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

US FDA pregnancy category: Not assigned.

Risk Summary: There is no available data on use in pregnant women to evaluate for any drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; human IgG antibodies are known to cross the placental barrier; therefore, this drug may be transmitted from the mother to the developing fetus. Animal studies have not shown fetal harm.

Comments:
-For women with poorly or moderately controlled asthma during pregnancy, there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate; the level of asthma control should be closely monitored, and treatment adjusted as necessary to maintain optimal control.

Animal studies in cynomolgus monkeys have shown no drug related adverse effects on maternal health, pregnancy outcome, embryo-fetal development, or neonatal growth and development (up to 6.5 months of age). Pregnant monkeys were administered this drug at the beginning of organogenesis, and once every 7 days until the end of gestation at doses estimated up to 168 times the maximum recommended human dose. This drug crossed the placenta in cynomolgus monkeys with serum concentrations 0.5- to 6.7-fold higher in infants relative to maternal animals. There are no controlled data in human pregnancy.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

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Administration of this drug in doses 168 times the expected human exposure, resulted in milk concentrations up to 0.5% of the maternal serum concentrations in cynomolgus monkeys. Although, concentration in animal milk is not necessarily predictive of the concentration of drug in human milk.

Benefit should outweigh risk

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-No information available on the presence of this drug in human milk, the effects on the breastfed infant, or the effects on milk production; maternal IgG is known to be present in human milk.
-Developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects on the breastfed infant from this drug or from the underlying maternal condition.

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