Rituximab Pregnancy and Breastfeeding Warnings

Brand names: Riabni, Rituxan, Ruxience, Truxima

Medically reviewed by Drugs.com. Last updated on Dec 25, 2023.

Rituximab Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk.

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

Risk Summary: Based on human data, this drug can cause adverse developmental outcomes including B-cell lymphocytopenia in infants exposed in utero. In animal studies, IV administration during the period of organogenesis caused lymphoid B-cell depletion in the newborn offspring at doses resulting in 80% of the exposure (based on AUC) of those achieved following a dose of 2 grams in humans.

Comments:
-Advise pregnant women of the risk to a fetus.
-Women of childbearing potential should use effective contraception while taking this drug and for 12 months after.
-Postmarketing data indicate that B cell lymphocytopenia generally lasting less than 6 months can occur in infants exposed to this drug in utero. This drug was detected postnatally in the serum of infants exposed in utero.

Offspring of pregnant animals exposed to this drug did not exhibit any teratogenic effects but did have decreased lymphoid tissue B cells regardless of the timing of exposure. The B cell counts returned to normal levels, and immunologic function was restored within 6 months postpartum. There are no controlled data in human pregnancy.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. 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

Rituximab Breastfeeding Warnings

Use is not recommended.

Excreted into human milk: Unknown; however, IgG is excreted into human milk
Excreted into animal milk: Yes

Comments:
-The effects in the nursing infant are unknown.
-Because maternal IgG is excreted in human milk, and this drug is detectable in milk from animal studies, women should not breastfeed while treated with this drug and for at least 6 months after.

-Published data suggest that antibodies in breast milk do not enter the neonatal and infant circulations in substantial amounts.
-No information is available on the use of this drug during breastfeeding.
-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 GI tract.
-Some experts say that if this drug is required by the mother, it is not a reason to discontinue breastfeeding.

See references

Further information

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