Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: UCB Pharma S.A., Allée de la Recherche 60, B-1070, Bruxelles, Belgium
Cimzia, in combination with methotrexate (MTX), is indicated for:
Cimzia has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with MTX.
Cimzia is indicated for the treatment of adult patients with severe active axial spondyloarthritis, comprising:
Adults with severe active ankylosing spondylitis who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).
Adults with severe active axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have had an inadequate response to, or are intolerant to NSAIDs.
Cimzia, in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate.
Cimzia can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Cimzia is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
For details on therapeutic effects, see section 5.1.
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.
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.
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.
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 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.
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.
The safety and efficacy of Cimzia in children and adolescents below age 18 years have not yet been established. No data are available.
No dose adjustment is required. Population pharmacokinetic analyses showed no effect of age (see section 5.2).
Cimzia has not been studied in these patient populations. No dose recommendations can be made (see section 5.2).
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 pre-filled syringe with needle guard should only be used by healthcare professionals. The physician should discuss with the patient which injection presentation option is the most appropriate.
No dose-limiting toxicity was observed during clinical trials. Multiple doses of up to 800 mg subcutaneously and 20 mg/kg intravenously have been administered. In cases of overdose, it is recommended that patients are monitored closely for any adverse reactions or effect, and appropriate symptomatic treatment initiated immediately.
Shelf life: 2 years.
See also section 6.4 for shelf-life related to storage at room temperature up to a maximum of 25°C.
Store in a refrigerator (2°C–8°C).
Do not freeze.
Keep the pre-filled syringe in the outer carton in order to protect from light.
The pre-filled syringes may be stored at room temperature (up to 25°C) for a single period of maximum 10 days with protection from light. At the end of this period the pre-filled syringes must be used or discarded.
One ml pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber), containing 200 mg of certolizumab pegol. The needle shield is styrene butadiene rubber which contains a derivative of natural rubber latex (see section 4.4).
Pack size of 2 pre-filled syringes and 2 alcohol wipes.
Multipack containing 6 (3 packs of 2) pre-filled syringes and 6 (3 packs of 2) alcohol wipes.
Multipack containing 10 (5 packs of 2) pre-filled syringes and 10 (5 packs of 2) alcohol wipes.
Pack size of 2 pre-filled syringes with needle guard and 2 alcohol wipes (for use by healthcare professionals only).
Not all pack sizes may be marketed.
Comprehensive instructions for the preparation and administration of Cimzia in a pre-filled syringe are given in the package leaflet.
This medicinal product is for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.
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