Alectinib Pregnancy and Breastfeeding Warnings

Brand names: Alecensa

Alectinib Pregnancy Warnings

Use is not recommended.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.

Risk Summary: Based on animal studies and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman.

Comments:
-This drug can harm a developing fetus.
-Advise females of reproductive potential to use effective contraception during therapy and for 1 week after.
-Advise males with female partners of reproductive potential to use effective contraception during therapy and for 3 months after.

Animal studies have revealed evidence of embryotoxicity and abortion at maternally toxic doses approximately 2.7 times the recommended human dose. 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.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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

Use is not recommended.

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.
-Breastfeeding is not recommended during therapy and for one week after.

Because this drug is more than 99% bound to plasma proteins, the amount in milk is likely to be low; however, its half-life is 33 hours and it may accumulate in the infant.

See references

Further information

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

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