CIMZIA PACKAGE INSERT PDF

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 the risks and benefits of CIMZIA treatment prior to initiating or continuing therapy in a patient with known malignancy.

Skip to main content. Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation. 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 cellleucopenia low white blood 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 received a marketing authorisation valid throughout the EU on 1 October Pegylation of biological molecules and potential benefits: Certolizumab pegol has been designed to attach to a messenger protein in the body called tumour necrosis factor alpha TNF-alpha.

Dosing Information

Treatment with Cimzia mg every two insery in the two studies led to Adults with severe active ankylosing spondylitis who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs NSAIDs.

Treatment starts with a mg dose given as two injections, followed by a further mg dose two and four weeks later. After training, patients may inject Cimzia themselves if their doctor agrees.

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International non-proprietary name INN or common name. Certolizumab pegol plus methotrexate is significantly more effective than placebo plus methotrexate in active rheumatoid arthritis: More detail is available in the summary of product characteristics.

Nine main studies involving over 3, patients have found Cimzia effective for reducing symptoms of inflammatory conditions.

Patients with rheumatoid arthritis, particularly those with highly active disease, are at a higher risk of lymphoma than the general population. 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 clinical response in adults with moderately to severely active disease who have had an inadequate response to conventional therapy CIMZIA is indicated for the treatment of adults with moderate-to-severe plaque psoriasis PSO who are candidates for systemic therapy or phototherapy.

PEGylated antibodies and antibody fragments for improved therapy: Similar results were seen in a study with patients who had not adequately responded to other medicines such as methotrexate.

Some cases have been fatal.

Leave this field blank. Malignancies, some fatal, have been reported among children, adolescents, and young adults being treated with TNF blockers.

Cimzia | European Medicines Agency

A monoclonal antibody is a protein that has been designed to recognise and attach to a specific structure in the body. Axial spondyloarthritis Cimzia is indicated for the treatment of adult patients with severe active axial spondyloarthritis, comprising: If an infection develops, monitor carefully and initiate appropriate therapy.

For the full list of restrictions, see the package leaflet. Rheumatoid arthritis Cimzia, in combination with methotrexate MTXis indicated for: 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: As for all medicines, data on the use of Cimzia are continuously monitored.

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Minimal to no transfer of certolizumab pegol into breast milk: The studies included adults with active rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis and moderate to severe plaque psoriasis: 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. You are therefore advised to be selective pacmage which sections or pages you wish to print.

Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. In the treatment of moderate to severe plaque psoriasis, Cimzia was compared with placebo in two main studies.

Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Lack of placental transfer of certolizumab pegol during pregnancy: Efficacy of certolizumab pegol on signs and symptoms of axial spondyloarthritis including ankylosing spondylitis: Cimzia can only be obtained with a prescription and treatment should only be started by a specialist doctor pacjage has experience in diagnosing and treating the diseases that Cimzia is used to treat.

Initial marketing-authorisation documents List item. Please see full Prescribing Information. For the full list of side effects of Cimzia, see the package leaflet.