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  • Cimzia
    / Neopharm


    Active Ingredient
    Certolizumab Pegol 200 mg/ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Pre-filled Syringe

    2 X 1 ml X 200 mg

    partial basket chart 13383

    Related information


    Dosage

    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. 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.
    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.
    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.
    Renal and hepatic impairment: Cimzia has not been studied in these patient populations. No dose recommendations can be made.
    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.


    Indications

    Rheumatoid arthritis: 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.
    Axial spondyloarthritis: Cimzia is indicated for the treatment of adult patients with severe active axial spondyloarthritis, comprising:
    Ankylosing spondylitis (AS): Adults with severe active ankylosing spondylitis who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).
    Axial spondyloarthritis without radiographic evidence of AS: 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.
    Crohn’s Disease: Cimzia is indicated for reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients.
    Active tuberculosis or other severe infections such as sepsis or opportunistic infections.
    Moderate to severe heart failure (NYHA classes III/IV).


    Special Precautions

    Infections: Patients must be monitored closely for signs and symptoms of infections including tuberculosis before, during and after treatment with Cimzia. Because the elimination of certolizumab pegol may take up to 5 months, monitoring should be continued throughout this period.
    Tuberculosis: Before initiation of therapy with Cimzia, all patients must be evaluated for both active or inactive (latent) tuberculosis infection. If active tuberculosis is diagnosed prior to or during treatment, Cimzia therapy must not be initiated and must be discontinued.
    Hepatitis B virus (HBV) reactivation: Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including certolizumab pegol, who are chronic carriers of this virus (i.e., surface antigen positive). Some cases have had a fatal outcome.
    Patients should be tested for HBV infection before initiating treatment with Cimzia. For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
    Congestive heart failure: Cimzia is contraindicated in moderate or severe heart failure.
    Elderly patients: In the clinical trials, there was an apparently higher incidence of infections among subjects ≥ 65 years of age, compared to younger subjects, although experience is limited. Caution should be exercised when treating the elderly patients, and particular attention paid with respect to occurrence of
    infections.
    See prescribing information for full details.


    Side Effects

    Rheumatoid arthritis: The most common adverse reactions belonged to the system organ classes Infections and infestations, reported in 14.4% of patients on Cimzia and 8.0% of patients on placebo, General disorders and administration site conditions, reported in 8.8% of patients on Cimzia and 7.4% of patients on placebo, and Skin and subcutaneous tissue disorders, reported in 7.0% of patients on Cimzia and 2.4% of patients on placebo.
    Axial spondyloarthritis: The safety profile for axial spondyloarthritis patients treated with Cimzia was consistent with the safety profile in rheumatoid arthritis and previous experience with Cimzia.
    See prescribing information for full details.


    Drug interactions

    Concomitant treatment with methotrexate, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs) and analgesics showed no effect on the pharmacokinetics of certolizumab pegol based on a population pharmacokinetics analysis.
    The combination of certolizumab pegol and anakinra or abatacept is not recommended.
    Co-administration of Cimzia with methotrexate had no significant effect on the pharmacokinetics of methotrexate. In study-to-study comparison, the pharmacokinetics of certolizumab pegol appeared similar to those observed previously in healthy subjects.


    Pregnancy and Lactation

    Pregnancy: Cimzia should only be used during pregnancy if clinically needed.
    Lactation: Since certolizumab pegol is a protein that is degraded in the gastrointestinal tract after oral administration, the absolute bioavailability is expected to be very low in a breastfed infant. Consequently, Cimzia can be used during breastfeeding.
    See prescribing information for full details.


    Overdose

    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.


    Important notes

    Storage: Store in a refrigerator (2°C– 8°C). Do not freeze.
    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.


    Manufacturer
    UCB S.A., Belgium
    Licence holder
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