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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In study-to-study comparison, the pharmacokinetics of certolizumab pegol appeared similar to those observed previously in healthy subjects. Erosion score Week At week 12 and 24 improvements in parameters of peripheral activity characteristic of psoriatic arthritis e.

Concomitant use with other biologics Severe infections and neutropaenia were reported in clinical trials with concurrent use of anakinra an interleukin-1 antagonist or abatacept a CD28 modulator and another TNF-antagonist, etanercept, with no added benefit compared to TNF-antagonist therapy alone.

Once clinical response is confirmed, an alternative maintenance dosing of mg every 4 weeks can be considered. 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. The most frequent serious infections included pneumonia, tuberculosis infections.

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. The overall percentage of patients with antibodies to Cimzia detectable on pu least one occasion up to Week 24 was Interference with thrombin time TT and prothrombin time PT assays have not been observed. Cimzia patients demonstrated significantly less radiographic progression than patients receiving placebo at Week 24 and Week 52 see Table 5.

Axial spondyloarthritis Cimzia is indicated for the treatment of adult patients with severe active axial spondyloarthritis, comprising: 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.

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Appropriate screening tests, e.

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.

Patients should be given the special alert card. Interference with certain coagulation assays has been detected in patients treated with Cimzia. Patients received a loading dose of Cimzia mg at Weeks 0, 2 and 4 for both treatment arms or placebo followed p either Cimzia mg every 2 weeks or mg every 4 weeks or placebo every 2 weeks.

Cimzia | European Medicines Agency

Axial spondyloarthritis After the starting dose, the recommended maintenance dose of Cimzia for adult patients with axial ccimzia is mg every 2 weeks or mg every 4 weeks.

Treatment starts with a mg dose given as two injections, followed by a further mg dose two and four weeks later.

In the Phase III placebo- and active-controlled studies, the percentages of patients who were positive for antibodies to Cimzia on at least one occasion during treatment up to Week 48 were 8. Effects on sperm motility measures and comzia trend of reduced sperm count in male rodents have been observed with no apparent effect on fertility see section 5. PEGylation, the covalent attachment of PEG polymers to peptides, delays the elimination of these entities from the circulation by a variety of mechanisms, including decreased renal clearance, decreased proteolysis, and decreased immunogenicity.

Cimzia 200 mg solution for injection in pre-filled syringe

The incidence rate of new cases of infections in placebo-controlled clinical trials in psoriasis was 1,37 per patient-year for all Cimzia-treated patients and 1. For cimzua full list of side effects of Cimzia, see the package leaflet.

Caution should be exercised when considering TNF-antagonist therapy for patients with a history of malignancy or when considering continuing treatment in patients who develop malignancy. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

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TGA eBS – Product and Consumer Medicine Information

Axial spondyloarthritis Overall Population. Each pre-filled syringe contains mg certolizumab pegol in one ml. Skin and subcutaneous tissue disorders. Initial marketing-authorisation documents List item. Cimzia should only be used during pregnancy if clinically needed. Contact with natural rubber latex may cause severe allergic reactions in individuals sensitive to latex. The recommended starting dose of Cimzia for adult patients is mg given as 2 subcutaneous injections of mg each at weeks 0, 2 and 4.

The de-conjugated PEG component is rapidly eliminated from plasma and is to an unknown extent excreted renally. It is recommended that the conduct of these tests should be recorded in the patient’s alert card.

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. Adverse reactions of the haematologic system, including medically significant cytopaenia e.

Therefore, caution should be exercised when using any TNF-antagonist in COPD patients, as well as in patients with increased risk for malignancy due to heavy smoking. Cimzia is contraindicated in moderate or severe heart failure see section 4. The cimzzia should discuss with the patient which injection presentation option is the most appropriate. For details on therapeutic effects, see section 5.

Consequently, Cimzia can be used during breastfeeding. This messenger is po in causing inflammation and is found at high levels in patients with the diseases that Cimzia is used for.