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Obinutuzumab Pregnancy and Breastfeeding Warnings

Obinutuzumab is also known as: Gazyva

Obinutuzumab Pregnancy Warnings

This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. AU TGA pregnancy category: C US FDA pregnancy category: C Comments: -Women of childbearing potential should use effective contraception during and for 12 months after treatment. (AU, US) -Women of childbearing potential should use effective contraception during and for 18 months after treatment. (UK) -Infants born to mothers who have been exposed to this drug during pregnancy should not receive live vaccines until their B-cell levels are within normal ranges.

Animal studies (in cynomolgus monkeys) have failed to reveal evidence of teratogenicity at 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. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. 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

A decision should be made whether to discontinue nursing, or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: -The effects in the nursing infant are unknown. -Human IgG is excreted in human milk and this drug is a monoclonal antibody of the IgG1 subclass. -Women should be advised to discontinue breast-feeding during therapy and for 12 months after the last dose. (AU) -Women should be advised to discontinue breast-feeding during therapy and for 18 months after the last dose. (UK)

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