Posology : מינונים

4.2   Posology and method of administration
Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Cimzia is indicated.

Posology
Rheumatoid arthritis, axial spondyloarthritis, plaque psoriasis

Loading dose
The recommended starting dose of Cimzia for adult patients is 400 mg (given as 2 subcutaneous injections of 200 mg each) at weeks 0, 2 and 4. For rheumatoid arthritis, MTX should be continued during treatment with Cimzia where appropriate.

Maintenance dose
Rheumatoid arthritis
After the starting dose, the recommended maintenance dose of Cimzia for adult patients with rheumatoid arthritis is 200 mg every 2 weeks. Once clinical response is confirmed, an alternative maintenance dosing of 400 mg every 4 weeks can be considered. MTX should be continued during treatment with Cimzia where appropriate.

Axial spondyloarthritis
After the starting dose, the recommended maintenance dose of Cimzia for adult patients with axial spondyloarthritis is 200 mg every 2 weeks or 400 mg every 4 weeks.

For the above indications, available data suggest that clinical response is usually achieved within 12 weeks of treatment. Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within the first 12 weeks of treatment.

Plaque psoriasis
After the starting dose, the maintenance dose of Cimzia for adult patients with plaque psoriasis is 200 mg every 2 weeks. A dose of 400 mg every 2 weeks can be considered in patients with insufficient response (see section 5.1).
Available data in adults with plaque psoriasis suggest that a clinical response is usually achieved within 16 weeks of treatment. Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within the first 16 weeks of treatment. Some patients with an initial partial response may subsequently improve with continued treatment beyond 16 weeks.

Crohn’s Disease
After the starting dose, in patients who obtain a clinical response, the recommended maintenance dose is 400 mg every four weeks.


Missed dose
Patients who miss a dose should be advised to inject the next dose of Cimzia as soon as they remember and then continue injecting subsequent doses as instructed.

Special populations
Paediatric population (< 18 years old)
The safety and efficacy of Cimzia in children and adolescents below age 18 years have not yet been established. No data are available.

Elderly patients (≥ 65 years old)
No dose adjustment is required. Population pharmacokinetic analyses showed no effect of age (see section 5.2).

Renal and hepatic impairment
Cimzia has not been studied in these patient populations. No dose recommendations can be made (see section 5.2).

Method of administration
The total content (1 ml) of the pre-filled syringe should be administered as a subcutaneous injection only. Suitable sites for injection would include the thigh or abdomen.

After proper training in injection technique, patients may self-inject using the pre-filled syringe if their physician determines that it is appropriate and with medical follow-up as necessary. The physician should discuss with the patient which injection presentation option is the most appropriate.