SIMPONI- golimumab injection, solution 
Janssen Biotech, Inc.

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MEDICATION GUIDE
SIMPONI® (SIM-po-nee)
(golimumab)

Read the Medication Guide that comes with SIMPONI before you start taking it and each time you get a refill. 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 using SIMPONI.

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

SIMPONI is a medicine that affects your immune system. SIMPONI can lower the ability of your immune system to fight infections. Some people have serious infections while taking SIMPONI, 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 start taking SIMPONI if you have any kind of infection unless your doctor says it is okay.

Before starting SIMPONI, tell your doctor if you:

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

Cancer

What is SIMPONI?

SIMPONI is a prescription medicine called a Tumor Necrosis Factor (TNF) blocker. SIMPONI is used in adults:

You may continue to use other medicines that help treat your condition while taking SIMPONI, such as non-steroidal anti-inflammatory drugs (NSAIDs) and prescription steroids, as recommended by your doctor.

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

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

Tell your doctor about all the medicines you take, including prescription and non-prescription 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 use SIMPONI?

What are the possible side effects with SIMPONI?

SIMPONI can cause serious side effects, including:

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

Hepatitis B infection in people who carry the virus in their blood.

Heart failure, including new heart failure or worsening of heart failure that you already have. New or worse heart failure can happen in people who use TNF-blocker medicines including SIMPONI.

Nervous System Problems

Rarely, people using TNF-blocker medicines, including SIMPONI, have nervous system problems such as multiple sclerosis or Guillain-Barré syndrome.

Liver Problems

Liver problems can happen in people who use TNF-blocker medicines, including SIMPONI. These problems can lead to liver failure and death. Call your doctor right away if you have any of these symptoms:

Blood Problems

Low blood counts have been seen with TNF-blockers, including SIMPONI. Your body may not make enough blood cells that help fight infections or help stop bleeding. Symptoms include fever, bruising or bleeding easily, or looking pale. Your doctor will check your blood counts before and during treatment with SIMPONI.

Common side effects with SIMPONI include:

Other side effects with SIMPONI include:

These are not all of the side effects with SIMPONI. 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.

How should I store SIMPONI?

Keep SIMPONI and all medicines out of the reach of children.

General Information about SIMPONI

What are the ingredients in SIMPONI?

Active ingredient: golimumab.

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

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

© Janssen Biotech, Inc. 2013

Revised: 11/2013

Revised: 01/2014
 
Janssen Biotech, Inc.