Incruse Ellipta

/ GSK

Adults: The recommended dose is one inhalation of umeclidinium bromide once daily.
The drug should be administered once daily at the same time of the day each day to maintain bronchodilation. The maximum dose is one inhalation of umeclidinium bromide once daily.
Elderly patients: No dosage adjustment is required in patients over 65 years.
Renal impairment: No dosage adjustment is required in patients with renal impairment.
Hepatic impairment: No dosage adjustment is required in patients with mild or moderate hepatic impairment.
The drug has not been studied in patients with severe hepatic impairment and should be used with caution.
Paediatric population: There is no relevant use of the drug in the paediatric population (under 18 years of age) in the indication for COPD.  

The drug is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Hypersensitivity to the active substance or to any of the excipients.

Asthma: Umeclidinium bromide should not be used in patients with asthma since it has not been studied in this patient population.
Paradoxical bronchospasm: Administration of umeclidinium bromide may produce paradoxical bronchospasm that may be life-threatening. Treatment should be discontinued immediately if paradoxical bronchospasm occurs and alternative therapy instituted if necessary.
Deterioration of disease: Umeclidinium bromide is intended for the maintenance treatment of COPD. It should not be used for the relief of acute symptoms, i.e. as rescue therapy for the treatment of acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled short-acting bronchodilator. Increasing use of short-acting bronchodilators to relieve symptoms indicates deterioration of control. In the event of deterioration of COPD during treatment with umeclidinium bromide, a re-evaluation of the patient and of the COPD treatment regimen should be undertaken.
Cardiovascular effects: Cardiovascular effects, such as cardiac arrhythmias e.g. atrial fibrillation and tachycardia, may be seen after the administration of muscarinic receptor antagonists including umeclidinium bromide. In addition, patients with clinically significant uncontrolled cardiovascular disease were excluded from clinical studies. Therefore, umeclidinium bromide should be used with caution in patients with severe cardiovascular disorders, particularly cardiac arrhythmias.
Antimuscarinic activity: Consistent with its antimuscarinic activity, umeclidinium bromide should be used with caution in patients with urinary retention or with narrow-angle glaucoma.

Most common: Nasopharyngitis, Upper respiratory tract infection, Urinary tract infection, Sinusitis, Headache, Tachycardia, Cough.
See prescribing information for full details.

Clinically significant interactions mediated by umeclidinium bromide at clinical doses are considered unlikely due to the low plasma concentrations achieved after inhaled dosing.
Other antimuscarinics: Co-administration of umeclidinium bromide with other long-acting muscarinic antagonists or medicinal products containing this active substance has not been studied and is not recommended as it may potentiate known inhaled muscarinic antagonist adverse reactions.
Metabolic and transporter based interactions: Umeclidinium bromide is a substrate of cytochrome P450 2D6 (CYP2D6). The steady-state pharmacokinetics of umeclidinium bromide were assessed in healthy volunteers lacking CYP2D6 (poor metabolisers). No effect on umeclidinium AUC or Cmax was observed at a dose 4-fold higher than the therapeutic dose. An approximately 1.3-fold increase in umeclidinium bromide AUC was observed at an 8-fold higher dose with no effect on umeclidinium bromide Cmax. Based on the magnitude of these changes, no clinically relevant drug interaction is expected when umeclidinium is co-administered with CYP2D6 inhibitors or when administered to subjects genetically deficient in CYP2D6 activity (poor metabolisers). Umeclidinium bromide is a substrate of P-glycoprotein (P-gp) transporter. The effect of the moderate P-gp inhibitor verapamil (240 mg once daily) on the steady-state pharmacokinetics of umeclidinium bromide was assessed in healthy volunteers. No effect of verapamil was observed on umeclidinium bromide Cmax. An approximately 1.4-fold increase in umeclidinium bromide AUC was observed. Based on the magnitude of these changes, no clinically relevant interaction is expected when umeclidinium bromide is co-administered with P-gp inhibitors.
Other medicinal products for COPD: Although no formal in vivo interaction studies have been performed, inhaled umeclidinium bromide has been used concomitantly with other COPD medicinal products including short and long acting sympathomimetic bronchodilators and inhaled corticosteroids without clinical evidence of interactions.

Pregnancy: There are no data from the use of umeclidinium bromide in pregnant women. Umeclidinium bromide should be used during pregnancy only if the expected benefit to the mother justifies the potential risk to the fetus. See prescribing information for full details.
Lactation: It is unknown whether umeclidinium bromide is excreted in human milk. A risk to breastfed newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue Umeclidinium therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.                    

An overdose of umeclidinium bromide will likely produce signs and symptoms consistent with the known inhaled muscarinic antagonist adverse effects (e.g. dry mouth, visual accommodation disturbances and tachycardia). If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.

Lactose: Each delivered dose contains approximately 12.5 mg of lactose (as monohydrate).
Shelf-life: Use within 6 weeks after opening the tray. Do not open the tray until ready to inhale.
Storage: If stored in the refrigerator, allow the inhaler to return to room temperature for at least an hour before use.