Women should avoid pregnancy for up to 12 months after rituximab therapy
Rituximab may not be safe for pregnant women or their unborn children; therefore, women assigned the chimeric monoclonal antibody should use contraception and avoid pregnancy during treatment and for up to 12 months after treatment, according to study results.
Reports from an analysis of data on 153 pregnancies in which the mother was exposed to the drug were collected in the BioGen Idec/Genentech/Roche rituximab (Rituxan) global drug-safety database, which contains “all reported pregnancies/pregnancy-related events from clinical trials and events spontaneously reported through regulatory health authorities, direct reporting of exposure by consumers and health care providers and review of the literature for published case reports,” the researchers wrote.
Ninety pregnancies (58.9%) resulted in live births, whereas 21% of those pregnancies ended in first-trimester miscarriages. More than three-quarters of live births were full-term births. Twenty-four children were premature, but no woman gave birth before 30 weeks of gestation.
One fetus died at 20 weeks because of fetal hypoxemia from an umbilical cord knot.
Seventy women became pregnant during or after exposure to rituximab in a clinical trial. Nine of those pregnancies ended in premature births and 22 pregnancies were carried to full term. Twenty-one pregnancies ended in first-trimester spontaneous abortions, more than 60% of which were exposed to concomitant teratogenic medications. Seventeen pregnancies were electively terminated.
Twenty-one pregnant women were diagnosed with life-threatening disease or relapse. Twenty of those pregnancies ended in live births and one woman was still pregnant. There were no maternal deaths, neonatal deaths or congenital malformations reported, and 11 births were full term. However, physicians reported neonatal cytopenias in seven of those cases.
Two children were born with congenital malformations.
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