Animal studies have revealed evidence of embryofetotoxicity. There are no controlled data in human pregnancy. If this drug is used during pregnancy or if the patient becomes pregnant during therapy, the patient should be advised of the potential hazard to the developing fetus.

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.

Use is not recommended.

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

Risk Summary: This drug can cause fetal harm based on animal studies and its mechanism of action. Embryofetal toxicity (including congenital malformations) were reported in animal reproduction studies during organogenesis.

Comments:
-This drug can cause fetal harm when administered to a pregnant woman.
-Women of childbearing potential should use 2 methods of contraception during therapy and for 6 months following the final dose.
-This drug may damage spermatozoa and testicular tissue, resulting in possible genetic abnormalities. Males with female sexual partners of reproductive potential should use contraception during therapy and for at least 6 months after the final dose.
-Men being treated with this drug are advised to have sperm samples frozen and stored before therapy. They should not father a child during therapy and for up to 6 months following the final dose. Effects on spermatogenesis cannot be excluded after a 6-month therapy-free period.

See references

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:
-Breastfeeding should be avoided due to the potential for serious adverse reactions in the breastfed child from this drug, including cytopenias and neurologic or GI toxicities.

No information is available on the use of this drug during breastfeeding. Because it is a large protein molecule, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant GI tract.

See references