All the Active Ingredient Drugs
Tyrosine Kinase Inhibitor. Imatinib 100 mg, 400 mg. F.C. TABS: 20, 60 x 100 mg; 10, 30 x
400mg.
Doses of 400 mg or 600 mg should be
admin. once dly., whereas a daily dose
of 800 mg should be admin. as 400 mg
×2/d in the morn. and even.
Tmt. of adult pts. and child. 3 yrs. of age
and above with Ph+ chron. myeloid
leukaemia (Ph+ -CML) in chron. phase
accelerat. phase or blast crisis. Glivec is
also indicat. for the tmt. of adult pts.s
with Kit (CD117) posit. unresect. and/or
metastat. malignant GI strom. tumour.
(GIST). Also indicated for the tmt. of :
Adult pts. with newly diagnosed
Philadelphia chromos. posit. acute
lymphoblastic leukemia (Ph+ ALL) integrated with chemotherapy. Adult pts.
with relapsed or refract. Ph + ALL as
monother. Adult pts. with unresect.
dermatofibrosarcoma protuberans
(DFSP) and adult pts. with recurrent and/
or metastat. DFSP who are not eligible
for surg. Adult pts. with myelodyspiastic/
myeloproliferative dis.(MDS/MPD) assoc.
with PDGFR ( platelet - derived growth
factor recept. ) gene re- arrangements.
Adult pts. with hypereosinophilic syndr.
(HES) and/or chronic eosinophilic
leukaemia (CEL) who have the FIP1L1-
PDGFRalfa fusion kinase (mutational
analysis or FISH demonstration fo CHIC2
allele deletion) and for pts. with HES and/
or CEL who are FIP1L1-PDGFR alfa fusion
kinase negative . Adult pts. with aggress.
systemic mastocytosis (ASM) without the
D816V c-kit mutation .Adjuvant tmt. of
adult pts. follow. complete gross resec. of
Kit (CD117) positive GIST.
C/I: Hypersens.
Protein Kinase Inhibitor. Imatinib 100 mg, 400 mg. FC Tabs. 60X100 mg, 30X400 mg. Ther. should be init. by a phys. exper. in tmt. of hematological malign. and malign. sarcomas. See lit.
Tmt of adlt. pts. and child. 3 years of age and above with Ph+ chron. myeloid leukaemia (Ph+ -CML) in chron. phase, accel phase or blast crisis.• Tmt of adlt. pts. with Kit (CD117) posit. unresect. and/or metast. malign. GI stromal tumours (GIST). • Adjuv. tmt of adlt. pts. follow. compl. gross resect. of Kit (CD117) posit. GIST.• Tmt of adlt. pts. with newly diagn. Philadelphia chrom. posit. ac. lymphoblastic leukemia (Ph+ ALL) integr. with chemother. • Tmt. of adlt. pts. with relapsed or refract. Ph+ ALL as monother. • Tmt. of adlt. pts. with unresect. dermatofibrosarcoma protuberans (DFSP) and adlt. pts. with recur. and/or metast. DFSP who are not elig. for surgery.• Tmt. of adlt. pts. with myelodysplastic/myeloproliferat. dis. (MDS/MPD) assoc. with PDGFR (platelet-derived growth factor receptor) gene re-arrangements. • Tmt. of adlt. pts. with hypereosinophilic syndr. (HES) and/or chron. eosinophilic leukaemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutation. analysis or FISH demonstr. of CHIC2 allele delet.) and for pts. with HES and/or CEL who are FIP1L1- PDGFRα fusion kinase neg. • Tmt. of adlt. pt.s with aggress. syst. mastocytosis (ASM) without the D816V c-kit mutat.
C/I: Hypersens.
Protein Kinase Inhibitor. Imatinib 100 mg, 400 mg. TABS:60X100 mg, 30X400 mg. -
400 mg or 600 ×1/d, whereas a dly.-
dose of 800 mg should be administ. as-
400 mg ×2/d , in the morn. and in the-
even. Tmt. should be cont. as long-
as the pt. cont. to benefit. Should be-
administ. P.O. with meal and a large-
glass of water. See lit.-
Tmt. of adult pts. and child. ≥ 3yrs. with-
Ph+ -CML in chron. phase acceler. phase-
or blast crisis. Tmt. of adult pts. with newly-
diagnosed Philadelphia chromosome-
posit. Ph+ ALL integrated with chemother..-
Adult pts. with relapsed or refractory Ph +-
ALL as monother. Adult pts. with unresec.-
DFSP and adult pts. with recur. and/or-
metast. DFSP who are not eligible for-
surgery. Adult pts. with MDS/MPD assoc.-
with PDGFR gene re- arrang. Adult pts.-
with HES and/or CEL who have the FIP1L1--
PDGFR alfa fusion kinase (mutational-
analysis or FISH demonst. for CHIC2 allele-
deletion) and for pts. with HES and/or CEL-
who are FIP1L1-PDGFR alfa fusion kinase-
negative . Adult pts. with ASM without the-
D816V c-kit mutation. Adult pts. with Kit (CD117) -
posit. unresect. and/or metast. malignant GIST. -
Adjuv. tmt. of adult pts. following compl.-
gross resect. of Kit (CD117) posit. GIST.-
C/I: Hypersens.
Protein Kinase Inhibitor. Imatinib 100 mg, 400 mg. TAB 10/20/30/60 X 100/400 mg
Ther. to be init. by a physic. exper. in haematological malign. and malignant sarcomas. Adults: 400-800 mg/d. Chldr with CML: 340 mg/m2/d.
For doses other than 400 mg and 800 mg, a 100 mg divisible tablet is available. Tmt. to be be contin. as long as the pt. continues to benefit. See lit.
Tmt. of adult pts. and childr. 3 years of age and above with Ph+ chronic myeloid leukaemia(Ph+ -CML) in chron. phase, acceler. phase or blast crisis /
Adult pts with newly diagnosed Philadelphia chromosome posit. ac. lymphoblastic leukemia (Ph+ALL) integrated with chemother./ Adult pts. with relapsed or refractory Ph + ALL as monother./Adult pts. with unresectable dermatofibrosarcoma protuberans (DFSP) and with recurrent and/or metast. DFSP who are not eligible for surgery.Adult pts. with myelodyspiastic/ myeloproliferative dis. (MDS/MPD) assoc. with PDGFR ( platelet - derived growth factor receptor ) gene re- arrangements.Adult pts. with hypereosinophilic syndrome (HES) and/or chron. eosinophilic leukaemia (CEL) who have the FIP1L1- PDGFR alfa fusion kinase (mutational analysis or FISH demonstr. fo CHIC2 allele deletion) and for pts. with HES and/or CEL who are FIP1L1-PDGFR alfa fusion kinase neg. Adult pts. with aggressive syst. mastocytosis (ASM) without the D816V c-kit mutation/ Adult pts. with Kit (CD117) pos. unresectable and/or metast. malign. GI stromal tumours (GIST)/ Adjuvant tmt. of adult pts. following complete gross resection of Kit (CD117) pos. GIST.
C/I: hypersens.
