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 can be given as monotherapy in case of li to MTX or when continued treatment with MTX is inappropriate.
Cimzia has been shown to reduce the rate of progression of joint damage as measured by X-ray cjmzia to improve physical function, when given in combination with MTX. Cimzia is indicated for the treatment of adult patients with severe active axial spondyloarthritis, comprising:.
Adults with severe active ankylosing spondylitis who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs NSAIDs. Cimzia, in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate.
Cimzia can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Cimzia is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Cimzia is indicated.
Patients should be given the special alert cikzia. 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. For rheumatoid arthritis and psoriatic arthritis, MTX should be continued during treatment with Cimzia where appropriate. After the starting dose, the recommended maintenance dose of Cimzia for adult patients with rheumatoid arthritis is mg every 2 weeks.
Once clinical response is confirmed, an alternative maintenance dosing of mg every 4 weeks can be considered. MTX should be continued during treatment with Cimzia ciimzia appropriate. After the starting dose, the recommended maintenance dose of Cimzia for adult patients with axial spondyloarthritis is mg every 2 weeks or mg every 4 weeks.
After the starting dose, the recommended maintenance dose of Cimzia for adult patients with psoriatic arthritis is mg every 2 weeks. For the above indications, available data suggest that clinical response is usually achieved within 12 weeks of treatment.
Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within the first 12 weeks of treatment. After the starting dose, the maintenance dose of Cimzia for adult patients with plaque psoriasis is mg every 2 weeks. A dose of mg every 2 weeks can be considered in patients with insufficient response see section 5. Available data in adults with plaque psoriasis suggest that a clinical response is usually achieved within 16 weeks of treatment.
Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within the first 16 weeks of treatment. Cimzzia patients with an initial partial cmizia may subsequently improve with continued treatment beyond 16 weeks. Patients who miss a dose should be advised to inject the next dose of Cimzia as soon as they remember and then continue injecting subsequent doses as instructed.
The safety and efficacy of Cimzia in children and adolescents below age 18 years have not yet been established. No data are available. No dose adjustment is required.
Population pharmacokinetic analyses showed no effect of age see section 5. Cimzia has not been studied in these patient populations. No dose recommendations can be made see section 5.
The total content 1 ml of the pre-filled syringe should be administered as a subcutaneous injection only. Suitable sites for injection would include the thigh or abdomen. After proper training in injection technique, patients may self-inject using the pre-filled syringe if their physician determines that it is appropriate and with medical follow-up as necessary. The pre-filled syringe with needle guard should only be used by healthcare professionals.
The physician should discuss with the patient which injection presentation option is the most appropriate. Active tuberculosis ;i other severe infections such as sepsis or opportunistic infections see section 4.
Patients must be monitored closely for signs and symptoms of infections including tuberculosis before, during and after treatment with Cimzia. Because ;i elimination of certolizumab pegol may take up to 5 months, monitoring should be continued throughout this period see section 4.
Treatment with Cimzia must not be initiated in patients with a clinically important active infection, including chronic or localised infections, until the infection is controlled see section 4.
Patients who develop a new infection while undergoing treatment with Cimzia should be monitored closely. Administration of Cimzia should be discontinued if a patient develops a new serious infection until the infection is controlled. Physicians should exercise caution when considering the use of Cimzia in patients with a history of recurring or opportunistic infection or with underlying conditions which may predispose patients to infections, including the use of concomitant immunosuppressive medications.
Patients with rheumatoid arthritis may not manifest typical symptoms of infection, including fever, due to their disease and concomitant medicinal products. Therefore, early detection of any infection, particularly atypical clinical presentations of a serious infection, is critical to minimise delays in diagnosis and initiation of treatment.
Serious infections, including sepsis and tuberculosis including miliary, disseminated and extrapulmonary diseaseand opportunistic infections e. Some of these events have been fatal. Before initiation of therapy with Cimzia, all patients must be evaluated for both active or inactive latent tuberculosis infection. Appropriate screening tests, e. It is recommended that the conduct of these tests should be recorded in the patient’s alert card.
Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
If active tuberculosis is diagnosed prior to or during treatment, Cimzia therapy must not be initiated and must be discontinued see section 4. If inactive ‘latent’ tuberculosis is suspected, a physician with expertise in the treatment clmzia tuberculosis should be consulted.
If latent tuberculosis is diagnosed, appropriate anti-tuberculosis therapy must be started before initiating treatment with Cimzia and in accordance with local recommendations.
Cimzia | European Medicines Agency
Use of anti-tuberculosis therapy should also be considered before the initiation of Cimzia in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and in patients who have significant risk factors for tuberculosis despite a negative test for latent tuberculosis. Biological tests for tuberculosis screening should be considered before starting Cimzia treatment if there is any potential latent tuberculosis infection, regardless of BCG vaccination.
Despite previous or concomitant prophylactic treatment for tuberculosis, cases of active tuberculosis have occurred in patients treated with TNF-antagonists including Cimzia. Some patients who have been successfully treated for active tuberculosis have redeveloped tuberculosis while being treated with Cimzia. Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including certolizumab pegol, who are chronic carriers of this virus i. Some cases have had a fatal outcome.
Patients should be tested for HBV infection before initiating treatment with Cimzia. For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended. Carriers of HBV who require treatment with Cimzia should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Adequate data of treating patients who are carriers of HBV with anti-viral therapy in conjunction with TNF-antagonist therapy to prevent HBV reactivation are not available. In patients who develop HBV reactivation, Cimzia should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
The potential role of TNF-antagonist therapy in the development of malignancies is not known. 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.
With the current knowledge, a possible risk for the development of lymphomas, leukaemia or other malignancies in patients treated with a TNF-antagonist cannot be excluded. In clinical trials with Cimzia and other TNF-antagonists, more cases of lymphoma and other malignancies have been reported among patients receiving TNF-antagonists than in control patients receiving placebo see section 4.
In the post marketing setting, cases of leukaemia have been reported in patients treated with a TNF-antagonist. There is an increased background risk for lymphoma and leukaemia in rheumatoid arthritis patients with long-standing, highly active, inflammatory disease, which complicates the risk estimation.
Cimzia 200 mg solution for injection in pre-filled syringe
No trials have been conducted that include patients with a history of malignancy, or cinzia continue treatment in patients who develop malignancy, while receiving Cimzia. Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-antagonists including certolizumab pegol see cimzzia 4. Periodic skin examination is recommended, particularly for patients with risk factors for skin cancer. Approximately half the cases were lymphomas.
The other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression. A risk for the development of malignancies in children and adolescents treated with TNF-antagonists cannot be excluded. This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal. The majority of reported TNF-antagonist cases occurred in adolescent and young adult males with Crohn’s disease or ulcerative colitis.
A risk for development of hepatosplenic T-cell lymphoma in patients treated with Cimzia cannot be excluded. In an exploratory clinical trial evaluating the use of another TNF-antagonist, infliximab, in patients with moderate to severe chronic obstructive pulmonary disease COPDmore malignancies, mostly in the lung or head and neck, were reported in infliximab-treated patients compared with control patients. All patients had a history of heavy smoking. Therefore, caution should be exercised when using any TNF-antagonist in COPD patients, as well as in patients cimzix increased risk for malignancy due li heavy smoking.
Cimzia is contraindicated in moderate or severe ximzia failure see section 4. In a clinical trial with another TNF-antagonist, worsening congestive heart failure and increased mortality due to congestive heart failure have been observed.
Cases of congestive heart failure have also been reported in rheumatoid arthritis patients receiving Cimzia. Treatment with Cimzia must be cimiza in patients who develop new or worsening symptoms of congestive heart failure. Reports of pancytopaenia, including aplastic anaemia, have been rare with TNF-antagonists.
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Adverse reactions of the haematologic system, including medically significant cytopaenia e. All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection e. Discontinuation of Cimzia therapy should be considered in patients with confirmed significant haematological abnormalities.
In patients with pre-existing or recent onset of demyelinating disorders, the benefits and risks of TNF-antagonist treatment should be carefully considered before cikzia of Cimzia therapy. Rare cases of neurological disorders, including seizure disorder, neuritis and peripheral neuropathy, have been reported in patients treated with Cimzia. Severe hypersensitivity reactions have been reported ppi following Cimzia administration.
Some of these reactions occurred after the first administration of Cimzia. If severe reactions occur, administration of Cimzia should be discontinued immediately and appropriate therapy instituted. There are limited data on the use of Cimzia in patients who have experienced a severe hypersensitivity reaction towards another TNF-antagonist; in these patients caution is needed.
The needle shield inside the removable cap of the CIMZIA pre-filled syringe contains cizia derivative of natural rubber latex see section 6. Contact with natural rubber latex may cause severe allergic reactions in individuals sensitive to latex. No antigenic latex protein has to fimzia been detected in the removable needle cap of the Cimzia pre-filled syringe.