Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2012 Publisher: UCB Pharma SA Allée de la Recherche 60 B-1070 Bruxelles Belgium
Cimzia, in combination with methotrexate (MTX), is indicated for the treatment of moderate to severe, active rheumatoid arthritis (RA) in adult patients when the response to disease-modifying antirheumatic drugs (DMARDs) including methotrexate, has been inadequate.
Cimzia can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
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 methotrexate.
Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis. Patients should be given the special alert card.
The recommended starting dose of Cimzia for adult patients with rheumatoid arthritis is 400 mg (as 2 injections of 200 mg each on one day) at weeks 0, 2 and 4, followed by a maintenance dose of 200 mg every 2 weeks. MTX should be continued during treatment with Cimzia where appropriate.
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.
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 every 2 weeks as originally 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 if their physician determines that it is appropriate and with medical follow-up as necessary.
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.
18 months.
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.
One ml pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber), containing 200 mg of certolizumab pegol.
None of the components of the syringe contain latex.
Pack size of 2 syringes and 2 alcohol wipes, and multipack containing 6 (3 packs of 2) pre-filled syringes and 6 (3 packs of 2) alcohol wipes.
Not all pack sizes may be marketed.
This medicinal product is for single use only.
Any unused product or waste material should be disposed of in accordance with local requirements.
Comprehensive instructions for the preparation and administration of Cimzia in a pre-filled syringe are given in the package leaflet.
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