Oral Oncology/Hematology Reference Indications & Common Dosing Name FDA Indication Compendia Approved Uses Adult Dosing
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1 Oral Oncology/Hematology Reference Indications & Common Dosing Name FDA Indication Compendia Approved Uses Adult Dosing ABIRATERONE Prostate CA: castrate Prostate CA: castrate resistant metastatic dz Prostate CA: ACETATE resistant met dz (ZYTIGA ) w/ prednisone: 1,000 mg CAPECITABINE (XELODA ) Colorectal CA: adj tx Duke s C (stage III) as monotherapy when fluoropyrimidine therapy alone is preferred; met dz (monotherapy) Breast CA: met dz resistant to taxane/anthracycline Colon CA: adj tx Duke s B or C or post-resection liver or lung mets; neoadj or initial tx in presence of liver or lung mets; 1-3 rd line met dz Rectal CA: neoadj or adj tx as concurrent chemo/rt or for resectable mets in combination with oxaliplatin +/- bevacizumab; initial tx for unresectable dz in combination with XRT or with oxaliplatin +/- bevacizumab, or bevacizumab alone as 1 st line tx Breast CA: recurrent or met dz as monotherapy or in combination with multiple agents (incl: bevacizumab, ixabepilone, lapatinib, docetaxel, trastuzumab) Esophageal CA: pre- or post-operative tx w/ XRT; definitive tx w/ XRT for resectable pts; 1 st line met dz or recurrent disease Gastric CA: pre- or post-operative w/ XRT for resectable dz; metastatic or recurrent disease; radiosensitization with XRT after resection for margin +/- dz in medically fit pts Hepatobiliary CA/Extra-Hepatic Cholangiocarcinoma: single agent or combo agent(with chemo or RT) for primary unresectable or met dz; adj tx in resected dz as part of chemo/rt or combination chemotherapy Neuroendocrine Tumors: In combination with temozolomide for met dz carcinoid tumors: as a single agent in regional or metastatic disease, and clinically significant tumor burden Ovarian Epithelial CA: Recurrent dz as a single agent in pts w/ specific characteristics (increasing CA-125 levels); stage II-IV dz showing partial response to initial chemotherapy Pancreatic CA: adj tx; locally adv or met dz; thymic tumors: in combination with RT as adjuvant tx for incomplete resection Renal Cell CA: in combination with immunotherapy for locally advanced dz; as a single agent for met dz Colon or Rectal CA: monotx: 1,250 mg/m 2 PO BID days 1-14 q21d as CAPOX or CAPOX + bevacizumab: 850 1,000 mg/m 2 PO BID days 1-14 q21d w/ bevacizumab: 1,000-1,250 mg/m 2 PO BID days 1-14 q21 days or 1,750 mg/m 2 PO BID days 1-7 q14d w/ irinotecan:1250 mg/m 2 PO BID days 2-15 q21d w/ XRT: 825 mg/m 2 PO BID during XRT Breast CA: monotx: 1,000-1,250 mg/m 2 PO BID days 1-14 q21d w/ lapatinib: 1,000 mg/m 2 PO BID days 1-14 q21d w/ docetaxel, ixabepilone, bevacizumab, or trastuzumab: 1,250 mg/m 2 PO BID days 1-14 q21d Esophageal CA: w/ cisplatin, irinotecan, docetaxel or oxaliplatin: 1,000 mg/m 2 PO BID days 1-14 Q 21d in EOX or ECX: 625mg/m 2 PO BID continuously Gastric CA: in EOX or ECX: 625 mg/m 2 PO BID continuously monotx or with cisplatin: 1250 mg/m 2 PO BID D1-14 q21d w/ cisplatin, docetaxel, irinotecan, or oxaliplatin +/- trastuzumab: 1000 mg/m 2 PO BID D1-14 q21d w/ XRT: mg/m 2 PO BID D1-5 q7d Hepatobilliary CA: monotx: 1,000 mg/m 2 PO BID days 1-14 q21d w/ oxaliplatin: 1,000 mg/m 2 BID days 1-14 q21d w/ XRT: 850 mg/m 2 PO BID during XRT Neuroendocrine Tumors: w/ temozolomide: 750 mg/m 2 PO BID days 1-14 q28d Ovarian Epithelial CA: monotx: 1,000-1,250 mg/m 2 PO BID days 1-14 q21d Pancreatic CA: Monotx: 830 mg/m 2 PO BID days 1-21 q28d; Monotx or with oxaliplatin: 1,000 mg/m 2 PO BID days 1-14 q21d Renal Cell CA: Monotx:1,250 mg/m 2 PO BID days 1-14 q21d 9/2011. Source: McKesson Medication Therapy Management and Resource Guides,
2 Name FDA Indication Compendia Approved Uses Adult Dosing CRIZOTINIB (XALKORI ) DASATINIB (SPRYCEL ) NSCLC: tx of locally advanced or metastatic ALK (+)nonsmall cell lung cancer pts Ph+ Chronic Myelogenous Leukemia (CML): chronic, accelerated, or blast phase (myeloid or lymphoid) w/ resistance or intolerance to prior tx Ph+ Acute Lymphoblastic Lymphoma (ALL): w/ resistance or intolerance to prior tx N/A CML, Chronic Phase: minimal to no response or relapse following imatinib tx in following situations: no hematologic remission or hematologic relapse at 3 mos, no cytogenetic response or relapse at 6 mos, minor cytogenetic response or relapse at 12 mos, or no complete cytogenetic remission or relapse at 18 mos of tx Post-transplant follow-up tx in pts with molecular relapse (PCR +) following cytogenetic remission, or cytogenetic relapse or those who are not in cytogenetic remission In setting of imatinib intolerance (severe nonhematological toxicity, including hepatotoxicity) CML Accelerated Phase or Blast Crisis: accelerated phase: 2 nd line tx following dz on imatinib tx as a single agent blast crisis(lymphoid or myeloid): as a single agent or in combination with induction chemotherapy In setting of imatinib intolerance (severe nonhematological toxicity, including hepatotoxicity) ALL: de novo Ph+ ALL in combo w/ chemo; in setting of imatinib intolerance (severe non-hematological toxicity, including hepatotoxicity) NSCLC (ALK+): 250 mg PO BID until dz CML: chronic phase: 100 mg until accelerated phase/blast crisis: 140 mg until ALL: 140 mg until Dose Titration: Increase dose to 140 mg daily (chronic phase CML) or 180 mg (advanced phase CML and Ph+ ALL) if no hematologic or cytogenetic response ELTROMBOPAG (PROMACTA ) Chronic Idiopathic Thrombocytopenic Purpura (ITP): in pts with an insufficient response to corticosteroids, immunoglobulins, or splenectomy; ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding; not to be used in attempt to normalize platelet counts Relapsed/Refractory Tx of Chronic ITP: as a single agent; especially if they have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy and in whom the degree of thrombocytopenia and clinical status may increase bleeding risk Chronic ITP: 50 mg pts with East Asian ancestry or with moderate or severe hepatic insufficiency: 25 mg Adjust the dose to maintain a platelet count of > 50 x 10 9 /L in order to reduce bleeding, do not exceed 75 mg daily ERLOTINIB (TARCEVA ) Non-Small Cell Lung CA (NSCLC): maintenance tx in locally adv/met dz that has not progressed after 4 cycles of platinum-based 1st-line chemo; monotherapy in adv/met dz after failure of at least 1 prior chemo regimen Pancreatic CA: 1 st line tx in locally adv, unresectable, or met dz in combination with gemcitabine NSCLC: 1 st line tx for locally adv/met dz in EGFR(+) pts; 2 nd or 3 rd line tx for progressive dz in pts with PS 0-2 (may be considered for pts w/ PS 3-4 w/ a known EGFR mutation); recurrent/met dz as single-agent in pts w/ PS 0-2 who achieve tumor response or stable dz following 1 st line chemo Pancreatic CA: 1 st line tx locally adv/met dz and good PS in combination with gemcitabine NSCLC: monotx: 150 mg until, taken 1 hr before or 2 hrs after a meal Pancreatic CA w/ gemcitabine: 100 mg until, taken 1 hr before or 2 hrs after a meal EVEROLIMUS (AFINITOR ) Renal Cell CA (RCC): tx of relapsed or medically unresectable Stage IV predominant clear cell RCC in pts who have progressed on tyrosine kinase inhibitor (sorafenib or sunitinib) Subependymal Giant Cell Astrocytoma (SEGA): initial tx as a single agent in SEGA that is associated with tuberous sclerosis in noncandidates for surgery Renal Cell CA(RCC): tx of 2 nd line metastatic dz w/ bevacizumab for pts who progress on TKIs Neuroendocrine Tumors Islet Cell Tumors: as a single agent for progressive metastatic pancreatic NET w/ bone mets or unresectable liver and lung locoregional or metastatic dz Waldenstrom s Macroglobulinemia/ Lymphoplasmacytic Lymphoma: as a single agent for recurrent/refractory dz RCC: Monotx or with bevacizumab: 10 mg until or intolerable side effects Subependymal Giant Cell Astrocytoma: BSA of m 2 : start dose at 2.5 mg BSA of m 2 : start dose at 5 mg BSA of >/= 2.2m 2 : start dose at 7.5 mg Neuroendocrine/Islet Cell Tumors and Waldenstrom s Macroglobulinemia/ Lymphoplasmacytic Lymphoma: 10 mg until or intolerable side effects
3 Oral Oncology/Hematology Reference Indications & Common Dosing Name FDA Indication Compendia Approved Uses Adult Dosing IMATINIB (GLEEVEC ) LAPATINIB (TYKERB ) Ph+ Chronic Myelogenous Leukemia (CML): newly diagnosed pts in chronic phase, accelerated phase, or blast crisis; relapsed/refractory dz following tx failure (adults, peds) or SCT (peds) Ph+ Acute Lymphoblastic Leukemia (ALL): relapsed/refractory dz Myelodysplastic Syndrome (MDS)/MPD: for pts w/ associated PDGFR gene rearrangements Aggressive Systemic Mastocytosis (ASM): w/o D816V c-kit mutation or w/ unknown c-kit status; ASM associated w/ eosinophilia Hypereosinophilic Syndrome (HES/CEL): pts positive for, negative for, or w/ unknown FIP1L1-PDGFRα fusion kinase status Dermatofibrosarcoma protuberans (DFSP): pts w/ unresectable, recurrent, or met dz GI Stromal Tumors (GIST): Kit (CD117) positive unresectable or met dz; adj tx in adults w/ surgically removed Kit (CD117) positive GIST Breast CA: with capecitabine in advanced or metastatic dz w/ HER2 over-expression and prior tx w/ an anthracycline, a taxane, and trastuzumab; with letrozole in hormone receptor-positive metastatic dz w/ HER2 receptor overexpression in postmenopausal women for whom hormonal tx is indicated Ph+ CML: post-sct for relapsed dz or not in complete remission Ph+ Non-Hodgkin s Lymphoma (NHL) Lympoblastic lymphoma: de novo dz in combination w/ chemo Desmoid tumors: gross residual dz following surgery or unresectable dz; recurrent dz Breast CA: in combination w/ trastuzumab for recurrent or metastatic dz in pts w/ hormone receptor-negative, HER2-positive dz and prior tx w/ an anthracycline, a taxane, and trastuzumab Ph+ CML chronic phase: 400 mg (increased dose of 600 mg may be considered) accelerated phase or blast crisis: 600 mg (increased dose of 400 mg PO BID may be considered) post-sct: mg (or divided twice daily) pediatric, newly diagnosed: 340 mg/m 2 (not to exceed 600 mg) pediatric, chronic phase: 260 mg/m 2 Ph+ ALL: 600 mg MDS/MPD: 400 mg ASM: 400 mg w/ eosinophilia: 100 mg, with dose escalation up to 400 mg if insufficient response HES/CEL: 400 mg w/ FIP1L1-PDGFRα fusion kinase: 100 mg, with dose escalation up to 400 mg if insufficient response DFSP: 800 mg (given as 400 mg PO BID) GIST: dz /absence of severe side effects: 800 mg (given as 400 mg PO BID) following complete resection: 400 mg Ph+ NHL: mg in combo w/ chemo until or SCT performed Desmoid Tumors: unresectable: 300 mg PO BID recurrent dz: 400 mg PO BID Breast CA: w/ capecitabine: 1,250 mg until w/ letrozole: 1,500 mg until w/ trastuzumab: 1,000 mg until 9/2011. Source: McKesson Medication Therapy Management and Resource Guides,
4 Name FDA Indication Compendia Approved Uses Adult Dosing LENALIDOMIDE (REVLIMID ) NILOTINIB (TASIGNA ) Multiple Myeloma (MM): 2 nd line tx in combo w/ dexamethasone Myelodysplastic Syndrome (MDS): initial tx as a single agent for transfusiondependent anemia due to low or intermediate-1 risk MDS associated w/ del(5q) +/- additional cytogenic abnormalities Ph +CML: chronic, and accelerated phase pts who are newly diagnosed or resistant to or intolerant of prior tx including imatinib MM: initial/induction tx in combo w/ dexamethasone +/- bortezomib for transplant candidates or in combo w/ low-dose dexamethasone for non-transplant candidates; maintenance tx as monotherapy in active myeloma responding to primary induction tx or in stable/responsive dz after SCT; recurrent/refractory dz tx as a single agent or in combo w/ dexamethasone +/- bortezomib Systemic Light Chain Amyloidosis: primary tx in combo w/ dexamethasone MDS: initial tx in pts w/ del(5q) w/ clinically significant cytopenias and symptomatic anemia; initial tx in low/intermediate risk pts w/ symptomatic anemia, no del(5q), serum EPO > 500 mu/ml and a low probability of response to immunosuppressive tx; 2 nd line tx in low/intermediate risk pts w/ symptomatic anemia, no del(5q), and no response to initial tx w/ epoetin alfa, darbepoetin alfa, hypomethylating agents, or immunosuppressive tx Non-Hodgkin s Lymphoma (NHL): 2 nd line tx for relapsed, refractory, or progressive dz in pts w/ diffuse large B-cell, follicular lymphoma, nodal marginal zone lymphoma, gastric MALT lymphoma, non-gastric MALT lymphoma (for recurrent stage I-II dz or progressive dz in patients with indications for tx), primary cutaneous B-cell lymphoma, splenic marginal zone lymphoma or mantle cell NHL Chronic Lymphocytic Lymphoma (CLL): as a single agent in 2 nd line tx Ph +CML: chronic phase: minimal to no response or relapse following imatinib tx (no hematologic remission or hematologic relapse at 3 mos, no cytogenetic response or cytogenetic relapse at 6 mos, minor cytogenetic response or cytogenetic relapse at 12 mos, or no complete cytogenetic remission or cytogenetic relapse at 18 mos of tx); post-transplant follow-up tx in pts w/ molecular relapse (PCR +) following cytogenetic remission or w/ cytogenetic relapse or those not in cytogenetic remission; patients w/imatinib/dasatinib intolerance accelerated phase: 2 nd line tx following disease on imatinib tx; patients w/imatinib/dasatinib intolerance Gastrointestinal Stromal Tumors (GIST): 2 nd line tx following disease on imatinib or sunitinib MM: w/ dexamethasone: 25 mg days 1-21 q28d w/ dexamethasone + bortezomib: 25 mg PO days 1-14 Q 21d x 8 cycles for induction; 15 mg PO days 1-14 q21d up to 8 cycles for salvage tx; single agent, maintenance tx: mg until or intolerable side effects single agent, palliative tx: 30 mg PO days 1-21 q28d until or intolerable side effects w/ dexamethasone + cyclophosphamide: 25 mg days 1-21 q28d for up to 9 cycles as salvage tx MDS: del(5q): 10 mg until or intolerable side effects no del(5q): 10 mg PO days 1-21 Q 28 days until or intolerable side effects NHL: 25 mg PO days 1-21 Q 28 days until or intolerable side effects Systemic Light Chain Amyloidosis: w/ dexamethasone: 25 mg up to 12 monthly cycles CLL: 5-25mg days 1-21 q28d (escalate dose by 5 mg q28d to max of 25 mg) Ph+ CML and GIST: 400 mg PO BID daily on a continuous basis until or intolerance PAZOPANIB (VOTRIENT ) Renal Cell Carcinoma (RCC): Therapy for advanced RCC RCC: 1 st line tx as a single agent for relapsed or unresectable metastatic dz for clear cell and non clear cell histology; 2 nd line metastatic tx as a single agent for clear cell histology Thyroid Cancer: refractory tx for metastatic, rapidly progressive or symptomatic dz in pts with nonradioiodine responsive tumors at sites other than the CNS RCC: 800 mg until or intolerance Thyroid CA: 800 mg until or intolerance
5 Oral Oncology/Hematology Reference Indications & Common Dosing Name FDA Indication Compendia Approved Uses Adult Dosing SORAFENIB (NEXAVAR ) SUNITINIB (SUTENT ) TEMOZOLOMIDE (TEMODAR ) Renal Cell CA (RCC): advanced dz Hepatocellular CA (HCC): unresectable dz RCC: Stage IV initial tx or recurrent/refractory tx GIST: Tx of GIST following dz on or intolerance to imatinib Glioblastoma Multiforme (GBM): initial tx in combo w/ XRT; maintenance tx following initial tx w/ temozolomide + XRT Anaplastic Astrocytoma (AA), mixed Anaplastic oligoastrocytoma or Anaplastic Oligodendroglioma (A0): single agent tx in recurrent/refractory dz RCC: 1 st line tx in relapsed or medically unresectable/ stage IV non-clear cell histology, selected pts w/ predominant clear cell histology; 2 nd line tx for relapsed or unresectable stage IV dz w/ predominant clear cell histology HCC: tx Child Pugh Class A or B localized dz and dz deemed unresectable or inoperable by PS or comorbidity; tx Child Pugh Class A or B met dz Thyroid CA: Tx of progressive or symptomatic met dz in pts with non-radioiodine avid tumors at non- CNS system sites (follicular CA, papillary CA and Hurthle cell CA); tx of disseminated symptomatic medullary carcinoma Gastrointestinal Stromal Tumors: GIST when imatinib or sunitinib is no longer beneficial Angiosarcoma: in the extremity or peritoneum/abdomen as a single agent Thyroid CA: tx of progressive or symptomatic met dz in pts with non-radioiodine avid tumors at non-cns system sites(follicular CA, papillary CA and Hurthle cell CA); tx of disseminated symptomatic medullary carcinoma Bone CA (Ewing s Sarcoma and Mesenchymal Chondrosarcoma): use w/ irinotecan +/- vincristine and growth factor support for relapsed dz w/ or w/o XRT, or progressive dz following primary tx Central Nervous System (CNS) Lymphoma: progressive/refractory dz, use as single agent or in combo w/ rituximab Neuroendocrine Tumors Islet Cell: single agent for management of bone, lung, or liver mets in pts w/ symptoms, clinically significant tumor burden, or significant Mycosis Fungoides (MF) and Sezary Syndrome (SS): 2 nd line tx for progressive dz as single agent GBM: recurrent/refractory dz; palliative tx Melanoma, Metastatic: initial tx of metastatic disease, metastatic recurrence, +/- interferon alfa- 2b RCC and HCC: 400 mg PO BID on a continuous basis Thyroid CA: 400 mg PO BID on a continuous basis GIST: 400 mg PO BID on a continuous basis Angiosarcoma: 400 mg PO BID on a continuous basis RCC, GIST, and Thyroid CA: 50 mg days 1-28 q42d until or intolerance GBM: Initial tx: 75 mg/m 2 /day PO days concomitant XRT Maintenance tx: cycle 1: 150 mg/m 2 /day PO days 1-5 q28d x 1 cycle, then mg/m 2 /day PO days 1-5 q28d x 5 cycles Recurrent/refractory tx: mg/m 2 /day PO days 1-5 q28d until AA or AO: mg/m 2 /day PO days 1-5 q28d CNS Lymphoma: single agent: mg/m 2 /day PO days 1-5 q28d until w/ rituximab: mg/m 2 /day PO days 1-5 q28d for up to 8 cycles or until Bone CA (w/ irinotecan): 100 mg/m 2 /day PO days 1-5 q21 or 28d until Melanoma: 200 mg/m 2 day PO days 1-5 q28d until Neuroendocrine tumors: mg/m 2 /day PO days 1-5 q28d until MF/SS: 150 mg/m 2 /day PO days 1-5 q28d x 1 cycle then 200 mg/m 2 /day PO days 1-5 q28d x 2 cycles 9/2011. Source: McKesson Medication Therapy Management and Resource Guides,
6 Name FDA Indication Compendia Approved Uses Adult Dosing THALIDOMIDE (THALOMID ) Multiple Myeloma (MM): initial tx in combo w/ dexamethasone for newly diagnosed dz MM: induction tx: in combo w/ dexamethasone and bortezomib for transplant pts, in combo w/ dexamethasone for transplant or non-transplant pts, in combo w/ melphalan and prednisone for nontransplant pts or elderly pts, as a part of T-VAD Doxil, or in combo w/ doxorubicin and dexamethasone supported by SCT consolidation tx: in combo w/ dexamethasone or cyclophosphamide, cisplatin, doxorubicin, etoposide, and dexamethasone supported by SCT maintenance tx: as single agent or w/ prednisone; recurrent tx: as a single agent, in combo w/ dexamethasone, in combo w/ melphalan and prednisone, in combination with pegylated interferon for relapse after chemotherapy, or as part of the DT- PACE regimen Systemic Light Chain Amyloidosis: initial tx w/ dexamethasone +/- cyclophosphamide; recurrent tx as a single agent or in combination with dexamethasone Waldenstrom s Macroglobulinemia: primary or recurrent tx as single agent or in combo w/ rituximab Mantle Cell Lymphoma (MCL): recurrent tx as 2 nd line tx in combo w/ rituximab Non-Hodgkin s Lymphoma (NHL): recurrent tx as a single agent Hodgkin Lymphoma (HL): recurrent tx as a single agent Acute Myelogenous Leukemia (AML): recurrent tx as a single agent Glioblastoma Multiforme/Astrocytoma: recurrent tx as a single agent or w/carmustine Cerebellar Hemangioblastoma: recurrent tx as a single agent Kaposi s Sarcoma: initial tx as a single agent Hepatocellular Carcinoma: initial tx for advanced, or unresectable dz Melanoma: relapsed dz in patients not eligible for surgery Myelodysplastic Syndrome: initial tx for all FAB subtypes Ovarian CA: recurrent tx in epithelial ovarian ca Neuroendocrine tumor (pancreas): recurrent tx for previously tx metastatic dz Prostate CA: recurrent tx for previously tx, metastatic, castrate-resistant dz Renal Cell CA: recurrent tx for metastatic dz MM: Induction: w/ dexamethasone: 200 mg q28d x 4 cycles w/ dexamethasone + bortezomib: 200 mg Q 21 days x 3 cycles w/ dexamethasone + doxorubicin: mg q28d x 3 cycles w/ melphalan + prednisone: 100 mg q28d x 6 cycles followed by 100 mg as a single agent until or toxicity; for elderly nontransplant eligible: mg PO daily q42d x 12 cycles w/t-vad Doxil: 200 mg days 1-28 x 4 cycles Maintenance: w/ prednisone or as a single agent: 200 mg until or toxicity Recurrent/Refractory: single agent: mg until low dose: 50 mg until disease w/ DT-PACE: 400 mg w/ pegylated interferon: mg until disease Systemic Light Chain Amyloidosis: w/dexamethasone + cyclophosphamide: 200 mg until or toxicity as a single agent: 200mg until dz w/ dexamethasone: mg PO daily until Waldenstrom s Macroglobulinemia: single agent: mg until tx resistance or toxicity w/ rituximab: 200 mg for 14 weeks, then increase to 400 mg PO daily for 50 weeks Non-Hodgkin s Lymphoma (MCL): mg until or toxicity as a single agent for recurrent dz: mg until dz Hodgkin Lymphoma: recurrent dz: mg until AML: mg until dz GBM/Astrocytoma: recurrent tx as a single agent: mg until w/ carmustine: mg d1-28 q42d until dz Kaposi s Sarcoma: 100-1,000 mg PO daily until Hepatocellular CA: mg PO daily until Melanoma: mg until dz MDS: mg x 12 weeks; mg for up to 56 weeks until dz Ovarian CA: mg until dz Neuroendocrine tumor of Pancreas: mg until Renal Cell CA/Prostate CA: mg PO Daily until dz
7 Oral Oncology/Hematology Reference Indications & Common Dosing Name FDA Indication Compendia Approved Uses Adult Dosing TOPOTECAN (HYCAMTIN ) TRETINOIN (VESANOID ) VANDETANIB (CAPRELSA ) VORINOSTAT (ZOLINZA ) Small Cell Lung CA (SCLC): 2 nd line tx in pts who relapse > 45 days from initial tx. Must have achieved a CR or PR from 1 st line tx Acute Promyelocytic Leukemia (APL): induction of remission in pts with FAB classification M3, characterized by presence of t(15:17) translocation and/or presence of PML/RAR alpha gene, who have relapsed from/are refractory to anthracycline-based tx or for whom anthracycline tx is contraindicated Thyroid CA: initial tx in unresectable symptomatic or progressive locoregional dz, or recurrent tx as single agent for tx of symptomatic or progressive medullary thyroid CA in pts with unresectable locally advanced or metastatic dz Cutaneous T-Cell Lymphoma (CTCL): progressive, persistent, or recurrent dz on or following 2 systemic therapies SCLC: 2 nd line tx in pts who relapse within 6 mos following CR or PR with initial tx; pts with primary progressive dz after 1 st line tx with a PS of 0-2 APL: induction tx: for induction of remission as single agent or in combo w/ arsenic trioxide for pts who cannot tolerate anthracycline-based tx, in combo w/ daunorubicin and cytarabine, or in combo w/ idarubicin consolidation tx: in combo w/ arsenic trioxide for pts who cannot tolerate anthracycline-based tx, w/ arsenic trioxide and daunorubicin, w/ daunorubicin, w/ idarubicin, cytarabine, and mitoxantrone in pts w/ high-risk disease, or w/ idarubicin and mitoxantrone in pts w/ low-risk disease maintenance tx: following consolidation tx as single agent or in combo w/ mercaptopurine and methotrexate recurrent tx: w/ arsenic trioxide Mycosis Fungoides (MF): initial tx: stage IA-IIA and III dz w/ blood involvement as single agent or in combo w/ skin-directed tx; stage IA w/ folliculotropic or large cell transformed dz or IIB (limited-extent tumor dz) as single agent; stage IB- IIB w/ folliculotropic or large cell transformed dz or stage IIB (generalized tumor dz or limited-extent tumor dz w/ blood involvement) as single agent or in combo w/ interferons, phototherapy, or photopheresis; or stage III dz w/ no blood involvement as single agent or in combo w/ skindirected tx adjuvant tx: stage IIB (generalized, limited-extent w/ blood involvement, or large cell transformed) dz after total skin electron beam therapy; or stage IV (bulky lymph nodes or visceral dz) after chemo recurrent tx: stage I-III relapsed or progressive dz w/ or w/o interferons or skin directed tx Sézary Syndrome (SS): initial tx as single agent or in combo w/ interferons or skin directed tx Kaposi s Sarcoma: initial tx as a single agent MDS: initial tx in combination with cytarabine for high risk pts ineligible for intensive chemo Osteosarcoma: recurrent dz tx in combination with interferon Thyroid Carcinoma - Medullary Carcinoma: initial tx for unresectable symptomatic or progressive locoregional dz, or recurrent tx for progressive or refractory dz (use in symptomatic distant mets, asymptomatic distant mets if progressive, or disseminated symptomatic dz) Sezary Syndrome (SS): primary systemic tx for pts w/ stage IA-IIB dz Mycosis Fungoides (MF): adjuvant systemic tx for IIB dz after total skin electron beam tx; after chemo for stage IV dz with bulky LN or visceral dz; refractory to skin-directed tx for stage IA-IIA or stage IIb dz; use with skin-directed tx for stage III dz with no blood involvement SCLC: 2.3 mg/m 2 /day PO days 1-5 Q 21 days until or intolerance Pts with moderate renal function: 1.8 mg/m 2 /day PO days 1-5 q21d until or intolerance APL: induction: 45 mg/m 2 /day PO divided BID until remission achieved consolidation: 45 mg/m 2 /day PO divided BID, administered per protocol schedule maintenance: 45 mg/m 2 /day PO divided BID MF and SS: initial tx as a single agent, adjuvant tx (MF), and recurrent tx (MF): 45 mg/m 2 /day PO divided BID until or toxicity initial tx w/ interferon: mg PO daily until or toxicity, escalate dose as tolerated Kaposi s Sarcoma: 45 mg/m 2 /day PO divided BID until MDS: 45 mg/m 2 /day PO divided BID, days 1-10 q28d Osteosarcoma: 60 mg/m 2 /day PO days 1,3,5,8,10,12,15,17,19 q21d x 4 months may be given for a total of 1 year for dz control Thyroid CA: 300 mg until or intolerable toxicity CTCL, MF, or SS: 400 mg until 9/2011. Source: McKesson Medication Therapy Management and Resource Guides,
8 Disclaimer: The information presented in this document is time-sensitive and current as of the date 9/1/2011. It is not a substitute for the judgment of a healthcare practitioner or the clinical evaluation and management of an individual patient. Every effort has been made to ensure that the information contained herein is accurate, up-to-date and complete, but no warranty or guarantee is made to that effect. ONMARK PROVIDES THIS INFORMATION ON AN "AS IS" BASIS. ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. Selection of appropriate drug treatment protocols for individual patients depend on a number of factors and Onmark makes no representation to such selection or use by physician or clinical staff. Unless otherwise attributed in the References section, this document and its contents are the property of McKesson Corporation and may not be reproduced in any form without the prior, express written consent of McKesson McKesson Corporation, All Rights Reserved
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