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Ofatumumab Pregnancy and Breastfeeding Warnings

Ofatumumab is also known as: Arzerra

Ofatumumab Pregnancy Warnings

Animal studies did not demonstrate maternal toxicity or teratogenicity but did reveal evidence that fetuses exhibited depletion of peripheral B cells and decreased spleen and placental weights. There are no controlled data in human pregnancy. FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus 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.

FDA pregnancy category: C Ofatumumab should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

See references

Ofatumumab Breastfeeding Warnings

Caution is recommended if ofatumumab is administered to a nursing woman. Excreted into human milk: Unknown Excreted into animal milk: Unknown The effects in the nursing infant are unknown.

There are no data on the excretion of ofatumumab into human milk. However, human IgG is secreted in human milk. Published data suggest that neonatal and infant consumption of breast milk does not result in substantial absorption of these maternal antibodies into circulation.

See references

References for pregnancy information

  1. "Product Information. Arzerra (ofatumumab)." GlaxoSmithKline, Research Triangle Park, NC.

References for breastfeeding information

  1. "Product Information. Arzerra (ofatumumab)." GlaxoSmithKline, Research Triangle Park, NC.

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