Cimzia Dosage/Direction for Use

Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Cimzia is indicated. Patients should be given the special reminder card.
Posology: Rheumatoid arthritis, psoriatic 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 and psoriatic 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. After at least 1 year of treatment with Cimzia, in patients with sustained remission, a reduced maintenance dose of 200 mg every 4 weeks may be considered (see Pharmacology: Pharmacodynamics under Actions).
Psoriatic arthritis: After the starting dose, the recommended maintenance dose of Cimzia for adult patients with psoriatic 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.
For previously mentioned 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 Pharmacology: Pharmacodynamics under Actions).
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.
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 Pharmacology: Pharmacokinetics under Actions).
Renal and hepatic impairment: Cimzia has not been studied in these patient populations. No dose recommendations can be made (see Pharmacology: Pharmacokinetics under Actions).
Method of administration: The total content (1 ml) of the pre-filled pen 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 pen 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.