Bc Cancer Chemotherapy Preparation and Stability

Total Page:16

File Type:pdf, Size:1020Kb

Bc Cancer Chemotherapy Preparation and Stability BC CANCER CHEMOTHERAPY PREPARATION AND STABILITY CHART DRUG & STRENGTH Reconstitute To Give: Vial Product Product Stability Special (Storage Prior to Use, With: Stability (for IV bag size selection, Precautions/Notes Manufacturer, Preservative see Notes†) Status) AGS-16C3F 30 mg 5.1 mL SWI1 6 mg/mL1 discard unused ≥ 0.3 mg/mL1 complete - unopened vials (Astellas) portion1 administration within may be kept at RT (F)(PFL) swirl gently; do NOT 100 mL D5W2,3 6 h RT of for up to 4h prior to do not shake shake1 **(PFL)1 reconstitution1 use if protected no preservative1 mix by gentle from light1 allow foam to clear inversion1 **(PFL) before proceeding1 record time of reconstitution Aldesleukin 22 million units 1.2 mL SWI4 18 million unit/mL 48 h F, RT4 30-70 mcg/mL4 48 h F, RT4 - do NOT use in- (1.3 mg) (1.1 mg/mL)4 line filter4 (SteriMax) direct diluent against 50 mL D5W4 - avoid (F)(PFL) side of vial during bacteriostatic water no preservative4 reconstitution4 <30 mcg/mL: for injection or NS dilute in D5W due to increased do NOT shake4 containing human aggregation4 albumin 0.1%5 - bring to room temperature prior to infusion4 SC syringe6,7 14 d F7 **(PFL) BC Cancer Chemotherapy Preparation and Stability Chart© version 2.00. All rights reserved. 1/60 This document may not be reproduced in any form without the express written permission of BC Cancer Provincial Pharmacy. Activation Date: 2 March 2006 Revised Date: 1 September 2021 BC CANCER CHEMOTHERAPY PREPARATION AND STABILITY CHART DRUG & STRENGTH Reconstitute To Give: Vial Product Product Stability Special (Storage Prior to Use, With: Stability (for IV bag size selection, Precautions/Notes Manufacturer, Preservative see Notes†) Status) Aldesleukin intralesional 1.2 mL SWI4 18 million unit/mL 48 h F, RT4 add 3.2 mL D5W syringe: - avoid 22 million units (1.1 mg/mL)4 to reconstituted vial 48 h F8 bacteriostatic water (1.3 mg) direct diluent against to give (discard any remaining for injection or NS (SteriMax) side of vial during 5 million units/mL8,9 unused syringes due to increased (F)(PFL) reconstitution4 following procedure) aggregation4 no preservative4 withdraw entire do NOT shake4 contents of vial into syringes for administration8,10 Alemtuzumab 30 mg/mL N/A filter NOT discard unused SC syringe13 discard at the end of - do NOT shake14 (Genzyme/Bayer)11 required12 portion12 the day F, RT (F)(PFL) 12 do not shake 30 mg/mL 12 no preservative 100 mL 8 h F, RT12 12 NS, D5W **(PFL)14 BC Cancer Chemotherapy Preparation and Stability Chart© version 2.00. All rights reserved. 2/60 This document may not be reproduced in any form without the express written permission of BC Cancer Provincial Pharmacy. Activation Date: 2 March 2006 Revised Date: 1 September 2021 BC CANCER CHEMOTHERAPY PREPARATION AND STABILITY CHART DRUG & STRENGTH Reconstitute To Give: Vial Product Product Stability Special (Storage Prior to Use, With: Stability (for IV bag size selection, Precautions/Notes Manufacturer, Preservative see Notes†) Status) Amivantamab 350 mg N/A 50 mg/mL discard unused 250 mL NS, D5W15 complete - do NOT shake15 (Janssen) portion15 administration within - discard if (F)(PFL) dilute to final volume 10 h RT15 discolouration or no preservative15 by withdrawing visible particles are volume from bag present15 equal to volume of drug to be added15 mix by gentle inversion15 Amsacrine 75 mg/1.5 mL glass syringes 5 mg/mL16 24 h RT16 500 mL D5W16 7 d F, 48 h RT16-18 - contains DMA*** (Erfa Canada) preferred during (RT) reconstitution; **(PFL)16 (plastic or glass no preservative16 max. time in plastic container)16 syringe16: 15 min 13.5 mL supplied diluent (L-lactic acid)1 transfer 1.5mL from ampoule into the diluent vial16 BC Cancer Chemotherapy Preparation and Stability Chart© version 2.00. All rights reserved. 3/60 This document may not be reproduced in any form without the express written permission of BC Cancer Provincial Pharmacy. Activation Date: 2 March 2006 Revised Date: 1 September 2021 BC CANCER CHEMOTHERAPY PREPARATION AND STABILITY CHART DRUG & STRENGTH Reconstitute To Give: Vial Product Product Stability Special (Storage Prior to Use, With: Stability (for IV bag size selection, Precautions/Notes Manufacturer, Preservative see Notes†) Status) Arsenic trioxide 12 mg/6 mL N/A 2 mg/mL19 discard unused 100-250 mL 72 h F, 24 h RT19 (Teva) portion19 NS, D5W19 (RT) no preservative19 Erwinia asparaginase (asparaginase Erwinia 1-2 mL NS20 10,000-5000 15 min RT20 syringe20 4 h RT20 - contact with the chrysanthemi) units/mL rubber stopper may 10,000 units do not shake; mix denature the (CGF/Jazz) gently to minimize reconstituted drug, (F) bubbles and contact creating filaments no preservative20 with stopper20 of insoluble material; if present, administer with 5 micron filter20 - do not use sterile water for reconstitution as the resulting product is not isotonic20 PEG-asparaginase - see pegaspargase in L-Z chart (pegylated asparaginase E. coli) BC Cancer Chemotherapy Preparation and Stability Chart© version 2.00. All rights reserved. 4/60 This document may not be reproduced in any form without the express written permission of BC Cancer Provincial Pharmacy. Activation Date: 2 March 2006 Revised Date: 1 September 2021 BC CANCER CHEMOTHERAPY PREPARATION AND STABILITY CHART DRUG & STRENGTH Reconstitute To Give: Vial Product Product Stability Special (Storage Prior to Use, With: Stability (for IV bag size selection, Precautions/Notes Manufacturer, Preservative see Notes†) Status) Atezolizumab 840 mg/14 mL N/A 60 mg/mL21 discard unused 250 mL NS21 24 h F, 8 h RT21 - do NOT shake21 1200 mg/20 mL portion21 (Hoffman-La Roche) mix by gentle (F)(PFL) inversion21 do not shake no preservative21 Avelumab 200 mg/10 mL N/A 20 mg/mL22 discard unused 250 mL complete - do NOT shake22 (EMD) portion23 NS, ½-NS22 administration within - administer with (F)(PFL) 24 h F, 8 h RT22 0.2 micron in-line no preservative22 if refrigerated, mix by gentle filter22 bring vial to RT inversion22 if refrigerated, bring prior to use22 bag to RT prior to administration22 BC Cancer Chemotherapy Preparation and Stability Chart© version 2.00. All rights reserved. 5/60 This document may not be reproduced in any form without the express written permission of BC Cancer Provincial Pharmacy. Activation Date: 2 March 2006 Revised Date: 1 September 2021 BC CANCER CHEMOTHERAPY PREPARATION AND STABILITY CHART DRUG & STRENGTH Reconstitute To Give: Vial Product Product Stability Special (Storage Prior to Use, With: Stability (for IV bag size selection, Precautions/Notes Manufacturer, Preservative see Notes†) Status) azaCITIDine 100 mg 4 mL SWI24 25 mg/mL24 45 min RT, SC syringe24 45 min RT (including - discard if contains (Celgene) 8 h F24 preparation time), large particles24 (RT) shake vigorously24 8 h F24 - re-suspend no preservative24 syringe contents record time of refrigerate syringe before injection by reconstitution immediately after vigorously rolling preparation if not to be syringe between used within 45 min of palms24 reconstitution25 -if cold diluent reconstitution is Refrigerated used to extend syringes24: stability, minimize allow up to 30 min exposure to RT; prior to administration ensure proper to reach a refrigeration of temperature of diluent, ~20-25°C reconstituted vial, discard syringe if and final product time elapsed at RT is greater than 30 min cold diluent 25 mg/mL24 22 h F26,27 22 h F26,27 reconstitution: 4 mL SWI at 2- 8°C26,27 BC Cancer Chemotherapy Preparation and Stability Chart© version 2.00. All rights reserved. 6/60 This document may not be reproduced in any form without the express written permission of BC Cancer Provincial Pharmacy. Activation Date: 2 March 2006 Revised Date: 1 September 2021 BC CANCER CHEMOTHERAPY PREPARATION AND STABILITY CHART DRUG & STRENGTH Reconstitute To Give: Vial Product Product Stability Special (Storage Prior to Use, With: Stability (for IV bag size selection, Precautions/Notes Manufacturer, Preservative see Notes†) Status) azaCITIDine 100 mg 4 mL SWI28 25 mg/mL28 45 min RT, SC syringe28 45 min RT (including - do not filter28 (Dr. Reddy‘s) 8 h F28 preparation time), - discard if contains (RT) shake vigorously28 8 h F28 large particles28 no preservative28 - re-suspend refrigerate syringe syringe contents immediately after before injection by preparation if not to be vigorously rolling used within 45 min of syringe between reconstitution28 palms28 Refrigerated syringes28: allow up to 30 min prior to administration to reach a temperature of ~20-25°C discard syringe if time elapsed at RT is greater than 30 min BC Cancer Chemotherapy Preparation and Stability Chart© version 2.00. All rights reserved. 7/60 This document may not be reproduced in any form without the express written permission of BC Cancer Provincial Pharmacy. Activation Date: 2 March 2006 Revised Date: 1 September 2021 BC CANCER CHEMOTHERAPY PREPARATION AND STABILITY CHART DRUG & STRENGTH Reconstitute To Give: Vial Product Product Stability Special (Storage Prior to Use, With: Stability (for IV bag size selection, Precautions/Notes Manufacturer, Preservative see Notes†) Status) BCG (Tice substrain) 1 mL preservative- 1 to 8×108 2 h F29 transfer from vial to use within 2 h F of - auxiliary info: intravesical free NS29 CFU/vial29 60 mL syringe, rinse reconstitution29,30 biohazard30 50 mg = 1 to 8 x 108 **(PFL)29 vial with another 1 mL - do NOT filter29 CFU allow to stand for a NS; add rinse to **(PFL)29 - do NOT shake29 (Merck Canada) few minutes, then same 60 mL syringe (F)(PFL) gently swirl to and qs to 50 mL with no preservative29 suspend29 NS29 record time of if a closed system reconstitution transfer device is used: transfer from vial to 60 mL syringe and qs to 50 mL with NS; do NOT rinse vial29 BCG (Tice substrain) 1 mL preservative 1 to 8×108 2 h F31 transfer from vial to use within 2 h F of - auxiliary info: intravesical free NS31 CFU/vial31 60 mL syringe and qs reconstitution30,31 biohazard30 50 mg = 1 to 8 x 108 **(PFL31 to 50 mL with NS31 - do NOT filter31 CFU allow to stand for a **(PFL)31 - do NOT shake31 (Merck USA) few minutes, then (F)(PFL) gently swirl to no preservative31 suspend31 record time of reconstitution BC Cancer Chemotherapy Preparation and Stability Chart© version 2.00.
Recommended publications
  • A Phase II Study of the Novel Proteasome Inhibitor Bortezomib In
    Memorial Sloan-Kettering Cance r Center IRB Protocol IRB#: 05-103 A(14) A Phase II Study of the Novel Proteas ome Inhibitor Bortezomib in Combination with Rituximab, Cyclophosphamide and Prednisone in Patients with Relapsed/Refractory I Indolent B-cell Lymphoproliferative Disorders and Mantle Cell Lymphoma (MCL) MSKCC THERAPEUTIC/DIAGNOSTIC PROTOCOL Principal Investigator: John Gerecitano, M.D., Ph.D. Co-Principal Carol Portlock, M.D. Investigator(s): IFormerly: A Phase I/II Study of the Nove l Proteasome Inhibitor Bortezomib in Combinati on with Rituximab, Cyclophosphamide and Prednisone in Patients with Relapsed/Refractory Indolent B-cell Lymphoproliferative Disorders and Mantle Cell Lymphoma (MCL) Amended: 07/25/12 Memorial Sloan-Kettering Cance r Center IRB Protocol IRB#: 05-103 A(14) Investigator(s): Paul Hamlin, M.D. Commack, NY Steven B. Horwitz, M.D. Philip Schulman, M.D. Alison Moskowitz, M.D. Stuart Lichtman, M.D Craig H. Moskowitz, M.D. Stefan Berger, M.D. Ariela Noy, M.D. Julie Fasano, M.D. M. Lia Palomba, M.D., Ph.D. John Fiore, M.D. Jonathan Schatz, M.D. Steven Sugarman, M.D David Straus, M.D. Frank Y. Tsai, M.D. Andrew D. Zelenetz, M.D., Ph.D. Matthew Matasar, M.D Rockville Center, NY Mark L. Heaney, M.D., Ph.D. Pamela Drullinksy, M.D Nicole Lamanna, M.D. Arlyn Apollo, M.D. Zoe Goldberg, M.D. Radiology Kenneth Ng, M.D. Otilia Dumitrescu, M.D. Tiffany Troso-Sandoval, M.D. Andrei Holodny, M.D. Sleepy Hollow, NY Nuclear Medicine Philip Caron, M.D. Heiko Schoder, M.D. Michelle Boyar, M.D.
    [Show full text]
  • Cardiac Events During Treatment with Proteasome Inhibitor Therapy for Multiple Myeloma John H
    Chen et al. Cardio-Oncology (2017) 3:4 DOI 10.1186/s40959-017-0023-9 RESEARCH Open Access Cardiac events during treatment with proteasome inhibitor therapy for multiple myeloma John H. Chen1*, Daniel J. Lenihan2, Sharon E. Phillips3, Shelton L. Harrell1 and Robert F. Cornell1 Abstract Background: Proteasome inhibitors (PI) bortezomib and carfilzomib are cornerstone therapies for multiple myeloma. Higher incidence of cardiac adverse events (CAEs) has been reported in patients receiving carfilzomib. However, risk factors for cardiac toxicity remain unclear. Our objective was to evaluate the incidence of CAEs associated with PI and recognize risk factors for developing events. Methods: This was a descriptive analysis of 96 patients with multiple myeloma who received bortezomib (n = 44) or carfilzomib (n = 52). We compared the cumulative incidence of CAEs using a log rank test. Patient-related characteristics were assessed and multivariate analysis was used to identify risk factors for developing CAEs. Results: PI-related CAEs occurred in 21 (22%) patients. Bortezomib-associated CAEs occurred in 7 (16%) patients while carfilzomib-associated cardiac events occurred in 14 (27%) patients. The cumulative incidence of CAEs was not significantly different between agents. Events occurred after a median of 67.5 days on PI therapy. Heart failure was the most prevalent event type. More patients receiving carfilzomib were monitored by a cardiologist. By multivariate analysis, a history of prior cardiac events and longer duration of PI therapy were identified as independent risk factors for developing CAEs. Conclusions: AEs were common in patients receiving PIs. Choice of PI did not impact the cumulative incidence of CAEs.
    [Show full text]
  • VELCADE® (Bortezomib) for Injection
    1 VELCADE® (bortezomib) for Injection 2 PRESCRIBING INFORMATION 3 DESCRIPTION 4 VELCADE® (bortezomib) for Injection is an antineoplastic agent available for intravenous 5 injection (IV) use only. Each single dose vial contains 3.5 mg of bortezomib as a sterile 6 lyophilized powder. Inactive ingredient: 35 mg mannitol, USP. 7 Bortezomib is a modified dipeptidyl boronic acid. The product is provided as a mannitol boronic 8 ester which, in reconstituted form, consists of the mannitol ester in equilibrium with its 9 hydrolysis product, the monomeric boronic acid. The drug substance exists in its cyclic 10 anhydride form as a trimeric boroxine. 11 The chemical name for bortezomib, the monomeric boronic acid, is [(1R)-3-methyl-1-[[(2S)-1- 12 oxo-3-phenyl-2-[(pyrazinylcarbonyl) amino]propyl]amino]butyl] boronic acid. 13 Bortezomib has the following chemical structure: O OH H N N B N OH H O N 14 15 The molecular weight is 384.24. The molecular formula is C19H25BN4O4. The solubility of 16 bortezomib, as the monomeric boronic acid, in water is 3.3 to 3.8 mg/mL in a pH range of 2 to 17 6.5. 18 CLINICAL PHARMACOLOGY 19 Mechanism of Action 20 Bortezomib is a reversible inhibitor of the chymotrypsin-like activity of the 26S proteasome in 21 mammalian cells. The 26S proteasome is a large protein complex that degrades ubiquitinated 22 proteins. The ubiquitin-proteasome pathway plays an essential role in regulating the intracellular 23 concentration of specific proteins, thereby maintaining homeostasis within cells. Inhibition of 24 the 26S proteasome prevents this targeted proteolysis, which can affect multiple signaling 25 cascades within the cell.
    [Show full text]
  • 214120Orig1s000
    CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 214120Orig1s000 MULTI-DISCIPLINE REVIEW Summary Review Office Director Cross Discipline Team Leader Review Clinical Review Non-Clinical Review Statistical Review Clinical Pharmacology Review NDA Multidisciplinary Review and Evaluation Application Number NDA 214120 Application Type Type 3 Priority or Standard Priority Submit Date 3/3/2020 Received Date 3/3/2020 PDUFA Goal Date 9/3/2020 Office/Division OOD/DHM1 Review Completion Date 9/1/2020 Applicant Celgene Corporation Established Name Azacitidine (Proposed) Trade Name Onureg Pharmacologic Class Nucleoside metabolic inhibitor Formulations Tablet (200 mg, 300 mg) (b) (4) Applicant Proposed Indication/Population Recommendation on Regulatory Regular approval Action Recommended Indication/ For continued treatment of adult patients with acute Population myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy. SNOMED CT for the Recommended 91861009 Indication/Population Recommended Dosing Regimen 300 mg orally daily on Days 1 through 14 of each 28-day cycle Reference ID: 4664570 NDA Multidisciplinary Review and Evaluation NDA 214120 Onureg (azacitidine tablets) TABLE OF CONTENTS TABLE OF CONTENTS ................................................................................................................................... 2 TABLE OF TABLES .......................................................................................................................................
    [Show full text]
  • Gy Total Body Irradiation Followed by Allogeneic Hematopoietic St
    Bone Marrow Transplantation (2009) 44, 785–792 & 2009 Macmillan Publishers Limited All rights reserved 0268-3369/09 $32.00 www.nature.com/bmt ORIGINAL ARTICLE Fludarabine, amsacrine, high-dose cytarabine and 12 Gy total body irradiation followed by allogeneic hematopoietic stem cell transplantation is effective in patients with relapsed or high-risk acute lymphoblastic leukemia F Zohren, A Czibere, I Bruns, R Fenk, T Schroeder, T Gra¨f, R Haas and G Kobbe Department of Haematology, Oncology and Clinical Immunology, Heinrich Heine-University, Du¨sseldorf, Germany In this prospective study, we examined the toxicity and Introduction efficacy of an intensified conditioning regimen for treatment of patients with relapsed or high-risk acute The use of intensified conventional induction chemothera- lymphoblastic leukemia who undergo allogeneic hemato- pies in the treatment of newly diagnosed ALL in adult poietic stem cell transplantation. Fifteen patients received patients has led to initial CR rates of up to 90%. But, as fludarabine 30 mg/m2, cytarabine 2000 mg/m2, amsacrine some patients are even refractory to first-line therapy, the 100 mg/m2 on days -10, -9, -8 and -7, anti-thymocyte majority of the responding patients unfortunately suffer globulin (ATG-Fresenius) 20 mg/kg body weight on days from relapse. Therefore, the probability of long-term -6, -5 and -4 and fractionated total body irradiation disease-free survival is o30%.1–5 Risk stratification based 2 Â 2 Gy on days -3, -2 and -1 (FLAMSA-ATG-TBI) on prognostic factors allows identification of high-risk before allogeneic hematopoietic stem cell transplantation. ALL patients with poor prognosis.6–12 Myeloablative At the time of hematopoietic stem cell transplantation, 10 conditioning therapy followed by allogeneic hematopoietic patients were in complete remission (8 CR1; 2 CR2), 3 stem cell transplantation (HSCT) is currently the treatment with primary refractory and 2 suffered from refractory of choice for these high-risk patients.13–15 A combination of relapse.
    [Show full text]
  • Intravesical Instillation of Azacitidine Suppresses Tumor Formation Through TNF-R1 and TRAIL-R2 Signaling in Genotoxic Carcinogen-Induced Bladder Cancer
    cancers Article Intravesical Instillation of Azacitidine Suppresses Tumor Formation through TNF-R1 and TRAIL-R2 Signaling in Genotoxic Carcinogen-Induced Bladder Cancer Shao-Chuan Wang 1,2,3, Ya-Chuan Chang 2, Min-You Wu 2, Chia-Ying Yu 2, Sung-Lang Chen 1,2,3 and Wen-Wei Sung 1,2,3,* 1 Department of Urology, Chung Shan Medical University Hospital, Taichung 40201, Taiwan; [email protected] (S.-C.W.); [email protected] (S.-L.C.) 2 School of Medicine, Chung Shan Medical University, Taichung 40201, Taiwan; [email protected] (Y.-C.C.); [email protected] (M.-Y.W.); [email protected] (C.-Y.Y.) 3 Institute of Medicine, Chung Shan Medical University, Taichung 40201, Taiwan * Correspondence: [email protected] or fl[email protected]; Tel.: +886-4-2473-9595 Simple Summary: Approximately 70% of all bladder cancer is diagnosed as non-muscle invasive bladder cancer and can be treated by transurethral resection of the bladder tumor, followed by intravesical instillation chemotherapy. Bacille Calmette-Guérin (BCG) is the first-line agent for intravesical instillation, but its accessibility has been limited for years due to a BCG shortage. Here, our aim was to evaluate the therapeutic role of intravesical instillation of azacitidine, a DNA methyltransferase inhibitor, in bladder cancer. Cell model experiments showed that azacitidine inhibited TNFR1 downstream pathways to downregulate HIF-1α, claspin, and survivin. Concomitant Citation: Wang, S.-C.; Chang, Y.-C.; upregulation of the TRAIL R2 pathway by azacitidine ultimately drove the tumor cells to apoptosis. Wu, M.-Y.; Yu, C.-Y.; Chen, S.-L.; Sung, Rats with genotoxic carcinogen-induced bladder cancer showed a significantly reduced in vivo tumor W.-W.
    [Show full text]
  • Abstract in Vivo Mouse Studies Drug Resistant Myeloma Cell Lines Ex
    Overcoming Drug-resistance in Multiple Myeloma by CRM1 Inhibitor Combination Therapy Joel G. Turner1, Ken Shain1, Yun Dai2, Jana L. Dawson1, Chris Cubitt1, Sharon Shacham3, 1 3 2 1 H. LEE MOFFITT CANCER CENTER & RESEARCH INSTITUTE, Sharon Shacham , Michael Kaffman , Steven Grant and Daniel M. Sullivan AN NCI COMPREHENSIVE CANCER CENTER – Tampa, FL 1-888-MOFFITT (1-888-663-3488) www.MOFFITT.org 1 Moffitt Cancer Center and Research Institute, Tampa, FL © 2010 H. Lee Moffitt Cancer Center and Research Institute, Inc. 2 Virginia Commonwealth University, Richmond, VA 3 Karyopharm Therapeutics, Natick, MA Abstract Drug Resistant Myeloma Cell Lines In Vivo Mouse Studies Ex vivo Apoptosis Assay Introduction Newly Diagnosed Newly Diagnosed Significant progress has been made over the past several years in the treatment A 70 VC B 70 VC KPT-330 of multiple myeloma (MM). However patients eventually develop drug resistance A B 60 60 KPT-330 KOS-2464 KOS-2464 and die from progressive disease. The incurable nature of MM clearly 50 50 demonstrates the need for novel agents and treatments. 40 40 The overall objective of this study was to investigate the use of CRM1 inhibitors 30 30 Apoptosis (%) Apoptosis (KPT330 and KOS2464) to sensitize de novo and acquired drug-resistant MM (%) Apoptosis 20 20 cells to the proteosome inhibitors bortezomib (BTZ)and carfilzomib (CFZ) and to 10 10 the topoisomerase II (topo II) inhibitor doxorubicin (DOX). 0 0 Methods VC or Drug BTZ CFZ DOX VC or Drug BTZ CFZ DOX Drug resistant U266 and 8226 MM cell lines were developed at VCU (Steven Relapsed Relapsed Grant) and the Moffitt Cancer Center (Ken Shain) respectively by the incremental C 70 VC D 70 VC KPT-330 exposure to BTZ.
    [Show full text]
  • Vorinostat—An Overview Aditya Kumar Bubna
    E-IJD RESIDENTS' PAGE Vorinostat—An Overview Aditya Kumar Bubna Abstract From the Consultant Vorinostat is a new drug used in the management of cutaneous T cell lymphoma when the Dermatologist, Kedar Hospital, disease persists, gets worse or comes back during or after treatment with other medicines. It is Chennai, Tamil Nadu, India an efficacious and well tolerated drug and has been considered a novel drug in the treatment of this condition. Currently apart from cutaneous T cell lymphoma the role of Vorinostat for Address for correspondence: other types of cancers is being investigated both as mono-therapy and combination therapy. Dr. Aditya Kumar Bubna, Kedar Hospital, Mugalivakkam Key Words: Cutaneous T cell lymphoma, histone deacytelase inhibitor, Vorinostat Main Road, Porur, Chennai - 600 125, Tamil Nadu, India. E-mail: [email protected] What was known? • Vorinostat is a histone deacetylase inhibitor. • It is an FDA approved drug for the treatment of cutaneous T cell lymphoma. Introduction of Vorinostat is approximately 9. Vorinostat is slightly Vorinostat is a histone deacetylase (HDAC) inhibitor, soluble in water, alcohol, isopropanol and acetone and is structurally belonging to the hydroxymate group. Other completely soluble in dimethyl sulfoxide. drugs in this group include Givinostat, Abexinostat, Mechanism of action Panobinostat, Belinostat and Trichostatin A. These Vorinostat is a broad inhibitor of HDAC activity and inhibits are an emergency class of drugs with potential anti- class I and class II HDAC enzymes.[2,3] However, Vorinostat neoplastic activity. These drugs were developed with the does not inhibit HDACs belonging to class III. Based on realization that apart from genetic mutation, alteration crystallographic studies, it has been seen that Vorinostat of HDAC enzymes affected the phenotypic and genotypic binds to the zinc atom of the catalytic site of the HDAC expression in cells, which in turn lead to disturbed enzyme with the phenyl ring of Vorinostat projecting out of homeostasis and neoplastic growth.
    [Show full text]
  • Testicular Cancer Treatment Regimens
    Testicular Cancer Treatment Regimens Clinical Trials: The NCCN recommends cancer patient participation in clinical trials as the gold standard for treatment. Cancer therapy selection, dosing, administration, and the management of related adverse events can be a complex process that should be handled by an experienced healthcare team. Clinicians must choose and verify treatment options based on the individual patient; drug dose modifications and supportive care interventions should be administered accordingly. The cancer treatment regimens below may include both U.S. Food and Drug Administration-approved and unapproved indications/regimens. These regimens are only provided to supplement the latest treatment strategies. These Guidelines are a work in progress that may be refined as often as new significant data becomes available. The National Comprehensive Cancer Network Guidelines® are a consensus statement of its authors regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult any NCCN Guidelines® is expected to use independent medical judgment in the context of individual clinical circumstances to determine any patient’s care or treatment. The NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way. Note: All recommendations are category 2A unless otherwise indicated. uPrimary Chemotherapy for Germ Cell Tumors1 REGIMEN DOSING Preferred Regimens BEP (Bleomycin + Etoposide + Days 1-5: Cisplatin 20mg/m2 IV over 60 minutes dailya Cisplatin)2,a,b Days 1-5: Etoposide 100mg/m2 IV over 60 minutes daily Days 1,8,15 OR Days 2,9,16: Bleomycin 30 units IV over 10 minutes daily.
    [Show full text]
  • CK0403, a 9‑Aminoacridine, Is a Potent Anti‑Cancer Agent in Human Breast Cancer Cells
    MOLECULAR MEDICINE REPORTS 13: 933-938, 2016 CK0403, a 9‑aminoacridine, is a potent anti‑cancer agent in human breast cancer cells YUAN-WAN SUN1, KUEN-YUAN CHEN2, CHUL-HOON KWON3 and KUN-MING CHEN1 1Department of Biochemistry and Molecular Biology, College of Medicine, Pennsylvania State University, Hershey, PA 17033, USA; 2Department of Surgery, National Taiwan University Hospital, Taipei 8862, Taiwan, R.O.C.; 3Department of Pharmaceutical Sciences, College of Pharmacy and Allied Health Professions, St. John's University, New York, NY 11439, USA Received November 11, 2014; Accepted October 22, 2015 DOI: 10.3892/mmr.2015.4604 Abstract. 3-({4-[4-(Acridin-9-ylamino)phenylthio]phenyl} reduced growth inhibitory activity under hypoxic conditions, (3-hydroxypropyl)amino)propan-1-ol (CK0403) is a which can induce autophagy. Collectively, the present results sulfur-containing 9-anilinoacridine analogue of amsacrine and supported that CK0403 is highly potent and more effective than was found to be more potent than its analogue 2-({4-[4-(acridin- CK0402 against estrogen receptor-negative and 9-ylamino)phenylthio]phenyl}(2-hydroxyethyl)amino) HER2-overexpressing breast cancer cell lines, suggesting its ethan-1-ol (CK0402) and amsacrine in the inhibition of the future application for chemotherapy in breast cancer. topoisomerase II-catalyzed decatenation reaction. A previous study by our group reported that CK0402 was effective against Introduction numerous breast cancer cell lines, and the combination of CK0402 with herceptin enhanced its activity in HER2(+) Breast cancer is the most common type of cancer diagnosed SKBR-3 cells. In order to identify novel chemotherapeutic agents in American women and is the second most common cause with enhanced potency, the present study explored the potential of cancer-associated mortality.
    [Show full text]
  • Prednisolone-Rituximab-Vincristine (Rpacebom)
    Chemotherapy Protocol LYMPHOMA BLEOMYCIN-CYCLOPHOSPHAMIDE-DOXORUBICIN-ETOPOSIDE-METHOTREXATE- PREDNISOLONE-RITUXIMAB-VINCRISTINE (RPACEBOM) Regimen Lymphoma – RPACEBOM-Bleomycin-Cyclophosphamide-Doxorubicin-Etoposide- Methotrexate-Prednisolone-Rituximab-Vincristine Indication CD20 Positive Non Hodgkin’s Lymphoma Toxicity Drug Adverse Effect Bleomycin Pulmonary toxicity, rigors, skin pigmentation, nail changes Cyclophosphamide Dysuria, haemorrragic cystitis (rare), taste disturbances Doxorubicin Cardiotoxicity, urinary discolouration (red) Etoposide Hypotension on rapid infusion, alopecia, hyperbilirubinaemia Methotrexate Stomatitis, conjunctivitis, renal toxicity Weight gain, GI disturbances, hyperglycaemia, CNS disturbances, Prednisolone cushingoid changes, glucose intolerance Severe cytokine release syndrome, increased incidence of Rituxumab infective complications, progressive multifocal leukoencephalopathy Vincristine Peripheral neuropathy, constipation, jaw pain The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Version 1.2 (Jan 2015) Page 1 of 16 Lymphoma- RPACEBOM-Bleomycin-Cyclophospham-Doxorubicin-Etoposide-Methotrexate-Prednisolone-Rituximab-Vincristine Monitoring Drugs FBC, LFTs and U&Es prior to day one and fifteen Albumin prior to each cycle Regular blood glucose monitoring Check hepatitis B status before starting treatment with rituximab The presence of a third fluid compartment e.g. ascites or renal failure may delay the clearance of methotrexate
    [Show full text]
  • Australian Public Assessment Report for Aminolevulinic Acid Hcl
    Australian Public Assessment Report for Aminolevulinic acid HCl Proprietary Product Name: Gliolan Sponsor: Specialised Therapeutics Australia Pty Ltd March 2014 Therapeutic Goods Administration About the Therapeutic Goods Administration (TGA) · The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health, and is responsible for regulating medicines and medical devices. · The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary. · The work of the TGA is based on applying scientific and clinical expertise to decision- making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices. · The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. TGA investigates reports received by it to determine any necessary regulatory action. · To report a problem with a medicine or medical device, please see the information on the TGA website < http://www.tga.gov.au>. About AusPARs · An Australian Public Assessment Record (AusPAR) provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve a prescription medicine submission. · AusPARs are prepared and published by the TGA. · An AusPAR is prepared for submissions that relate to new chemical entities, generic medicines, major variations, and extensions of indications. · An AusPAR is a static document, in that it will provide information that relates to a submission at a particular point in time. · A new AusPAR will be developed to reflect changes to indications and/or major variations to a prescription medicine subject to evaluation by the TGA.
    [Show full text]