rituxan and pregnancy?

[757cutie]

Has anyone been pregnant after having rituxan treatments or know someone that had a baby while on rituxan? I've read that it was not known if it had an effect on pregnancy.

[Redwings]

I've read that it was not known if it had an effect on pregnancy.

Hi 757cutie:
What you read was taken out of context and is an oversimplification of what the prescribing information for Rituxan actually says. Rituxan is an FDA Pharmaceutical Pregnancy Category C drug. Category C includes drugs for which:
"Animal reproduction studies have shown an adverse effect on the fetus [emphasis mine] 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."

Rituxan has been found in the blood of infants exposed in-utero. In animal studies, low lymphocyte counts were found in baby monkeys, and post-marketing studies have shown the same for human infants. Low lymphocyte counts increase a newborn's risk of infection, the same as in other age groups. The risk can be worse for infants because their immune systems haven't fully developed yet.

The good news is that money studies showed no evidence that Rituxan caused birth defects.

That's all very different than "not knowing if there's any effect on pregnancy." The prescribing information states very clearly:
"Rituximab should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus."

Likewise, with regard to breastfeeding, the prescribing information says that it isn't know whether Rituxan is excreted in human breast milk. That's FDA-safe language meaning that it hasn't been tested for, not that it isn't excreted. It's also an FDA-safe way of avoiding the mention of what the possible effects to the infant might be from ingesting Rituxan. However, the prescribing information does say:
"The unknown risks to the infant from oral ingestion of Rituxan should be weighed against the known benefits of breastfeeding."

WebMD takes a tough stand against breastfeeding while on Rituxan, saying that Rituxan is an "absolute contraindication" to nursing.

All of that strongly indicates that you should have a detailed discussion with your neurologist, oncologist and OB/GYN -- and they should all consult with each other -- about the feasibility of you being treated with Rituxan during pregnancy and whether you should breastfeed if Rituxan is still in your system. If you were pregnant at the time of a Rituxan treatment, the prescribing information indicates that there isn't an increased risk of birth defects, but the baby's lymphocyte level should be tested after birth.