Glycopyrrolate / indacaterol Pregnancy and Breastfeeding Warnings

Brand names: Utibron Neohaler

Glycopyrrolate / indacaterol Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B3
US FDA pregnancy category: C

Comments: Beta-agonists may potentially interfere with uterine contractility; women should contact their physician if they become pregnant while taking this drug.

Animal studies with glycopyrrolate or indacaterol do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant exposures. There were no effects on peri-natal and post-natal developments in rats at more than the maximum recommended human dose in adults. There are no controlled data with this drug or its individual components in human pregnancy.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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Glycopyrrolate / indacaterol Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown (glycopyrrolate-indacaterol)
Excreted into animal milk: Yes (glycopyrrolate-indacaterol)

Comments: The effects in the nursing infant are unknown.

Indacaterol: Indacaterol and its metabolites have been detected in the milk of lactating rats.

Glycopyrrolate: Glycopyrrolate and its metabolites have been detected in the milk of lactating rats and reached up to 10-fold higher concentrations in the milk than in the blood of the dam.

Reduced body weight gain was observed in pups of rats treated with indacaterol or glycopyrrolate, while impaired learning and decreased fertility were observed in pups of rats treated with indacaterol during pregnancy and lactation.

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Further information

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