Simponi Dosage/Direction for Use

Dosing Considerations: SIMPONI is intended for use under the guidance and supervision of a physician. After an initial training in proper subcutaneous injection technique, an adult patient with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or ulcerative colitis may self-inject with 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.
Comprehensive instructions for the administration of SIMPONI are given in Instructions for Injecting SIMPONI Using a Single-Use SmartJect Autoinjector under Patient Counselling Information for preparation and giving an injection of SIMPONI. Patients should be instructed to inject the full amount of SIMPONI according to the directions provided in Patient Counselling Information.
Recommended Dose and Dosage Adjustment: SIMPONI is administered by subcutaneous injection.
Adult Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-Radiographic Axial Spondyloarthritis Patients: 50 mg of SIMPONI given as a subcutaneous injection once a month, on the same date each month.
For all the previously mentioned indications, available data from clinical trials suggest that clinical response is usually achieved within 14 to 16 weeks of treatment (after 4 doses). Continued therapy should be carefully reconsidered in a patient not responding within this time period.
Data from clinical trials for RA and PsA suggest that efficacy does not increase with doses higher than 50 mg. Doses higher than 50 mg have not been studied in nr-Ax SpA.
Adult Ulcerative Colitis: 200 mg initially administered by subcutaneous injection at Week 0, followed by 100 mg at Week 2 and then 50 mg every 4 weeks, thereafter.
The maintenance dose of 100 mg every 4 weeks can be considered at the discretion of the treating physician. In addition to the clinical assessment, measurement of golimumab levels may be taken into account before considering dose optimization as some patients may not benefit from dose escalation.
During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.
Missed Dose: Patients who miss a dose of SIMPONI, should be advised to inject this missed dose as soon as they become aware of it, and then follow with their next scheduled dose.
Special Populations: Geriatrics: Pharmacokinetic parameters including apparent clearance were not influenced by age in SIMPONI clinical trials. Dose adjustment is not required in elderly patients (see Use in the Elderly under Precautions).
Pediatrics: The safety and efficacy of SIMPONI have not been established in pediatric patients aged 17 years and younger.
Renal impairment: Specific studies of SIMPONI have not been conducted in patients with renal impairment.
Hepatic impairment: Specific studies of SIMPONI have not been conducted in patients with hepatic impairment. SIMPONI should be used with caution in subject with impaired hepatic function.
Administration: SIMPONI is supplied as a single-use, sterile solution in a pre-filled syringe and single-use autoinjector administered by subcutaneous injection (see Dosing Considerations as previously mentioned).