Airlevo Use In Pregnancy & Lactation

Pregnancy: Risk Summary: There are no adequate and well-controlled studies of Levosalbutamol Tartrate Inhalation Aerosol in pregnant women. There are clinical considerations with the use of Levosalbutamol Tartrate Inhalation Aerosol in pregnant women.
Following oral administration of levosalbutamol HCl to pregnant rabbits, there was no evidence of teratogenicity at doses up to 25 mg/kg/day [approximately 750 times the maximum recommended human daily inhalation dose (MRHDID) of levosalbutamol tartrate for adults on a mg/m2 basis]; however, racemic salbutamol sulfate was teratogenic in mice (cleft palate) and rabbits (cranioschisis) at doses slightly higher than the human therapeutic range.
The estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations: Disease-Associated Maternal and/or Embryo/Fetal Risk: In women with poorly or moderately controlled asthma, there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. Pregnant women should be closely monitored and medication adjusted as necessary to maintain optimal control.
Labor or Delivery: Because of the potential for beta-adrenergic agonists to interfere with uterine contractility, the use of Levosalbutamol Tartrate Inhalation Aerosol for the treatment of bronchospasm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk.
Levosalbutamol Tartrate Inhalation Aerosol has not been approved for the management of preterm labor. The benefit:risk ratio when levosalbutamol tartrate is administered for tocolysis has not been established. Serious adverse reactions, including maternal pulmonary edema, have been reported during or following treatment of premature labor with beta2-agonists, including racemic salbutamol.
Animal Data: The oral administration of levosalbutamol HCl to pregnant New Zealand White rabbits during the period of organogenesis found no evidence of teratogenicity at doses up to 25 mg/kg/day (approximately 750 times the MRHDID of levosalbutamol tartrate for adults on a mg/m² basis). In a rat developmental study, a racemic salbutamol sulfate (comprising approximately 50% levosalbutamol) HFA-134a formulation administered by inhalation did not produce any teratogenic effects at exposures approximately 160 times the MRHDID (on a mg/m² basis at a maternal dose of 10.5 mg/kg).
However, other developmental studies with the racemic salbutamol sulfate, did result in teratogenic effects in mice and rabbits at doses slightly higher than the human therapeutic range. In a rabbit development study, orally administered salbutamol sulfate induced cranioschisis in 7 of 19 fetuses (37%) at approximately 1500 times the MRHDID (on a mg/m² basis at a maternal dose of 50 mg/kg). In a mouse developmental study, subcutaneously administered salbutamol sulfate produced cleft palate formation in 5 of 111 (4.5%) fetuses at an exposure approximately 2 times MRHDID for adults (on a mg/m² basis at a maternal dose of 0.25 mg/kg/day) and in 10 of 108 (9.3%) fetuses at approximately 20 times MRHDID (on a mg/m² basis at a maternal dose of 2.5 mg/kg/day). Similar effects were not observed at approximately 0.2 times MRHDID of levosalbutamol tartrate for adults on a mg/m² basis (i.e., less than the therapeutic dose). Cleft palate also occurred in 22 of 72 (30.5%) fetuses from females treated subcutaneously with isoproterenol (positive control).
Lactation: Risk Summary: There are no available data on the presence of levosalbutamol in human milk, the effects on the breastfed child, or the effects on milk production.
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Levosalbutamol Tartrate Inhalation Aerosol and any potential adverse effects on the breastfed child from Levosalbutamol Tartrate Inhalation Aerosol or from the underlying maternal condition.