Animal reproductive toxicology studies of this drug have not been conducted and there are no adequate and well-controlled studies in pregnant women. Immunoglobulins are known to cross the placenta.

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 contraindicated.

US FDA pregnancy category: Unassigned

Risk Summary:
-This drug may cause fetal harm when administered to a pregnant woman.
-Potential fetal risk should be considered and informed if pregnancy occurs while receiving treatment with this drug.

Comments:
-Encourage male and female patients to use adequate methods of contraception during and for a minimum of 12 months following treatment.
-Pregnancy testing in females should be conducted prior to treatment.

See references

Use should be avoided during treatment, and for 6 months after the last dose. According to some authorities the use during lactation is contraindicated.

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

Comment:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.

See references