g of the ankles/legs, palpitations, weight gain of more than 5 pounds in 24 hours, dizziness or loss of consciousness [see Warnings and Precautions (5.2)].
•Advise pregnant women and females of reproductive potential that KADCYLA exposure can result in fetal harm, including embryo-fetal death or birth defects [see Warnings and Precautions (5.3), Use in Specific Populations (8.1, 8.6)].
•Advise females of reproductive potential to use effective contraception while receiving KADCYLA and for 6 months following the last dose of KADCYLA [See Warnings and Precautions (5.3) and Use in Specific Populations (8.1, 8.6)].
•Advise nursing mothers treated with KADCYLA to discontinue nursing or discontinue KADCYLA, taking into account the importance of the drug to the mother [see Use in Specific Populations (8.3)].
•Encourage women who are exposed to KADCYLA during pregnancy to enroll in the MotHER Pregnancy Registry by contacting 1-800-690-6720 [see Warnings and Precautions (5.3) and Use in Specific Populations (8.1, 8.6)].
KADCYLA™ [ado-trastuzumab emtansine]
4862200
Manufactured by:
Initial U.S. Approval: February 2013
Genentech, Inc.
A Member of the Roche Group
KADCYLA is a trademark of Genentech, Inc.
1 DNA Way
©2013 Genentech, Inc.
South San Francisco, CA 94080-4990
U.S. License No: 1048
Representative sample of labeling (see the HOW SUPPLIED section for complete listing):
PRINCIPAL DISPLAY PANEL - 100 mg Vial Label
NDC 50242-088-01
Kadcyla™
(ado-trastuzumab
emtansine)
For Injection
100 mg per vial
For Intravenous Infusion Only
Reconstitute and Dilute prior
to administration
Single-Dose Vial –
Discard Unused Portion
KEEP REFRIGERATED
Rx only
1 vial
Genentech
10135258
PRINCIPAL DISPLAY PANEL - 160 mg Vial Label
NDC 50242-087-01
Kadcyla™
(ado-trastuzumab
emtansine)
For Injection
160 mg per vial
For Intravenous Infusion Only
Reconstitute and Dilute prior
to administration
Single-Dose Vial –
Discard Unused Portion
KEEP REFRIGERATED
Rx only
1 vial
Genentech
4862100
KADCYLA
trastuzumab emtansine injection, powder, lyophilized, for solution
Product Information
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Item Code (Source)
NDC:50242-088
Route of Administration
INTRAVENOUS
DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
TRASTUZUMAB EMTANSINE (TRASTUZUMAB EMTANSINE)
TRASTUZUMAB EMTANSINE
20 mg in 1 mL
Inactive Ingredients
Ingredient Name
Strength
SUCROSE
60 mg in 1 mL
SUCCINIC ACID
1.18 mg in 1 mL
SODIUM HYDROXIDE
0.45 mg in 1 mL
POLYSORBATE 20
0.2 mg in 1 mL
WATER
Packaging
Item Code
Package Description
1
NDC:50242-088-01
1 in 1 CARTON
1
5 mL in 1 VIAL, SINGLE-USE
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
BLA
