You may also report side effects to Genentech at 1-888-835-2555.

General information about ACTEMRA

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. This Medication Guide summarizes the most important information about ACTEMRA.

If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about ACTEMRA that is written for health professionals.

For more information, go to www.ACTEMRA.com or call 1-800-ACTEMRA.

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.

MG Revised: April 2011

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

AAI_4877533_PI_10142010_K

AAI_4877533_MG_10142010_K

PI Revised: April 2011

© 2011 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 20mg in1mL
 
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 1VIALIn1BOX contains a VIAL, SINGLE-USE
1  4mLIn1VIAL, SINGLE-USE This package is contained within the BOX(50242-135-01)
2 50242-135-04 4VIALIn1BOX contains a VIAL, SINGLE-USE
2  4mLIn1VIAL, 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 20mg in1mL
&nb