Simponi Dosage/Direction for Use

SIMPONI treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non- radiographic axial spondyloarthritis or ulcerative colitis.
SIMPONI is administered by subcutaneous injection or intravenous infusion.
The efficacy and safety of switching between IV and SC formulations have not been established.
Posology: SIMPONI Solution for Injection: Subcutaneous injection: Rheumatoid arthritis: SIMPONI 50 mg given once a month, on the same date each month.
SIMPONI should be given concomitantly with MTX.
Psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis: SIMPONI 50 mg given once a month, on the same date each month.
For all of the previous indications, available data suggest that clinical response is usually achieved within 12 to 14 weeks of treatment (after 3-4 doses). Continued therapy should be reconsidered in patients who show no evidence of therapeutic benefit within this time period.
Patients with bodyweight greater than 100 kg: For all of the above indications, in patients with RA, PsA or AS, or nr-Axial SpA with a body weight of more than 100 kg who do not achieve an adequate clinical response after 3 or 4 doses, increasing the dose of golimumab to 100 mg once a month may be considered, taking into account the increased risk of certain serious adverse drug reactions with the 100mg dose compared with the 50mg dose (see Adverse Reactions). Continued therapy should be reconsidered in patients who show no evidence of therapeutic benefit after receiving 3 to 4 additional doses of 100mg.
Ulcerative colitis: Patients with body weight less than 80 kg: SIMPONI given as an initial dose of 200 mg, followed by 100mg at week 2. Patients who have an adequate response should receive 50mg at week 6 and every 4 weeks thereafter. Patients who have an inadequate response may benefit from continuing with 100mg at week 6 and every 4 weeks thereafter (see Pharmacology: Pharmacodynamics under Actions).
Patients with body weight greater than or equal to 80 kg: SIMPONI given as an initial dose of 200 mg, followed by 100mg at week 2, then 100mg every 4 weeks, thereafter (see Pharmacology: Pharmacodynamics under).
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.
SIMPONI IV 12.5mg/1ml Concentrate for Solution for Infusion: Administration by intravenous infusion is indicated only for rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis.
Rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis: 2 mg/kg of SIMPONI given as a 30-minute intravenous infusion at Weeks 0 and 4, then every 8 weeks thereafter (see Instructions for Use and Handling and Disposal under Patient Counselling Information).
Missed dose: If a patient forgets to inject SIMPONI on the planned date, the forgotten dose should be injected as soon as the patient remembers. Patients should be instructed not to inject a double dose to make up for the forgotten dose.
The next dose should be administered based on the following guidance: if the dose is less than 2 weeks late, the patient should inject his/her forgotten dose and stay on his/her original schedule; if the dose is more than 2 weeks late, the patient should inject his/her forgotten dose and a new schedule should be established from the date of this injection.
Special populations: Elderly (≥ 65 years): No dosage adjustment is required in the elderly.
Renal and hepatic impairment: SIMPONI has not been studied in these patient populations. No dose recommendations can be made.
Paediatric patients: The safety and efficacy of SIMPONI in patients aged less than 18 have not yet been established. No data are available.
Method of administration: Subcutaneous injection: SIMPONI Solution for Injection is for subcutaneous use. After proper training in subcutaneous injection technique, patients may self-inject with SIMPONI Solution for Injection if their physician determines that this is appropriate, with medical follow-up as necessary. Patients should be instructed to inject the full amount of SIMPONI Solution for Injection according to the comprehensive instructions for administration provided in the package leaflet. If multiple injections are required, the injections should be administered at different sites on the body.
For administrative instructions, see "Instructions for use, handling and disposal" under Patient Counselling Information.
Intravenous infusion: Intravenous infusion of SIMPONI IV 12.5mg/1ml Concentrate for Solution for Infusion should be administered by qualified health care professionals trained to detect any infusion-related issues.
Comprehensive instructions for the intravenous infusion of SIMPONI IV 12.5mg/1ml Concentrate for Solution for Infusion are given in Instructions for use, handling, and disposal under Patient Counselling Information.