Fam-trastuzumab deruxtecan Pregnancy and Breastfeeding Warnings

Medically reviewed by Drugs.com. Last updated on Feb 3, 2021.

Fam-trastuzumab deruxtecan is also known as: Enhertu

Fam-trastuzumab deruxtecan Pregnancy Warnings

In postmarketing reports in pregnant women receiving a HER2-directed antibody, cases of oligohydramnios manifesting as fatal pulmonary hypoplasia, skeletal abnormalities, and neonatal death have been reported.

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.

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. Use of a HER2-directed antibody during pregnancy resulted in cases of oligohydramnios manifesting as fatal pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Based on its mechanism of action, the topoisomerase inhibitor component of this drug can also cause embryofetal harm when administered to a pregnant woman because it is genotoxic and targets actively dividing cells.

Comments:
-This drug can harm a developing fetus.
-Adequate methods of contraception should be encouraged.
-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.
-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.

See references

Fam-trastuzumab deruxtecan Breastfeeding Warnings

Use should be avoided.

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

Comments:
Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during therapy and for 7 months after.

See references

Further information

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