All the Therapeutic System Drugs
Folic Acid Analog. Methotrexate 25 mg/ml. VIAL (sol. for inj.): 25 mg/ ml X 2 ml, 4 ml,
8 ml, 20 ml, 40 ml. Dose must be ajust.
individ. for each pt. accord. to med.
cond. See lit.
Antineopl. Chemother.
Tmt. of gestational choriocarcinoma,
chorioadenoma destruens and
hydatidiform mole. Palliation of ALL. Tmt.
and proph. of menin. leukemia.
Greatest effect has been observed in
palliation of acute lymphoblast.(stemcell)
leukemias in child. In comb. with
other anticancer agents, may be used for
the induc. of remis.,but is most common.
used in the mainten. of induced remis.
May be used alone, or in comb. with other
antineoplastic drugs, in the manag. of
breast canc., epidermoid cancers of the
head and neck, lung cancer (partic.
squamous cell ,small cell types), bladder
cancer and osteogenic cancer. Tmt. of the
advan.stages (III and IV, Peter’s Staging
system) of lymphosarcoma, partic. in
child., and in advanced cases of mycosis
fungoides.
Psoriasis. Indic. only in the sympt. control
of sev. recalcitrant, disabling psoriasis
which is not adeq. responsive to other
forms of therapy, and only when the diag.
has been established, as by biopsy and/or
after dermat. consult. RA:Tmt. of selec.
adul.with sev. RA, only when the diag. has
been well established accord. to rheumat.
standards, with inadeq. response to other
forms of antirheum. ther., includ. full dose
NSAIDs and usually a trial of at least one
or more dis.-modif. antirheum. drugs.
C/I: Pregnancy, lact., pts. in poor state of
nutrition, sev. ren. impair. (crCL <20 ml/
min), sev. liver impair., bone marrow
hypoplasia, leucopenia,
thrombocytopenia, anemia, alcohol
abuse, hypersens. and lung toxic.due to
methotrexate, serious, acute or chronic
infect. such as tuberculosis and HIV,
ulcers of the oral cavity and known
active GI ulcer dis. Concur. vaccin. with
live vaccines.
Interleukin-6 Receptor Inhibitor. Tocilizumab 20 mg/ml, 162 mg / 0.9 ml. VIALS: 1, 4 x 80 mg/4 ml; 200mg/10 ml;
400 mg/20 ml.
RA : 8mg/kg bdy wt. I.V. 1 x every 4
weeks.
Pts. bdy wt. > 100 kg, dose exceed. 800
mg/infus. not recommend. See lit. SJIA:
<30 kg bdywt: 12 mg/kg bdywt, every
2 wks; ≥30 kg bdywt: 8 mg/kg bdywt,
every 2 wks.
Reduce signs/sympts. in adult pts with
mod-severe active rheum. arthrit. when
inad. response to one/more DMARDS or
TNF antags., or in pts unable to use
DMARDs. Can be used alone/in comb. with
methotrexate/other DMARDs. Reduce rate
progress. joint damage as measured by
X-ray, improve physic. funct. when in
combinat. methotrexate. Tmt. active
system. juv. idiopath. arthrit. in pts. > 2 yrs.
C/I: Hypersens., active severe infects.
Interleukin-6 Receptor Inhibitor. Tocilizumab 162 mg / 0.9 ml. PRE- FILLED SYRINGE.: 4 x 162 mg/0.9 ml
Inj. S.C. 162 mg once a week.
In comb. with MTX, for the tmt. of moder.-
severe active RA in adult pt. who have
either responded inadequate. to, or who
were intoler. to, prev. therapy with one or
more DMARDs or TNF antagonists. In
these pts., Tocilizumab can be given as
monother. in case of intolerance to MTX or
where continued tmt. with MTX is
inappropriate.
C/I: Hypersens., active severe infects.
Interleukin Inhibitor. Secukinumab 150 mg. VIAL(pwdr. for sol. for inj.): 1×6ml.
PRE FILL. PEN/SYR (sol. for inj.): 1, 2×1ml Plaque psorias.: 300 mg by SC inj. with init. dosing at Weeks 0, 1, 2, 3 and 4, follow. by mnthly. mainten. dosing. Each 300 mg dose is given as two SC inj. of 150 mg. Psoriat. arthrit.: For pts. with concom. moder.-sev. plaque psorias. or who are anti-TNFα inadeq. responders (IR): 300 mg by SC inj. with init. dosing at Weeks 0, 1, 2, 3 and 4, follow. by mnthly. mainten. dosing. Each 300 mg dose is given as two SC inj. of 150 mg.
For other pts.: dose is 150 mg by SC inj. with init. dosing at Weeks 0, 1, 2, 3 and 4, follow. by monthly mainten. dosing. Ankylos. spondylit.: 150 mg by SC inj. with init. dosing at Weeks 0, 1, 2, 3 and 4, follow. by mnthly. mainten. dosing.
For all of the above indications, usually achieved within 16 wks. of tmt. Consider. should be given to discont. tmt. in pts. who have shown no response by 16 wks. of tmt. Some pts. with an init. partial response may subseq. improve with continued tmt. beyond 16 wks.
Plaque psorias.: Tmt. of moder.- sev. plaque psorias. in adult. who are candidates for system. ther.
Psoriat. arthrit.: Alone or in comb. with methotrexate (MTX): tmt. of active psoriat. arthrit. in adult pts. when the response to previous dis.-modif. anti-rheumatic drug (DMARD) ther. has been inadeq.
Ankylosing spondylitis: Tmt. of active ankylos. spondylitis in adult. who have responded inadeq. to convent. ther.
C/I: Severe hypersens. Clinical. important, active infec. (e.g. active tuberculosis).
TNF Blocking Agent. Etanercept 25, 50 mg. (pwdr. for inj.): 25 mg.
PRE-FILL. SYR. (soln for inj.): 1 x 25 mg;
1 x 50 mg.
PRE-FILL. PEN (soln 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 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).
