All the Active Ingredient Drugs
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.
Immunosuppressant. Everolimus 0.25, 0.5, 0.75 mg. TABS: 60 x 0.25 mg, 0.5 mg, 0.75 mg.
Initial: Gen. kidney and heart
transplant: 0.75 mg b.i.d. as soon as
possible aft. transplant in 2 div. doses
consistently with/out food and at same
time as cyclosporin for microemuls., to
be swallowed whole with glass of
water. May adjust dose at 4-5 day
intervals. See lit.
Proph. organ reject. in adult pts at lowmod.
immunolog. risk receiv. allogeneic
ren./cardiac transplant, in combinat.
with cyclosporin for microemuls. and
corticosteroids. Proph. organ reject. in
hepat. transplant, in combinat. with
tacrolimus and corticosteroids.
C/I: Hypersens. to everolimus, sirolimus
or any of the excips.
experienced in immunosuppress. ther.
See lit.
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. of pts. with SEGA associated with tuberous sclerosis Complex (TSC) who req. therap. intervent .but not candidates for curative surgical resection.
Tmt. of progress. neuroendocrine tumors of pancreatic origin (PNET) in pts. with unresectable, locally advanced or metastatic dis.
Tmt. of hormone receptor-positive, HER2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.
Tmt. of adult pts.with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery.
Tmt. of pts.with advanced renal cell carcinoma, whose disease has progressed on or after tmt. with VEGF-targeted therapy.
Tmt. of unresectable, locally advanced or metastatic, well-differentiated (Grade 1 or Grade 2) nonfunctional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease.
C/I: Hypersens. to active substances, other rapamycin derivs.
