All the Drug Class 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).
TNF-A Inhibitors. Infliximab 100 mg. VIAL: 1,2,3,5×15 ml. Dosage should be ajust. individ. according to the pt. medical cond. See lit.
RA: In comb. with methotrexate- reduct. of signs and sympt. as well as the improve. in physical funct. in:
Adult pts. with active dis. when the response to dis. modif. antirheum. drugs (DMARDs), includ. methotrexate, has been inadeq.
Adult pts. with severe, active and progress. dis. not previous. treated with methotrexate or other DMARDs. In these pt. populations, a reduct. in the rate of the progres. of joint damage, as measured by X ray, has been demonstr.
Ankylosing spondylitis: Tmt. of severe, active ankylos. spondylitis, in adult pts. who have responded inadeq. to convent. ther.
Psoriatic arthritis: Tmt. of active and progres. psoriat. arthritis in adult pts. when the response to previous DMARD ther. has been inadeq. the drug should be admin. in comb. with methotrexate or alone in pts. who show intoler. to methotrexate or for whom methotrexate is contraind.
Infliximab has been shown to improve physical func. in pts. with psoriat. arthrit., and to reduce the rate of progress. of peripher. joint damage as measured by X ray in pts. with polyarticular symmetry. subtypes of the dis.
Psoriasis: Tmt. of moder. to sev. plaque psorias. in adult pts. who failed to respond to, or who have a contraindicat. to, or are intolerant. to other system. ther. include, cyclosporine, methotrexate or psoralen ultra-violet A (PUVA).
Adult Crohn’s dis.: Moder. to sever. active Crohn’s dis., in adult pts. who have not respond. despite a full and adequate course of ther. with a corticosteroid and/or an immunosuppressant; or who are intoler. to or have med. contraindicate. for such therapies. Tmt. of fistulising, active Crohn’s dis., in adult pts. who have not responded despite a full and adequate course of ther. with convent. tmt. (includ. antibiotics, drainage and immunosuppressive ther.).
Ulcer. colitis: Tmt. of moder. to sever. active ulcerat. colitis in adult pts. who have had an inadeq, response to convent. ther. includ. corticosteroids and 6 mercaptopurine (6 MP) or azathioprine (AZA), or who are intoler. to or have medical contraindicat. for such therapies.
C/I: Hypersens. the active substance, to other murine proteins. Pts. with tuberculosis or other severe infec. such as sepsis, abscesses, and opportunis. infec. Pts. with moder. /severe HF (NYHA class III/IV).
TNF-A Inhibitors. Infliximab 100 mg / 10 ml, Infliximab 120 mg/ml. VIAL (Pwdr. for concentr. for sol.for infus.):20ml & SC (sol. for subcutan. injection). Dosage must be ajust. individ. accord. to pt. med. cond.
RA: in comb.with methotrexate, for the reduct. of signs and sympt. as well as the improv. in physic. func. in: Adult pts. with active dis. when the response to DMARDs, include. methotrexate, has been inadeq. Adult pts. with sev., act. and progres. dis. not prev. treated with methotrexate or other DMARDs. In these pt. populations, a reduct. in the rate of the progres. of joint damage, as measured by X‑ray, has been demonst. Ankylos. spondyl.:tmt. of sev., act. ankyl. spondyl., in adult pts. who have responded inadeq. to convent. ther. Psoriatic arthr. tmt. of active and progres. psoriatic arthr. in adult pts. when the response to prev. DMARD ther. has been inadeq. Infliximab should be admin. in comb. with methotrexate. Or alone in pts. who show intoler. to methotrexate or for whom methotrexate is contraind.
C/I: Pts. with a history of hypers. to infliximab or to other murine proteins. Pts. with tuberculosis or other sev. infect. such as sepsis, abscesses, and opportunistic infect. Pts. with moder./ or sev. heart fail. (NYHA class III/IV).
