Herceptin hylecta Pregnancy Warnings
Use is not recommended.
US FDA pregnancy category: Not assigned.
Risk Summary: This drug can cause fetal harm when administered to a pregnant woman. In postmarketing reports, use of trastuzumab during pregnancy resulted in cases of oligohydramnios and of oligohydramnios sequence, manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. There are clinical considerations if this drug is used in a pregnant woman or if a patient becomes pregnant within 7 months following the last dose.
Comments:
-A pregnancy exposure registry is available.
-This drug can harm a developing fetus.
-Advise females of reproductive potential to use effective contraception during therapy and for 7 months after.
-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.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
Animal studies have revealed evidence of embryotoxicity and teratogenicity.
To monitor the outcomes of pregnant women exposed to this drug during, or for 7 months after completing therapy, a pregnancy registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling Genentech at 1-888-835-2555.
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
Herceptin hylecta Breastfeeding Warnings
The manufacturer makes no recommendation regarding use during lactation.
Excreted into human milk: Hyaluronidase: Unknown; Trastuzumab: Unknown
Excreted into animal milk: Trastuzumab: Yes
Comments:
-Human IgG is present in human milk but does not enter the neonatal and infant circulation in substantial amounts.
-The effects in the nursing infant are unknown.
-Trastuzumab has a washout period of 7 months which should be taken into consideration for nursing mothers.
See references
