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 .
|Published (Last):||10 January 2017|
|PDF File Size:||17.66 Mb|
|ePub File Size:||5.93 Mb|
|Price:||Free* [*Free Regsitration Required]|
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.
The primary endpoint of the study was the ACR 20 responder rate at week The proportion of patients who discontinued treatment due to adverse events in the controlled clinical studies was 1. Live vaccines should not be administered concurrently with Cimzia.
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. The potential role of TNF-antagonist therapy in the development of malignancies is not known. For subjects who were anti-dsDNA antibody negative at baseline, 2. However, the dose of Cimzia used in this study was higher than the usual dose. This medicinal product is for single use only. Axial spondyloarthritis Cimzia was studied in patients with active axial spondyloarthritis in the AS 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.
The oi percentage of patients with antibodies to Cimzia detectable on at least one occasion up to Week 24 was 4.
Leave this field blank. The infections consisted primarily of upper respiratory tract infections, urinary tract infections, and cinzia respiratory tract infections and herpes viral infections see sections 4.
During the week follow-up, no treatment effects of certolizumab pegol were seen on semen quality parameters compared to placebo.
Interference with thrombin time TT and prothrombin time PT assays have not been observed.
Adults with severe active ankylosing spondylitis who have had an inadequate response to, or are intolerant cinzia nonsteroidal anti-inflammatory drugs NSAIDs. Therefore, reproductive toxicology studies have been performed with a homologous reagent recognising rat TNF.
A patient who requires surgery while on Cimzia should be closely monitored for infections, and appropriate actions should be taken. Melanoma and Merkel cell carcinoma have been reported in patients treated cimziz TNF-antagonists including certolizumab pegol see section 4.
Cimzia 200 mg solution for injection in pre-filled syringe
The most common adverse reactions belonged to the system organ classes Infections and infestations, reported in Interference with certain coagulation assays has been detected in patients treated with Cimzia. 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. 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.
Population pharmacokinetic analyses showed no effect of age see section 5. Contact with natural rubber latex may cause severe allergic reactions in individuals sensitive to latex. Clearance following subcutaneous dosing was estimated to be Gender There was no effect of gender on the pharmacokinetics of certolizumab pegol.
There are limited data on the use of Cimzia in patients who have experienced a severe hypersensitivity reaction towards another TNF-antagonist; in these patients caution is needed. 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.
This was also the case for the other parameters of peripheral activity e. The incidence rate of new cases of infections in placebo-controlled clinical trials in rheumatoid arthritis was 1. Additionally, the observed incidence of antibodies in an assay may be influenced by several factors including sample handling, timing of sample collection, concomitant medicinal products, and underlying disease.
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.
In vitro functional studies of human vacuolated macrophages indicated all functions tested were retained. To bookmark a medicine you must sign up and log in.
TGA eBS – Product and Consumer Medicine Information
Biological tests for tuberculosis screening should be considered before starting Cimzia treatment if there is any potential latent tuberculosis infection, regardless of BCG vaccination. In addition, cjmzia 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.
Malignancies and lymphoproliferative disorders The potential role of TNF-antagonist therapy in the development of malignancies is not known. Among patients remaining in the study, improvements in all afore-mentioned key efficacy outcomes were maintained through Week in the overall population as well cjmzia in the subpopulations. ACR70 Week 12 Week Cimzia can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate.