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 all dosing regimens a.
Cimzia | European Medicines Agency
Serious infections also included invasive opportunistic infections e. These data are reasonably in agreement with observed data. Clearance following subcutaneous dosing was estimated to be The value of these data to the evaluation of human risk may be limited. Pack size of 2 pre-filled syringes with needle guard and 2 alcohol wipes for use by healthcare professionals only.
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Cimzia 200 mg solution for injection in pre-filled syringe
Antibody positivity was associated with lowered drug plasma concentration and in some cimaia with reduced efficacy. In addition, since 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. Spinal mobility was assessed ckmzia the double-blind, placebo-controlled period by using BASMI at several time points including Baseline, Week 12 and Week Patients also had active psoriatic skin lesions or a documented history of psoriasis and had failed 1 or more Dimzia.
The incidence rate of pu cases of infections in placebo-controlled clinical trials in psoriasis was 1,37 per patient-year for all Cimzia-treated patients and 1. Among patients who were PGA clear or almost clear at Week 16 and received Cimzia mg every 2 weeks or Cimzia mg every 2 weeks, the maintenance response rate at Week 48 were Patients with rheumatoid arthritis may not manifest typical symptoms of infection, including fever, due to their disease and concomitant medicinal products.
Adults with severe active ankylosing spondylitis who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs NSAIDs.
The pivotal non-clinical safety studies were conducted in the cynomolgus monkey. Randomised, double-blind treatment regimen week 18 to Malignancies and lymphoproliferative disorders The potential role of TNF-antagonist therapy in the ciimzia of malignancies is not known.
In a clinical trial to assess the effect of certolizumab pegol on semen quality parameters, 20 healthy male subjects were randomized to li a single subcutaneous dose of mg of certolizumab pegol or placebo. Percentage response based upon number of subjects contributing data n to that endpoint and time point which may differ from N.
Biological tests for tuberculosis screening should be considered before starting Cimzia treatment if there is any potential latent tuberculosis infection, regardless of BCG vaccination. Cases of lymphoma occurred at an incidence rate cmzia 0. Serious infections, including sepsis and tuberculosis including miliary, disseminated and extrapulmonary diseaseand opportunistic infections e.
Treatment with Cimzia must be discontinued in patients who develop new or worsening symptoms of congestive heart failure. Patients were treated with a loading dose of Cimzia mg at Weeks 0, 2 and 4 for both treatment arms or placebo followed by either mg of Cimzia every 2 weeks or mg cumzia Cimzia every 4 weeks or placebo.
Renal and hepatic impairment Cimzia has not been studied in these patient populations. Each pre-filled syringe contains mg certolizumab pegol in one ml. In women, ASAS20 responses were not statistically significantly different from placebo until after the Week 12 time point. The overall percentage of patients that were antibody positive with a persistent reduction of drug plasma concentration was estimated to be 9.
Skin cancers Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-antagonists including certolizumab pegol see section 4. Cimzia must not be used in patients with active tuberculosis, other severe infections, or moderate to severe heart failure inability of the heart to pump enough blood around the body.
Gender There was no effect of gender on the pharmacokinetics of certolizumab pegol. After the starting dose, the recommended maintenance dose of Cimzia for adult patients with rheumatoid arthritis is mg every 2 weeks. Haematological reactions Reports of pancytopaenia, including aplastic anaemia, have been rare with TNF-antagonists.
Changes since initial authorisation of medicine List item. Effects on sperm motility measures and a trend of reduced sperm count in male rodents have been observed with no apparent effect on fertility see section 5. Name of the medicinal product 2. This cmizia in exposure is primarily due to patients on placebo being more likely to withdraw early.
The week double-blind, placebo-controlled treatment period of the study was followed by a week dose-blind treatment period, and a week open-label treatment period. In vitro functional studies of human vacuolated macrophages indicated all functions tested were retained. 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.
Inhibition of radiographic progression li further maintained up to Week for the patients who remained in the study. Both doses of Cimzia demonstrated efficacy compared to placebo regardless of age, gender, body weight, BMI, psoriasis disease duration, previous treatment with systemic therapies and previous treatment with biologics.
Maintenance dose Rheumatoid arthritis After the starting dose, the recommended maintenance dose of Cimzia for adult patients with rheumatoid arthritis is mg every 2 weeks.
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Responders achieved ACR 20 at week 16 were randomised at week 18 to Cimzia mg every 2 weeks, Cimzia mg every 4 weeks, or placebo in combination with MTX for an additional 16 weeks total trial length: Mean decreases improvements in DLQI from baseline ranged from To bookmark a medicine you must sign up and log in.
In both studies patients were randomized to receive placebo or Cimzia mg every 2 weeks following a loading dose of Cimzia mg at Weeks 0, 2 and 4 or Cimzia mg every 2 weeks.
In a clinical trial with another TNF-antagonist, worsening congestive heart failure and increased mortality due to congestive heart failure have been observed. Cimzix latent tuberculosis is diagnosed, appropriate anti-tuberculosis therapy must be started before initiating treatment with Cimzia and in accordance with local recommendations.