All the biological system drugs
Anti-Androgen. Abiraterone Acetate 250 mg. TABS.: 120.
Intended for male pts. only. 1,000 mg (4×250mg tabs.) once dly. in comb. with prednisone.
Indicated in comb. with prednisone for the tmt. of pts. with metastat. castration-resist. prostate cancer.
C/I: Hypersensitivity to active substance or any of its excipients. Use in female patients. Severe hepatic impairment.
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.
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
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
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
Monoclonal Antibody. Brentuximab Vedotin 50 mg. VIAL (Pwdr. for conc. for solution for IV infus.): 1 x 50 mg. Previous. Untreat. HL: The recom. dose in comb. with chemother. (doxorubicin [A], vinblastine [V] and dacarbazine [D] [AVD]) is 1.2 mg/kg admin. as an IV infus. over 30 min. on days 1 and 15 of each 28-day cycle for 6 cycles.
Primary prophylaxis with growth factor support (G-CSF), begin. with the 1ST dose, is recom. for all pts. with prev. untreat. HL receiv. comb. ther.
HL at incr. risk of relapse or progression: 1.8 mg/kg admin. as an IV infus. over 30 min. every 3 wks.
Tmt. should start follow. recovery from ASCT based on clinical judgment. These pts. should receive up to 16 cycles.
Relapsed or refract. HL: 1.8 mg/kg admin. as an IV infus. over 30 min. every 3 wks. dose for the retreatment of pts. who have previously responded to tmt. -1.8 mg/kg admin. as an IV infus. over 30 min. every 3 wks.. Alternatively, tmt. may be started at the last tolerated dose.
Previous. untreated sALCL or other CD30-express. peripheral T-cell lymphomas: in comb. with chemother. (cyclophosphamide [C], doxorubicin [H]& prednisone [P] [CHP]) is 1.8 mg/kg admin. as an IV infus. over 30 min. every 3 wks for 6 to 8 cycles.
Primary prophylaxis with G-CSF, beginning with the first dose, is recom. for all pts. with prev. untreated sALCL or other CD30-expressing peripheral T-cell lymphomas, receiving comb. ther.
Refer to the SmPCs of chemotherapy agents given in comb. with ADCETRIS for pts. with prev. untreated sALCL or other CD30-expressing peripheral T-cell lymphomas.
Relapsed or refractory sALCL: 1.8 mg/kg admin. as an IV infus. over 30 min. every 3 wks.
Init. dose for the retreatment of pts. who have prev. responded to tmt. with Brentuximab vedotin is 1.8 mg/kg admin. as an IV infus. over 30 min. every 3 wks. See lit.
Tmt. of adult pts. with previos. untreated Stage III or IV classical Hodgkin lymphoma (cHL), in comb. with doxorubicin, vinblastine, and dacarbazine.
Tmt. of adult pts. with CD30+ HL at incr. risk of relapse or progress. follow. autologous stem cell transplant (ASCT).
Tmt. of adult pts. with relapsed or refractory CD30+ Hodgkin lymphoma (HL): ASCT, or at least two prior therapies when ASCT or multi-agent chemother. is not a tmt. option.
Syst. anaplastic large cell lymphoma & Peripheral T-cell lymphomas (PTCL).
Tmt. of adult pts. with previously untreated system. anaplastic large cell lymphoma (sALCL) or other CD30-expres. peripheral T-cell lymphomas (PTCL), includ. angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in comb. with cyclophosphamide, doxorubicin, and prednisone.
Tmt. of adult pts. with relapsed or refract. sALCL.
Tmt. of adult pts. with CD30+ cutan. T-cell lymphoma (CTCL) after at least 1 prior system. ther.
C/I: Hypersens., comb. use with Bleomycin.
Protein Kinase Inhibitor. Everolimus 2.5, 5, 10 mg. TABS: 30 x 2.5 mg, 5 mg, 10 mg. Tmt. to
be initiated by physician experienced
in the use of anticancer ther. Orally
once dly., at the same time ev. d. See
Tmt. pts. with advanced ren. cell
carcinoma aft. fail. of tmt. with sunitinib or
sorafenib. Tmt. pts. with SEGA assoc. with
tuberous sclerosis complex who req. ther.
but not candidates for curative surg.
resect. Effect. based on analys. of change
in SEGA vol. Clin. benefit in improvement
dis.-relat,. sympts/increase in overall
survival has not been demonstrat. Tmt.
progress. neuroendocrine tumors
pancreat. origin in pts. with unresect.,
locally advanced/metastat. dis. Safety/
effectivenss in tmt. carcinoid tumors have
not been established. Tmt. of horm.
receptor-pos., HER2/neu neg. advanc.
breast canc. in combi. with exemestane in
postmen. women w/o symp. visceral dis.
after recur. or progress. following nonsteroid.
aromat. inh.. Tmt. of adult pts.
with renal angiomyolipoma and tuberous
sclerosis comp., nor req. immediate surg.
Effectiv. of the drug in tmt. of renal
angiomyolipoma based on an analysis of
durable obj. respons. in pts. treat. for a
median of 8.3 mnths. Further follow-up of
pts. is req. to determine long-term
Tmt. of unresect., local. advanc. /metastat.,
well-different. (Grade 1/ Grade 2) nonfunct.
neuroendocrine tumour. of GI or
lung origin in adults with progress. dis.
C/I: Hypersens. to active substances,
other rapamycin derivs., excips.
Protein Kinase Inhibitor. Alectinib 150 mg. HARD CAPS.:240.
600 mg (4×150 mg caps.) ×2/d with food , max. dly. dose of 1200 mg). See lit.
Tmt. of pts. with ALK posit., local. advanc. or metast. non-small cell lung cancer (NSCLC) who progres. on or are intolerant to crizotinib. Alectinib as monother. - for the 1st -line tmt. of adult pts. with anaplastic lymphoma kinase (ALK)-posit. advanc. non-small cell lung cancer. (NSCLC).