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 .

Author: Nizilkree Vibar
Country: Comoros
Language: English (Spanish)
Genre: Relationship
Published (Last): 17 December 2017
Pages: 103
PDF File Size: 7.11 Mb
ePub File Size: 11.35 Mb
ISBN: 993-4-63504-830-3
Downloads: 18357
Price: Free* [*Free Regsitration Required]
Uploader: Tazahn

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. Similar to the placebo-controlled studies, antibody positivity was associated with reduced efficacy in some patients.

Keep pii pre-filled syringe in the outer carton in order to protect from light. Effects on sperm motility measures and a trend of reduced sperm count in male rodents have been observed with no apparent effect on fertility see section 5. Randomised, double-blind treatment regimen week 18 to Serious infections also included invasive opportunistic infections e. It is given by injection under the skin, usually cimzi the thigh or abdomen tummy. A patient who requires surgery while on Cimzia should be closely monitored for infections, and appropriate actions should be taken.

This was also the case for the other parameters of peripheral activity e. There are insufficient data to provide a dosing recommendation in moderate and severe renal impairment. You are therefore advised to be selective about which sections or pages you wish to print. PASI 90 at Week 16 was a key secondary endpoint in all 3 studies.

Cimzia 200 mg solution for injection in pre-filled syringe

In RA-I, structural joint damage was assessed radiographically and expressed as change in mTSS and its components, the erosion score and joint space narrowing JSN score, ximzia Week 52, compared to baseline.

If inactive ‘latent’ tuberculosis is suspected, a physician with expertise in the treatment of tuberculosis should be consulted.

  ECJS SECONDE PDF

Pack size of 2 pre-filled syringes and 2 alcohol wipes. For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended. Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within the first 12 weeks of treatment. Therefore, caution should be exercised when using any TNF-antagonist in COPD patients, as well as in patients with increased risk for malignancy due to heavy smoking.

Cimzia received a marketing authorisation valid throughout the EU on 1 October In cases of overdose, it is recommended that patients are monitored closely for any adverse reactions or effect, and appropriate symptomatic treatment initiated immediately.

Surgery There is limited safety experience with surgical procedures in patients treated with Cimzia. Initial marketing-authorisation documents List item.

JSN score Week Autoimmunity Treatment with Cimzia may result in the formation of antinuclear antibodies ANA and, uncommonly, in the development of a lupus-like syndrome see section 4.

The ACR 20 endpoint was achieved for both Cimzia mg every 2 weeks and mg every 4 weeks. Major cijzia response is defined as achieving ACR 70 response at every assessment over a continuous 6-month period Wald p-values are quoted for the comparison of treatments using logistic cijzia with factors for treatment and region.

Serious infections, including sepsis and tuberculosis including miliary, disseminated and extrapulmonary diseaseand opportunistic infections e.

Cimzia | European Medicines Agency

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 clmzia class.

Axial spondyloarthritis Cimzia is indicated for the treatment of adult patients with severe active axial spondyloarthritis, comprising: Antibody positivity was associated with lowered drug plasma concentration and in some patients with reduced efficacy. Similarly, on the basis of Phase III clinical trial data in patients with psoriasis, a population exposure-response relationship was established between plasma concentration of certolizumab pegol and PASI with an EC90 of Biotransformation and elimination PEGylation, the covalent attachment of PEG polymers cimziaa peptides, delays the elimination of these entities from the circulation by a variety of mechanisms, including decreased renal clearance, decreased proteolysis, and decreased immunogenicity.

  DESCRIPTION SETTING RON ROZELLE PDF

Last updated on eMC: During the week follow-up, no treatment effects of certolizumab pegol were seen on semen quality parameters compared to placebo. Tuberculosis Before initiation of therapy with Cimzia, all patients must be evaluated for both active or inactive latent tuberculosis infection.

TGA eBS – Product and Consumer Medicine Information

Live vaccines should not be administered concurrently with Cimzia. Treatment starts with a mg dose given as two injections, followed by a further mg dose two and four weeks later.

The proportion of patients cimzzia discontinued treatment due to adverse events in the controlled clinical studies was 1. Adults with severe active ankylosing spondylitis who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs NSAIDs.

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. 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 vitro functional studies of human vacuolated macrophages indicated all functions tested were retained.

Table 2 Clinical trial description Study number Patient numbers Active dose regimen Study objectives RA-I 52 weeks mg 0,2,4 weeks with MTX mg or mg every 2 weeks with MTX Evaluation for treatment of signs and symptoms and inhibition of structural damage. No dose adjustment is required. Patients also had active psoriatic skin lesions or a documented history of psoriasis and had failed 1 or more DMARDs.

Partial remission c,d Week 12 Week Marketing authorisation holder 8. Cimzia can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. In a clinical study in pii lactating women treated with Cimzia, minimal transfer of certolizumab pegol from plasma to breast milk was observed.