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U.S. Department of Health and Human Services

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Trastuzumab - (Labeling Change)

Labeling Changes Regarding Safety Information (fatal fetal pulmonary hypoplasia) for trastuzumab (Herceptin, Genentech Incorporated).
Trastuzumab is indicated for the adjuvant treatment of HER2-overexpressing breast cancer and for the treatment of HER2-overexpressing metastatic gastric cancers and HER2-overexpressing metastatic breast cancer.

This notice is to inform you of important new safety information regarding the already labeled adverse reaction of oligohydramnios (decreased amniotic fluid). Based on post-marketing adverse event reports, cases of oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death have been reported in the offspring of mothers exposed to trastuzumab during pregnancy. 
The changes being made to the prescribing information regarding these new safety findings include the following:

New information is added to the BOXED WARNING

Embryo-Fetal Toxicity: Exposure to Herceptin during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. [see Warnings and Precautions (5.3), Use in Specific Populations (8.1)]

A new subsection is added to the “WARNINGS” section of the label.

Embryo-Fetal Toxicity: Herceptin can cause fetal harm when administered to a pregnant woman. In post-marketing reports, use of Herceptin during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise women of the potential hazard to the fetus resulting from Herceptin exposure during pregnancy and provide contraception counseling to women of childbearing potential.[see Use in Specific Populations (8.1), Patient Counseling Information (17)].

New information is added under “USE IN SPECIFIC POPULATIONS” section of the label.

Pregnancy: Category D [see Warnings and Precautions (5.3), Nonclinical Toxicology (13.2)]

Herceptin can cause fetal harm when administered to a pregnant woman. In post‑marketing reports use of Herceptin during pregnancy resulted in cases of oligohydramnios and of oligohydramnios sequence, manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death.
These case reports described oligohydramnios in pregnant women who received Herceptin either alone or in combination with chemotherapy. In some case reports, amniotic fluid index increased after Herceptin was stopped. In one case, Herceptin therapy resumed after the amniotic fluid index improved, and oligohydramnios recurred.
Monitor women exposed to Herceptin during pregnancy for oligohydramnios. If oligohydramnios occurs, perform fetal testing that is appropriate for gestational age and consistent with community standards of care. The efficacy of IV hydration in management of oligohydramnios due to Herceptin exposure is not known.
Advise women of the potential hazard to the fetus resulting from Herceptin exposure during pregnancy. Encourage pregnant women with breast cancer who are using Herceptin to enroll in MotHER‑the Herceptin Pregnancy Registry: phone 1‑800‑690‑6720. [see Patient Counseling Information (17)].

Full prescribing information, including clinical trial information, safety, dosing, drug-drug interaction, contraindications is available at http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103792s5256lbl.pdf

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by phone at 1-800-FDA-1088, by facsimile 1-800-FDA-0178m by mail using the Form 3500 at http://www.fda.gov/medwatch/index.html