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Tositumomab Pregnancy and Breastfeeding Warnings

Tositumomab is also known as: Bexxar Dosimetric, BexxarTherapeutic

Tositumomab Pregnancy Warnings

FDA pregnancy category: D Use of tositumomab should be avoided. Males and females of reproductive potential should use contraception during treatment and for 12 months thereafter.

There are no controlled data in animal or human pregnancy. Due to the transplacental passage of I-131, administration of the tositumomab regimen to a pregnant woman may result in fetal harm, including severe and potentially irreversible hypothyroidism. Limited data suggest an increased risk of miscarriage up to a year following administration. Tositumomab therapeutic regimen may cause transient ovarian or testicular dysfunction lasting up to 12 months after treatment. FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Tositumomab Breastfeeding Warnings

A decision should be made to discontinue breast-feeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Yes (radiolabeled iodine); Unknown (tositumomab) Excreted into animal milk: Unknown The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. BexxarTherapy (tositumomab)." GlaxoSmithKline Inc, Oakville, IA.
  2. "Product Information. Bexxar I 131 Therapeutic (iodine I 131 tositumomab)." GlaxoSmithKline, Research Triangle Park, NC.

References for breastfeeding information

  1. "Product Information. BexxarTherapy (tositumomab)." GlaxoSmithKline Inc, Oakville, IA.
  2. "Product Information. Bexxar I 131 Therapeutic (iodine I 131 tositumomab)." GlaxoSmithKline, Research Triangle Park, NC.

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