CIMZIA PI PDF
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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The clinical significance of low levels certolizumab pegol for infants is unknown. Date of first authorisation: The overall percentage of patients with antibodies to Cimzia detectable on at least one occasion up to Week 24 was Adverse reactions of the haematologic system, including medically significant cytopaenia e. Cimzia can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
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In the treatment of moderate to severe plaque psoriasis, Cimzia was compared with placebo in cimziz main studies. For the full list of side effects of Cimzia, see the package leaflet. Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within the first 12 weeks of treatment.
Cimzia was studied in patients with psoriatic arthritis in the PsA clinical study for up to 4 years which includes a week placebo-controlled phase followed by a week dose-blind period and a week open-label treatment period.
There is an increased background risk for lymphoma and leukaemia in rheumatoid arthritis patients with long-standing, highly active, inflammatory disease, icmzia complicates the risk estimation. Date of issue of marketing authorisation valid throughout the European Union.
Cimzia 200 mg solution for injection in pre-filled syringe
Cimzia has not been studied specifically in a lupus population see section 4. Data from more than prospectively collected pregnancies exposed to Cimzia with known pregnancy outcomes, including more than pregnancies exposed during the first trimester, does not indicate a malformative effect of Cimzia.
Cimzia | European Medicines Agency
Reactivation of hepatitis Cizia has occurred in patients receiving a TNF-antagonist including certolizumab pegol, who are chronic carriers of this virus i. A total of subjects Plaque psoriasis After the starting dose, the maintenance dose of Cimzia for adult patients with plaque psoriasis is mg every 2 weeks.
The studies included adults with active rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis and moderate to severe plaque psoriasis:.
PGA clear or almost clear b. After the starting dose, cimzi recommended maintenance dose of Cimzia for adult patients with psoriatic arthritis is mg every 2 weeks. Cimzia was studied in 4, patients with rheumatoid arthritis in controlled and open label trials for up to 92 months.
MTX should be continued during treatment with Cimzia where appropriate.
Concomitant use with other biologics 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.
Cimzzia of the medicinal product 2. Both doses of Cimzia demonstrated efficacy compared to placebo regardless of age, gender, body weight, BMI, psoriasis disease duration, previous treatment with systemic therapies and previous treatment with biologics.
The maximum duration of the study was weeks. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
Before initiation of therapy with Cimzia, all patients must cimzi evaluated for both active or inactive latent tuberculosis infection.
Patients also had active psoriatic skin lesions or a documented history of psoriasis and had failed 1 or more DMARDs. Pharmacokinetics observed in patients with rheumatoid arthritis and psoriasis were consistent ;i those seen in healthy subjects. Cimzia may have a minor influence on the ability to drive and use machines. Malignancies and lymphoproliferative disorders The potential role of TNF-antagonist therapy in the development of malignancies is not known.
Table of pl Overview Authorisation details Product information Assessment history.
The pivotal non-clinical safety studies were conducted in the cynomolgus monkey.