IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

GOLIMUMAB - SUBCUTANEOUS INJECTION

(goe-LIM-ue-mab)

COMMON BRAND NAME(S): Simponi

WARNING: This medication can decrease your body\'s ability to fight an infection. This effect can lead to very serious (possibly fatal) infections (such as fungal infections, bacterial infections including tuberculosis). Tell your doctor your medical history, especially of past/recent/current infections. You should also tell your doctor if you have lived or traveled in areas where certain fungal infections (such as coccidioidomycosis, histoplasmosis) are common or if you have been near someone with tuberculosis. Areas where these types of fungal infections are commonly found include the Ohio and Mississippi River valleys and the southwestern United States. Your doctor will test you for tuberculosis (TB) infection before and during treatment with this drug. If you are diagnosed with TB, your doctor will first prescribe treatment for this to prevent a serious TB infection while using golimumab. Though it is very unlikely to happen, there is a risk (especially in children/teens/young adults) of developing cancer (such as lymphoma, skin cancer) due to this medication or due to your medical condition. Discuss the risks and benefits of treatment with your doctor. Tell your doctor right away if you develop symptoms such as unusual lumps/growths, swollen glands, unexplained weight loss, persistent fever, or night sweats.

USES: This medication is used to reduce pain and swelling due to certain types of arthritis (such as rheumatoid, psoriatic, and ankylosing spondylitis). It works by blocking a protein (tumor necrosis factor or TNF) found in the body\'s immune system that causes joint swelling and damage. By reducing joint swelling, the medication helps to reduce further joint damage and preserve joint function. Depending on the type of arthritis that is being treated, this drug may be used alone or in combination with another drug called methotrexate. This medication is also used to treat a certain bowel condition (ulcerative colitis). It is used to help lessen symptoms of moderate to severe ulcerative colitis (such as abdominal pain/cramping, diarrhea, bloody stools).

HOW TO USE: Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using golimumab and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist. Use this medication exactly as prescribed. This drug is given by injection under the skin of the thigh, abdomen, or upper arm as directed by your doctor, usually once a month. If you are using this medication to treat ulcerative colitis, your doctor may prescribe a different schedule/higher dose at the start of your treatment. Carefully follow your doctor\'s directions for using this medication. Learn all preparation and usage instructions in the product package. Never shake this product. Doing so may decrease the effectiveness of the drug. Remove this medication from the refrigerator and leave it at room temperature for at least 30 minutes before injecting. Do not warm up this medication any other way such as by heating in the microwave or placing in hot water. Before using, check this product visually for particles or discoloration. The liquid is usually colorless to pale yellow and may contain tiny particles that are white or that you can see through. If the liquid is any darker than pale yellow, if it is discolored in any other way, if it is cloudy, or if it contains large particles, do not use the liquid. Before injecting each dose, clean the injection site with rubbing alcohol. It is important to change the injection site with each dose. Do not inject into any areas of skin that are sore, bruised, red, scaly, or hard. If using an autoinjector, remove the cap before injecting this medication. Use this medication regularly to get the most benefit from it. To help you remember, mark the day on the calendar when you need to receive the medication. Learn how to store and discard needles and medical supplies safely. Never reuse syringes or needles. Consult your pharmacist. Tell your doctor if your condition persists or worsens.

SIDE EFFECTS: See also Warning section. Redness, itching, pain, or swelling at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, numbness/tingling of the hands/feet, unsteadiness, unexplained muscle weakness, vision changes, muscle/joint pain, butterfly-shaped rash on the nose and cheeks, symptoms of heart failure (including shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain), signs of infection (such as fever/chills/cough/persistent sore throat, unusual sweating), symptoms of liver damage (including dark urine, persistent nausea/vomiting/loss of appetite, stomach/abdominal pain, yellow eyes/skin). Get medical help right away if you have any very serious side effects, including: chest pain, seizures. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also Warnings section. Before using golimumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as natural rubber/latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/bone marrow problems (such as low red/white blood cells and platelets), certain brain/nerve disorders (such as multiple sclerosis, Guillain-Barre syndrome), cancer, current/recent/repeated infections (including fungal, hepatitis B, tuberculosis), heart disease (especially congestive heart failure), lupus, seizures. Golimumab can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details. Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose). To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Older adults may be more sensitive to the effects of this drug, especially the risk of infections. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Mothers who have used this medication during pregnancy should ask a doctor about immunizations/vaccinations for their newborn babies. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor\'s approval. Some products that may interact with this drug include: other TNF-blockers (such as adalimumab, certolizumab, etanercept, infliximab), other drugs that weaken the immune system (such as abatacept, anakinra, cyclosporine). Avoid treatments that contain live bacteria or viruses (such as BCG, flu vaccine inhaled through the nose) since they may increase your risk for serious infections while you are using golimumab.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others. Laboratory and/or medical tests (such as complete blood counts, liver function, skin exams) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details. This medication has been prescribed for your current condition only. Do not use it later for another condition unless your doctor directs you to do so. A different medication may be necessary in that case.

MISSED DOSE: If you miss a dose, contact your doctor or pharmacist to establish a new dosing schedule.

STORAGE: Store in the original carton in the refrigerator away from light. Do not freeze. Discard any unused portion of this medication. This medication may also be stored in the original carton at room temperature for up to 30 days. If stored at room temperature, do not return drug to refrigerator and discard drug after 30 days if not used. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Information last revised November 2019. Copyright(c) 2019 First Databank, Inc.