All the Drug Class Drugs
TNF Blocking Agent. Adalimumab 50 mg/ml.. PRE-FILLED SYRINGE: 2 ×(20 mg/0.4 mL, 40mg/0.8ml)
PRE-FILLED PEN: 2× (40mg /0.8 ml).
Dosage ajust. individ. accord. to pt. med. condit.
RA: in comb. with methotrexate-tmt. of moder.-sev., active RA in adult pts. when the response to dis.-modif. anti-rheumat.drugs includ. methotrexate has been inadequate.
The tmt. of sev., active and progres. RA in adult.not previous. treated with methotrexate, given as monother. in case of intolerance to methotrexate or when continued tmt. with methotrexate is inappropr. AMGEVITA has been shown to reduce the rate of progress. of joint damage as measured by X-ray and to improve physical funct., when given in comb. with methotrexate.
Axial spondyloarthritis Ankylosing spond. (AS): tmt. of adult. with severe active AS who have had an inadeq. response to convent. ther.
Axial spondyloarthritis without radiograph. evidence of AS: tmt. of adults with sev. axial spondyloarthritis without radiograph.evidence of AS, but with object. signs of inflamm. by radiolog. and/or lab. tests includ. MRI and serum CRP levels, who have had an inadequate response to, or are intoler, to,NSAID’s.
Psoriatic arthritis: tmt. of active and progress. psoriat. arthritis in adults when the response to previous dis.-modif. anti-rheum.drug ther. has been inadequate. Adalimumab has been shown to reduce the rate of progress. of peripher. joint damage as measured by X-ray in pts. with polyarticular symmetr. subtypes of the dis. and to improve physic. func.
Psoriasis: tmt. of moder.-sev. chron. plaque psoriasis in adult pts. who are candidates for system. ther.
Hidradenitis suppurativa (HS): tmt. of active moder.- sev. hidradenitis suppurativa (acne inversa) in adult pts. with an inadequate response to convent. system. HS ther.
Crohn’s dis. : reducing signs and sympt.and induc.and maintain. clinical remiss. in adult pts. with moder.- sev. active Crohn’s dis. who have had an inadequate response to convent. ther. AMGEVITA is indic. for reduc. signs and sympt. and induc. clinical remiss. in these pts. if they have also lost response to or are intoler. to infliximab.
Ulcerat. colit.: tmt. of moder.-sev. active ulcerat. colit. in adult pts. who have had an inadequate response to convent. ther. includ. corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intoler. to or have med. contraindicat. for such therapies.
Uveitis : tmt. of non-infect. intermed., posterior and panuveitis in adult pts. who have had an inadequate response to corticosteroids, in pts. in need of corticosteroid-sparing, or in whom corticosteroid tmt. is inappropr.
Intestinal Behcet's dis.: tmt. of intestin. Behcet’s dis. in pts. who have had an inadequate response to convention. ther.
C/I: Hypersens.
Active tuberculosis or other sev. infect. such as sepsis, and opportunist.infec.
Moder.-sev. HF(NYHA class III/IV).
TNF Blocking Agent. Etanercept 25, 50 mg. VIAL (pwdr.& solvent ): 25 mg.
PRE-FILL. SYR. (sol. for inj.): 1 x 25 mg;
1 x 50 mg.
PRE-FILL. PEN (sol. for inj.): 1 x 50 mg.
Dosage must be ajust. individ.
RA: Tmt. of active RA in adult. when the
response to DMARDs include.
methotrexate (unless contraindic. ) has
been inadeq. Can be used in comb. with
methotrexate in pts. who do not respond
adeq. to methotrexate alone. Reduc.
signs&sympt. and inhibit. the progress. of
structur. damage in pts. with moder. –
sev. act. RA.
Alone or in comb. with methotrexate, has
been shown to reduce the rate of
progress. of joint damage as measure. by
X-ray and to improve. physic. funct.
Polyarticul. juven. idiopathic arthrit.:
Tmt. of active polyarticul. juven.
idiopathic arthrit. in child. & adolesc. ≥2
yrs. who have had an inadeq. respon. to,
or who have proved intoler. of,
methotrexate. The drug has not been
studi. in child. < 2 yrs.
Psor. arthrit.: Tmt. of act. & progress. psor.
arthrit. in adults when the response to
prev. DMARDs ther. has been inadeq.
The has been shown to improve. physic.
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 polyarticul. symmetric. subtypes of
the dis.
Ankylos. spondyl.: Tmt. of adult. with sev.
act. ankylos. spondyl. who have had an
inadeq. response to convent. ther.
Plaque psorias.: Tmt. of adults pts. (18 yrs.
or older) with moderate to severe plaque
psor. who are candidates for system. ther.
or photother.
Ped. plaque psor. Tmt. of chron. sev.
plaque psor. in child. &adolesc. from the
age of 6 yrs. who are inadeq. control. by,
or are intoler. to, other system. ther. or
photother.
Juven. idiopat. arthrit. tmt. of polyarthrit.
(rheumat. factor posit. or neg.) and
extended oligoarthritis in child. &
adolesc. ≥2 yrs who have had an inadeq. response to, or who have proved intoler.
of, methotrexate.
Tmt. of psor. arthrit. in adolesc. ≥12 yrs.
who have had an inadeq. response to, or
who have proved intol. of, methotrexate.
Tmt. of enthesitis-related arthrit. in
adolesc. ≥ 12 yrs. who have had an
inadeq. respon. to, or who have proved
intoler. of, convent. ther.
Axial spondyloarthritis Ankylos.
spondylitis: Tmt. of adults with sev. active
ankylosing spondylitis who have had an
inadeq. response to convent. ther.
Non-radiograph. axial spondyloarthritis:
Tmt. of adult. with sev. non-radiograph.
axial spondyloarthritis with object. signs
of inflamm. as indic. by elev. CRP and MRI
evidence, who have had an inadeq.
response to NSAIDs.
C/I: Hypersens., sepsis or risk of sepsis,
Pts. with active infec. , includ. chron. or
localised infec.
TNF Blocking Agent. Adalimumab 40mg/0.8ml. 2 Pre-filled syringes/pens: Dosage must be adjust. individ. accord. to pt. med. cond.
RA: In comb. with methotrexate for moder.- sev., active RA in adult pts. when the resp. to dis.-modif. anti-rheum. drugs includ. methotrexate has been inadeq.
Tmt. of sev., active and progres. RA in adults not prev. treated with methotrexate. Can be given as monother. in case of intoler. to methotrexate or when continued tmt. with methotrexate is inappropr. This drug has been shown to red. the rate of progres. of joint damage as measured by X-ray and to impr. physic. funct., when given in comb. with methotrexate.
Axial spondyloarthritis, Ankylosing spondylitis (AS): Tmt. of adults with sev. act. ankylos. spondylitis who have had an inadeq.resp. to convent. ther.
Axial spondyloarthritis without radiographic evidence of AS: Tmt. of adults with sev. axial spondyloarthritis without radiograp. evidence of AS, but with object. signs of inflam. by radiolog. and/or lab. tests includ. MRI and serum CRP levels, who have had an inadeq. resp. to, or are intoler. to, NSAIDS.
Psoriatic arthritis: Tmt. of act. and progres. psoriat. arthritis in adult. when the resp. to prev. dis.-modif. anti-rheum. drug ther. has been inadeq. Adalimumab has been shown to red. the rate of progres. of periph. joint damage as measured by X-ray in pts. with polyarticular symetr. subtypes of the dis. and to impr. physic. funct.
Psoriasis: Tmt. of moder.- sev. chron. plaque psoriasis in adult pts. who are candidates for syst. ther.
Hidradenitis suppurativa (HS): Tmt. of active moder.- sev. HS (acne inversa) in adult with an inadeq. resp. to convent. syst. HS ther.
Crohn’s dis.: Indic. for reduc. signs and sympt. and induc. and maintain. clin. remiss. in adult pts. with moder. - sev. active Crohn’s dis. who have had an inadeq. resp. to convent. ther. The drug is indic. for reduc. signs and sympt. and induc. clin. remiss. in these pts. if they have also lost resp. to or are intoler. to infliximab.
Ulcer. colit.: Tmt. of moder.- sev. active ulcer. colit. in adult pts. who have had an inadeq. resp. to conven. ther. include. corticost. and 6-mercaptopurine or azathioprine, or who are intoler. to or have med. contraind. for such ther.
Uveitis: Tmt. of non-infec. intermed. posterior and panuveitis in adult pts. who have had an inadeq. resp. to corticost., in pts. in need of corticost. sparing, or in whom corticost. tmt. is inappropr.
Intestinal Behcet's dis.: in pts. who have had an inadeq. resp. to convent. ther.
C/I: Hypersens. Active tuberc., other sev. infect. such as sepsis and opportun. infect. Moder. - severe HF (NYHA class III/IV).
TNF Blocking Agent. Adalimumab 20 mg / 0.2 ml, 40 mg / 0.4 ml, 80 mg / 0.8 ml. PRE-FILLED SYRINGE: 2 (20 mg/0.2 mL, 40mg/0.4ml, 80 mg/0.8 mL).
PRE-FILLED PEN: 2. (40mg /0.4ml, 80 mg/0.8 mL).
VIAL (with adaptor): 2. S.C. Dosage must be adjust. individ. accord. to pt. med. cond.
RA: In comb. with methotrexate: The tmt. of moder.- sev., active RA in adult pts.
when the response to dis.-modif. anti-rheumatic drugs include. methotrexate has been inadequate.
The tmt. of severe, active and progres. RA in adults not prev. treated with methotrexate. Can be given as monother. in case of intoler. to methotrexate or when continued tmt. with methotrexate is inapprop.
This drug has been shown to reduce the rate of progres. of joint damage as measured by X-ray and to improve physic. funct., when given in comb. with methotrexate.
Juvenile idiopat. arthritis Polyarticular juvenile idiopat. arthritis: In comb. with methotrexate- tmt. of active polyarticular juvenile idiopat. arthritis, in pts. from the age of 2 yrs. who have had an inadequate response to one or more DMARDs. Adalimumab can be given as monother. in case of intoler. to methotrexate or when continued tmt. with methotrexate is inapprop. (for the efficacy in monother.). Adalimumab has not been studied in pts. aged less than 2 yrs.
Axial spondyloarthritis, Ankylosing spondylitis (AS): Tmt. of adults with sev. act. ankylos. spondylitis who have had an inadequate response to convent. ther.
Axial spondyloarthritis without radiographic evidence of AS: Tmt. of adults with severe axial spondyloarthritis without radiograp. evidence of AS, but with object. signs of inflame. by radiolog. and/or lab.tests includ. MRI and serum CRP levels, who have had an inadequate response to, or are intoler. to, non-steroidal anti-inflam. drugs.
Psoriatic arthritis: Tmt. of active and progres. psoriat. arthritis in adult. when the response to previous dis.-modif. anti-rheum. drug ther. has been inadequate. Adalimumab has been shown to reduce the rate of progres. of periph. joint damage as measured by X-ray in pts. with polyarticular symmetr. subtypes of the dis. and to improve physic. funct.
Psoriasis: Tmt. of moder.- sev. chron. plaque psoriasis in adult pts. who are candidates for systemic ther.
Ped. plaque psoriasis: Tmt. of sev. chron. plaque psoriasis in child. and adolesc. from 4 yrs. of age who have had an inadequate response to or are inappropr. candidates for topical ther. and phototherapies. Hidradenitis suppurativa (HS): Tmt. of active moder.- sev. HS (acne inversa) in adult, adolesc. from 12 yrs. of age with an inadequate response to convent. syst. HS ther.
Crohn’s dis.: Indic. for reduc. signs and sympt. and induc. and maintain. clin. remiss. in adult pts. with moder. - sev. active Crohn’s dis. who have had an inadequate response to conven. ther. The drug is indic. for reduc. signs and sympt. and induc. clin. remiss. in these pts. if they have also lost response to or are intoler. to infliximab.
Ped.Crohn's dis.: Tmt. of moder. – sev. active Crohn's dis. in ped. pts. (from 6 yrs. of age) who have had an inadequate response to convent. ther. include. prim. nutrition ther. and corticosteroid, and/or an immunomodulator, or who are intoler. or have contraindic. for such ther.
Ulcer. colit.: Tmt. of moder.- sev. active ulcer. colit. in adult pts. who have had an inadequate response to conven. ther. include. corticoster. and 6-mercaptopurine or azathioprine, or who are intoler. to or have med. contraind. for such therap.
Enthesitis-related arthritis: Tmt. of active enthesitis-related arthritis in pts., 6 yrs. of age and older, who have had an inadequate response to, or who are intoler. of conven. ther.
Uveitis: Tmt. of non-infec. intermediate, posterior and panuveitis in adult pts. who have had an inadequate response to corticosteroid., in pts. in need of corticosteroid sparing, or in whom corticosteroid tmt. is inappropriate.
Intestinal Behcet's dis.: Tmt. of intestinal Behcet’s dis. in pts. who have had an inadequate response to convent. ther.
C/I: Hypersens. Active tuberc., other severe infec. such as sepsis, and opportun. infec. Moder. - severe HF(NYHA class III/IV).
TNF Blocking Agent. Golimumab 50 mg/0.5 ml. PREFILLED PEN: 1 x 0.5 ml.
PREFILLED SYRINGE: S.C. 1 x monthly,
same date.
Rheumatoid arthrit: In comb. with
methotrexate. Psoriatic arthrit: Alone/in
combinat. with methotrexate.Ankylosing
spondyl.
Ulcerative ColitisSimponi is indicated for
treatment of moderately to severely active
ulcerative colitis in adult patients who
have had an inadequate response to
conventional therapy including
corticosteroids and 6-mercaptopurine
(6-MP) or azathioprine (AZA), or who are
intolerant to or have medical
contraindications for such therapies.
C/I: Hypersens., activte tuberculosis/
other severe infect., mod/severe heart
fail.