Animal studies have revealed evidence of embryotoxicity and teratogenicity. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Use is not recommended.

AU TGA pregnancy category: D
US FDA pregnancy category: C

Comments:
-Females and males of reproductive potential should use highly effective contraception during and for a minimum of 3 months after.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

See references

Use is not recommended.

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

Comments:
-The effects in the nursing infant are unknown.
-There are no data on the excretion of this drug into human milk.
-The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug.

Because this drug 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's GI tract; however, it is usually used in combination with other potentially toxic chemotherapy agents and most sources consider breastfeeding to be contraindicated during maternal antineoplastic drug therapy.

See references