Clearance Simponi Aria: 6.9 mL/day/kg (healthy patients); 7.6 mL/day/kg (RA) Half-life Simponi Aria: 12 days (healthy patients); 14 days (RA) Simponi: 14 days (healthy patients and patients with active RA, PsA, or AS) IV Preparation Simponi Aria only Inspect vial; solution is colorless to light yellow and opalescent Do not use if opaque particles, discoloration or other foreign particles are present Dilute calculated dose volume with 0.9% NaCl to a final volume of 100 mL; alternatively, 0.45% NaCl Injection, USP can also be used; gently mix (DO NOT SHAKE) Discard any unused drug remaining in the vials IV Administration Simponi Aria only Use only an infusion set with an in-line, sterile, nonpyrogenic, low protein-binding filter (pore size 0.22 micrometer or less) Do not administer concomitantly in same IV line with other agents Infuse over 30 minutes SC Administration Simponi only Warm by sitting at room temperature for 30 min; do NOT heat or microwave If multiple injections required, administer at different site on the body Injection sites: Front of thighs (recommended), lower abdomen (except for a 2-inch area right around the navel); back of the upper arms (only if someone else is administering it) Rotate injection sites for each administration Do not administer in area where the skin is tender, bruised, red, or hard Storage Refrigerate unopened IV and SC products at 2-8ºC (36-46ºF); do not freeze Keep the product in the original carton to protect from light until the time of use Once diluted, IV infusion solution may be stored for 4 hr at room temperature BRAND FORM. UNIT PRICE PILL IMAGE Simponi ARIA intravenous- 12.5 mg/mL vialSimponi subcutaneous- 50 mg/0.5 mL injectionSimponi subcutaneous- 100 mg/mL injectionSimponi subcutaneous- 50 mg/0.5 mL solutionSimponi subcutaneous- 100 mg/mL solutionCopyright © 2010 First DataBank, Inc.Select a drug:golimumab intravenousgolimumab subcutaneousPrint Patient Educationgolimumab intravenous GOLIMUMAB - INJECTION (goe-LIM-ue-mab) COMMON BRAND NAME(S): Simponi Aria 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 fever that doesn't go away, unusual lumps/growths, swollen glands, unexplained weight loss, or night sweats. USES: This medication is used to treat certain types of arthritis (such as rheumatoid arthritis, psoriatic arthritis, polyarticular juvenile idiopathic arthritis, ankylosing spondylitis). Golimumab belongs to a class of drugs known as TNF blockers. It works by blocking a protein (tumor necrosis factor - TNF) in your body's immune system that causes joint swelling and damage. Golimumab helps slow joint damage and reduce joint pain/swelling so you can move better. HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using golimumab and each time you get a refill. If you have any questions, ask your doctor or pharmacist.This drug is given by slow injection into a vein by a health care professional, usually over 30 minutes. After the first dose, this medication is usually given again 4 weeks later, then every 8 weeks as directed by your doctor. The dosage is based on your weight. For children, the dosage is based on their body size.You should receive this medication regularly to get the most benefit from it. To help you remember, mark your calendar to keep track of when to receive the next dose.Tell your doctor if your symptoms do not improve or if they worsen. SIDE EFFECTS: See also Warning section.Redness, irritation, or pain at the injection site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor 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/sore throat that doesn't go away, unusual sweating), symptoms of liver damage (including nausea/vomiting that doesn't stop, loss of appetite, dark urine, stomach/abdominal pain, yellow eyes/skin).Get medical help right away if you have any very serious side effects, including: chest pain, seizures.Golimumab can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Tell your doctor right away if you develop any rash.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 Warning 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, 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 make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.Tell your health care professional that you are using golimumab before having any immunizations/vaccinations. 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 side 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.Lab and/or medical tests (such as complete blood counts, liver function, skin exams, TB/hepatitis B tests) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details. MISSED DOSE: If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. STORAGE: Not applicable. This medication is given in a hospital or clinic and will not be stored at home. 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 March 2023. Copyright(c) 2023 First Databank, Inc. 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. FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.Create Your List of PlansAdding plans allows you to:View the formulary and any restrictions for each plan.Manage and view all your plans together – even plans in different states.Compare formulary status to other drugs in the same class.Access your plan list on any device – mobile or desktop. The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information. View explanations for tiers and restrictions Tier Description 1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs. 2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs. 3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs. 4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. NC NOT COVERED – Drugs that are not covered by the plan. Code Definition PA Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription. QL Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered. ST Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription. OR Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription. 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