Golimumab Injection

Using golimumab injection may decrease your ability to fight infection and increase the risk that you will get a serious infection. These infections may need to be treated in a hospital and may cause death. Tell your doctor if you often get any type of infection or if you think you may have any type of infection now. This includes minor infections (such as open cuts or sores), infections that come and go (such as cold sores) and chronic infections that do not go away. Also tell your doctor if you have or have ever had diabetes, human immunodeficiency virus (HIV), or any condition that affects your immune system. Tell your doctor if you live or have ever lived in areas such as the Ohio or Mississippi river valleys where severe fungal infections are more common. Ask your doctor if you are not sure if these infections are common in your area. Tell your doctor if you are taking medications that decrease the activity of the immune system.

Your doctor will monitor you for signs of infection during and after your treatment. If you have any of the following symptoms before you begin your treatment or if you experience any of the following symptoms during or shortly after your treatment, call your doctor immediately: weakness; sweating; sore throat; cough; coughing up bloody mucus; fever; chills; weight loss; extreme tiredness; diarrhea; stomach pain; warm, red, or painful skin; sores on the skin; painful, difficult, or frequent urination; or other signs of infection.

You may be infected with tuberculosis (TB, a type of lung infection) or hepatitis B (a type of liver disease) but not have any symptoms of the disease. In this case, golimumab injection may increase the risk that your infection will become more serious and you will develop symptoms. Your doctor will perform a skin test to see if you have an inactive TB infection and may order blood tests to see if you have an inactive hepatitis B infection. If necessary, your doctor will give you medication to treat this infection before you start using golimumab injection. Tell your doctor if you have or have ever had TB or hepatitis B, if you have visited any country where TB is common, or if you have been around someone who has TB. If you have any of the following symptoms of TB, or if you develop any of these symptoms during your treatment, call your doctor immediately: cough, weight loss, loss of muscle tone, or fever. Also call your doctor immediately if you have any of these symptoms of hepatitis B or if you develop any of these symptoms during or after your treatment: excessive tiredness, yellowing of the skin or eyes, loss of appetite, nausea or vomiting, muscle aches, dark urine, clay-colored bowel movements, fever, chills, stomach pain, or rash.

Some children, teenagers, and young adults who received golimumab injection and similar medications developed severe or life-threatening cancers. Tell your child's doctor if your child has ever had any type of cancer. If your child experiences any of the following symptoms, call the doctor immediately: unexplained weight loss; swollen glands in the neck, underarms, or groin; or easy bruising or bleeding.

You will be given the Medication Guide. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm to obtain the Medication Guide.

Talk to your doctor about the risks of receiving golimumab injection.

Golimumab injection is used to treat the symptoms of:

• 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 joint damage),
• psoriatic arthritis (condition that causes joint pain and swelling and scales on the skin),
• ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum), and
• polyarticular juvenile idiopathic arthritis (PJIA; a type of childhood arthritis that affects five or more joints during the first six months of the condition, causing pain, swelling, and loss of function).

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.

Golimumab injection comes as a solution (liquid) in a single-dose prefilled syringe and prefilled autoinjector to inject subcutaneously (under the skin). It also comes as a solution to inject intravenously (into a vein) over 30 minutes by a doctor or nurse in a health care setting. Your doctor will tell you how often to use golimumab injection based on your condition or age.

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 subcutaneous dose of golimumab injection in your doctor's office. After that, you can inject the medicine yourself or have a caregiver give 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.

Use each syringe or autoinjector 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 device 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.

Remove the prefilled syringe or autoinjector from the refrigerator. Place it on a flat surface and allow it to warm to room temperature for 30 minutes before using it. 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 autoinjector device or the cover from the prefilled syringe while the medication is warming. Remove the cap or cover no more than 5 minutes before you inject the medication. Do not replace the cap or cover after you remove it. Do not use the syringe or device if you drop it on the floor while it is uncapped or uncovered.

Never shake the autoinjector device or the prefilled syringe. This may damage the medication.

Always look at golimumab injection before injecting it. Check that the expiration date has not passed and the liquid is clear and colorless or slightly yellow. The liquid may contain a few small white particles. Do not use a prefilled syringe or autoinjector device if it is damaged, expired, or if the medication is cloudy or discolored or contains large particles.

You can inject golimumab is anywhere on the front of your thighs (upper leg) or lower stomach area below your navel (belly button), except the 2 inch (5 centimeters) area around it. If someone else is giving the injection, the back of the upper arms also may be used. Choose a different spot for each injection. Do not inject into an area where the 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.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before using golimumab injection,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while using golimumab injection. 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 causing weakness, numbness, loss of muscle coordination and problems with vision, speech, and bladder control) or Guillain Barre syndrome (weakness, tingling, and possible paralysis due to sudden nerve damage), a low number of any type of blood cell, heart failure, or heart disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using golimumab injection, call your doctor. If you use golimumab injection during your pregnancy, your baby may need to receive certain vaccines later than usual.
• do not have any vaccinations without talking to your doctor.

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

Inject the missed dose as soon as you remember it, and then inject your next dose at the regular scheduled time. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not inject a double dose to make up for a missed one. Call your doctor or pharmacist if you do not know when to inject golimumab injection.

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

• redness, itching, bruising, pain, or swelling 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 or get emergency medical help:

• chest pain, shortness of breath, sudden weight gain, or swelling of the ankles or lower legs
• vision changes, weakness in arms or legs, or numbness or tingling in any part of the body
• red scaly patches or pus-filled bumps on the skin
• new or changing skin lesions or skin growths or bumps
• loss of appetite, vomiting, yellowing of the skin or eyes, or pain in the upper right part of the stomach
• easy bruising or bleeding
• pale skin
• rash on the cheeks or other part of the body; sensitivity to the sun; new muscle or joint pain; tiredness; chest pain; shortness of breath; or swelling of the feet ankles, or legs
• hives; itching; swelling of the eyes, face, lips, tongue, mouth, or throat; or difficulty breathing or swallowing

Golimumab injection may increase the risk of developing melanoma (a type of skin cancer), lymphoma (cancer that begins in the cells that fight infection), leukemia (cancer that begins in the white blood cells), and other types of cancer than people who do not receive the medication. Your doctor may check your skin during your treatment fo signs of skin cancer. Talk to your doctor about the risks of receiving 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 (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it in the refrigerator but do not freeze it. Keep the medication in the original carton to protect it from light.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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