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Cimzia is a brand name for Certolizumab Pegol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Rheumatoid arthritis Cimzia, in combination with methotrexate (MTX), is indicated for: • the treatment of moderate to severe, active rheumatoid arthritis (RA) in adult patients when the response to disease-modifying antirheumatic drugs (DMARDs) including MTX, has been inadequate. Cimzia can be given as monotherapy in…
Verbatim from this product's EMA label. Tap a section to expand.
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 reminder card. Posology Rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis Loading dose The recommended starting dose of Cimzia for adult patients is 400 mg (given as 2 subcutaneous injections of 200 mg each) at weeks 0, 2 and 4.
For rheumatoid arthritis and psoriatic arthritis, MTX should be continued during treatment with Cimzia where appropriate. Maintenance dose Rheumatoid arthritis After the starting dose, the recommended maintenance dose of Cimzia for adult patients with rheumatoid arthritis is 200 mg every 2 weeks.
Once clinical response is confirmed, an alternative maintenance dosing of 400 mg every 4 weeks can be considered. MTX should be continued during treatment with Cimzia where appropriate. Axial spondyloarthritis After the starting dose, the recommended maintenance dose of Cimzia for adult patients with axial spondyloarthritis is 200 mg every 2 weeks or 400 mg every 4 weeks.
1). Psoriatic arthritis After the starting dose, the recommended maintenance dose of Cimzia for adult patients with psoriatic arthritis is 200 mg every 2 weeks. Once clinical response is confirmed, an alternative maintenance dosing of 400 mg every 4 weeks can be considered.
MTX should be continued during treatment with Cimzia where appropriate. 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.
Plaque psoriasis After the starting dose, the maintenance dose of Cimzia for adult patients with plaque psoriasis is 200 mg every 2 weeks. 1). 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. Some patients with an initial partial response may subsequently improve with continued treatment beyond 16 weeks.
4 Missed dose 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. Special populations Paediatric population (< 18 years old) The safety and efficacy of Cimzia in children and adolescents below age 18 years have not been established.
Summary of the safety profile Rheumatoid arthritis Cimzia was studied in 4,049 patients with rheumatoid arthritis in controlled and open label trials for up to 92 months. In the placebo-controlled studies, patients receiving Cimzia had an approximately 4 times greater duration of exposure compared with the placebo group.
This difference in exposure is primarily due to patients on placebo being more likely to withdraw early. In addition, Studies RA-I and RA-II had a mandatory withdrawal for non-responders at Week 16, the majority of whom were on placebo.
7% for patients treated with placebo. 4% of patients on placebo. Axial spondyloarthritis Cimzia was initially studied in 325 patients with active axial spondyloarthritis (including ankylosing spondylitis and non-radiographic axial spondyloarthritis) in the AS001 clinical study for up to 4 years, which includes a 24-week placebo-controlled phase followed by a 24-week dose-blind period and a 156-week open-label treatment period.
Cimzia was subsequently studied in 317 patients with non- radiographic axial spondyloarthritis in a placebo-controlled study for 52 weeks (AS0006). Cimzia was also studied in patients with axial spondyloarthritis (including ankylosing spondylitis and non- radiographic axial spondyloarthritis) in a clinical study for up to 96 weeks, which included a 48-week open-label run-in phase (N=736) followed by a 48-week placebo-controlled phase (N=313) for patients in sustained remission (C-OPTIMISE).
Cimzia was also studied in a 96-week open-label study in 89 axSpA patients with a history of documented anterior uveitis flares. In all 4 studies, the safety profile for these patients was consistent with the safety profile in rheumatoid arthritis and previous experience with Cimzia.
Psoriatic arthritis Cimzia was studied in 409 patients with psoriatic arthritis in the PsA001 clinical study for up to 4 years which includes a 24-week placebo-controlled phase followed by a 24-week dose-blind period and a 168-week open-label treatment period.
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Infections Patients must be monitored closely for signs and symptoms of infections including tuberculosis before, during and after treatment with Cimzia.
3). 3). 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.
5 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.
g. histoplasmosis, nocardia, candidiasis) have been reported in patients receiving Cimzia. Some of these events have been fatal. Tuberculosis Before initiation of therapy with Cimzia, all patients must be evaluated for both active or inactive (latent) tuberculosis infection.
This evaluation should include a detailed medical history for patients with a personal history of tuberculosis, with possible previous exposure to others with active tuberculosis, and with previous and/or current use of immunosuppressive therapy.
g. tuberculin skin test and chest X-ray, should be performed in all patients (local recommendations may apply). It is recommended that the conduct of these tests should be recorded in the patient's reminder card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
1. 4). 4).
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Cimzia should not be used in children and adolescents below 18 years of age. Elderly patients (≥ 65 years old) No dose adjustment is required. 2). Renal and hepatic impairment Cimzia has not been studied in these patient populations. 2).
Method of administration 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.
The safety profile for psoriatic arthritis patients treated with Cimzia was consistent with the safety profile in rheumatoid arthritis and previous experience with Cimzia. Plaque psoriasis Cimzia was studied in 1112 patients with psoriasis in controlled and open-label studies for up to 3 years.
1). The long-term safety profile of Cimzia 400 mg every 2 weeks and Cimzia 200 mg every 2 weeks was generally similar and consistent with previous experience with Cimzia. 7% for placebo. 4% for patients treated with placebo. 8% of patients on placebo.
Tabulated list of adverse reactions Adverse reactions based primarily on experience from the placebo-controlled clinical trials and postmarketing cases at least possibly related to Cimzia are listed in Table 1 below, according to frequency and system organ class.
Frequency categories are defined as follows:
Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1000 to < 1/100); Rare (≥ 1/10,000 to < 1/1000); Very rare (< 1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Table 1 Adverse reactions in clinical trials and postmarketing System Organ Class Frequency Adverse reactions Infections and infestations Common bacterial infections (including abscess), viral infections (including herpes zoster, papillomavirus, influenza) Uncommon sepsis (including multi-organ failure, septic shock), tuberculosis (including miliary, disseminated and extrapulmonary disease), fungal infections (includes opportunistic) Neoplasms benign, malignant and unspecified (including cysts and polyps) Uncommon blood and lymphatic system malignancies (including lymphoma and leukaemia), solid organ tumours, non- melanoma skin cancers, pre-cancerous lesions (including oral leukoplakia, melanocytic nevus), benign tumours and cysts (including skin papilloma) Rare gastrointestinal tumours, melanoma Not known Merkel cell carcinoma*, Kaposi’s sarcoma Blood and the lymphatic system disorders Common eosinophilic disorders, leukopaenia (including neutropaenia, lymphopaenia) Uncommon anaemia, lymphadenopathy, thrombocytopaenia, thrombocytosis Rare pancytopaenia, splenomegaly, erythrocytosis, white blood cell morphology abnormal Immune system disorders Uncommon vasculitides, lupus erythematosus, drug hypersensitivity (including anaphylactic shock), allergic disorders, auto-antibody positive Rare angioneurotic oedema, sarcoidosis, serum sickness, panniculitis (including erythema nodosum), worsening of symptoms of […]
3). If inactive (‘latent’) tuberculosis is suspected, a physician with expertise in the treatment of tuberculosis should be consulted. In all situations described below, the benefit/risk balance of Cimzia therapy should be very carefully considered.
If latent tuberculosis is diagnosed, appropriate anti-tuberculosis therapy must be started before initiating treatment with Cimzia and in accordance with local recommendations. 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. g. persistent cough, wasting/weight loss, low grade fever, listlessness) suggestive of a tuberculosis infection occur during or after therapy with Cimzia.
, surface antigen positive). 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 6 who develop HBV reactivation, Cimzia should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated. Malignancies and lymphoproliferative disorders 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.
8). In the post marketing setting, cases […]