CIMZIA 200 MG / 1 ML 2 PREFILLED SYRINGES (XX)

* Certolizumab pegol is a pegylated TNF antibody fragment that binds specifically to TNFalpha and neutralises membrane-associated and soluble human TNFalpha in a dose-dependent manner. It also inhibits the production of lipopolysaccharide-induced TNFalpha and interleukin-1beta (IL-1beta). Elevated levels of TNF and IL-1 have been found in the affected tissues and fluids of patients with rheumatoid arthritis, ankylosing spondylitis including axial spondyloarthritis, and psoriatic arthritis (see Spondyloarthropathies), and Crohn’s disease (see Inflammatory Bowel Disease). Certolizumab pegol is described as a biological disease-modifying antirheumatic drug (DMARD).

Certolizumab pegol is used in the treatment of moderate to severe, active rheumatoid arthritis and active psoriatic arthritis. In the treatment of rheumatoid arthritis, UK licensed product information recommends that certolizumab pegol should be given with methotrexate to patients who have had an inadequate response to DMARDs, although monotherapy may be used in those who have had an inadequate response to, or are intolerant of, methotrexate. Certolizumab pegol is also used in the treatment of active ankylosing spondylitis: UK licensed product information recommends that it should only be used in patients with severe disease who have had an inadequate response to, or are intolerant of, NSAIDs. In the UK, it is also licensed for the treatment of severe axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in patients who have had an inadequate response to, or are intolerant of, NSAIDs. Certolizumab pegol is used in the treatment of moderate to severe, active Crohn’s disease unresponsive to conventional treatment.

* Indications:
Rheumatoid arthritis; Crohn’s disease; axial spondyloarthritis; psoriatic arthritis; ankylosing spondylitis.

* Dosage:
For all the above indications, the initial dose is 400 mg given as two subcutaneous injections of 200 mg, repeated after 2 and 4 weeks. In the treatment of inflammatory joint disorders, this is followed by 200 mg every other week although maintenance with 400 mg every 4 weeks may be considered. Patients with Crohn’s disease who have a clinical response may receive a maintenance dose of 400 mg every 4 weeks.