Golimumab Injection

Conditions Treated

Golimumab injection is used alone or with other medications to relieve the symptoms of certain autoimmune disorders (conditions in which the immune system attacks healthy parts of the body and causes pain, swelling, and damage) including:

• rheumatoid arthritis (condition in which the body attacks its own joints causing pain, swelling, and loss of function),
• ankylosing spondylitis (condition in which the body attacks the joints of the spine and other areas causing pain and loss of function),
• psoriatic arthritis (condition that causes joint pain and swelling and scales on the skin).

Golimumab is in a class of medications called tumor necrosis factor (TNF) inhibitors. It works by blocking the action of TNF, a substance in the body that causes inflammation.

Possible Side Effects

What Side Effects Can This Cause?

Golimumab injection may cause side effects. Tell your doctor if either of these symptoms is severe or does not go away:

• redness in the place where golimumab was injected
• dizziness

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• shortness of breath
• swelling of the ankles or lower legs
• vision changes
• weakness, numbness, or tingling of the arms or legs
• red scaly patches or pus-filled bumps on the skin
• blisters
• pain in the upper right part of the stomach
• easy bruising or bleeding
• pale skin
• rash on the cheeks
• sensitivity to the sun
• joint pain
• hives
• swelling of the eyes, face, lips, tongue, mouth, or throat
• difficulty breathing or swallowing

Using golimumab injection may increase the chance that you will develop certain serious medical conditions including heart failure, multiple sclerosis, psoriasis, and liver disease.Receiving golimumab injection may increase the risk of developing leukemia (cancer that begins in the white blood cells) and other types of cancer in adults and children. Talk to your doctor about the risks of receiving golimumab injection.Talk to your doctor about the risks of using golimumab injection.Golimumab injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

Usage Instructions

How Should This Medication Be Used

Golimumab injection comes as a liquid in a prefilled syringe and as a liquid in an auto-injection device to inject under the skin. It is usually injected once every month. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use golimumab injection exactly as directed. Do not inject more or less of it or inject it more often than prescribed by your doctor. You will receive your first dose of golimumab injection in your doctor's office. After that, your doctor may allow you to inject golimumab yourself or have a friend or relative perform the injections. Before you use golimumab injection yourself the first time, read the written instructions that come with it. Ask your doctor or pharmacist to show you or the person who will be injecting the medication how to inject it. Golimumab injection comes in prefilled syringes and auto-injection devices. Use each syringe or device only once and inject all the solution in the syringe or device. Even if there is still some solution left in the syringe or pen after you inject, do not inject again. Dispose of used syringes and devices in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container. Thirty minutes before you are ready to inject golimumab injection, you will need to remove the medication from the refrigerator, take it out of its carton, and allow it to rest on a flat suface so that it can warm to room temperature. Do not try to warm the medication by heating it in a microwave, placing it in hot water, or through any other method. Do not remove the cap from the auto-injection device or the cover from the prefilled syringe while the medication is warming. You should not remove the cap or cover until just before you inject the medication. Never shake the auto-injection device or the prefilled syringe. This may damage the medication. Always look at golimumab injection before injecting it. Check the expiration date printed on the auto-injection device or carton and do not use the medication if the expiration date has passed. Do not use a prefilled syringe or auto-injection device that appears damaged, and do not use an auto-injection device if the security seal is broken. Look through the viewing window on the prefilled syringe or auto-injection device. The liquid inside should be clear and colorless or slightly yellow, but it may contain some small white particles or an air bubble. Do not use the syringe or device if the medication is cloudy or discolored or contain large particles. The best place to inject golimumab is the front of the middle thighs. However, you can also inject golimumab in your lower stomach below your navel, except for the 2 inch area around the navel. If someone else is giving you the injection, that person can also inject the medication into your upper arms. Choose a different spot to inject the medication every day. Do not inject into an area where your skin is red, bruised, tender, hard or scaly, or where you have scars or stretch marks. Golimumab injection may help control your condition but will not cure it. Continue to use golimumab injection even if you feel well. Do not stop using golimumab injection without talking to your doctor.

What Dietary Instructions Should I Follow

Unless your doctor tells you otherwise, continue your normal diet.

Are There Any Special Instructions

Before using golimumab injection, tell your doctor and pharmacist if you are allergic to golimumab injection, any other medications, or any of the ingredients in golimumab injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients. Also tell your doctor if you or the person who will be helping you inject golimumab injection are allergic to latex or rubber. tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section anticoagulants ('blood thinners') such as warfarin (Coumadin), cyclosporine (Gengraf, Neoral, Sandimmune), theophylline (Theochron, Theoloair, Uniphyl), and other TNF-blockers such as adalimumab (Humira), certolizumab (Cimzia), etancercept (Enbrel), and infliximab (Remicade). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. tell your doctor if you have or have ever had cancer, psoriasis (a skin disease in which red scaly patches form on the skin), any condition that affects your nervous system such as multiple sclerosis (MS, a disease in which the nerves do not function properly and patients may experience weakness, numbness, loss of muscle coordination and problems with vision, speech, and bladder control), a low number of any type of blood cell, or heart disease. do not have any vaccinations without talking to your doctor.