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 mean PASI score at baseline was 20 and ranged from 12 to Among patients initially randomised to Cimzia mg every 2 weeks and Cimzia mg every 4 weeks, Adults with severe active ankylosing spondylitis who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs NSAIDs. Marketing authorisation holder 8. 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.
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. Non-clinical studies suggest low or negligible level of placental transfer of a homologue Fab-fragment of certolizumab pegol no Fc region see section 5. The safety profile for psoriatic arthritis patients treated with Cimzia was consistent with the safety profile in rheumatoid arthritis and previous experience with Cimzia.
Cimzia | European Medicines Agency
Treatment with Cimzia must be discontinued in patients who develop new or worsening symptoms of congestive heart failure. 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. The pre-filled syringe with needle guard should only be used by healthcare professionals.
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. This medicinal product is comzia single use only.
Caution should be exercised when treating the elderly patients, and particular attention paid with respect to occurrence of infections. Neoplasms benign, malignant and unspecified including cysts and polyps. Among patients remaining in the study, ACR 20, 50 and 70 response rates were maintained through Week At the end of this period the pre-filled syringes must be used or discarded.
Axial spondyloarthritis Cimzia is indicated for the treatment of adult patients with severe active axial spondyloarthritis, comprising: For the full list of restrictions, see the package leaflet.
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.
TGA eBS – Product and Consumer Medicine Information
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. Patients on Cimzia mg every 2 weeks were re-randomized to Cimzia mg every 2 weeks, Cimzia mg every 4 weeks or placebo. Following subcutaneous administration, peak plasma concentrations of certolizumab pegol were attained between 54 and hours post-injection.
The ACR 20 endpoint was achieved for both Cimzia mg every 2 weeks and mg every 4 weeks. At week 16, patients randomized to Cimzia who achieved a PASI 50 response continued to receive Cimzia up to Week 48 at the same randomized dose. After patients receive Cimzia, careful attention should be given to interpretation of abnormal coagulation results. In addition, at Week 16, Cimzia treatment was associated with a greater proportion of patients achieving a DLQI score of 0 or 1 Cimzia mg every 2 weeks, Musculoskeletal, connective tissue and bone disorders.
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.
All patients had a history of heavy smoking. Some patients who have been successfully treated for active tuberculosis have redeveloped tuberculosis while being treated with Cimzia. Therefore the use of certolizumab pegol in combination with anakinra or abatacept is not recommended see section 4. The studies included adults with active rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis and moderate to severe plaque psoriasis:.
Cimzia 200 mg solution for injection in pre-filled syringe
Radiographic set with linear extrapolation. Patients received a loading dose of Cimzia mg at Weeks 0, 2 and 4 for both treatment arms or placebo followed by either Cimzia mg every 2 weeks or mg every 4 weeks or placebo every 2 weeks. 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. Vaccinations Patients treated with Cimzia may receive vaccinations, except for live vaccines.
Method of administration The total content 1 ml of the pre-filled syringe should be administered as a subcutaneous injection only.
icmzia The potential role of TNF-antagonist therapy in the development of malignancies is not known. 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. If latent tuberculosis is diagnosed, appropriate anti-tuberculosis therapy must be started before initiating treatment with Cimzia and in accordance with local recommendations.
In RA-I, structural joint damage was assessed radiographically and expressed as change in mTSS and its components, the erosion score and joint space narrowing JSN score, at Week 52, compared to baseline. Response rates and p-values based on a logistic regression model. Patients should be tested for HBV infection before initiating treatment with Cimzia. The Fab’ fragment comprises protein compounds and is expected to be degraded to peptides and amino acids by proteolysis.
Inhibition of radiographic progression was further maintained up to Week for the patients who remained in the study. Activated partial thromboplastin time aPTT assay Interference with certain coagulation assays has been detected in patients treated with Cimzia.