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Cobimetinib Pregnancy and Breastfeeding Warnings

Cobimetinib is also known as: Cotellic

Cobimetinib Pregnancy Warnings

Animal studies have revealed teratogenicity and embryotoxicity at doses resulting in exposures 0.9 to 1.4 times the exposure at the recommended human dose of 60 mg. Adverse effects included increased post-implantation loss and fetal malformations of the great vessels and skull (eye sockets). Animal studies have also revealed fertility impairment in males and females; fertility effects included testicular degeneration and increased apoptosis/necrosis of the corpora lutea and vaginal epithelial cells. There are no controlled data in human pregnancy. 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.

This drug may cause fetal harm and impair fertility based on its mechanism of action and animal studies; safety has not been established during pregnancy. US FDA pregnancy category: Not Assigned Comments: Females of reproductive potential should use effective contraception during treatment and for 2 weeks after the final dose.

See references

Cobimetinib Breastfeeding Warnings

Breastfeeding is not recommended during treatment and for 2 weeks after the final dose. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: The effects in the nursing infant and on milk production are unknown.

See references

References for pregnancy information

  1. "Product Information. Cotellic (cobimetinib)." Genentech, South San Francisco, CA.

References for breastfeeding information

  1. "Product Information. Cotellic (cobimetinib)." Genentech, South San Francisco, CA.

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