Innovair/Innovair NEXThaler Use In Pregnancy & Lactation

Fertility: There are no data in humans. In animal studies in rats, the presence of beclometasone dipropionate at high doses in the combination was associated with reduced female fertility and embryotoxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Pregnancy: There are no relevant clinical data on the use of Innovair/Innovair Nexthaler in pregnant women. Animal studies using beclometasone dipropionate and formoterol combination showed evidence of toxicity to reproduction after high systemic exposure (see Pharmacology: Toxicology: Preclinical safety data under Actions). High doses of corticosteroids administered to pregnant animals are known to cause abnormalities of fetal development including cleft palate and intra-uterine growth retardation. Because of the tocolytic actions of beta₂-sympathomimetic agents particular care should be exercised in the run up to delivery. Formoterol should not be recommended for use during pregnancy and particularly at the end of pregnancy or during labour unless there is no other (safer) established alternative.
Administration of Innovair/Innovair Nexthaler during pregnancy should only be considered if the expected benefits outweigh the potential risks.
Lactation: There are no relevant clinical data on the use of Innovair/Innovair Nexthaler during lactation in humans.
Although no data from animal experiments are available, it is reasonable to assume that beclometasone dipropionate is secreted in milk, like other corticosteroids.
While it is not known whether formoterol passes into human breast milk, it has been detected in the milk of lactating animals.
Administration of Innovair/Innovair Nexthaler to women who are breast-feeding should be considered if the expected benefits outweigh the potential risks.
Innovair: There is no experience with or evidence of safety of propellant HFA-134a in human pregnancy or lactation. However, studies of the effect of HFA-134a on reproductive function and embryofetal development in animals have revealed no clinically relevant adverse effects.
Innovair NEXThaler: A decision must be made whether to discontinue breastfeedingor to discontinue/abstain from Innovair Nexthaler therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.