Posology : מינונים

4.2   Posology and method of administration
Treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, or ulcerative colitis.
Patients treated with Simponi should be given the Patient Reminder Card.


Posology
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 above 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 body weight greater than 100 kg
For all the above indications, in patients with RA, PsA, 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 reactions with the 100 mg dose compared with the 50 mg dose (see section 4.8). Continued therapy should be reconsidered in patients who show no evidence of therapeutic benefit after receiving 3 to 4 additional doses of 100 mg.

Ulcerative colitis
Patients with body weight less than 80 kg
Simponi given as an initial dose of 200 mg, followed by 100 mg at week 2. Patients who have an adequate response should receive 50 mg at week 6 and every 4 weeks thereafter. Patients who have an inadequate response may benefit from continuing with 100 mg at week 6 and every 4 weeks thereafter (see section 5.1), taking into account the increased risk of certain serious adverse drug reactions with the 100 mg dose compared with the 50 mg dose.


Patients with body weight greater than or equal to 80 kg
Simponi given as an initial dose of 200 mg, followed by 100 mg at week 2, then 100 mg every 4 weeks, thereafter (see section 5.1).

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.

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 the forgotten dose and stay on the original schedule.
•     if the dose is more than 2 weeks late, the patient should inject the forgotten dose and a new schedule should be established from the date of this injection.

Special populations
Eldery (≥ 65 years)
No dose 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 population
Simponi 50 mg:
The safety and efficacy of Simponi in patients aged less than 18 for indications other than pJIA have not been established.

Polyarticular juvenile idiopathic arthritis
Simponi 50 mg administered once a month, on the same date each month, for children with a body weight of at least 40 kg.

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 children who show no evidence of therapeutic benefit within this time period.

Simponi 100 mg:
Simponi 100 mg is not recommended in children aged less than 18.

Method of administration
Simponi is for subcutaneous use. After proper training in subcutaneous injection technique, patients may self-inject 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 according to the comprehensive instructions for use provided in the package leaflet.
If multiple injections are required, the injections should be administered at different sites on the body.
For administration instructions, see section 6.6.