What are the ingredients in ACTEMRA?

Active ingredient: tocilizumab

Inactive ingredients: sucrose, polysorbate 80, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

ACTEMRA is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.

Genentech, Inc.
A Member of the Roche Group
1 DNA Way
South San Francisco, CA 94080-4990
US License No. 1048

10094884

AAI_4877533_PI_062009_N_5

AAI_4877533_MG_062009_N_5

PI Issued: January 2010

© 2010 Genentech, Inc. All rights reserved.

Representative sample of labeling (see the HOW SUPPLIED section for complete listing):

PRINCIPAL DISPLAY PANEL - 10 mL Carton

NDC 50242-136-01

Actemra®
(tocilizumab)
Injection

200 mg/10 mL

(20 mg/ mL)

For Intravenous Infusion only after
dilution.

Single-Use Vial; Discard unused portion

ATTENTION PROVIDER: Each patient is
required to receive the enclosed
Medication Guide

No Preservative

Rx only

Genentech
ACTEMRA 
tocilizumab   injection, solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 50242-135
Route of Administration INTRAVENOUS DEA Schedule      
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
tocilizumab (tocilizumab)  tocilizumab 20 mg  in 1 mL
 
Inactive Ingredients
Ingredient Name Strength
sucrose  
polysorbate 80  
sodium phosphate, dibasic, dodecahydrate  
sodium phosphate, monobasic, dihydrate  
 
Product Characteristics
Color      Score     
Shape  Size 
Flavor  Imprint Code 
Contains     
 
Packaging
# NDC Package Description Multilevel Packaging
1 50242-135-01 1 VIAL In 1 BOX contains a VIAL, SINGLE-USE
1  4 mL In 1 VIAL, SINGLE-USE This package is contained within the BOX (50242-135-01)
2 50242-135-04 4 VIAL In 1 BOX contains a VIAL, SINGLE-USE
2  4 mL In 1 VIAL, SINGLE-USE This package is contained within the BOX (50242-135-04)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125276 01/08/2010 

ACTEMRA 
tocilizumab   injection, solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 50242-136
Route of Administration INTRAVENOUS DEA Schedule      
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
tocilizumab (tocilizumab)  tocilizumab 20 mg  in 1 mL
 
Inactive Ingredients
Ingredient Name Strength
sucrose  
polysorbate 80  
sodium phosphate, dibasic, dodecahydrate  
sodium phosphate, monobasic, dihydrate  
 
Product Characteristics
Color      Score    &nb