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Atezolizumab Pregnancy and Breastfeeding Warnings

Atezolizumab is also known as: Tecentriq

Atezolizumab Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk. AU TGA pregnancy category: US FDA pregnancy category: Risk Summary: -Based on animal studies, this drug impair fertility in females of reproductive potential while receiving treatment -Based on its mechanism of action, this drug can cause harm to a developing fetus.

Animal reproduction studies have not been conducted to evaluate the effect on reproduction and fetal development. A literature-based assessment of the effects on reproduction demonstrated that a central function of the PD-L1/PD-1 pathway is to preserve pregnancy by maintaining maternal immune tolerance to a fetus. Blockage of PD-L1 signaling has been shown to disrupt tolerance to a fetus and to result in an increase in fetal loss; therefore. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

See references

Atezolizumab Breastfeeding Warnings

Use should be avoided. Excreted into human milk: Data not available Excreted into animal milk: Data not available Comments: -There is no information regarding the presence of this drug in human milk, or the effects on milk production. Because human IgG is excreted in human milk, the potential for absorption and harm to the infant is unknown. -Lactating women should not breastfeed during treatment and for at least 5 months after the last dose.

See references

References for pregnancy information

  1. "Product Information. Tecentriq (atezolizumab)." Genentech, South San Francisco, CA.

References for breastfeeding information

  1. "Product Information. Tecentriq (atezolizumab)." Genentech, South San Francisco, CA.

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