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Oncology related (including new drugs, antagonists, etc)

Recent updates

[Link to latest additions] - Majority of agents below
Alphabetized (List) by GENERIC name Alphabetized (List) by BRAND name
Oncology Dilution Monographs
Anti-Emetics - Monographs

Listed by generic name

abiraterone acetate -ZYTIGA™ (ado-trastuzumab emtansine) - KADCYLA ®
afatinib - GILOTRIF™ (alectinib) - ALECENSA ®
atezolizumab -TECENTRIQ™ --
axitinib - INLYTA® (belinostat) - BELEODAQ®
(blinatumomab) - BLINCYTO™ bosutinib - BOSULIF®
cabozantinib - COMETRIQ™ carfilzomib - KYPROLIS®
Ceritinib - ZYKADIA™ caps cobimetinib fumarate- COTELLIC™
crizotinib - XALKORI® dabrafenib -TAFINLAR®
daratumumab - DARZALEX ™ dasatinib - SPRYCEL®
denosumab - Xgeva® elotuzumab - EMPLICITI ™
enzalutamide - XTANDI® eribulin mesylate -HALAVEN ™
ibrutinib - IMBRUVICA™ (idelalisib) - ZYDELIG®
(ipilimumab) - YERVOY ® irinotecan liposome -ONIVYDE™
ixazomib citrate- NINLARO® lenvatinib - LENVIMA™
(mechlorethamine)- VALCHLOR (mercaptopurine) - PURIXAN®
necitumumab - PORTRAZZA ™ (nivolumab) - OPDIVO ®
obinutuzumab - GAZYVA™ (olaparib) - LYNPARZA™
(omacetaxine mepesuccinate) - SYNRIBO ® osimertinib - TAGRISSO ™
palbociclib - IBRANCE® panobinostat lactate - FARYDAK®
pazopanib- VOTRIENT® (pembrolizumab) - KEYTRUDA ®
pertuzumab -PERJETA™ pomalidomide -POMALYST®
(ponatinib) - ICLUSIG ® Ramucirumab -CYRAMZA™
regorafenib - STIVARGA® sonidegib phosphate -ODOMZO®
sorafenib - NEXAVAR® sunitinib malate - SUTENT®
trabectedin - YONDELIS ® trametinib -MEKINIST™
trifluridine and tipiracil HCL - LONSURF® (vandetanib) - CAPRELSA®
vemurafenib - ZELBORAF™ venetoclax -VENCLEXTA™
vismodegib - ERIVEDGE™ vorinostat - ZOLINZA®
ziv-aflibercept - ZALTRAP® --
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Listed by BRAND name

ALECENSA ® -(alectinib) BELEODAQ® -(belinostat)
BLINCYTO™ -(blinatumomab) BOSULIF® - bosutinib
CAPRELSA® -(vandetanib) COMETRIQ™ - cabozantinib
COTELLIC™ -cobimetinib fumarate CYRAMZA™ -Ramucirumab
DARZALEX ™ -daratumumab EMPLICITI ™ -elotuzumab
ERIVEDGE™ - vismodegib FARYDAK® -panobinostat lactate
GAZYVA™ - obinutuzumab GILOTRIF™ -afatinib
HALAVEN ™ - eribulin mesylate IBRANCE® - palbociclib
ICLUSIG ® -(ponatinib) IMBRUVICA™ - ibrutinib
INLYTA®- axitinib KADCYLA ® -(ado-trastuzumab emtansine)
KEYTRUDA ® -(pembrolizumab) KYPROLIS® -carfilzomib
LENVIMA™ -lenvatinib LONSURF® -trifluridine and tipiracil HCL
LYNPARZA™ -(olaparib) MEKINIST™ -trametinib
NEXAVAR® - sorafenib NINLARO® -ixazomib citrate
ODOMZO® -sonidegib phosphate ONIVYDE™ -irinotecan liposome
OPDIVO ® -(nivolumab) PERJETA™ -pertuzumab
POMALYST® -pomalidomide PORTRAZZA ™ -necitumumab
PURIXAN® - (mercaptopurine) SPRYCEL® -dasatinib
STIVARGA® -regorafenib SUTENT® -sunitinib malate
SYNRIBO®- (omacetaxine mepesuccinate) TAFINLAR® -dabrafenib
TAGRISSO ™ -osimertinib  TECENTRIQ™ -atezolizumab
VALCHLOR -(mechlorethamine) VENCLEXTA™ -venetoclax
VOTRIENT® -pazopanib XALKORI® -crizotinib
Xgeva® -denosumab XTANDI® -enzalutamide
YERVOY ® -(ipilimumab) YONDELIS ® -trabectedin
ZALTRAP® -ziv-aflibercept ZELBORAF™ -vemurafenib
ZOLINZA® -vorinostat ZYDELIG® -(idelalisib)
ZYKADIA™ -Ceritinib caps ZYTIGA™ -abiraterone acetate
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Disclaimer - Please see package insert for additional information and possible updates. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.   Read the disclaimer

(ado-trastuzumab emtansine) - KADCYLA ®: top of page

Drug UPDATES: (ado-trastuzumab emtansine) - KADCYLA ®  for injection, for intravenous use
[Drug information  /  PDF]  
Dosing:  Click (+) next to Dosage and Administration section (drug info link)
ABBREVIATED MONOGRAPH - SEE PACKAGE INSERT.

Initial U.S. Approval:  2013

Mechanism of Action: Ado-trastuzumab emtansine is a HER2-targeted antibody-drug conjugate. The antibody is the humanized anti-HER2 IgG1, trastuzumab. The small molecule cytotoxin, DM1, is a microtubule inhibitor. Upon binding to sub-domain IV of the HER2 receptor, ado-trastuzumab emtansine undergoes receptor-mediated internalization and subsequent lysosomal degradation, resulting in intracellular release of DM1-containing cytotoxic catabolites. Binding of DM1 to tubulin disrupts microtubule networks in the cell, which results in cell cycle arrest and apoptotic cell death. In addition, in vitro studies have shown that similar to trastuzumab, ado-trastuzumab emtansine inhibits HER2 receptor signaling, mediates antibody-dependent cell-mediated cytotoxicity and inhibits shedding of the HER2 extracellular domain in human breast cancer cells that overexpress HER2.

INDICATIONS AND USAGE:
KADCYLA is a HER2-targeted antibody and microtubule inhibitor conjugate indicated, as a single agent, for the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either:
Received prior therapy for metastatic disease, or
Developed disease recurrence during or within six months of completing adjuvant therapy.

HOW SUPPLIED: Lyophilized powder in single-use vials containing 100 mg per vial or 160 mg per vial.

(alectinib) - ALECENSA ®: top of page

Drug UPDATES: (alectinib) - ALECENSA ®  capsules    
[Drug information ] Dosing:  Click (+) next to Dosage and Administration section
ABBREVIATED MONOGRAPH - SEE PACKAGE INSERT.

Initial U.S. Approval:  2015

INDICATIONS AND USAGE:
ALECENSA is a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.


HOW SUPPLIED/STORAGE AND HANDLING:
Hard capsules, white 150 mg capsules with "ALE" printed in black ink on the cap and "150 mg" printed in black ink on the body, available in:
240 capsules per bottle: NDC 50242-130-01

Storage and stability: Do not store above 30°C (86°F). Store in the original container to protect from light and moisture.

axitinib - INLYTA®: top of page

Drug UPDATES
INLYTA ® (axitinib) tablets for oral administration
[Drug information  /  PDF]  
Dosing:  Click (+) next to Dosage and Administration section (drug info link)
ABBREVIATED MONOGRAPH - SEE PACKAGE INSERT.

Initial U.S. Approval:  2012

Mechanism of Action: Axitinib has been shown to inhibit receptor tyrosine kinases including vascular endothelial growth factor receptors (VEGFR)-1, VEGFR-2, and VEGFR-3 at therapeutic plasma concentrations. These receptors are implicated in pathologic angiogenesis, tumor growth, and cancer progression. VEGF-mediated endothelial cell proliferation and survival were inhibited by axitinib in vitro and in mouse models. Axitinib was shown to inhibit tumor growth and phosphorylation of VEGFR-2 in tumor xenograft mouse models.

INDICATIONS AND USAGE:  INLYTA is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma after failure of one prior systemic therapy.

DOSAGE AND ADMINISTRATION
The starting dose is 5 mg orally twice daily. Dose adjustments can be made based on individual safety and tolerability. (2.1, 2.2)
Administer INLYTA dose approximately 12 hours apart with or without food. (2.1)
INLYTA should be swallowed whole with a glass of water. (2.1)
If a strong CYP3A4/5 inhibitor is required, decrease the INLYTA dose by approximately half. (2.2)
For patients with moderate hepatic impairment, decrease the starting dose by approximately half. (2.2)

HOW SUPPLIED: 1 mg and 5 mg tablets


WARNINGS AND PRECAUTIONS:
[See package insert - extensive list]

(belinostat) - BELEODAQ®: top of page

Drug UPDATES:  (belinostat) - BELEODAQ®  for injection, for intravenous administration
[Drug information  /  PDF]  
Dosing:  Click (+) next to Dosage and Administration section (drug info link)
ABBREVIATED MONOGRAPH - SEE PACKAGE INSERT.

Initial U.S. Approval:  2014

Mechanism of Action: Beleodaq is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from the lysine residues of histones and some non-histone proteins. In vitro, belinostat caused the accumulation of acetylated histones and other proteins, inducing cell cycle arrest and/or apoptosis of some transformed cells. Belinostat shows preferential cytotoxicity towards tumor cells compared to normal cells. Belinostat inhibited the enzymatic activity of histone deacetylases at nanomolar concentrations (<250 nM).

INDICATIONS AND USAGE:  Beleodaq is a histone deacetylase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on tumor response rate and duration of response. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.

HOW SUPPLIED: For injection: 500 mg, lyophilized powder in single-use vial for reconstitution

(blinatumomab) - BLINCYTO™: top of page

Drug UPDATES:  (blinatumomab) - BLINCYTO™  for injection
[Drug information  /  PDF]  
Dosing:  Click (+) next to Dosage and Administration section (drug info link)
ABBREVIATED MONOGRAPH - SEE PACKAGE INSERT.

Initial U.S. Approval:  2014

Mechanism of Action: Blinatumomab is a bispecific CD19-directed CD3 T-cell engager that binds to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T cells. It activates endogenous T cells by connecting CD3 in the T-cell receptor (TCR) complex with CD19 on benign and malignant B cells. Blinatumomab mediates the formation of a synapse between the T cell and the tumor cell, upregulation of cell adhesion molecules, production of cytolytic proteins, release of inflammatory cytokines, and proliferation of T cells, which result in redirected lysis of CD19+ cells.

INDICATIONS AND USAGE:  BLINCYTO is indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification of clinical benefit in subsequent trials .

HOW SUPPLIED: For injection: 35 mcg of lyophilized powder in a single-use vial for reconstitution.

bosutinib - BOSULIF®: top of page


BOSULIF ® (bosutinib) tablets, for oral use
Drug UPDATES

[Drug information  /  PDF]  
Dosing:  Click (+) next to Dosage and Administration section (drug info link)

Initial U.S. Approval:  2012

Mechanism of Action: Bosutinib is a tyrosine kinase inhibitor. Bosutinib inhibits the Bcr-Abl kinase that promotes CML; it is also an inhibitor of Src-family kinases including Src, Lyn, and Hck. Bosutinib inhibited 16 of 18 imatinib-resistant forms of Bcr-Abl expressed in murine myeloid cell lines. Bosutinib did not inhibit the T315I and V299L mutant cells. In mice, treatment with bosutinib reduced the size of CML tumors relative to controls and inhibited growth of murine myeloid tumors expressing several imatinib-resistant forms of Bcr-Abl.

INDICATIONS AND USAGE: BOSULIF is a kinase inhibitor indicated for the treatment of adult patients with chronic, accelerated, or blast phase Ph+ chronic myelogenous leukemia (CML) with resistance or intolerance to prior therapy.

DOSAGE AND ADMINISTRATION (see link above for recent package insert)
Recommended Dose: 500 mg orally once daily with food. (2.1)
Consider dose escalation to 600 mg daily in patients who do not reach complete hematologic response by week 8 or complete cytogenetic response by week 12 and do not have Grade 3 or greater adverse reactions. (2.2)
Adjust dosage for toxicity and organ impairment (2)

Recommended Starting Dosage with Hepatic Impairment or Renal Impairment
Organ Function Status Recommended Starting Dosage
Normal hepatic and renal function 500 mg once daily
Hepatic impairment
  Mild (Child-Pugh A), Moderate (Child-Pugh B) or severe (Child-Pugh C) 200 mg daily
Renal impairment
  Creatinine clearance 30 to 50 mL/min 400 mg daily
  Creatinine clearance less than 30 mL/min 300 mg daily


WARNINGS AND PRECAUTIONS:
Gastrointestinal toxicity: Monitor and manage as necessary. Withhold, dose reduce, or discontinue BOSULIF.

Myelosuppression: Monitor blood counts and manage as necessary.

Hepatic toxicity: Monitor liver enzymes at least monthly for the first three months and as needed. Withhold, dose reduce, or discontinue BOSULIF.

Fluid retention: Monitor patients and manage using standard of care treatment. Withhold, dose reduce, or discontinue BOSULIF.

Embryofetal toxicity: May cause fetal harm. Females of reproductive potential should avoid becoming pregnant while being treated with BOSULIF.


HOW SUPPLIED: Tablets: 100 mg and 500 mg.


®: top of page

 

Reference(s)

National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates.  A local search option of this data can be found here.

Disclaimer

Listed dosages are for - Adult patients ONLY. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER. GlobalRPH does not directly or indirectly practice medicine or provide medical services and therefore assumes no liability whatsoever of any kind for the information and data accessed through the Service or for any diagnosis or treatment made in reliance thereon.

David F. McAuley, Pharm.D., R.Ph.  GlobalRPh Inc.
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