Vannair Use In Pregnancy & Lactation

Effects on fertility: There are no animal studies on the effect of the budesonide/formoterol combination on fertility.
Long-term treatment of female mice and rats with formoterol fumarate causes ovarian stimulation, the development of ovarian cysts, and hyperplasia of granulosa/theca cells as a result of the β-agonist properties of the compound. A study by another company showed no effect on fertility of female rats dosed orally with formoterol fumarate at 60 mg/kg/day for two weeks. This finding was repeated in an AstraZeneca study where no effect was seen on the fertility of female rats dosed orally with formoterol fumarate at 15 mg/kg/day for two weeks.
Testicular atrophy was observed in mice given formoterol fumarate in the diet at 0.2 to 50 mg/kg/day for 2 years, but no effect on male fertility was observed in rats dosed orally at 60 mg/kg/day for 9 weeks, in studies undertaken by another company.
Use in pregnancy - Category (Category B3): For the concomitant treatment with budesonide and formoterol, no clinical data on exposed pregnancies are available. Fetal malformations (umbilical hernia and cleft palate), typical of glucocorticoid toxicity in animals, occurred in rats dosed with the Vannair pMDI formulation at the inhaled dose of 12 μg/kg/day budesonide and 0.66 μg/kg/day formoterol, with plasma AUC values for both drugs below that expected in patients at the maximum recommended clinical dose. No teratogenic effect was detected at 2.5 μg/kg/day of budesonide and 0.14 μg/kg/day of formoterol.
Vannair pMDI should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Only after special consideration should Vannair pMDI be used during the first 3 months and shortly before delivery.
Because β-agonists, including formoterol, may potentially interfere with uterine contractility due to a relaxant effect on uterine smooth muscle, Vannair pMDI should be used during labour only if the potential benefit justifies the potential risk.
Budesonide: Results from a large prospective epidemiological study and from world-wide post marketing experience indicate no adverse effects of inhaled budesonide during pregnancy on the health of the fetus/newborn child.
If treatment with glucocorticosteroids during pregnancy is unavoidable, inhaled corticosteroids such as budesonide should be considered due to their lower systemic effect. The lowest effective dose of budesonide to maintain asthma control should be used.
Formoterol: No teratogenic effects were observed in rats receiving formoterol fumarate at doses up to 60 mg/kg/day orally or 1.2 mg/kg/day by inhalation. Foetal cardiovascular malformations were observed in one study in which pregnant rabbits were dosed orally at 125 or 500 mg/kg/day during the period of organogenesis, but similar results were not obtained in another study at the same dose range. In a third study, an increased incidence of subcapsular hepatic cysts was observed in foetuses from rabbits dosed orally at 60 mg/kg/day. Decreased birth weight and increased perinatal/postnatal mortality were observed when formoterol fumarate was given to rats at oral doses of 0.2 mg/kg/day or greater during late gestation.
Use in lactation: Budesonide is excreted in breast milk. However, due to the relatively low doses used via the inhalational route the amount of drug present in the breast milk, if any, is likely to be low.
It is not known whether formoterol passes into human breast milk. In rats, formoterol was excreted into breast milk. There are no studies in lactating animals using the budesonide/formoterol combination. Increased postnatal mortality at maternal formoterol doses of 0.2 mg/kg/day PO or greater, and retardation of pup growth at 15 mg/kg/day PO were observed in a rat study. There are no well-controlled human studies using Vannair pMDI in nursing mothers. Because many drugs are excreted in human breast milk, administration of Vannair pMDI to women who are breastfeeding should only be considered if the expected benefit to the mother is greater than any possible risk to the child.