic agonists may produce significant hypokalemia in some patients.

As with other beta2-adrenergic agonists, indacaterol should be administered with extreme caution in patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or other drugs known to prolong the QTc interval because these agents may potentiate the action of adrenergic agonists on the cardiovascular system.

As with other beta2-adrenergic agonists, UTIBRON NEOHALER should be used with caution in patients treated with additional adrenergic drugs, non-potassium-sparing diuretics, and beta-blockers.

UTIBRON NEOHALER, like all medicines containing sympathomimetic amines, should be used with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines.

UTIBRON NEOHALER should be used with caution in patients with narrow-angle glaucoma and in patients with urinary retention. 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) and of urinary retention (e.g., difficulty passing urine, painful urination), especially in patients with prostatic hyperplasia or bladder-neck obstruction. Patients should be instructed to consult a physician immediately should any of these signs or symptoms develop.

The most common adverse events reported in ≥1% of patients taking UTIBRON NEOHALER, and occurring more frequently than in patients taking placebo, were nasopharyngitis (4.1% vs 1.8%), hypertension (2.0% vs 1.4%), back pain (1.8% vs 0.6%), and oropharyngeal pain (1.6% vs 1.2%).

UTIBRON capsules must not be swallowed as the intended effects on the lungs will not be obtained. UTIBRON capsules are only for oral inhalation and should only be used with the NEOHALER device.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For additional information, please see full Prescribing Information and Patient Information for UTIBRON NEOHALER.



Indication
 

UTIBRON® NEOHALER® (indacaterol and glycopyrrolate) Inhalation Powder is a combination of indacaterol and glycopyrrolate indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Important limitations: UTIBRON NEOHALER is not indicated to treat acute deteriorations of COPD and is not indicated to treat asthma.