Cotellic Pregnancy Warnings
Animal studies have revealed evidence of embryotoxicity and teratogenicity at exposures of 0.9 to 1.4-times those observed in humans at the recommended human dose. Fetal malformations of the great vessels and skull (eye sockets) occurred at the same exposures. There are no controlled data in human pregnancy.
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.
Use is not recommended.
AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.
Risk Summary: Based on findings from animal reproduction 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 at least 2 weeks. Some authorities advise using two effective methods of contraception for at least 3 months after the final dose.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
See references
Cotellic Breastfeeding Warnings
No information is available on the use of this drug during breastfeeding. Because it is 90% bound to plasma proteins, the amount in milk is likely to be low; however, its half-life is about 44 hours and it might accumulate in the infant. The manufacturer recommends that breastfeeding be discontinued during therapy and for 2 weeks after.
A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available.
Comments:
-The effects in the nursing infant are unknown.
See references
