¬¬This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.

Risk Summary: Studies show the proportion of infants with major birth defects is higher for women exposed to this drug than for unexposed women; however, there has been a lack of pattern of major birth defects.

Comments:
-Women of childbearing potential should be advised to use appropriate contraception during therapy and for 3 weeks after discontinuation of therapy.
-This drug crosses the placenta and has been detected in the serum of infants born to female patients treated during pregnancy. The clinical impact of this is unknown; however, infants may be at increased risk of infection.
-Administration of live vaccines to infants for 16 weeks after the mother's last dose of this drug is generally not recommended.

Developmental toxicity studies performed in animals have revealed no evidence of harm to the fetus. There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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.

See references

This drug is minimally excreted into breastmilk and poorly absorbed by the infant, which would be expected because of its high molecular weight. Some experts feel that the drug is a low risk to the nursing infant and can be given during breastfeeding.

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

Excreted into human milk: Yes

Comments:
-The effects in the nursing infant are unknown.

See references