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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 women of childbearing potential that Herceptin exposure can result in fetal harm [see Warnings and Precautions (5.3) and Use in Specific Populations (8.1)].
Advise women of childbearing potential to use effective contraceptive methods during treatment and for a minimum of six months following Herceptin [see Warnings and Precautions (5.3)].
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 (8.3)].
Encourage women who are exposed to Herceptin during pregnancy to enroll in MotHER the Herceptin Pregnancy Registry (1-800-690-6720) [see Warnings and Precautions (5.3) and Use in Specific Populations (8.1)].
HERCEPTIN® [trastuzumab]
Manufactured by:
Genentech, Inc.
A Member of the Roche Group
1 DNA Way
South San Francisco, CA 94080-4990
4851301
Initial US Approval: September 1998
Revision Date: October 2010
Herceptin® is a registered trademark of Genentech, Inc.
©2010 Genentech, Inc.
PRINCIPAL DISPLAY PANEL - Herceptin® 440 mg Vial Carton
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