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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Suitable sites for injection would include the thigh or abdomen. Live vaccines should not be administered concurrently with Cimzia. The impact of long-term treatment with Cimzia on the development of autoimmune diseases is unknown. Available data in adults with plaque psoriasis suggest that a clinical response is usually achieved within 16 weeks of treatment.

The incidence of serious infections was 0.

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. The safety profile for axial spondyloarthritis patients treated with Cimzia was consistent with the safety profile in rheumatoid arthritis and previous experience with Cimzia.

Patients originally randomized to Cimzia who achieved a PASI75 response at Week 16 were re-randomized based on their original dosing schedule.

These 3 groups were well balanced with regards to clinical response following the active run-in period ACR This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal.

Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-antagonists including certolizumab pegol see section 4. Fertility 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.

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Each pre-filled syringe contains mg cizia pegol in one ml. Qualitative and quantitative composition 3. Statistically significantly greater ACR 20 and ACR 50 responses were achieved from Week 1 and Week 2, respectively, in both clinical trials compared to placebo.

The most common side effects with Cimzia affecting up to 1 in 10 people are bacterial infections including abscesses cavities containing pusviral infections including herpes, papillomavirus and influenzaeosinophilic disorders disorders of eosinophils, a type of white blood cellleucopenia low white blood cell countsnausea feeling sickheadaches including migrainesensory abnormalities such as numbness, tingling and burning sensationhigh blood pressure, hepatitis liver inflammation including increased levels of liver enzymes, rash, fever, pain, weakness, itching and reactions at the injection site.

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The additional following adverse reactions have been observed uncommonly with Cimzia in other indications: ACR20 Week 12 Week This number decreases with increasing doses of concomitant MTX treatment. A total of subjects All subjects who did not achieve a PASI 75 response at Week 16 entered an escape arm and received Cimzia mg every 2 weeks.

Specific clinical trials have not been performed to assess the effect of hepatic impairment on the pharmacokinetics of certolizumab pegol. Skin cancers Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-antagonists including certolizumab pegol see section 4.

Results are from the randomized set. Patients must be monitored closely for signs and symptoms of infections including tuberculosis before, during and after treatment with Cimzia.

Antibody formation was associated with lowered drug plasma cmizia and in some patients, reduced efficacy. 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.

Psoriatic arthritis 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 200 mg solution for injection in pre-filled syringe

At Weeks 12 and 24, the percentage of subjects with an ASAS40 response was greater in the Cimzia-treated groups compared to placebo.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cimzia have been included in the summary of product characteristics and the package leaflet.

Of these, completed 2 years of open-label follow-up and thus had a total exposure to Cimzia of weeks overall. In both placebo-controlled and open-label follow-up clinical trials for rheumatoid arthritis, cases of lupus-like syndrome were reported uncommonly. Concomitant use with other biologics Severe infections and neutropaenia were reported in clinical trials with concurrent use of anakinra an interleukin-1 antagonist cimzla abatacept a CD28 modulator and another TNF-antagonist, etanercept, with no added benefit compared to TNF-antagonist therapy alone.

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. Continue typing to refine. In patients with pre-existing or recent dimzia of demyelinating disorders, the benefits and risks of TNF-antagonist treatment should be carefully considered before initiation of Cimzia therapy. One ml pre-filled syringe type I glass with a plunger stopper bromobutyl rubbercontaining mg of certolizumab pegol.

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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. Hepatitis B virus HBV reactivation Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including certolizumab pegol, who are chronic carriers of this virus i. Product details Name Cimzia. Cimzia is contraindicated in moderate or severe heart failure see section 4.

Pregnancy Data from more than prospectively collected pregnancies exposed to Cimzia with known pregnancy outcomes, including cimaia than pregnancies exposed during the first trimester, does not indicate a malformative effect of Cimzia. The mean PASI score at baseline was 20 and ranged from 12 to Active tuberculosis or other severe infections such as sepsis or opportunistic infections see section 4.

The clinical significance of low levels certolizumab pegol for infants is unknown. The recommended starting dose of Cimzia for cimmzia patients is mg given as 2 subcutaneous injections of mg each at weeks 0, 2 and 4.

In the placebo-controlled clinical trials, there were more new cases of serious infection in the Cimzia treatment groups 0.

Cimzia | European Medicines Agency

PEGylation, the covalent attachment of PEG polymers to peptides, delays the elimination of these entities from the circulation by a variety of mechanisms, including decreased renal clearance, decreased proteolysis, cimia decreased immunogenicity. The safety and efficacy of Cimzia in children and adolescents below age 18 years have not yet been established.

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, at Week 52, compared to baseline.

Antibody formation was associated with lowered drug plasma concentration.