Simponi Dosage/Direction for Use

Golimumab (Simponi) is administered by subcutaneous injection.
Adult patients with: Rheumatoid arthritis/Psoriatic arthritis/Ankylosing spondylitis/Non-radiographic axial spondyloarthritis: 50 mg of Golimumab (Simponi) given as a subcutaneous injection once a month, on the same date each month.
Ulcerative colitis: Patients with body weight less than 80 kg: Golimumab (Simponi) given as an initial dose of 200 mg, followed by 100 mg at Week 2, then 50 mg every 4 weeks, thereafter (see Pharmacology: Pharmacodynamics: Clinical Efficacy under Actions).
Patients with body weight greater than or equal to 80 kg: Golimumab (Simponi) given as an initial dose of 200 mg, followed by 100 mg at Week 2, then 100 mg every 4 weeks, thereafter (see Pharmacology: Pharmacodynamics: Clinical Efficacy under Actions).
During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.
Available data suggest that clinical response is usually achieved within 12‑14 weeks of treatment (after 4 doses). Continued therapy should be reconsidered in patients who show no evidence of therapeutic benefit within this time period.
Golimumab (Simponi) is intended for use under the guidance and supervision of a physician. After proper training in subcutaneous injection technique, a patient may self‑inject with Golimumab (Simponi) if a physician determines that it is appropriate and with medical follow‑up as necessary.
At the time of dosing, if multiple injections are required, the injections should be administered at different sites on the body. Patients should be instructed to inject the full amount of Golimumab (Simponi) according to the directions provided in Instructions for Injecting Golimumab (Simponi) Using a Single‑Use SmartJect Autoinjector/Pre‑Filled Pen under Cautions for Usage.
Special Populations: Pediatrics (17 years of age and younger): The safety and efficacy of Golimumab (Simponi) in pediatric patients aged 17 years and younger for indications other than pJIA have not been established (see Pharmacology: Pharmacodynamics under Actions).
Polyarticular juvenile idiopathic arthritis: 50 mg of Golimumab (Simponi) administered once a month, on the same date each month, for children with a body weight of at least 40 kilograms.
Available data suggest that clinical response is usually achieved within 12 to 14 weeks of treatment (after 3 to 4 doses). Continued therapy should be reconsidered in children who show no evidence of therapeutic benefit within this time period.
Elderly (65 years of age and older): Dose adjustment is not required in elderly patients (see Precautions).
Renal impairment: Specific studies of Golimumab (Simponi) have not been conducted in patients with renal impairment.
Hepatic impairment: Specific studies of Golimumab (Simponi) have not been conducted in patients with hepatic impairment.