CIMZIA PI PDF

CIMZIA PI PDF

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December 6, 2020

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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Plaque psoriasis Cimzia is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. See also section 6. 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.

Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation. Marketing authorisation holder 8. The safety profile for axial spondyloarthritis patients treated cizmia Cimzia was consistent with the safety profile in rheumatoid arthritis and previous experience with Cimzia. Surgery There is limited safety experience with surgical procedures in patients treated with Cimzia. 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.

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. In patients who develop HBV reactivation, Cimzia should be stopped and effective anti-viral therapy with appropriate supportive cinzia should be initiated.

Cimzia 200 mg solution for injection in pre-filled syringe

Pack size of 2 pre-filled cimziaa and 2 alcohol wipes. Response rates and p-values based on ckmzia logistic regression model. 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.

The combination of certolizumab pegol and anakinra or abatacept is not recommended see section 4.

Absorption Following subcutaneous administration, peak plasma concentrations of certolizumab pegol were attained between 54 and hours post-injection.

At Weeks 12 and 24, the percentage of subjects with an ASAS40 response was greater in the Cimzia-treated groups compared to placebo. Caution should be exercised when considering TNF-antagonist therapy for patients with a history of malignancy or when considering continuing treatment in cimzua who develop malignancy. Axial spondyloarthritis Pj the starting dose, the recommended maintenance dose of Cimzia for adult patients with axial spondyloarthritis is mg every 2 cimiza or mg every 4 weeks.

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Because of the nature of the adverse events seen with the combination of another TNF-antagonist with either abatacept cimaia anakinra therapy, similar toxicities may also result from the combination of anakinra or abatacept and other TNF-antagonists.

The recommended starting dose of Cimzia for adult patients is mg given as 2 subcutaneous injections of mg each at cimziw 0, 2 and 4. Interference with thrombin time TT and prothrombin time PT assays have not been observed. 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.

The value of these data to the evaluation of human risk may be limited. At week 12, po inhibition of inflammatory signs in both sacroiliac joints and the spine was observed in the Cimzia-treated patients all dose groupin the overall axial spondyloarthritis population as well as in the sub-populations of ankylosing spondylitis and non-radiographic axial spondyloarthritis.

Erosion score Week Effects on sperm motility measures and a trend of reduced sperm count pu male rodents have been observed with no apparent effect on fertility see section 5. At week 16, patients randomized to Cimzia who achieved a PASI 50 response continued to receive Cimzia up to Week 48 at the same randomized dose.

Patients also had active psoriatic skin lesions or a documented history of psoriasis and had failed 1 or more DMARDs. This information is intended cmizia use by health pii. Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within the first 12 weeks of treatment.

Cimzia was administered subcutaneously in combination with oral MTX for a minimum of 6 months with stable doses of at least 10 mg weekly for 2 months in both trials.

If latent tuberculosis is diagnosed, appropriate anti-tuberculosis therapy must be started before initiating treatment with Cimzia and in accordance with local recommendations. Non-clinical studies vimzia low or negligible level of placental transfer of a homologue Fab-fragment of certolizumab pegol no Fc region see section 5.

Patients on Cimzia mg every 2 weeks were re-randomized to Cimzia mg every 2 weeks, Cimzia mg every 4 weeks or placebo. Pharmacokinetics observed in patients with rheumatoid arthritis and psoriasis were consistent with those seen in healthy subjects. Some patients who have been successfully treated for active tuberculosis have redeveloped tuberculosis while being treated with Cimzia.

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Population pharmacokinetic analyses showed no effect of age see section 5. 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.

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

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Immunosuppression Since tumour necrosis factor TNF mediates inflammation and modulates cellular immune responses, the possibility exists for TNF-antagonists, including Cimzia, to cause immunosupression, affecting host defences against infections and malignancies.

The key results from the study are presented in table 4. In vitro functional studies of human vacuolated macrophages indicated all functions tested were pj. The results at week 34 are shown in Table 7. To bookmark a medicine you must sign up and log in. BCG vaccineunless the benefit of the vaccination clearly outweighs the theoretical risk of administration of live or live-attenuated vaccines to the infants.

Cimzia may cause erroneously elevated aPTT assay results in patients without coagulation abnormalities. Data from a human closed-circuit placental transfer model ex vivo suggest low or negligible transfer to the cimziq compartment. 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.

Patients were randomized to receive placebo, or Cimzia mg every 2 weeks following a loading dose of Cimzia mg at Weeks 0, 2 and 4or Cimzia mg every 2 weeks up to Week 16, or etanercept 50 mg twice weekly, up to Week 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.

Vaccinations Patients treated with Cimzia may receive vaccinations, except for live vaccines. For the full list of restrictions, see the package leaflet. Despite previous or concomitant prophylactic treatment for tuberculosis, cases of active tuberculosis have occurred in patients treated with TNF-antagonists including Cimzia.

Certolizumab pegol does not bind to the human neonatal Fc receptor FcRn. Evaluation for treatment of signs and symptoms and inhibition of structural damage.