trouble breathing
swelling of the lips, tongue, or face
chest pain
feeling dizzy or faint
moderate or severe abdominal pain or vomiting
Nervous system problems. While rare, Multiple Sclerosis has been diagnosed in people who take ACTEMRA. It is not known what effect ACTEMRA may have on some nervous system disorders.
Common side effects of ACTEMRA include:
upper respiratory tract infections (common cold, sinus infections)
headache
increased blood pressure (hypertension)
injection site reactions
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of ACTEMRA. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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 of Intravenous ACTEMRA: sucrose, polysorbate 80, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate.
Inactive ingredients of Subcutaneous ACTEMRA: L-arginine, L-arginine hydrochloride, L-methionine, L-histidine, L-histidine hydrochloride monohydrate.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
MG Revised: October 2013
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
© 2014 Genentech, Inc. All rights reserved.
SPL UNCLASSIFIED SECTION
Representative sample of labeling (see the HOW SUPPLIED section for complete listing):
PRINCIPAL DISPLAY PANEL - 4 ML VIAL BOX
NDC 50242-135-01
Actemra®
(tocilizumab)
Injection
80 mg/4 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
Principal Display Panel - 4 mL Vial Box
PRINCIPAL DISPLAY PANEL - 10 ML VIAL BOX
NDC 50242-136-01
Actemra®
(tocilizumab)
Injection
200mg/10 mL
(20mg/mL)
For Intravenous Infusion only after
dilution.
Single-Use Vial; Discard unused
portio
ATTENTION PROVIDER: Each patient
is required to receive the enclosed
Medication Guide
No Preservative
Rx onl
Genentech
Principal Display Panel - 10 mL Vial Box
PRINCIPAL DISPLAY PANEL - 20 ML VIAL BOX
NDC 50242-137-01
Actemra®
(tocilizumab)
Injection
400 mg/20 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
Medicati |
