Golimumab Injection

Using golimumab injection may decrease your ability to fight infection and increase the risk that you will get a serious infection, including severe fungal, bacterial, or viral infections that spread through the body. 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) , acquired immunodeficiency syndrome (AIDS), or any other condition that affects your immune system. You should also 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 such as the following: abatacept (Orencia); anakinra (Kineret); methotrexate (Rheumatrex); rituximab (Rituxan); steroids including dexamethasone, methylprednisolone (Medrol), prednisolone (Prelone) and prednisone; tocilizumab (Actemra); and other TNF-blockers such as adalimumab (Humira), certolizumab (Cimzia), etanercept (Enbrel), and infliximab (Remicade).

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; 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 including lymphoma (cancer that begins in the cells that fight infection). Some teenage and young adult males who took golimumab or similar medications developed hepatosplenic T-cell lymphoma (HSTCL), a very serious form of cancer that often causes death within a short period of time. Most of the people who developed HSTCL were being treated for Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) or ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum) with golimumab or a similar medication along with another medication called azathioprine (Imuran) or 6-mercaptopurine (Purinethol). Children and teenagers should not normally receive golimumab injection, but in some cases, a doctor may decide that golimumab injection is the best medication to treat a child's condition. If golimumab injection is prescribed for your child, you should talk to your child's doctor about the risks and benefits of using this medication. If your child develops any of these symptoms during his treatment, call his doctor immediately: unexplained weight loss; swollen glands in the neck, underarms, or groin; or easy bruising or bleeding.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with golimumab injection and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm)or the manufacturer's website to obtain the Medication Guide.

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

Golimumab injection (Simponi) is used 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) along with methotrexate (Otrexup, Rasuvo, Trexall) in adults,
• ankylosing spondylitis (condition in which the body attacks the joints of the spine and other areas causing pain and joint damage) in adults,
• psoriatic arthritis (condition that causes joint pain and swelling and scales on the skin) alone or in combination with methotrexate in adults, and
• ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum) when other medications and treatments did not help or could not be tolerated.

Golimumab injection (Simponi Aria) is also used to relieve the symptoms of certain autoimmune disorders including:

• rheumatoid arthritis (condition in which the body attacks its own joints causing pain, swelling, and loss of function) along with methotrexate (Otrexup, Rasuvo, Trexall) in adults,
• ankylosing spondylitis (condition in which the body attacks the joints of the spine and other areas causing pain and joint damage) in adults,
• psoriatic arthritis (condition that causes joint pain and swelling and scales on the skin) in adults and children 2 years of age and older,
• 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) in children 2 years of age and older.

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) to inject subcutaneously (under the skin) or intravenously (into a vein). When golimumab is given subcutaneously to treat rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis, it is usually given once a month. When golimumab is given subcutaneously to treat ulcerative colitis, it is usually given once every other week for the first two doses (at week 0 and week 2) and then once every 4 weeks afterwards. When golimumab is given intravenously by a doctor or nurse in a health care setting to treat rheumatoid arthritis, ankylosing spondylitis. psoriatic arthritis, or polyarticular juvenile idiopathic arthritis, it is usually given over 30 minutes once every other week for the first two doses (at week 0 and week 2) and then once every 4 weeks afterwards. 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 subcutaneous 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 (Simponi) comes in prefilled syringes and auto-injection devices for subcutaneous injection. 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.

Remove the prefilled syringe or prefilled autoinjector from the refrigerator and allow it to warm to room temperature for 30 minutes before using it. Take it out of its carton, and allow it to rest on a flat surface 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 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 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 contains 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 (5 centimeter) 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.

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

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 while using golimumamb 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, 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, be sure to talk to your baby's doctor about this after your baby is born. 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
• 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 or other part of the body
• sensitivity to the sun
• joint pain
• hives
• swelling of the eyes, face, lips, tongue, mouth, or throat
• 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. 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.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Simponi^®
• Simponi^® Aria