SIMPONI ARIA- golimumab solution 
Janssen Biotech, Inc.

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MEDICATION GUIDE

SIMPONI® ARIA™
(SIM-puh-nee AHR-ee-uh)
(golimumab)
For Infusion

Read the Medication Guide for SIMPONI ARIA before each infusion. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. It is important to remain under your doctor's care while receiving SIMPONI ARIA.

What is the most important information I should know about SIMPONI ARIA?

SIMPONI ARIA is a medicine that affects your immune system. SIMPONI ARIA can lower the ability of your immune system to fight infections. Some people have serious infections while taking SIMPONI ARIA, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that spread throughout their body. Some people have died from these serious infections.

You should not receive SIMPONI ARIA if you have any kind of infection unless your doctor says it is okay.

Before receiving SIMPONI ARIA, tell your doctor if you:

After receiving SIMPONI ARIA, call your doctor right away if you have any symptoms of an infection. SIMPONI ARIA can make you more likely to get infections or make worse any infection that you have.

Cancer

What is SIMPONI ARIA?

SIMPONI ARIA is a prescription medicine called a Tumor Necrosis Factor (TNF) blocker. SIMPONI ARIA is used with the medicine methotrexate to treat adults with moderately to severely active rheumatoid arthritis (RA).

SIMPONI ARIA is not for children under 18 years of age.

What should I tell my doctor before starting treatment with SIMPONI ARIA?

SIMPONI ARIA may not be right for you. Before receiving SIMPONI ARIA, tell your doctor about all your medical conditions, including if you:

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your doctor if you:

Ask your doctor if you are not sure if your medicine is one listed above.

Keep a list of all your medications with you to show your doctor and pharmacist each time you get a new medicine.

How should I receive SIMPONI ARIA?

What are the possible side effects of SIMPONI ARIA?

SIMPONI ARIA can cause serious side effects, including:

The most common side effects of SIMPONI ARIA include:

Other side effects with SIMPONI ARIA include:

These are not all of the side effects with SIMPONI ARIA. Tell your doctor about any side effect that bothers you or does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

General Information about SIMPONI ARIA

Medicines are sometimes prescribed for purposes other than those listed in the Medication Guide. Do not use SIMPONI ARIA for a condition for which it was not prescribed.

This Medication Guide summarizes the most important information about SIMPONI ARIA. If you would like more information, talk to your doctor. You can ask your doctor or pharmacist for information about SIMPONI ARIA that is written for health professionals.

For more information go to www.SimponiAria.com or call 1-800-JANSSEN (1-800-526-7736).

What are the ingredients in SIMPONI ARIA?

Active ingredient: golimumab

Inactive ingredients: L-histidine, L-histidine monohydrochloride monohydrate, sorbitol, polysorbate 80, and water for injection. SIMPONI ARIA does not contain preservatives, natural rubber or latex.

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

Manufactured by:
Janssen Biotech, Inc.
Horsham, PA 19044
US License No. 1864 at
Cilag AG
Schaffhausen, Switzerland

© Janssen Biotech, Inc. 2013

Approved: February 2014

Revised: 02/2014
 
Janssen Biotech, Inc.