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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For rheumatoid arthritis and psoriatic arthritis, MTX should be continued during treatment with Cimzia where appropriate. Adverse reactions based primarily on experience from the placebo-controlled clinical trials cimziw postmarketing cases at least possibly related to Cimzia are listed in Table 1 below, according to frequency and system organ class.
No data are available. Latex-sensitivity The needle shield inside the removable cap of the CIMZIA pre-filled syringe contains a derivative of natural rubber latex see section 6. In a clinical study 16 women were treated with ip pegol mg every 2 weeks or mg every 4 weeks during pregnancy.
To view the changes to a medicine you must sign up and log in. Biotransformation and elimination PEGylation, the covalent attachment of PEG polymers to peptides, delays the elimination of these entities from the circulation by cijzia variety of mechanisms, including decreased renal clearance, decreased proteolysis, and decreased immunogenicity. Patient on Cimzia mg every 2 weeks were re-randomized to Cimzia mg every 2 weeks, Cimzia mg every 2 weeks, or placebo. Cimzia-treated patients reported significant improvements in health-related quality cimmzia life as measured by the psoriatic arthritis QoL PsAQoL and the SF Physical and Mental Components and in psoriatic arthritis-related productivity at work and within household, as reported by the Work Productivity Survey compared to placebo.
The maximum duration ppi the study was weeks. To email a medicine you must sign up and log in. No data are available on the response to live vaccinations or the secondary transmission of infection by live vaccines in patients receiving Cimzia. Psoriatic arthritis 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. Of these, completed 2 years of open-label follow-up and thus had a li exposure to Cimzia of weeks overall.
The Fab’ fragment comprises protein compounds and is expected to be degraded to peptides and amino acids by proteolysis.
Psoriatic arthritis 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. This information cimza intended for use by health professionals. Cimzia is mostly used for conditions that are severe, moderately severe or getting worse, or when patients cannot use other treatments.
Specific clinical trials have not been performed in elderly patients subjects.
Cimzia 200 mg solution for injection in pre-filled syringe
Therefore, early detection of any infection, particularly atypical clinical presentations of a serious infection, is critical to minimise delays in diagnosis and initiation of treatment. A risk for the development of malignancies in children and adolescents treated with TNF-antagonists cannot be excluded.
For the full list of restrictions, see the package leaflet.
Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised. Solution for injection injection. Carriers of HBV who require treatment with Cimzia should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
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TGA eBS – Product and Consumer Medicine Information
Vaccinations Patients treated with Cimzia may receive vaccinations, except for live vaccines. In clinical trials with Cimzia and other TNF-antagonists, more cases of lymphoma and other malignancies have been reported among patients receiving TNF-antagonists than in control patients receiving placebo see section 4.
In patients who develop HBV reactivation, Cimzia should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
In study-to-study comparison, the pharmacokinetics of certolizumab pegol cimzzia similar to those observed previously in healthy subjects. Missing data were imputed using multiple imputation based on the MCMC method.
PGA clear or almost clear b. 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.
The ACR 20 endpoint was achieved for both Cimzia mg every 2 weeks and mg every 4 weeks.
Women of childbearing potential The use of adequate contraception should be considered for women of childbearing potential. After the starting dose, the recommended maintenance dose of Cimzia for adult patients with psoriatic arthritis is mg every 2 weeks. Serious infections also included invasive opportunistic infections e. General disorders and administration site conditions.
Carcinogenicity studies have not been performed with certolizumab pegol. For patients remaining in the study, improvements in all afore-mentioned outcomes were largely vimzia through Week Autoimmunity Treatment with Cimzia may result in the formation of antinuclear antibodies ANA and, uncommonly, in the development of a lupus-like syndrome see section 4.
All patients had a history of heavy smoking. Cimzia can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. However, the available clinical experience is too limited to, with a reasonable certainty, conclude that there is no increased risk associated with Cimzia administration during pregnancy. MTX should be continued during treatment with Cimzia where appropriate.
For women planning pregnancy, continued contraception may be considered for 5 months after the last Cimzia dose due to its elimination rate see section 5. For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
Antibody formation was associated with lowered drug plasma concentration and in some patients, reduced efficacy.