CIMZIA PI PDF

PI & CMI Trade Names and Active Ingredients containing certolizumab. 2 Documents cimzia, PI, Certolizumab pegol. Cimzia, CMI, Certolizumab pegol. Cimzia mg solution for injection in pre-filled syringe. 2. QUALITATIVE The recommended starting dose of Cimzia for adult patients is mg (given as 2. An overview of Cimzia and why it is authorised in the EU. Cimzia is a medicine that is used in adults to treat the following diseases: active rheumatoid arthritis (a .

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The infections consisted primarily of upper respiratory tract infections and viral infections including herpes infections.

A monoclonal antibody is a protein that has been designed to recognise and attach to a specific structure in the body. One case of lymphoma was also observed in the Phase III psoriatic arthritis clinical trial. A risk for the development of malignancies in children and adolescents treated with TNF-antagonists cannot be excluded. Adequate data of treating patients who are carriers of HBV with anti-viral therapy in conjunction with TNF-antagonist therapy to prevent HBV reactivation are not available.

Cimzia patients demonstrated significantly less radiographic progression than patients receiving placebo at Week 24 and Week 52 see Table 5.

Cimzia 200 mg solution for injection in pre-filled syringe

Adverse reactions based primarily on experience from the placebo-controlled clinical trials and postmarketing cases at least possibly related to Cimzia are listed in Table 1 below, according to frequency and system organ class. Some patients who have been successfully treated for active tuberculosis have redeveloped tuberculosis while being treated with Cimzia. However, these are insufficient with respect to human reproductive toxicity see section 5.

An ANCOVA was fitted to the ranked change from baseline for each measure with region and treatment as factors and rank baseline as a covariate. The day half-life of certolizumab pegol should be taken into consideration if a surgical procedure is planned.

This site uses cookies. Nine main studies involving over 3, patients have found Cimzia effective for reducing symptoms of inflammatory conditions. Statistically significantly greater ACR 20 and ACR 50 responses were achieved from Week 1 and Week 2, respectively, in both clinical trials compared to placebo. No mutagenic or clastogenic effects were demonstrated in preclinical studies. Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including certolizumab pegol, who are chronic carriers of this virus i.

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Specific clinical trials have not been performed to assess the effect of hepatic impairment on the pharmacokinetics of certolizumab pegol.

Among patients initially randomised to Cimzia mg every 2 weeks and Cimzia mg every 4 weeks, In the placebo-controlled rheumatoid arthritis clinical trials, 5. Periodic skin examination is recommended, particularly for patients with risk factors for skin cancer. Over the course of the entire study up to weeksthe overall percentage of patients with antibodies to Cimzia detectable on at least one occasion was 9.

Patients on Cimzia mg every 2 weeks were re-randomized to Cimzia mg every 2 weeks, Cimzia mg every 4 weeks or placebo. The mean PASI score at baseline was 20 and ranged from 12 to In cases of overdose, it is recommended that patients are monitored closely for any adverse reactions or effect, and appropriate symptomatic treatment initiated immediately. Marketing authorisation number s 9. Cimzia can only be obtained with a prescription and treatment should only be started by a specialist doctor who has experience in diagnosing and treating the diseases that Cimzia is used to treat.

Certolizumab pegol does not bind to the human neonatal Fc receptor FcRn. Effects on sperm motility measures and a cimia of reduced sperm count in male rodents have been observed with no apparent effect on cizmia see section 5.

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. Physicians should exercise caution when considering the use of Cimzia in patients with a history of recurring or opportunistic infection or with underlying conditions which may predispose patients to infections, including the use of concomitant immunosuppressive medications.

Clear to opalescent, colourless to yellow solution.

After the starting dose, the recommended maintenance dose of Cimzia for adult patients with rheumatoid arthritis is mg every 2 weeks. Patients originally randomized to Cimzia clmzia achieved a PASI75 response at Week 16 were re-randomized based on their original dosing schedule.

Solution for injection injection. Date of revision of the text. Caution should be exercised when considering TNF-antagonist therapy for patients with a history of malignancy or when considering continuing treatment in patients who develop malignancy.

For the full list of excipients, see section 6. The majority of reported TNF-antagonist cases occurred in adolescent and young adult cizmia with Crohn’s disease or ulcerative colitis.

Activated partial thromboplastin time aPTT assay Interference with certain coagulation assays has been detected in patients treated with Cimzia. Because of the nature of the adverse events seen with the combination of another TNF-antagonist with either abatacept or anakinra therapy, similar toxicities may also result from the combination of anakinra or abatacept and other TNF-antagonists.

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Maintenance dose Rheumatoid arthritis After the starting dose, the recommended maintenance dose of Cimzia for adult patients with rheumatoid arthritis is mg every 2 weeks.

Cimzia | European Medicines Agency

The potential role of TNF-antagonist therapy in the development of malignancies is not known. Cimzia was studied in 4, patients with rheumatoid arthritis in controlled and open label trials for up to 92 months. Both doses of Cimzia demonstrated efficacy compared to placebo regardless of age, gender, body weight, BMI, psoriasis disease duration, previous treatment with systemic therapies and previous treatment with biologics.

Spinal mobility was assessed in the double-blind, placebo-controlled period by using BASMI at several time points including Baseline, Week 12 and Week Special populations Renal impairment Specific clinical trials have not been performed to assess the effect of renal impairment on the pharmacokinetics of certolizumab pegol or its PEG fraction.

Cimzia was studied in patients with psoriatic arthritis in the PsA clinical study for up to 4 years which includes a week placebo-controlled phase followed by a week dose-blind period and a week open-label treatment period. Population pharmacokinetic analyses showed no effect of age see section 5. Cimzia has not been studied in these patient populations.

The recommended starting dose of Cimzia for adult patients is mg given as 2 subcutaneous injections of mg each at weeks 0, 2 and 4. It is recommended to wait a minimum of 5 months following the mother’s last Cimzia administration during pregnancy before administration of live or live-attenuated vaccines e.

Patients cimzoa randomized to receive placebo, or Cimzia mg every 2 weeks following a loading dose of Cimzia mg at Weeks 0, 2 and 4or Cimzia cizia every 2 weeks up to Week 16, or etanercept 50 mg twice weekly, up to Week Date of first authorisation: Severe hypersensitivity reactions have been reported rarely following Cimzia administration. Distribution studies have demonstrated that placental and milk transfer of cTN3 PF to the foetal and neonatal circulation is negligible.

The infections consisted primarily of upper respiratory tract infections, urinary tract infections, and lower respiratory tract infections and herpes viral infections see sections 4.