Golimumabdosage

RA, PsA, and AS: 50 mg administered by subcutaneous injection once a month UC: The recommended dosage and administration by subcutaneous injection in adults and pediatric patients weighing at least 15 kg is shown in the table Recommended Dosage Weight for Patients with UC Week 0 Week 2 Week 6 and every 4 weeks thereafter Adults and pediatric patients 40 kg and greater For pediatric patients weighing 15 kg or greater, administer the appropriate dose using the prefilled syringe (50 mg/0.5 mL or 100 mg/mL). 200 mg 100 mg 100 mg Pediatric patients at least 15 kg to less than 40 kg 100 mg 50 mg 50 mg

2.1 Recommended

Evaluations and Immunizations Before Initiating SIMPONI Prior to initiating treatment with SIMPONI: Evaluate patients for active tuberculosis and test for latent infection. Test patients for hepatitis B viral infection. If possible, complete all age-appropriate vaccinations according to current immunization guidelines.

2.2 Recommended

Dosage for Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis The recommended SIMPONI dosage in adults is 50 mg administered by subcutaneous injection once a month. For patients with rheumatoid arthritis (RA), SIMPONI should be given in combination with methotrexate and for patients with psoriatic arthritis (PsA) or ankylosing spondylitis (AS), SIMPONI may be given with or without methotrexate or other nonbiologic Disease-Modifying Antirheumatic Drugs (DMARDs). For patients with RA, PsA, or AS, corticosteroids, non-biologic DMARDs, and/or NSAIDs may be continued during treatment with SIMPONI.

2.3 Recommended

Dosage for Moderately to Severely Active Ulcerative Colitis in Adults and Pediatric Patients Weighing at least 15 kg The recommended dosage is shown in Table 1.

Table 1: Recommended Subcutaneous Dosage for Adults and Pediatric Patients Weighing at least 15 kg with Moderately to Severely Active Ulcerative Colitis Weight for Patients with UC Recommended Dosage of SIMPONI Week 0 Week 2 Week 6 and every 4 weeks thereafter Adults and pediatric patients 40 kg and greater For pediatric patients weighing 15 kg or greater, administer the appropriate dose using the prefilled syringe (50 mg/0.5 mL or 100 mg/mL). 200 mg 100 mg 100 mg Pediatric patients at least 15 kg to less than 40 kg 100 mg 50 mg 50 mg

2.4 Preparation and

Administration Instructions SIMPONI is intended for use under the guidance and supervision of a healthcare provider after proper training in subcutaneous injection technique. Patients may self-inject with SIMPONI if a physician determines that it is appropriate. Instruct patients to follow the directions provided in the Instructions for Use. SIMPONI Prefilled Syringe Adult and pediatric patients 12 years of age and older may self-inject with SIMPONI prefilled syringe. SIMPONI SmartJect ® Autoinjector Adult patients may self-inject with SIMPONI SmartJect ® autoinjector. Use of the SmartJect ® autoinjector for pediatric self-administration has not been evaluated.

To ensure proper use, allow the prefilled syringe or autoinjector to sit at room temperature outside the carton for at least 30 minutes prior to subcutaneous injection. Do not warm SIMPONI in any other way.

Prior to administration, visually inspect the solution for particles and discoloration through the viewing window. SIMPONI is clear to slightly opalescent and colorless to light yellow. Do not use SIMPONI, if the solution is discolored, or cloudy, or if foreign particles are present.

Do not use any leftover product remaining in the prefilled syringe or prefilled autoinjector.

Instruct patients sensitive to latex not to handle the needle cover on the prefilled syringe or the needle cover of the prefilled syringe within the autoinjector cap because it contains dry natural rubber (a derivative of latex).

At the time of dosing, if multiple injections are required, administer the injections at different sites on the body.

Rotate injection sites and never give injections into areas where the skin is tender, bruised, red, or hard.

If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.