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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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. cimziz

Results are from the Randomized Set. At the end of this period the pre-filled syringes must be used or discarded. During controlled clinical trials through Week 16, the proportion of patients with serious adverse events was 3.

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. Radiographic set with linear extrapolation. Accordingly, certolizumab pegol is an antibody Fab’ fragment cimziia with PEG in order to extend the terminal plasma elimination half-life of the Fab’ to a value comparable with a whole antibody product.

Cimzia | European Medicines Agency

Cimzia was administered subcutaneously in combination with oral MTX for a minimum of 6 months with stable doses of at least 10 mg weekly for 2 months in both trials. Healthcare professionals are asked to report any suspected adverse reactions via:. The safety and efficacy of Cimzia in children and adolescents below age 18 years have not yet been established. Patients on Cimzia mg every two weeks led to PEGylation, cinzia covalent attachment of PEG polymers to peptides, delays the elimination of these entities from the circulation by cimaia variety of mechanisms, including decreased renal clearance, decreased proteolysis, and decreased immunogenicity.

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In rats and monkeys, at doses higher than those given to humans, histopathology revealed cellular vacuolation, present mainly in macrophages, in a number of organs lymph nodes, injection sites, spleen, adrenal, uterine, cervix, choroid plexus of the brain, and in the epithelial cells of the choroid plexus.

In all 3 studies, the PASI 75 response rate was significantly greater for Cimzia compared to placebo starting at Week 4. Absorption Following subcutaneous administration, oi plasma concentrations of certolizumab pegol were attained between 54 and hours post-injection.

Cimzia is mostly used for conditions that are severe, moderately severe or getting worse, or when patients cannot use other treatments. Serious infections also included invasive opportunistic infections e. Cimzia has been shown oi reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with MTX.

Discontinuation of Cimzia therapy should be considered in patients with confirmed significant haematological abnormalities. Leave this field blank.

Reproductive system and breast disorders. The overall percentage of patients with antibodies to Cimzia detectable on at least one occasion cimzua to Week 24 was The safety profile for axial spondyloarthritis patients treated with Cimzia was consistent with the safety profile in rheumatoid arthritis and previous experience with Cimzia.

Cases of congestive heart failure have also been reported in rheumatoid arthritis patients receiving Cimzia.

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Infections Patients must be monitored closely for signs and symptoms of infections including tuberculosis before, during and after treatment with Cimzia. Treatment starts with a mg dose given as two injections, followed by a further mg dose two and four weeks later. There have been rare reports of other immune-mediated conditions; the causal relationship to Cimzia is not known.

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Because the elimination of certolizumab pegol may take up to 5 months, monitoring should be continued throughout this period see section 4. There is limited safety experience with surgical procedures in patients treated with Cimzia. Cimzia was studied in patients with psoriasis in controlled and open-label studies for up to 18 months.

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Patients receiving Cimzia and concomitant methotrexate had a lower humoral response compared with patients receiving Cimzia alone. Of the patients initially randomised to active treatment in RA-I, completed 52 weeks of placebo-controlled treatment and entered the open-label extension study.

Similar to the placebo-controlled studies, antibody positivity was associated with reduced efficacy in some cjmzia.

Cimzia 200 mg solution for injection in pre-filled syringe

Since tumour necrosis factor TNF mediates inflammation and modulates cellular immune responses, the possibility exists for TNF-antagonists, including Cimzia, to cause immunosupression, affecting host defences against infections and malignancies. Cimzia-treated patients reported significant improvements in axial spondyloarthritis-related productivity at work and within household, as reported by the Work Productivity Survey as compared to placebo.

In an exploratory clinical trial evaluating the use of another TNF-antagonist, infliximab, in patients with moderate to severe chronic obstructive pulmonary disease COPDmore malignancies, mostly in the lung or head and neck, were reported in infliximab-treated patients compared with control patients.

Surgery There is limited safety experience with surgical procedures in patients treated with Cimzia. The key results from the study are presented in table 4. Improvements in all afore-mentioned outcomes were maintained through Week Antibody formation pl associated with lowered drug plasma concentration and in some patients, reduced efficacy.