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Alectinib Pregnancy and Breastfeeding Warnings

Alectinib is also known as: Alecensa

Medically reviewed on May 11, 2018

Alectinib Pregnancy Warnings

This drug may cause fetal harm based on its mechanism of action and animal studies.

US FDA pregnancy category: Not Assigned

Comments:
-Females of reproductive potential should use effective contraception during treatment and for 1 week after the final dose.
-Based on genotoxicity findings, males with female partners of reproductive potential should use effective contraception during treatment and for 3 months following the final dose.

Animal studies have revealed evidence of embryofetal developmental toxicity, abortion, and mortality at maternally toxic doses with exposures approximately 2.7 to 4.5 times those observed in humans treated with the recommended dose. 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.

See references

Alectinib Breastfeeding Warnings

Breastfeeding is not recommended during treatment and for 1 week 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. Alecensa (alectinib)." Genentech, South San Francisco, CA.

References for breastfeeding information

  1. "Product Information. Alecensa (alectinib)." Genentech, South San Francisco, CA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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