DOCSLIB.ORG

Full Prescribing Information for TOPOTECAN INJECTION

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Full Prescribing Information for TOPOTECAN INJECTION HIGHLIGHTS OF PRESCRIBING INFORMATION Single-use vial containing 4 mg of topotecan free base as a 4 mg/4 mL (1 These highlights do not include all the information needed to use mg/mL) solution. (3) TOPOTECAN INJECTION safely and effectively. See full prescribing information for TOPOTECAN INJECTION. -------------------------------CONTRAINDICATIONS------------------------------ History of severe hypersensitivity reactions (e.g., anaphylactoid reactions) to TOPOTECAN INJECTION, for intravenous use topotecan. (4) Initial U.S. Approval: 1996 -----------------------WARNINGS AND PRECAUTIONS------------------------ Bone marrow suppression: Administer topotecan only to patients with WARNING: BONE MARROW SUPPRESSION adequate bone marrow reserves. Monitor peripheral blood counts and See full prescribing information for complete boxed warning. adjust the dose if needed. (5.1) Do not initiate topotecan treatment in patients with bone marrow Neutropenia colitis, in some cases fatal, can occur. (5.2) 3 suppression (e.g., neutrophil counts less than 1,500 cells/mm ). Monitor Interstitial lung disease: Topotecan can cause interstitial lung disease. peripheral blood counts frequently during treatment. Reduce or withhold Monitor patients for symptoms and discontinue topotecan if the topotecan dosing as recommended [see Dosage and Administration (2.1, diagnosis is confirmed. (5.3) 2.2), Warnings and Precautions (5.1)]. Embryofetal Toxicity: Topotecan can cause fetal harm. Advise women of potential risk to a fetus. (5.4, 8.1) ----------------------------RECENT MAJOR CHANGES-------------------------- ------------------------------ADVERSE REACTIONS------------------------------- Dosage and Administration (2) 2/2014 In patients with small cell lung cancer or other malignancies, the most ----------------------------INDICATIONS AND USAGE--------------------------- common (≥ 25%) adverse reactions are neutropenia (97%), anemia (89%), thrombocytopenia (69%), nausea (64%), alopecia (49%), vomiting (45%), Topotecan Injection is a topoisomerase inhibitor indicated: sepsis or pyrexia/infection with neutropenia (43%), diarrhea (32%), constipation (29%), fatigue (29%), and pyrexia (28%). (6.1) for the treatment of small cell lung cancers in patients with In patients with cervical cancer, the most common adverse reactions (≥ 25%) chemotherapy-sensitive disease after failure of first-line chemotherapy. are: anemia (94%), neutropenia (89%), thrombocytopenia (74%), pain (59%), (1.1) nausea (55%), dermatologic (48%), vomiting (40%), neurologic/non­ in combination therapy with cisplatin, for the treatment of stage IVB, neuropathy (35%), and infection/febrile neutropenia (28%). (6.1) recurrent, or persistent carcinoma of the cervix which is not amenable to To report SUSPECTED ADVERSE REACTIONS, contact TEVA USA, curative treatment with surgery or radiation therapy. (1.2) PHARMACOVIGILANCE at 1-866-832-8537 or [email protected]; or FDA at 1-800-FDA-1088 or ----------------------DOSAGE AND ADMINISTRATION----------------------- www.fda.gov/medwatch. Small cell lung cancer: Topotecan Injection 1.5 mg/m2 by intravenous infusion over 30 minutes daily on days 1 to 5 of each 21-day cycle. (2.1) -----------------------USE IN SPECIFIC POPULATIONS------------------------ 2 Cervical cancer: Topotecan Injection 0.75 mg/m by intravenous infusion over Nursing Mothers: Discontinue nursing when receiving topotecan. (8.3) 30 minutes daily on days 1, 2, and 3 of each 21-day cycle. (2.2) See Dosage Modification Guidelines for patients with neutropenia, thrombocytopenia, or renal impairment. (2.1, 2.2) See 17 for PATIENT COUNSELING INFORMATION ---------------------DOSAGE FORMS AND STRENGTHS---------------------- Revised: 2/2014 FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: BONE MARROW SUPPRESSION 8 USE IN SPECIFIC POPULATIONS 1 INDICATIONS AND USAGE 8.1 Pregnancy 1.1 Small Cell Lung Cancer 8.3 Nursing Mothers 1.2 Cervical Cancer 8.4 Pediatric Use 2 DOSAGE AND ADMINISTRATION 8.5 Geriatric Use 2.1 Small Cell Lung Cancer 8.6 Renal Impairment 2.2 Cervical Cancer 10 OVERDOSAGE 2.3 Instructions for Handling, and Preparation for Intravenous 11 DESCRIPTION Administration 12 CLINICAL PHARMACOLOGY 3 DOSAGE FORMS AND STRENGTHS 12.1 Mechanism of Action 4 CONTRAINDICATIONS 12.2 Pharmacodynamics 5 WARNINGS AND PRECAUTIONS 12.3 Pharmacokinetics 5.1 Bone Marrow Suppression 13 NONCLINICAL TOXICOLOGY 5.2 Neutropenic Colitis 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 5.3 Interstitial Lung Disease 14 CLINICAL STUDIES 5.4 Embryofetal Toxicity 14.1 Small Cell Lung Cancer 5.5 Extravasation 14.2 Cervical Cancer 6 ADVERSE REACTIONS 15 REFERENCES 6.1 Clinical Trials Experience 16 HOW SUPPLIED/STORAGE AND HANDLING 6.2 Postmarketing Experience 17 PATIENT COUNSELING INFORMATION 7 DRUG INTERACTIONS *Sections or subsections omitted from the full prescribing information are not listed. FULL PRESCRIBING INFORMATION Reference ID: 3463172 WARNING: BONE MARROW SUPPRESSION Do not initiate Topotecan Injection treatment in patients with bone marrow suppression (e.g., neutrophil counts less than 1,500 cells/mm3). Monitor peripheral blood counts frequently during treatment. Reduce or withhold Topotecan Injection dosing as recommended [see Dosage and Administration (2.1, 2.2) and Warnings and Precautions (5.1)]. 1 INDICATIONS AND USAGE 1.1 Small Cell Lung Cancer Topotecan Injection is indicated for the treatment of chemotherapy-sensitive small cell lung cancer (SCLC) after failure of first-line chemotherapy. Chemotherapy-sensitive SCLC is defined as responding to first-line chemotherapy but subsequently progressing at least 60 days after chemotherapy. 1.2 Cervical Cancer Topotecan Injection, in combination with cisplatin, is indicated for the treatment of stage IVB, recurrent or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy. 2 DOSAGE AND ADMINISTRATION Verify dose using body surface area prior to dispensing. Recommended dosage should generally not exceed 4 mg intravenously [see Overdosage (10)]. 2.1 Small Cell Lung Cancer Recommended Dosage: The recommended dose of Topotecan Injection is 1.5 mg/m2 by intravenous infusion over 30 minutes daily on days 1 to 5 of each 21-day cycle until disease progression. Dosage Modification Guidelines: Recommended dose modifications in patients with bone marrow suppression or renal impairment are provided in the table below [see Warnings and Precautions (5.1), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. Table 1. Recommended Dose Modifications in Patients with Small Cell Lung Cancer Adverse Reaction or Laboratory Values Recommended Dose Modification On Day 1 of first cycle Delay initiation of Topotecan Injection until hematologic or renal recovery --neutrophil count of ≤ 1,500 cells/mm3 or --platelet count ≤ 100,000 cells/mm3 or --serum creatinine > 1.5 mg/dL On Day 1 of subsequent cycles (cycle 2 and Delay next cycle of Topotecan Injection until beyond) hematologic or renal recovery --neutrophil count of ≤ 1,000 cells/mm3 or --platelet count ≤ 100,000 cells/mm3 or --hemoglobin < 9.0 gm/dL or --serum creatinine > 1.5 mg/dL For neutropenia < 500 cells/mm3 in Permanently reduce Topotecan Injection dose to preceding cycle 1.25 mg/m2 or administer prophylactic granulocyte colony-stimulating factor during subsequent cycles. For platelets < 25,000 cells/mm3 in Permanently reduce Topotecan Injection dose to preceding cycle 1.25 mg/m2 For creatinine clearance 20-39 mL/min Reduce the Topotecan Injection dose to 0.75 mg/m2 Reference ID: 3463172 2.2 Cervical Cancer Recommended Dosage: The recommended dose of Topotecan Injection is 0.75 mg/m2 by intravenous infusion over 30 minutes daily on days 1, 2, and 3 of each 21-day cycle. Administer cisplatin 50 mg/m2 by intravenous infusion on day 1 of each 21-day cycles. Dosage Modification Guidelines: Recommended dose modifications in patients with bone marrow suppression or renal impairment are provided in the table below [see Warnings and Precautions (5.1), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. See manufacturer’s prescribing information for cisplatin administration and hydration guidelines and for cisplatin dosage adjustment in the event of hematologic toxicity. Table 2. Recommended Dose Modifications in Patients with Cervical Cancer Adverse Reaction or Laboratory Values Recommended Dose Modification On Day 1 of first cycle Delay initiation of Topotecan Injection until hematologic or renal recovery --neutrophil count of ≤ 1,500 cells/mm3 or --platelet count ≤ 100,000 cells/mm3 or --serum creatinine > 1.5 mg/dL On Day 1 of subsequent cycles (cycle 2 and Delay next cycle of Topotecan Injection until beyond) hematologic or renal recovery --neutrophil count of ≤ 1,000 cells/mm3 or --platelet count ≤ 100,000 cells/mm3 or --hemoglobin < 9.0 gm/dL or --serum creatinine > 1.5 mg/dL For the first occurrence of febrile neutropenia [ Permanently reduce the daily Topotecan < 1,000 neutrophils/mm3 with fever ≥ 38.0°C (≥ Injection dose to 0.60 mg/m2 or administer 100.4°F) in preceding cycle prophylactic granulocyte colony-stimulating factor (G-CSF) during subsequent cycles. For re-occurrence of febrile neutropenia [< Permanently reduce the daily Topotecan 1,000 neutrophils/mm3 with fever ≥ 38.0°C (≥ Injection dose to 0.45 mg/m2 100.4°F) in preceding cycle despite use of G­ CSF For platelet nadir < 25,000 cells/mm3 in Permanently reduce the daily Topotecan preceding cycle Injection dose to 0.60 mg/m2 For serum creatinine
Load more

Recommended publications
  • SAAVTC Protocol
    BC Cancer Protocol Summary for Treatment of Recurrent and Refractory Neuroblastoma, Ewing’s Sarcoma, Osteogenic Sarcoma or Rhabdomyosarcoma with Topotecan and Cyclophosphamide Protocol Code SAAVTC Tumour Group Sarcoma Contact Physician Dr. Christine Simmons ELIGIBILITY: . Relapsed/refractory Ewing’s sarcoma, rhabdomyosarcoma, intra-abdominal small round blue cell tumour, or neuroblastoma . ECOG PS 0-2 . Adequate hematologic parameters (ANC greater than or equal to 1.5 x 109/L, and platelets greater than or equal to 100 x 109 /L). Adequate hepatic and renal function EXCLUSIONS: . Creatinine clearance less than 40 mL/min. Use with caution in patients with renal dysfunction. See DOSE MODIFICATIONS for reduction in dose in patients with renal dysfunction. ECOG PS 3-4 TESTS: . Baseline: CBC & diff, platelets, creatinine, BUN, bilirubin, ALT, sodium, potassium, phosphate, albumin, urinalysis (r+m) . Before each treatment cycle (Day 1): o CBC & diff, platelets, creatinine, BUN, bilirubin, ALT, sodium, potassium, phosphate, albumin o Urinalysis (r+m). Notify physician if patient has hematuria. Weekly: CBC & diff, platelets PREMEDICATIONS: . ondansetron 8 mg PO prior to treatment . dexamethasone 8 mg PO/IV prior to treatment . prochlorperazine 10 mg PO prn . LORazepam 1 mg PO prn PREHYDRATION: . Ensure patient has taken at least 500 mL of fluid prior to each day of therapy; if not, prehydrate daily with NS 500 mL over 30 minutes to 1 hour. BC Cancer Protocol Summary SAAVTC Page 1 of 3 Activated: 1 May 2014 Revised: 1 May 2021 (IV bag size, infusion time clarified) Warning: The information contained in these documents are a statement of consensus of BC Cancer professionals regarding their views of currently accepted approaches to treatment.
    [Show full text]
  • Topotecan, Pegylated Liposomal Doxorubicin Hydrochloride
    Topotecan, pegylated liposomal doxorubicin hydrochloride and paclitaxel for second-line or subsequent treatment of advanced ovarian cancer (report contains no commercial in confidence data) Produced by Centre for Reviews and Dissemination, University of York Authors Ms Caroline Main, Research Fellow, Systematic Reviews, Centre for Reviews and Dissemination, University of York, YO10 5DD Ms Laura Ginnelly, Research Fellow, Health Economics, Centre for Health Economics, University of York, YO10 5DD Ms Susan Griffin, Research Fellow, Health Economics, Centre for Health Economics, University of York, YO10 5DD Dr Gill Norman, Research Fellow, Systematic Reviews, Centre for Reviews and Dissemination, University of York, YO10 5DD Mr Marco Barbieri, Research Fellow, Health Economics, The Economic and Health Research Centre, Universitat Pompeu Fabra, Barcelona, Spain Ms Lisa Mather, Information Officer, Centre for Reviews and Dissemination, University of York, YO10 5DD Dr Dan Stark, Senior Lecturer in Oncology and Honorary Consultant in Medical Oncology, Department of Oncology, Bradford Royal Infirmary Mr Stephen Palmer, Senior Research Fellow, Health Economics, Centre for Health Economics, University of York, YO10 5DD Dr Rob Riemsma, Reviews Manager, Systematic Reviews, Centre for Reviews and Dissemination, University of York, YO10 5DD Correspondence to Caroline Main, Centre for Reviews and Dissemination, University of York, YO10 5DD, Tel: (01904) 321055, Fax: (01904) 321041, E-mail: [email protected] Date completed September 2004 Expiry date September 2006 Contributions of authors Caroline Main Lead reviewer responsible for writing the protocol, study selection, data extraction, validity assessment and writing the final report. Laura Ginnelly Involved in the cost-effectiveness section, writing the protocol, study selection, data extraction, development of the economic model and report writing.
    [Show full text]
  • Tandem High-Dose Chemotherapy with Topotecan–Thiotepa–Carboplatin
    International Journal of Clinical Oncology (2019) 24:1515–1525 https://doi.org/10.1007/s10147-019-01517-8 ORIGINAL ARTICLE Tandem high‑dose chemotherapy with topotecan–thiotepa–carboplatin and melphalan–etoposide–carboplatin regimens for pediatric high‑risk brain tumors Jung Yoon Choi1,2 · Hyoung Jin Kang1,2 · Kyung Taek Hong1,2 · Che Ry Hong1,2 · Yun Jeong Lee1 · June Dong Park1 · Ji Hoon Phi3 · Seung‑Ki Kim3 · Kyu‑Chang Wang3 · Il Han Kim2,4 · Sung‑Hye Park5 · Young Hun Choi6 · Jung‑Eun Cheon6 · Kyung Duk Park1,2 · Hee Young Shin1,2 Received: 13 December 2018 / Accepted: 20 July 2019 / Published online: 27 July 2019 © Japan Society of Clinical Oncology 2019 Abstract Background High-dose chemotherapy (HDC) and autologous stem-cell transplantation (auto-SCT) are used to improve the survival of children with high-risk brain tumors who have a poor outcome with the standard treatment. This study aims to evaluate the outcome of HDC/auto-SCT with topotecan–thiotepa–carboplatin and melphalan–etoposide–carboplatin (TTC/ MEC) regimens in pediatric brain tumors. Methods We retrospectively analyzed the data of 33 children (median age 6 years) who underwent HDC/auto-SCT (18 tandem and 15 single) with uniform conditioning regimens. Results Eleven patients aged < 3 years at diagnosis were eligible for HDC/auto-SCT to avoid or defer radiotherapy. In addi- tion, nine patients with high-risk medulloblastoma (presence of metastasis and/or postoperative residual tumor ≥ 1.5 cm2), eight with other high-risk brain tumor (six CNS primitive neuroectodermal tumor, one CNS atypical teratoid/rhabdoid tumor, and one pineoblastoma), and fve with relapsed brain tumors were enrolled.
    [Show full text]
  • Cyclophosphamide and Topotecan As First-Line Salvage Therapy in Patients with Relapsed Ewing Sarcoma at a Single Institution
    ORIGINAL ARTICLE Cyclophosphamide and Topotecan as First-line Salvage Therapy in Patients With Relapsed Ewing Sarcoma at a Single Institution Rawad Farhat, MD,* Roy Raad, MD,w Nabil J. Khoury, MD,w Julien Feghaly, BS,* Toufic Eid, MD,z Samar Muwakkit, MD,* Miguel Abboud, MD,* Hassan El-Solh, MD,* and Raya Saab, MD* stable disease (SD), with an overall objective response of Summary: The combination of cyclophosphamide and topotecan 35%.7 In a therapeutic window study conducted by the (cyclo/topo) has shown objective responses in relapsed Ewing sar- Children’s Oncology Group in the United States, treatment of coma, but the response duration is not well documented. We patients with Ewing sarcoma with cyclo/topo resulted in PR reviewed characteristics and outcome of 14 patients with Ewing in 21 of 37 patients, accounting for a response rate of 56%, sarcoma, treated uniformly at a single institution and offered cyclo/ 8 topo at first relapse. Six patients (43%) had relapse at distant and 15 more patients had SD. AreviewoftheGerman sites. All patients received first-line salvage therapy with cyclo- experience with this regimen, in patients with Ewing sarcoma phosphamide 250 mg/m2 and topotecan 0.75 mg/m2, daily for 5 days who received cyclo/topo at either first or second relapse, repeated every 21 days. The median number of cycles was 4 (range 1 showed a response rate of 32.6%.9 In that study, one third of to 10). All toxicities were manageable, the most common being the patients were alive at a median follow-up of 14.5 months transient cytopenias.
    [Show full text]
  • Camptothecin Derivatives Camptothecin-Derivate Dérivés De La Camptothécine
    (19) TZZ ¥_ _T (11) EP 2 443 125 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: C07D 491/14 (2006.01) C07D 491/22 (2006.01) 26.11.2014 Bulletin 2014/48 A61P 35/00 (2006.01) A61K 31/4741 (2006.01) (21) Application number: 10790151.4 (86) International application number: PCT/US2010/038890 (22) Date of filing: 16.06.2010 (87) International publication number: WO 2010/148138 (23.12.2010 Gazette 2010/51) (54) CAMPTOTHECIN DERIVATIVES CAMPTOTHECIN-DERIVATE DÉRIVÉS DE LA CAMPTOTHÉCINE (84) Designated Contracting States: • CAO: "Preparationof 14- nitrocamptothecin...", J. AL AT BE BG CH CY CZ DE DK EE ES FI FR GB CHEM.SOC., PERKIN TRANS. 1, vol. 21, 1996, GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO pages 2629-2632, XP002684965, PL PT RO SE SI SK SM TR • CHENG KEJUN ET AL: "14-azacamptothecin: a potent water-soluble topoisomerase I poison.", (30) Priority: 17.06.2009 US 218043 P JOURNAL OF THE AMERICAN CHEMICAL 16.04.2010 US 325223 P SOCIETY 26 JAN 2005 LNKD- PUBMED: 15656613, vol. 127, no. 3, 26 January 2005 (43) Date of publication of application: (2005-01-26), pages838-839, XP002684966, ISSN: 25.04.2012 Bulletin 2012/17 0002-7863 • VADWAI VIRAL ET AL: "Insilico analysis of (73) Proprietor: Threshold Pharmaceuticals, Inc. homocamptothecin (hCPT) analogues for anti- Redwood City, California 94063 (US) tumour activity", INTERNATIONAL JOURNAL OF BIOINFORMATICS RESEARCH AND (72) Inventors: APPLICATIONS, INDERSCIENCE PUBLISHERS, • CAI, Xiaohong BUCKS, GB, vol.
    [Show full text]
  • The Role of ABCG2 in Modulating Responses to Anti-Cancer Photodynamic Therapy
    This is a repository copy of The role of ABCG2 in modulating responses to anti-cancer photodynamic therapy. White Rose Research Online URL for this paper: http://eprints.whiterose.ac.uk/152665/ Version: Accepted Version Article: Khot, MI orcid.org/0000-0002-5062-2284, Downey, CL, Armstrong, G et al. (4 more authors) (2020) The role of ABCG2 in modulating responses to anti-cancer photodynamic therapy. Photodiagnosis and Photodynamic Therapy, 29. 101579. ISSN 1572-1000 https://doi.org/10.1016/j.pdpdt.2019.10.014 © 2019 Elsevier B.V. All rights reserved. This manuscript version is made available under the CC-BY-NC-ND 4.0 license http://creativecommons.org/licenses/by-nc-nd/4.0/. Reuse This article is distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs (CC BY-NC-ND) licence. This licence only allows you to download this work and share it with others as long as you credit the authors, but you can’t change the article in any way or use it commercially. More information and the full terms of the licence here: https://creativecommons.org/licenses/ Takedown If you consider content in White Rose Research Online to be in breach of UK law, please notify us by emailing [email protected] including the URL of the record and the reason for the withdrawal request. [email protected] https://eprints.whiterose.ac.uk/ The role of ABCG2 in modulating responses to anti-cancer photodynamic therapy List of Authors: M. Ibrahim Khot, Candice L. Downey, Gemma Armstrong, Hafdis S. Svavarsdottir, Fazain Jarral, Helen Andrew and David G.
    [Show full text]
  • Evaluation of Floxuridine Oligonucleotide Conjugates Carrying Potential Enhancers of Cellular Uptake
    International Journal of Molecular Sciences Article Evaluation of Floxuridine Oligonucleotide Conjugates Carrying Potential Enhancers of Cellular Uptake Anna Aviñó 1,2,*, Anna Clua 1,2 , Maria José Bleda 1 , Ramon Eritja 1,2,* and Carme Fàbrega 1,2 1 Institute for Advanced Chemistry of Catalonia (IQAC-CSIC), Jordi Girona 18-26, E-08034 Barcelona, Spain; [email protected] (A.C.); [email protected] (M.J.B.); [email protected] (C.F.) 2 Networking Center on Bioengineering, Biomaterials and Nanomedicine (CIBER-BBN), Jordi Girona 18-26, E-08034 Barcelona, Spain * Correspondence: [email protected] (A.A.); [email protected] (R.E.); Tel.: +34-934-006-100 (A.A.) Abstract: Conjugation of small molecules such as lipids or receptor ligands to anti-cancer drugs has been used to improve their pharmacological properties. In this work, we studied the biological effects of several small-molecule enhancers into a short oligonucleotide made of five floxuridine units. Specifically, we studied adding cholesterol, palmitic acid, polyethyleneglycol (PEG 1000), folic acid and triantennary N-acetylgalactosamine (GalNAc) as potential enhancers of cellular uptake. As expected, all these molecules increased the internalization efficiency with different degrees depending on the cell line. The conjugates showed antiproliferative activity due to their metabolic activation by nuclease degradation generating floxuridine monophosphate. The cytotoxicity and apoptosis assays showed an increase in the anti-cancer activity of the conjugates related to the floxuridine oligomer, but this effect did not correlate with the internalization results. Palmitic and folic acid conjugates provide the highest antiproliferative activity without having the highest internalization Citation: Aviñó, A.; Clua, A.; Bleda, results.
    [Show full text]
  • BC Cancer Benefit Drug List September 2021
    Page 1 of 65 BC Cancer Benefit Drug List September 2021 DEFINITIONS Class I Reimbursed for active cancer or approved treatment or approved indication only. Reimbursed for approved indications only. Completion of the BC Cancer Compassionate Access Program Application (formerly Undesignated Indication Form) is necessary to Restricted Funding (R) provide the appropriate clinical information for each patient. NOTES 1. BC Cancer will reimburse, to the Communities Oncology Network hospital pharmacy, the actual acquisition cost of a Benefit Drug, up to the maximum price as determined by BC Cancer, based on the current brand and contract price. Please contact the OSCAR Hotline at 1-888-355-0355 if more information is required. 2. Not Otherwise Specified (NOS) code only applicable to Class I drugs where indicated. 3. Intrahepatic use of chemotherapy drugs is not reimbursable unless specified. 4. For queries regarding other indications not specified, please contact the BC Cancer Compassionate Access Program Office at 604.877.6000 x 6277 or [email protected] DOSAGE TUMOUR PROTOCOL DRUG APPROVED INDICATIONS CLASS NOTES FORM SITE CODES Therapy for Metastatic Castration-Sensitive Prostate Cancer using abiraterone tablet Genitourinary UGUMCSPABI* R Abiraterone and Prednisone Palliative Therapy for Metastatic Castration Resistant Prostate Cancer abiraterone tablet Genitourinary UGUPABI R Using Abiraterone and prednisone acitretin capsule Lymphoma reversal of early dysplastic and neoplastic stem changes LYNOS I first-line treatment of epidermal
    [Show full text]
  • Arsenic Trioxide As a Radiation Sensitizer for 131I-Metaiodobenzylguanidine Therapy: Results of a Phase II Study
    Arsenic Trioxide as a Radiation Sensitizer for 131I-Metaiodobenzylguanidine Therapy: Results of a Phase II Study Shakeel Modak1, Pat Zanzonico2, Jorge A. Carrasquillo3, Brian H. Kushner1, Kim Kramer1, Nai-Kong V. Cheung1, Steven M. Larson3, and Neeta Pandit-Taskar3 1Department of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, New York; 2Department of Medical Physics, Memorial Sloan Kettering Cancer Center, New York, New York; and 3Molecular Imaging and Therapy Service, Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, New York sponse rates when compared with historical data with 131I-MIBG Arsenic trioxide has in vitro and in vivo radiosensitizing properties. alone. We hypothesized that arsenic trioxide would enhance the efficacy of Key Words: radiosensitization; neuroblastoma; malignant the targeted radiotherapeutic agent 131I-metaiodobenzylguanidine pheochromocytoma/paraganglioma; MIBG therapy 131 ( I-MIBG) and tested the combination in a phase II clinical trial. J Nucl Med 2016; 57:231–237 Methods: Patients with recurrent or refractory stage 4 neuroblas- DOI: 10.2967/jnumed.115.161752 toma or metastatic paraganglioma/pheochromocytoma (MP) were treated using an institutional review board–approved protocol (Clinicaltrials.gov identifier NCT00107289). The planned treatment was 131I-MIBG (444 or 666 MBq/kg) intravenously on day 1 plus arsenic trioxide (0.15 or 0.25 mg/m2) intravenously on days 6–10 and 13–17. Toxicity was evaluated using National Cancer Institute Common Metaiodobenzylguanidine (MIBG) is a guanethidine analog Toxicity Criteria, version 3.0. Response was assessed by Interna- that is taken up via the noradrenaline transporter by neuroendo- tional Neuroblastoma Response Criteria or (for MP) by changes in crine malignancies arising from sympathetic neuronal precursors 123I-MIBG or PET scans.
    [Show full text]
  • Complications of Intrathecal Chemotherapy in Adults
    View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by Scholarly Commons@Baptist Health South Florida Baptist Health South Florida Scholarly Commons @ Baptist Health South Florida All Publications 2019 Complications of Intrathecal Chemotherapy in Adults: Single-Institution Experience in 109 Consecutive Patients Fernando Vargas Madueno Baptist Health Medical Group; Miami Cancer Institute, [email protected] Follow this and additional works at: https://scholarlycommons.baptisthealth.net/se-all-publications Citation Journal of Oncology (2019) 2019:4047617 This Article -- Open Access is brought to you for free and open access by Scholarly Commons @ Baptist Health South Florida. It has been accepted for inclusion in All Publications by an authorized administrator of Scholarly Commons @ Baptist Health South Florida. For more information, please contact [email protected]. Hindawi Journal of Oncology Volume 2019, Article ID 4047617, 7 pages https://doi.org/10.1155/2019/4047617 Research Article Complications of Intrathecal Chemotherapy in Adults: Single-Institution Experience in 109 Consecutive Patients Diana M. Byrnes ,1 Fernando Vargas,2 Christopher Dermarkarian ,3 Ryan Kahn,3 Deukwoo Kwon,4,5 Judith Hurley,5,6 and Jonathan H. Schatz 5,6 1 Hematology-Oncology Fellowship Program, Department of Medicine, Jackson Memorial Hospital, USA 2Miami Cancer Institute, Baptist Health South Florida, USA 3University of Miami Miller School of Medicine, USA 4Biostatistics and Bioinformatics Core, USA 5Sylvester Comprehensive Cancer Center, USA 6Division of Hematology, Department of Medicine, University of Miami Miller School of Medicine, Miami, FL, USA Correspondence should be addressed to Jonathan H. Schatz; [email protected] Received 11 January 2019; Revised 26 March 2019; Accepted 11 April 2019; Published 2 May 2019 Guest Editor: Riccardo Masetti Copyright © 2019 Diana M.
    [Show full text]
  • Polymer-Drug Conjugate, a Potential Therapeutic to Combat Breast and Lung Cancer
    pharmaceutics Review Polymer-Drug Conjugate, a Potential Therapeutic to Combat Breast and Lung Cancer Sibusiso Alven, Xhamla Nqoro , Buhle Buyana and Blessing A. Aderibigbe * Department of Chemistry, University of Fort Hare, Alice Eastern Cape 5700, South Africa; [email protected] (S.A.); [email protected] (X.N.); [email protected] (B.B.) * Correspondence: [email protected] Received: 24 November 2019; Accepted: 30 December 2019; Published: 29 April 2020 Abstract: Cancer is a chronic disease that is responsible for the high death rate, globally. The administration of anticancer drugs is one crucial approach that is employed for the treatment of cancer, although its therapeutic status is not presently satisfactory. The anticancer drugs are limited pharmacologically, resulting from the serious side effects, which could be life-threatening. Polymer drug conjugates, nano-based drug delivery systems can be utilized to protect normal body tissues from the adverse side effects of anticancer drugs and also to overcome drug resistance. They transport therapeutic agents to the target cell/tissue. This review article is based on the therapeutic outcomes of polymer-drug conjugates against breast and lung cancer. Keywords: breast cancer; lung cancer; chemotherapy; polymer-based carriers; polymer-drug conjugates 1. Introduction Cancer is a chronic disease that leads to great mortality around the world and cancer cases are rising continuously [1]. It is the second cause of death worldwide, followed by cardiovascular diseases [2]. It is characterized by an abnormal uncontrolled proliferation of any type of cells in the human body [3]. It is caused by external factors, such as smoking, infectious organisms, pollution, and radiation; it is also caused by internal factors, such as immune conditions, hormones, and genetic mutation [3].
    [Show full text]
  • Busulfan in Infant to Adult Hematopoietic Cell Transplant Recipients: a Population Pharmacokinetic Model for Initial and Bayesian Dose Personalization
    Published OnlineFirst November 11, 2013; DOI: 10.1158/1078-0432.CCR-13-1960 Clinical Cancer Predictive Biomarkers and Personalized Medicine Research Busulfan in Infant to Adult Hematopoietic Cell Transplant Recipients: A Population Pharmacokinetic Model for Initial and Bayesian Dose Personalization Jeannine S. McCune1,3, Meagan J. Bemer1, Jeffrey S. Barrett5, K. Scott Baker2,3,4, Alan S. Gamis6, and Nicholas H.G. Holford7 Abstract Purpose: Personalizing intravenous busulfan doses to a target plasma concentration at steady state (Css) is an essential component of hematopoietic cell transplantation (HCT). We sought to develop a population pharmacokinetic model to predict i.v. busulfan doses over a wide age spectrum (0.1–66 years) that accounts for differences in age and body size. Experimental Design: A population pharmacokinetic model based on normal fat mass and maturation based on postmenstrual age was built from 12,380 busulfan concentration time points obtained after i.v. busulfan administration in 1,610 HCT recipients. Subsequently, simulation results of the initial dose necessary to achieve a target Css with this model were compared with pediatric-only models. Results: A two-compartment model with first-order elimination best fit the data. The population busulfan clearance was 12.4 L/h for an adult male with 62 kg normal fat mass (equivalent to 70 kg total body weight). Busulfan clearance, scaled to body size—specifically normal fat mass, is predicted to be 95% of the adult clearance at 2.5 years postnatal age. With a target Css of 770 ng/mL, a higher proportion of initial doses achieved the therapeutic window with this age- and size-dependent model (72%) compared with dosing recommended by the U.S.
    [Show full text]