Hyaluronidase / rituximab Pregnancy and Breastfeeding Warnings

Brand names: Rituxan Hycela

Medically reviewed by Drugs.com. Last updated on Jan 3, 2024.

Hyaluronidase / rituximab Pregnancy Warnings

Use is not recommended.

US FDA pregnancy category: Not assigned.

Risk Summary: Rituximab-containing products can cause adverse developmental outcomes including B-cell lymphocytopenia in infants exposed in-utero.

Comments:
-Rituximab-containing products can harm a developing fetus.
-Advise pregnant women of the risk to a fetus.

Reduced fetal weight and increased fetal lethality were observed following administration of hyaluronidase human in animal studies at a dose greater than 2700 times the human dose. When rituximab was given in animal studies during organogenesis, it caused lymphoid B cell depletion in the newborn at doses resulting in 80% of the exposure (based on AUC) of those following a dose of 2 g in humans. Based on human data, rituximab can cause fetal harm due to B-cell lymphocytopenia in infants exposed in-utero.

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.

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Hyaluronidase / rituximab Breastfeeding Warnings

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; however, IgG is present in human milk
Excreted into animal milk: Yes

Comments:
-The effects in the nursing infant are unknown.
-Women should not breastfeed during therapy with this drug and for at least 6 months after the last dose due to the potential for serious adverse reactions in breastfed infants.

See references

Further information

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