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Obinutuzumab Pregnancy and Breastfeeding Warnings

Obinutuzumab is also known as: Gazyva

Obinutuzumab Pregnancy Warnings

Obinutuzumab should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. FDA pregnancy category: C Comments: Women of childbearing potential should use effective contraception while receiving obinutuzumab and for 12 months following treatment.

Animal studies (in cynomolgus monkeys) have failed to reveal evidence of teratogenicity at obinutuzumab exposures that were 2.4 times the recommended human exposure. However, B cells were completely depleted in offspring at day 28 postpartum. B-Cell counts and immunologic function returned to normal within 6 months after birth. 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.

Obinutuzumab Breastfeeding Warnings

Human IgG is excreted in human milk and obinutuzumab is a monoclonal antibody of the IgG1 subclass.

A decision should be made whether to discontinue nursing, or discontinue obinutuzumab, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes The effects in the nursing infant are unknown.

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