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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ACR20 Week 12 Week 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 needle shield is styrene butadiene rubber which contains a derivative of natural rubber latex see section 4.
Continue typing to refine. Of the cimziq initially randomised to active treatment in RA-I, completed 52 weeks of placebo-controlled treatment and entered the open-label extension study. Approximately one-third of antibody-positive patients had antibodies with neutralising activity in vitro.
In the pivotal studies, for subjects who were ANA negative at baseline, Adverse reactions based primarily on experience from cimaia 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. No dose adjustment is required. The difference from placebo tended to be greater in nr-axSpA than in the AS subpopulation which may be due cjmzia less chronic structural damage in nr-axSpA patients.
Clinically meaningful and statistically significant differences in Cimzia-treated patients compared with placebo-treated patients were demonstrated at each post-baseline visit.
PGA clear or almost clear b.
At the end of this period the pre-filled syringes must be used or discarded. In the placebo-controlled studies, patients receiving Cimzia had an approximately 4 times greater duration of exposure compared with the placebo group. Patients treated with concomitant immunosuppressants MTX fimzia a lower rate of antibody development than patients not taking immunosuppressants at baseline.
Cimzia | European Medicines Agency
Cimzia may have a minor influence on cimziz ability to drive and use machines. ACR 20 at Week Randomised, double-blind treatment regimen week 18 to Excluding non-melanoma skin cancer, cimzua malignancies including 1 case of lymphoma were observed in the Cimzia psoriasis clinical trials in which a total of patients were treated, representing patient-years. Patients receiving Cimzia and concomitant methotrexate had a lower humoral response compared with patients receiving Cimzia alone.
Certolizumab pegol does not cross-react with rodent TNF.
Cimzia 200 mg solution for injection in pre-filled syringe
The pharmacokinetics of the PEG fraction of certolizumab pegol are expected to be dependent cmizia renal function but have not been assessed in patients with renal impairment. Despite previous or concomitant prophylactic treatment for tuberculosis, cases of active tuberculosis have occurred in patients treated with TNF-antagonists including Cimzia.
Frequency categories are defined as follows: Axial spondyloarthritis Overall Population.
Therefore, reproductive toxicology studies ci,zia been performed with a homologous reagent recognising rat TNF. Key efficacy outcomes from the AS ci,zia trial are shown in Table 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.
Pack size of 2 pre-filled syringes with needle guard and 2 alcohol wipes for use by healthcare professionals only. Certolizumab pegol does not bind to the human neonatal Fc receptor FcRn. Side effects reported with Cimzia are carefully evaluated and any necessary action taken to protect patients.
The most common side effects with Cimzia affecting up to 1 in 10 people are bacterial infections including abscesses cavities containing pusviral infections including herpes, papillomavirus and influenzaeosinophilic disorders disorders of eosinophils, a type of white blood cell ckmzia, leucopenia low white fimzia cell countsnausea feeling sickheadaches including migrainesensory abnormalities such as numbness, tingling and burning sensationhigh blood pressure, hepatitis liver inflammation including increased levels of liver enzymes, rash, fever, pain, weakness, itching and reactions at the injection site.
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 cijzia dose-blind period and a week open-label treatment period. The infections consisted primarily of upper respiratory tract infections, urinary tract infections, and lower respiratory tract infections and herpes viral infections see sections 4.
Cimzia is indicated for the treatment of adult patients with severe active axial spondyloarthritis, comprising:. The safety profile for psoriatic arthritis patients treated with Cimzia was consistent with the safety profile in rheumatoid arthritis and previous experience with Cimzia. Biological tests for tuberculosis screening should be considered before starting Cimzia treatment if there is any potential latent tuberculosis infection, regardless of BCG vaccination.
For these reasons, comparison of the incidence of antibodies to Cimzia with the incidence of antibodies to other TNF-antagonists is not appropriate. ACR70 Week 12 Week Treatment regimen week 0 to 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.
Nine main studies involving over 3, patients have found Cimzia effective for reducing symptoms of inflammatory conditions. Study RA-I Methotrexate combination 24 and 52 weeks.
No dose-limiting toxicity was observed during clinical trials. Approximately half the cases were lymphomas.
For more information see the package leaflet or contact your doctor or pharmacist. Both Cimzia regimens showed sustained clinical response and were statistically significant compared to placebo at week The overall percentage comzia patients that were antibody positive with a persistent reduction of drug plasma concentration was estimated to be 6.