ember 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
ado-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
ADO-TRASTUZUMAB EMTANSINE (ADO-TRASTUZUMAB EMTANSINE) ADO-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 VIAL, SINGLE-USE 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 BLA125427 02/22/2013
Kadcyla
ado-trastuzumab emtansine injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:50242-087
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ADO-TRASTUZUMAB EMTANSINE (ADO-TRASTUZUMAB EMTANSINE) ADO-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:50242-087-01 1 VIAL, SINGLE-USE in 1 CARTON
1 8 mL in 1 VIAL, SINGLE-USE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125427 02/22/2013
Labeler - Genentech, Inc. (080129000)
Establishment
Name Address ID/FEI Operations
Genentech, Inc. (Hillsboro) 833220176 LABEL(50242-088, 50242-087), PACK(50242-088, 50242-087)
