Indacaterol and Glycopyrronium bromide

In patients with severe renal impairment or end-stage renal disease requiring dialysis it should be used only if the expected benefit outweighs the potential risk. These patients should be monitored closely for potential adverse reactions.

There are no data available for the use of indacaterol/glycopyrronium bromide in patients with severe hepatic impairment, therefore caution should be observed in these patients.

No data are available in patients with urinary retention, therefore indacaterol/glycopyrronium bromide should be used with caution in these patients.

No data are available in patients with narrow-angle glaucoma, therefore indacaterol/glycopyrronium bromide should be used with caution in these patients.

Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using indacaterol/glycopyrronium bromide should any of these signs or symptoms develop.

There are no data from the use of indacaterol/glycopyrronium bromide in pregnant women available. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant exposures.

Indacaterol may inhibit labour due to a relaxant effect on uterine smooth muscle. Therefore, indacaterol/glycopyrronium bromide should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the foetus.

It is not known whether indacaterol, glycopyrronium and their metabolites are excreted in human milk. Available pharmacokinetic/toxicological data have shown excretion of indacaterol, glycopyrronium and their metabolites in the milk of lactating rats. The use of indacaterol/glycopyrronium bromide by breast-feeding women should only be considered if the expected benefit to the woman is greater than any possible risk to the infant.

Fertility

Reproduction studies and other data in animals do not indicate a concern regarding fertility in either males or females.

This medicinal product has no or negligible influence on the ability to drive and use machines. However, the occurrence of dizziness may influence the ability to drive and use machines.

The presentation of the safety profile is based on the experience with indacaterol/glycopyrronium bromide and the individual active substances.

Summary of the safety profile

The safety experience with indacaterol/glycopyrronium bromide was comprised of exposure of up to 15 months at the recommended therapeutic dose.

Indacaterol/glycopyrronium bromide showed similar adverse reactions to the individual components. As it contains indacaterol and glycopyrronium, the type and severity of adverse reactions associated with each of these components may be expected in the combination.

The safety profile is characterised by typical anticholinergic and beta-adrenergic symptoms related to the individual components of the combination. Other most common adverse reactions related to the medicinal product (at least 3% of patients for indacaterol/glycopyrronium bromide and also greater than placebo) were cough, nasopharyngitis and headache.

Tabulated summary of adverse reactions

Adverse reactions detected during clinical trials and from post-marketing sources are listed by MedDRA system organ class (Table). Within each system organ class, the adverse reactions are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse reaction is based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

Adverse reactions:

¹ Adverse reaction observed with indacaterol/glycopyrronium bromide, but not with the individual components.
² Reports received from post-marketing experience; frequencies calculated, however, on the basis of clinical trial data.

Description of selected adverse reactions

Cough was common, but usually of mild intensity.