CIMZIA PACKAGE INSERT PDF

CIMZIA is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis; CIMZIA is indicated for the treatment of . drug interactions. o Cimzia is indicated for reducing signs and symptoms of Crohn’s disease and modifying anti-rheumatic drug (DMARD). 3. Cimzia [package insert]. Smyrna. Medscape – Rheumatoid arthritis and Crohn disease dosing for Cimzia ( certolizumab pegol), frequency-based adverse effects, comprehensive interactions.

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Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. Efficacy and safety of certolizumab pegol in a broad population of patients with active rheumatoid arthritis: Axial spondyloarthritis Cimzia is indicated for the treatment of adult patients with severe active axial spondyloarthritis, comprising: However, the dose of Cimzia used in this study was higher than the usual dose.

After this, depending on the condition being treated, patients should continue with mg or mg, given as one or two injections every two or four weeks. Similar results were seen in a study with patients who had not adequately responded to other medicines such as methotrexate. Initial marketing-authorisation documents List item.

Certolizumab pegol plus methotrexate is significantly more effective than placebo plus methotrexate in active rheumatoid arthritis: Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

In clinical trials, more cases of malignancies were observed among CIMZIA-treated patients compared to control patients. Mechanism of action of certolizumab pegol CDP Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. A monoclonal antibody is a protein that has been designed to recognise and attach to a specific structure in the body.

Consider the risks and benefits of CIMZIA treatment prior to initiating or continuing therapy in a patient with known malignancy. Table of contents Overview Authorisation details Product information Assessment history.

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Changes since initial authorisation of medicine List item. The needle shield inside the removable cap of the CIMZIA prefilled syringe contains a plastic derivative of natural rubber latex which may cause an allergic reaction in individuals sensitive to latex. Eli Lilly and Company; Nine main studies involving over 3, patients have found Cimzia effective for reducing symptoms of inflammatory pavkage. Cimzia is mostly used for conditions that ibsert severe, moderately severe or getting worse, or when patients cannot use other treatments.

Anatomical therapeutic chemical ATC code.

Cimzia | European Medicines Agency

Please see full Prescribing Information. Carefully consider the risks and benefits of treatment with CIMZIA prior to initiating therapy in the following patients: Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

How useful was this page? Expand all Collapse all. If an infection develops, monitor carefully and initiate appropriate therapy. This messenger is involved in causing inflammation and is found at high levels in patients with the diseases that Cimzia is used for. Placental transfer of anti-tumor necrosis factor agents in pregnant patients with inflammatory bowel disease.

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International non-proprietary name INN or common name. Indications CIMZIA is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis CIMZIA is indicated for the treatment of adults with active psoriatic arthritis CIMZIA is indicated for the treatment of adults with active ankylosing spondylitis CIMZIA is indicated for reducing signs and symptoms of Crohn’s disease and maintaining ccimzia response in adults with moderately to severely active disease who have had an inadequate response to ijsert therapy CIMZIA is indicated for the treatment of adults with moderate-to-severe plaque psoriasis PSO who are candidates for systemic therapy or phototherapy.

After training, patients may inject Cimzia themselves if their doctor agrees. Cases of acute and chronic leukemia were reported with TNF blocker use.

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Dosing Information

Effect of pegylation on pharmaceuticals. Pegylation decreases the rate at which the substance is removed from the body and allows the medicine to be given less often.

You are therefore advised to be selective about which sections or pages you wish to print. Discontinue treatment if symptoms of a lupus-like syndrome develop. Patients treated with CIMZIA are at increased risk for developing serious infections that may lead to hospitalization or death.

Cimzia contains the active substance certolizumab pegol. A third study compared Cimzia with placebo as well as another medicine called etanercept. Pegylation of biological molecules and potential cikzia 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: Click to open Full Prescribing Information.

Active tuberculosis TBincluding reactivation of latent TB. Some cases have been fatal. The impact of PEGylation on biologic therapies. Side effects reported with Cimzia are carefully evaluated and any necessary action taken to protect patients.

For the full list of restrictions, see the package leaflet.

Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation. Exercise caution and monitor carefully. It isnert given by injection under the skin, usually in the thigh or abdomen tummy.

Antigen and antibody testing for histoplasmosis may be negative in some patients with cizmia infection. For active rheumatoid arthritis that had not improved adequately with disease-modifying antirheumatic drug DMARD treatment, two main studies found Cimzia effective when used with methotrexate when compared with placebo dummy treatment.

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