"June 12, 2012 -- The FDA on Monday approved a new drug for the treatment of a type of late-stage breast cancer. The drug helped stop cancer growth for about six months longer than existing medications.
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- Advise patients to contact a health care professional immediately for any of the following: new onset or worsening shortness of breath, cough, swelling of the ankles/legs, swelling of the face, palpitations, weight gain of more than 5 pounds in 24 hours, dizziness or loss of consciousness [see BOXED WARNING: Cardiomyopathy].
- Advise pregnant women and females of reproductive potential that Herceptin exposure can result in fetal harm [see Use in Specific Populations].
- Advise women who are exposed to Herceptin during pregnancy or become pregnant within 7 months following the last dose of Herceptin, to immediately report exposure to the Genentech Adverse Event Line at 1-888-835-2555 [see Use in Specific Populations].
- Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Herceptin during pregnancy or within 7 months of conception. To enroll the patient in the MotHER Pregnancy Registry call 1-800-690-6720 [see Use in Specific Populations].
- Advise females of reproductive potential to avoid becoming pregnant while taking Herceptin. If contraceptive methods are being considered, advise female patients to use effective contraception during treatment and for at least 7 months following the last dose of Herceptin [see Use in Specific Populations].
- Advise nursing mothers treated with Herceptin to discontinue nursing or discontinue Herceptin, taking into account the importance of the drug to the mother [see Use in Specific Populations].
Last reviewed on RxList: 5/14/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Herceptin Information
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