Indacaterol + Glycopyrronium

Indacaterol + Glycopyrronium is an inhalation powder drug product for delivery of a combination of Glycopyrronium (an anticholinergic) and Indacaterol (a LABA) to patients by oral inhalation. Indacaterol acts locally in the lung as a bronchodilator and Glycopyrronium works by blocking the bronchoconstrictor action of acetylcholine on airway smooth muscle cells, thereby dilating the airways.

• Long-term maintenance bronchodilator treatment of airflow obstruction in COPD patients (including chronic bronchitis and emphysema)

Adult Dose (Inhalation):

• COPD: 1 inhalation once daily (1 capsule)
• Use at the same time every day; not more than 1 time every 24 hours
• Not for relief of acute bronchospasm or treatment of asthma

Geriatric (≥65 years): Use at recommended dose

Children & Adolescents: Safety and efficacy not established (17 years and younger)

Renal Impairment: Mild-moderate: recommended dose; severe or ESRD (eGFR <30): use only if benefit outweighs risk

Hepatic Impairment: Mild-moderate: recommended dose; severe: caution

Most Common (>3% and greater than placebo):

• Cough
• Oropharyngeal pain (including throat irritation)

Others: Indigestion, high blood pressure, nasopharyngitis, chest pain, fever, urinary retention, sore throat, headache, dizziness, allergic reaction, increased blood glucose, sinus inflammation, urinary tract infection

Precautions:

• LABA monotherapy increases risk of serious asthma-related events
• Do not initiate in acutely deteriorating COPD or asthma
• Do not use to treat acute symptoms
• If paradoxical bronchospasm occurs, discontinue
• Caution in cardiovascular disorders, convulsive disorders, thyrotoxicosis, diabetes mellitus
• Caution in narrow-angle glaucoma or prostatic hyperplasia
• Be alert to hypokalemia and hyperglycemia

Contraindications:

• Hypersensitivity to Glycopyrronium or Indacaterol or any other component
• Severe hypersensitivity to milk proteins
• All LABA contraindicated in asthma without long-term asthma control medication

Drug Interactions:

• Concomitant use with β-blockers, anticholinergics or sympathomimetic agents not recommended
• Sympathomimetic agents may potentiate adverse events of Indacaterol
• Caution with hypokalemic treatment

Food Interactions: It is unsafe to consume alcohol with Indacaterol + Glycopyrronium.

Use in Pregnancy: Category C; no data from use in pregnant women; use only if expected benefit justifies potential risk to fetus.

Use in Lactation: It is not known whether Indacaterol or Glycopyrronium are excreted in human milk; use only if expected benefit to woman is greater than possible risk to infant.

Renal Impairment: Recommended dose in mild-moderate renal impairment; severe or ESRD (eGFR <30) use only if benefit outweighs risk.

Hepatic Impairment: Recommended dose in mild-moderate hepatic impairment; no data for severe hepatic impairment, caution required.

Overdose: May cause tachycardia, tremor, palpitations, headache, nausea, vomiting, drowsiness, ventricular arrhythmias, metabolic acidosis, hypokalemia, hyperglycemia or anticholinergic effects; supportive and symptomatic treatment; serious cases require hospitalization.