Animal studies have revealed increased pre- and post-implantation loss, decreased live fetuses in the presence of maternal toxicity, and evidence of fetotoxicity. There are no controlled data in human pregnancy.

Women who become pregnant during treatment with this drug are encouraged to enroll in Amgen's Pregnancy Surveillance Program. Patients or their physicians should call 1-800-77-AMGEN to enroll. (US)

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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.

Use of preparations containing benzyl alcohol is contraindicated; use benzyl alcohol-free preparations during pregnancy only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Comments:
-Benzoyl alcohol is associated with serious adverse events and death when given intravenously to neonates and infants; similar risks may occur from exposure in utero.
-Do not mix with bacteriostatic saline because of its benzoyl alcohol content.
-There is insufficient data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.
-This drug is not recommended in pregnant surgical patients participating in an autologous blood predonation program.

See references

Benzoyl alcohol containing formulations are contraindicated during lactation.
Non-benzoyl alcohol containing formulations: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-This drug is not recommended in lactating surgical patients participating in an autologous blood predonation program.
-Advise lactating women not to breastfeed for at least 2 weeks after the last dose of benzyl alcohol-containing preparations of this drug.

See references