All the Active Ingredient Drugs
TNF-A Inhibitors. Certolizumab Pegol 200 mg/ml. PRE-FILL. SYR. (sol. for S.C. inj.): 2, 6×1ml. The recomm. init. dose adult pts. is 400 mg (given as 2 s.c. inj. of 200 mg each) at wks. 0, 2 and 4. For RA, MTX should be cont. during tmt. with Certolizumab pegol where approp.
Mainten. dose: RA: After the init. dose, the recomm. mainten. dose of Certolizumab pegol for adult pts. with RA is 200 mg every 2 wks. MTX should be cont. during tmt. with Certolizumab pegol where appropr.
Axial spondyloarthritis: After the init. dose, the recomm. mainten. dose of Certolizumab pegol for adult pts. with Axial spondyloarthrit. is 200 mg every 2 wks. or 400 mg every 4 wks.
For the above indicat., available data suggest that clinical response is usually achieved within 12 wks. of tmt. Continued ther. should be carefully reconsid. in pts. who show no evidence of therapeutic benefit within the first 12 wks. of tmt.
Crohn’s Dis.: After the init. dose, in pts. who obtain a clinical response, the recomm. mainten. dose is 400 mg every 4 wks.
Missed dose: Pts. who miss a dose should be advised to inject the next dose of Certolizumab pegol as soon as they remember and then cont. inject. subseq. doses as instructed.
RA: In comb. with methotrexate (MTX), is indic. for: The tmt. of moder. to sev., active RA in adult pts. when the response to dis.-modifying antirheum. drugs (DMARDs) includ. methotrexate, has been inadequate.
Can be given as monother. in case of intoler. to MTX or when cont. tmt. with MTX is inappropr.
Certolizumab pegol has been shown to reduce the rate of progres. of joint damage as measured by X-ray and to improve physic. func., when given in comb. with MTX.
Axial spondyloarthritis: Tmt. of adult pts. with sev. active axial spondyloarthritis, compris.: Ankylosing spondyl. (AS): Adults with sev. active AS who have had an inadeq. response to, or are intoler. to NSAIDs.
Axial spondyloarthritis without radiograp. evidence of AS: Adult. with sev. active AS without radiograph. evidence of AS but with object. signs of inflamm. by elevated CRP and/or MRI, who have had an inadeq. response to, or are intoler. to NSAIDs.
Crohn’s Dis.: Indic. for reduc. signs and sympt. of Crohn’s dis. and maintain. clinic. response in adult pts. with moderat. to sev. active dis. who have had an inadequ. response to convent. ther.
C/I: Hypersens. Active tuberculosis or other sev. infec. such as sepsis or opportunist. infect. Moder-to sev. heart fail. (NYHA classes III/IV).