All the biological system drugs
Bevacizumab 25 mg/ml. VIALS: 1 x 100 mg/4 ml; 1 x 400 mg/16ml
Metastatic carcinoma of the colon or rectum (mCRC)
5 mg/kg or 10 mg/kg once every 2 weeks or 7.5 mg/kg or 15 mg/kg once every 3 weeks. until progression of dis. or unacceptable tox.
Metastatic breast cancer (mBC)
10 mg/kg once every 2 weeks or 15 mg/kg once every 3 weeks until progression of dis. or unacceptable tox.
Non-small cell lung cancer (NSCLC)
First-line tmt. of non-squamous NSCLC in combin. with platinum-based chemother.:
in addition to platinum-based chemother. for up to 6 cycles of tmt. followed by this drug as a sgle. agent until dis. progress. 7.5 mg/kg or 15 mg/kg once every 3 weeks. Clinical benefit in NSCLC pts. has been demonstrated with both 7.5 mg/kg and 15 mg/kg doses. until progress. of dis. or unacceptable tox.
First-line tmt. of non-squamous NSCLC with EGFR activating mutations in combin. with erlotinib:
EGFR mutation testing should be performed prior to init. of tmt with the combin. of this drug and erlotinib. It is important that a well-validated and robust methodology is chosen to avoid false neg. or false posit. determination.
15 mg/kg once every 3 weeks until dis. progress.
Advanced and/or metastatic renal cell cancer (mRCC)
10 mg/kg once every 2 weeks until progress. of the dis. or unacceptable tox.
Malignant Glioma (WHO Grade IV) - Glioblastoma
10 mg/kg once every 2 weeks or 15 mg/kg once every 3 weeks. until progress. of dis. or unacceptable tox.
Epithelial ovarian, fallopian tube and primary peritoneal cancer
Front-line tmt.:
in addition to carboplatin and paclitaxel for up to 6 cycles of tmt. followed by cont. use of this drug as sgle. agent until dis. progress or for a max. of 15 months or until unacceptable tox., whichever occurs earlier. Dose of this prod. is 15 mg/kg once every 3 weeks.
Tmt. of platinum-sensitive recurrent dis.
in combin. with carboplatin and gemcitabine for 6 cycles and up to 10 cycles followed by cont. use of this drug as sgle. agent until dis. progress. Dose is 15 mg/kg once every 3 weeks.
Tmt. of platinum-resistant recurrent dis.
In combin. with one of the following – paclitaxel, topotecan (given weekly) or pegylated liposomal doxorubicin. The dose of this drug is 10 mg/kg once every 2 weeks. When admin. in comb. with topotecan (on days 1-5, every 3 weeks), the dose of this drug is 15 mg/kg g once every 3 weeks. until dis. progress. or unacceptable tox.
Cervical Cancer
in comb. with one of the following chemother. regimens: paclitaxel and cisplatin or paclitaxel and topotecan. The dose of this drug is 15 mg/kg once every 3 weeks. until progress. of dis. or until unacceptable tox.
In comb. with fluoropyrimidine-based chemother -tmt. of pts. with metastatic carcinoma of the colon or rectum.
In comb. with paclitaxel - first-line tmt. of adlt. pts. with metastatic breast cancer.
In addition to platinum-based chemother- first-line tmt. of pts. with unresectable adv. metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology.
In comb. with erlotinib -first-line tmt of adlt. pts. with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations.
In combin. with interferon alfa-2a - first line tmt. of pts. with adv. and/or metastatic renal cell cancer.
As a single agent, - tmt. of glioblastoma in patients with progress. dis. following prior ther.
In combin. with carboplatin and paclitaxel - front-line tmt. of advanced ([FIGO] stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients who are at high risk for recurrence (residual disease after debulking).
In comb. with carboplatin and gemcitabine, - tmt. of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior ther. with bevacizumab or other VEGF inhibit. or VEGF receptor-targeted agents.
In combin. with paclitaxel, topotecan, or pegylated liposomal doxorubicin – ttmt. of adult pts. with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemother. regimens and who have not received prior ther. with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents.
In combinat. with paclitaxel and cisplatin or, paclitaxel and topotecan, - tmt. of pts. with persistent, recurrent, or metastatic carcinoma of the cervix
C/I: Hypersens
Hypersens. to Chinese Hamster Ovary (CHO) cell prod. or other recomb. human or humanised antibodies. Pregn.
Alkylating Agent (platinum analog). Cisplatin 1 mg/ml. VIALS: 1 x 100 ml, 50 ml. See lit.
Palliative in add. to other modalities
in
tmt. metastat. testic. and ovar. cancer,
advanced bladder cancer.
Androgen Biosynthesis Inhibitor. Abiraterone Acetate 250 mg , 500 mg. TABS.: 250 mg x 120 , 500 mg x 60.
Intended for male pts. only. 1,000 mg (4×250mg tabs. or 2x500mg tabs.) once dly.
1. in combin. with prednisone for metast. castrat.-resist. prostate cancer.
2. For newly diag. high risk metast. hne. sensit. prostate cancer (mHSPC) in adlt. men in combinat. with androgen depriv. ther.(ADT) and in combin. with prednisone.
C/I: Hypersens./ by pregn. females or who may be potent. pregn../sev. hepat. impairm./ in combin. with Ra-223 if given with prednisone.
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.
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
lit.
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.
intervent.
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
outcomes.
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.
