Animal studies have revealed evidence of embryotoxicity, fetotoxicity, and teratogenicity. Malformations (e.g., missing and/or fused digits, open perineum and craniofacial anomalies) and retardations or variations (e.g., dilated renal pelvis, dilated ureter, incompletely or unossified sternal elements, centra of vertebrae, proximal phalanges and claws). There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Report pregnancies to Genentech at 1-888-835-2555. See https://www.erivedge.com/hcp/before-prescribing-erivedge.html?c=erv-163098fc98b&gclid=CMm-r-HM6eECFbGVxQId9EgBjg&gclsrc=ds for more information.

AU TGA pregnancy category X: Drugs which have such a high risk of causing permanent damage to the fetus that they should not be used in pregnancy or when there is a possibility of 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.

Use is contraindicated.

Risk Summary: Based on its mechanism of action and findings from animal reproduction studies, this drug can cause fetal harm when administered to a pregnant woman. Administration to pregnant animals during organogenesis at doses below the equivalent recommended human dose resulted in embryotoxicity, fetotoxicity, and teratogenicity.

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

Comments:
-A pregnancy exposure registry is available.
-Advise all patients of the risks of embryofetal death and severe birth defects and the need for contraception during and after therapy.
-A pregnancy test should be performed within 7 days prior to initiating and monthly during therapy.
-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.
-Females should use 2 methods of contraception (one highly effective and one barrier) during therapy and for 24 months after.
-Persistent lack of menses during therapy should be assumed to indicate pregnancy until medical confirmation.
-Amenorrhea can occur in females of reproductive potential. Reversibility of amenorrhea is unknown.
-This drug is present in semen. Males should use condoms with spermicide (even after a vasectomy) during sexual intercourse with females while being treated and for 3 months after.
-Advise males of the potential risk to an embryo or fetus if a female partner of reproductive potential is exposed to this drug.
-Advise males not to donate semen during therapy and for 3 months after.

See references

Use is contraindicated.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-This drug can harm a nursing infant.
-Women should not breastfeed during therapy and for 24 months following the final dose.

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 4 days and it might accumulate in the infant. Animal studies have reported irreversible adverse effects on growing teeth and premature closure of the epiphyseal plate.

See references