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.
Monoclonal Antibody. Belimumab 120 mg, 400 mg. VIAL (pwdr. for concentrate for sol. for infus.): 1×120mg.
VIAL (pwdr. for concentrate for sol. for infus.): 1×400mg.
Benlysta 120,400 mg: Premed. includ. an antihistamine, with/without an antipyretic, may be admin. before the infus. The recomm. dose is 10 mg/kg on Days 0, 14 and 28, and at 4-wk. interv. thereafter. The patient’s condition should be evaluated continuous. Discont. of tmt. should be consid. if there is no improve. in dis. control after 6 mnths. of tmt. See lit.
Indic. as add-on ther. in adult pts. with active, autoantibody-posit. system. lupus erythematosus (SLE) with a high degree of dis. activity (e.g., positive anti-dsDNA and low complement) despite standard ther.
C/I: Hypersens.
Monoclonal Antibody. Belimumab 200 mg. PRE-FILL. PEN (sol. for S.C. inj.): 1, 4×200mg/ml.
PRE-FILL.SYR. (sol. for S.C. inj.): 1, 4×200mg/ml.
Benlysta 200mg/ml: 200 mg once wkly., admin. S.C. dosing is not based on weight.
The pt’s. condition should be evaluat. continuous. Discont. of tmt. should be consid. if there is no improv. in dis. control after 6 mnths. of tmt.
If a dose is missed, it should be admin. as soon as possible. Thereafter, pts. can resume dosing on their usual day of admin., or start a new wkly.
Transit. from IV to S.C. admin.: If a pt. is being transitioned from IV admin. to S.C. admin., the 1st S.C. inj. should be admin. 1-4 wks. after the last IV dose. See lit.
Indic. as add-on ther. in adult pts. with active, autoantibody-posit. system. lupus erythematosus (SLE) with a high degree of dis. activity (e.g., positive anti-dsDNA and low complement) despite standard ther.
C/I: Hypersens.
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).
