Golimumab

Golimumab is used for:

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Treating rheumatoid arthritis in certain patients along with methotrexate. It is also used to treat psoriatic arthritis and ankylosing spondylitis. It may also be used for other conditions as determined by your doctor.

Golimumab is a tumor necrosis factor (TNF) blocker. It works by blocking a protein (TNF-alpha) found in the body that causes inflammation.

Do NOT use Golimumab if:

• you are allergic to any ingredient in Golimumab
• you have a severe infection (eg, sepsis) or any other active infection
• you are using abatacept, anakinra, or rilonacept, or if you will be receiving a live vaccine
• you are using another TNF blocker (eg, etanercept, infliximab)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Golimumab :

Some medical conditions may interact with Golimumab . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances, including rubber or latex
• if you have a history of an infection that keeps coming back; TB infection or positive TB skin test; hepatitis B infection; heart problems (eg, heart failure); diabetes; HIV; lymphoma or another type of cancer; or numbness, tingling, or other nervous system problems (eg, multiple sclerosis, Guillain-Barré syndrome)
• if you have an autoimmune disorder (eg, lupus) or other immune system problems, have recently received a vaccine, are scheduled to receive a vaccine, or are scheduled to have surgery
• if you have open cuts or sores on your body, have flu-like symptoms or other signs of infection (eg, fever; chills; cough; warm, red, or painful skin), or are using medicine to treat an infection
• if you have ever lived in or traveled to an area where TB is common, or if you have come into close contact with a person with active TB
• if you live, have lived, or traveled to certain parts of the country (eg, Ohio or Mississippi river valleys and the Southwest) where certain types of fungal infections (eg, histoplasmosis, coccidioidomycosis, blastomycosis) are common. Check with your doctor if you are not sure if you have lived or traveled in an area where these infections are common.
• if you have low blood platelets, white cells, or hemoglobin
• if you take medicine that may decrease your immune system (eg, cyclosporine) or if you have recently received rituximab

Some MEDICINES MAY INTERACT with Golimumab . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Abatacept, anakinra, corticosteroids (eg, prednisone), or rituximab because the risk of serious infection may be increased
• Anticoagulants (eg, warfarin), cyclosporine, or theophylline because their effectiveness may be decreased by Golimumab

This may not be a complete list of all interactions that may occur. Ask your health care provider if Golimumab may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Golimumab :

Use Golimumab as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Golimumab comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Golimumab refilled.
• Golimumab is given as an injection under the skin. A health care provider will teach you how to use it. Be sure you understand how to use Golimumab . Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Golimumab may be slightly yellow in color or have small particles that are white, or that you can see through. This is normal and will not change the effectiveness of Golimumab .
• Do not use Golimumab if it contains large particles, is cloudy or discolored, or if the syringe or autoinjector is cracked or damaged.
• Do not shake Golimumab before use.
• Allow the prefilled syringe or autoinjector to sit out at room temperature for 30 minutes before using. Do not warm Golimumab in any other way. Do not remove the needle cover or the cap on the autoinjector until right before use.
• Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into muscle.
• Rotate injection sites. New injections should be given at least 1 inch from an old site. Do not inject into areas where the skin is tender, bruised, red, or hard, or where you have scars or stretch marks.
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• If you miss a dose of Golimumab , use it as soon as you remember. Then go back to your regular dosing schedule.

Ask your health care provider any questions you may have about how to use Golimumab .

Important safety information:

• Golimumab may cause dizziness or vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Golimumab with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Golimumab may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
• TNF blockers may increase the risk of developing certain types of cancer. Patients with inflammatory diseases (eg, rheumatoid arthritis) who use Golimumab , especially those with more severe inflammatory diseases, have an increased risk of developing lymphoma. Talk with your doctor if you have questions about your risk of developing any type of cancer while using Golimumab .
• Tell your doctor or dentist that you take Golimumab before you receive any medical or dental care, emergency care, or surgery.
• Golimumab may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
• Do not receive a live vaccine (eg, measles, mumps) while you are taking Golimumab . Talk with your doctor before you receive any vaccine.
• Lab tests, including TB tests, liver function, and complete blood cell counts, may be performed while you use Golimumab . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Golimumab with caution in the ELDERLY; they may be more sensitive to its side effects, especially an increased risk of infection.
• Golimumab should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Golimumab while you are pregnant. It is not known if Golimumab is found in breast milk. Do not breast-feed while taking Golimumab .

Possible side effects of Golimumab :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Cold sores; cough; dizziness; mild pain, redness, or swelling at the injection site; nausea; runny or stuffy nose.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine or stools; butterfly-shaped rash on the nose and cheeks; chest pain; dark urine; diarrhea; fainting; fast or irregular heartbeat; increased sensitivity to the sun; loss of appetite; mental or mood changes; muscle pain or weakness; new or worsening joint pain; new or worsening red, scaly patches or raised bumps filled with pus on the skin; numbness, tingling, or pain in the hands or feet; open sore that does not heal; persistent cough; painful or frequent urination; pale stools; persistent pain, swelling, or redness at the injection site; red, swollen, or blistered skin; severe or persistent headache or dizziness; severe or persistent stomach pain; shortness of breath; signs of infection (eg, fever, chills, or sore throat; muscle aches; warm, red, or painful skin); swelling of the ankles, hands, or feet; unexplained weight loss; unusual bruising or bleeding; unusual lumps; unusual tiredness or weakness; unusually pale skin; vision changes; vomiting; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. 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 at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Store Golimumab in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Protect from light. Store in the original container until ready to use. If you need to take Golimumab with you, such as when traveling, store it in a cool carrier with an ice pack and protect it from light. Do not use after the expiration date on the prefilled syringe or autoinjector. Do not use Golimumab if it has ever been frozen. Keep Golimumab out of the reach of children and away from pets.

General information:

• If you have any questions about Golimumab , please talk with your doctor, pharmacist, or other health care provider.
• Golimumab is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Golimumab . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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