Enhertu Pregnancy Warnings
Animal toxicity studies with this drug showed adverse changes to the male reproductive organs in rats and monkeys, including decreased testes and epididymides weights, tubular degeneration and aspermia. Changes in testes of monkeys showed reversibility. No fertility human data is available.
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 should be avoided.
AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.
Risk Summary: Based on its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman. The topoisomerase inhibitor component of this drug is genotoxic and targets actively dividing cells. In postmarketing reports the use of a HER2-directed antibody during pregnancy resulted in cases of oligohydramnios manifesting as fatal pulmonary hypoplasia, skeletal abnormalities, and neonatal death.
Comments:
-This drug can harm a developing fetus.
-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 the pregnancy status of females of reproductive potential prior to the initiation of therapy.
-Adequate methods of contraception should be encouraged.
---Advise females of reproductive potential to use effective contraception during therapy and for at least 7 months after.
---Advise male patients with female partners of reproductive potential to use effective contraception during therapy and for at least 4 months after.
-Women who received this drug during pregnancy or within 7 months prior to conception should be monitored for oligohydramnios. If oligohydramnios occurs, perform fetal testing.
-Based on results from animal toxicity studies, this drug may impair male reproductive function and fertility.
-It is unknown if this drug or its metabolites can be found in seminal fluid, however, male patients must not freeze or donate sperm throughout their treatment and for at least 4 months after their final dose.
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