Consumer Medicine Information

Total Page:16

File Type:pdf, Size:1020Kb

Consumer Medicine Information DBL™ Docetaxel Concentrated Injection docetaxel Consumer Medicine Information What is in this leaflet It works by stopping cells from • wheezing or difficulty breathing growing and multiplying. or a tight feeling in your chest This leaflet answers some common Ask your doctor if you have any • swelling of the face, lips, tongue questions about DBL Docetaxel, questions about why this medicine or other parts of the body Concentrated Injection. has been prescribed for you. • rash, itching, hives or flushed, red It does not contain all the available Your doctor may have prescribed it skin information. It does not take the for another reason. • dizziness or light-headedness place of talking to your doctor or This medicine is not addictive. • back pain pharmacist. This medicine is available only with Do not use DBL Docetaxel, All medicines have risks and a doctor’s prescription. benefits. Your doctor has weighed Concentrated Injection if you have, You may have taken another the risks of you taking DBL or have had, any of the following Docetaxel, Concentrated Injection medicine to treat your breast, non medical conditions: small cell lung cancer, ovarian, against the benefits they expect it • severe liver problems prostate or head and neck cancer. will have for you. • blood disorder with a reduced However, your doctor has now number of white blood cells If you have any concerns about decided to treat you with docetaxel. taking this medicine, ask your There is not enough information to Do not use this medicine if you are doctor or pharmacist. recommend the use of this medicine pregnant or intend to become Keep this leaflet with the medicine. for children. pregnant either during treatment You may need to read it again. or in the three months following the last dose of docetaxel. Like most medicines used to treat Before you are given cancer, docetaxel is not What DBL Docetaxel, DBL Docetaxel, recommended for use during Concentrated Concentrated pregnancy, unless you and your Injection is used for Injection doctor have discussed the risks and benefits involved. Docetaxel is used to treat: When you must not be given Do not breast-feed if you are using this medicine. • breast cancer it • non small cell lung cancer It is not known if docetaxel passes Do not use DBL Docetaxel, into breast milk and there is a • ovarian cancer Concentrated Injection if you have possibility that your baby may be • prostate cancer an allergy to: affected. • any medicine containing • head and neck cancer If you are not sure whether you docetaxel or polysorbate 80 This medicine belongs to a group of should start using this medicine, medicines called antineoplastic or • any of the ingredients listed at the talk to your doctor. cytotoxic medicines. You may also end of this leaflet. hear of these being called Some of the symptoms of an allergic Before you are given it chemotherapy medicines. reaction may include: Tell your doctor if you have • shortness of breath allergies to any other medicines, foods, preservatives or dyes. DBL™ DOCETAXEL CONCENTRATED INJECTION 1 Docetaxel is not recommended for erythromycin, clarithromycin and • prescribe you an oral use in children. telithromycin. corticosteroid (eg Safety and effectiveness in children • Ketoconazole, itraconazole and dexamethasone) to help stop or have not been established. voriconazole, medicines used to reduce the severity of certain side treat fungal infections effects. For breast, lung, ovarian Tell your doctor if you have or and head and neck cancer, this • nifedipine, a medicine used to have had any of the following medicine is usually taken for treat high blood pressure and medical conditions: three days (one day before, the angina • blood disorder with a reduced day of and the day after your • some medicines called number of white blood cells infusion). These medicines are corticosteroids, such as very important. For prostate • hearing problems dexamethasone cancer, this is usually taken on • heart problems • medicines used to treat people the day of the infusion (12 hours, • high uric acid levels with epilepsy, such as 3 hours and 1 hour before your infusion). • kidney problems phenobarbitone • • test your blood to see how many • liver problems medicines used to treat or prevent HIV or Hepatitis C viral white blood cells you have. If infections, such as ritonavir, they are too low, your infusion Tell your doctor if you have an indinavir, nelfinavir and may be delayed. infection or high temperature. saquinavir. • test your blood for levels of liver Your doctor may decide to delay • medicines used to treat people enzymes. If these levels are high your treatment until the infection has with depression such as your doctor may reduce your dose gone. A mild illness, such as a cold, nefazodone or decide you should not have a docetaxel infusion at that time. is not usually a reason to delay These medicines may be affected by treatment. DBL Docetaxel, Concentrated Ask your doctor or pharmacist if Tell your doctor if you are Injection or may affect how well it you have any questions on these pregnant or plan to become works. You may need different medicines or tests. pregnant or are breast-feeding. amounts of your medicines, or you How much is given Your doctor can discuss with you the may need to take different medicines. risks and benefits involved. Your doctor and pharmacist have Your doctor will decide what dose more information on medicines to be you will receive. This depends on If you have not told your doctor your condition and other factors, careful with or avoid while taking about any of the above, tell such as your weight, kidney function this medicine. him/her before you start using and other chemotherapy medicines DBL Docetaxel, Concentrated you are being given. Injection. The usual dose of docetaxel is 75 to 100mg/m2 which is based on your Taking other medicines How DBL Docetaxel, 2 Concentrated body size (m ). Tell your doctor or pharmacist if you are taking any other Injection is given When docetaxel is given in medicines, including any that you combination with capecitabine Follow all directions given to you (another medicine used for the get without a prescription from by your doctor or pharmacist treatment of breast cancer) the usual your pharmacy, supermarket or carefully. dose of docetaxel is 75 mg/m2. health food shop. They may differ from the Some medicines and DBL Docetaxel, Docetaxel may be given alone or in information contained in this leaflet. Concentrated Injection may interfere combination with other drugs. with each other. These include: Docetaxel should only be administered by trained Several courses of docetaxel therapy • other medicines used to treat may be needed depending on your professionals, with appropriate cancer, radiation therapy or any response to treatment. handling, in a hospital or clinic other treatment which lowers environment. your immune system, including Additional treatment may not be repeated until your blood cell ciclosporin Before you are given your docetaxel infusion your doctor numbers return to acceptable levels • some medicines used to treat and any uncontrolled effects have should: bacterial infections, including been controlled. DBL™ DOCETAXEL CONCENTRATED INJECTION 2 check on your progress and detect be life threatening. In most cases, Ask your doctor if you want to know any unwanted side effects. fluid retention will go away within more about the dose of docetaxel you weeks or months after your receive. Tell any other doctors, dentists, treatments are completed. and pharmacists who treat you How it is given that you are taking this medicine. Things you must not do If you are about to be started on Do not use DBL Docetaxel, DBL Docetaxel, Concentrated any new medicine, tell your doctor, Concentrated Injection to treat any Injection is given as an infusion dentist or pharmacist that you are other complaints unless your (drip) into your veins, over 1 hour. having DBL Docetaxel, doctor tells you to. Concentrated Injection. How long it is given for If you plan to have surgery that Things to be careful of Docetaxel is given every 3 weeks. needs a general anaesthetic, tell Be careful driving or operating your doctor or dentist that you are machinery until you know how This is called one cycle of having docetaxel. DBL Docetaxel, Concentrated chemotherapy. Your doctor will Injection affects you. decide how many of these cycles you If you become pregnant while will need. having docetaxel, tell your doctor Docetaxel may cause dizziness, light- immediately. headedness, tiredness, drowsiness in If you are given too much some people. Make sure you know DBL Docetaxel, Concentrated how you react to docetaxel before (overdose) Injection can lower the number of you drive a car, operate machinery, white blood cells and platelets in As DBL Docetaxel, Concentrated or do anything else that could be Injection is given to you under the your blood. This means that you dangerous if you are dizzy or light- supervision of your doctor, it is have an increased chance of getting very unlikely that you will receive an infection or bleeding. headed. If this occurs do not drive. too much. However, if you If you drink alcohol, dizziness or experience any severe side effects The following precautions should light-headedness may be worse. after being given DBL Docetaxel, be taken to reduce your risk of Concentrated Injection, tell your infection or bleeding: doctor immediately or contact the • Avoid people who have National Poisons Centre (telephone infections. Check with your 0800 POISON or 0800 doctor immediately if you think Side effects 764 766) or go to Accident and you may be getting an infection, Emergency at the nearest hospital. or if you get a fever, chills, Tell your doctor or pharmacist as cough, hoarse throat, lower soon as possible if you do not feel back or side pain or find it You may need urgent medical well while you are taking DBL painful or difficult to urinate.
Recommended publications
  • Combination of Cabazitaxel and Plicamycin Induces Cell Death in Drug Resistant B-Cell Acute Lymphoblastic Leukemia
    Clinical and Translational Science Institute Centers 9-1-2018 Combination of cabazitaxel and plicamycin induces cell death in drug resistant B-cell acute lymphoblastic leukemia Rajesh R. Nair West Virginia University Debbie Piktel West Virginia University Werner J. Geldenhuys West Virginia University Laura F. Gibson West Virginia University Follow this and additional works at: https://researchrepository.wvu.edu/ctsi Part of the Medicine and Health Sciences Commons Digital Commons Citation Nair, Rajesh R.; Piktel, Debbie; Geldenhuys, Werner J.; and Gibson, Laura F., "Combination of cabazitaxel and plicamycin induces cell death in drug resistant B-cell acute lymphoblastic leukemia" (2018). Clinical and Translational Science Institute. 34. https://researchrepository.wvu.edu/ctsi/34 This Article is brought to you for free and open access by the Centers at The Research Repository @ WVU. It has been accepted for inclusion in Clinical and Translational Science Institute by an authorized administrator of The Research Repository @ WVU. For more information, please contact [email protected]. HHS Public Access Author manuscript Author ManuscriptAuthor Manuscript Author Leuk Res Manuscript Author . Author manuscript; Manuscript Author available in PMC 2019 September 01. Published in final edited form as: Leuk Res. 2018 September ; 72: 59–66. doi:10.1016/j.leukres.2018.08.002. Combination of cabazitaxel and plicamycin induces cell death in drug resistant B-cell acute lymphoblastic leukemia Rajesh R. Naira, Debbie Piktelb, Werner J. Geldenhuysc,
    [Show full text]
  • Identification of Inhibitors of Ovarian Cancer Stem-Like Cells by High-Throughput Screening Roman Mezencev, Lijuan Wang and John F Mcdonald*
    Mezencev et al. Journal of Ovarian Research 2012, 5:30 http://www.ovarianresearch.com/content/5/1/30 RESEARCH Open Access Identification of inhibitors of ovarian cancer stem-like cells by high-throughput screening Roman Mezencev, Lijuan Wang and John F McDonald* Abstract Background: Ovarian cancer stem cells are characterized by self-renewal capacity, ability to differentiate into distinct lineages, as well as higher invasiveness and resistance to many anticancer agents. Since they may be responsible for the recurrence of ovarian cancer after initial response to chemotherapy, development of new therapies targeting this special cellular subpopulation embedded within bulk ovarian cancers is warranted. Methods: A high-throughput screening (HTS) campaign was performed with 825 compounds from the Mechanistic Set chemical library [Developmental Therapeutics Program (DTP)/National Cancer Institute (NCI)] against ovarian cancer stem-like cells (CSC) using a resazurin-based cell cytotoxicity assay. Identified sets of active compounds were projected onto self-organizing maps to identify their putative cellular response groups. Results: From 793 screening compounds with evaluable data, 158 were found to have significant inhibitory effects on ovarian CSC. Computational analysis indicates that the majority of these compounds are associated with mitotic cellular responses. Conclusions: Our HTS has uncovered a number of candidate compounds that may, after further testing, prove effective in targeting both ovarian CSC and their more differentiated progeny. Keywords: High-throughput screening, Ovarian cancer, Cancer stem cells Background alternative strategies. One approach has been to evaluate Ovarian cancer is the most lethal of gynecological can- molecules known to be inhibitory against pathways cers [1] despite its typically high initial response rate to believed to be deregulated in CSC (e.g., the Hedgehog, chemotherapy [2].
    [Show full text]
  • Prevalence and Safety of Off-Label Use of Chemotherapeutic Agents in Older Patients with Breast Cancer: Estimates from SEER-Medicare Data
    Supplemental online content for: Prevalence and Safety of Off-Label Use of Chemotherapeutic Agents in Older Patients With Breast Cancer: Estimates From SEER-Medicare Data Anne A. Eaton, MS; Camelia S. Sima, MD, MS; and Katherine S. Panageas, DrPH J Natl Compr Canc Netw 2016;14(1):57–65 • eAppendix 1: J-Codes Representing Intravenous Chemotherapy • eAppendix 2: Established Sequential Adjuvant Chemotherapy Regimens for Breast Cancer • eTable 1: Patient Characteristics © JNCCN—Journal of the National Comprehensive Cancer Network | Volume 14 Number 1 | January 2016 Eaton et al - 1 eAppendix 1: J-Codes Representing Intravenous Chemotherapy J-Code Agent J-Code Agent J9000 Injection, doxorubicin HCl, 10 mg J9165 Injection, diethylstilbestrol diphosphate, 250 J9001 Injection, doxorubicin HCl, all lipid mg formulations, 10 mg J9170 Injection, docetaxel, 20 mg J9010 Injection, alemtuzumab, 10 mg J9171 Injection, docetaxel, 1 mg J9015 Injection, aldesleukin, per single use vial J9175 Injection, Elliotts’ B solution, 1 ml J9017 Injection, arsenic trioxide, 1 mg J9178 Injection, epirubicin HCl, 2 mg J9020 Injection, asparaginase, 10,000 units J9179 Injection, eribulin mesylate, 0.1 mg J9025 Injection, azacitidine, 1 mg J9180 Epirubicin HCl, 50 mg J9027 Injection, clofarabine, 1 mg J9181 Injection, etoposide, 10 mg J9031 BCG (intravesical) per instillation J9182 Etoposide, 100 mg J9033 Injection, bendamustine HCl, 1 mg J9185 Injection, fludarabine phosphate, 50 mg J9035 Injection, bevacizumab, 10 mg J9190 Injection, fluorouracil, 500 mg J9040 Injection,
    [Show full text]
  • Chemotherapy and Polyneuropathies Grisold W, Oberndorfer S Windebank AJ European Association of Neurooncology Magazine 2012; 2 (1) 25-36
    Volume 2 (2012) // Issue 1 // e-ISSN 2224-3453 Neurology · Neurosurgery · Medical Oncology · Radiotherapy · Paediatric Neuro- oncology · Neuropathology · Neuroradiology · Neuroimaging · Nursing · Patient Issues Chemotherapy and Polyneuropathies Grisold W, Oberndorfer S Windebank AJ European Association of NeuroOncology Magazine 2012; 2 (1) 25-36 Homepage: www.kup.at/ journals/eano/index.html OnlineOnline DatabaseDatabase FeaturingFeaturing Author,Author, KeyKey WordWord andand Full-TextFull-Text SearchSearch THE EUROPEAN ASSOCIATION OF NEUROONCOLOGY Member of the Chemotherapy and Polyneuropathies Chemotherapy and Polyneuropathies Wolfgang Grisold1, Stefan Oberndorfer2, Anthony J Windebank3 Abstract: Peripheral neuropathies induced by taxanes) immediate effects can appear, caused to be caused by chemotherapy or other mecha- chemotherapy (CIPN) are an increasingly frequent by different mechanisms. The substances that nisms, whether treatment needs to be modified problem. Contrary to haematologic side effects, most frequently cause CIPN are vinca alkaloids, or stopped due to CIPN, and what symptomatic which can be treated with haematopoetic taxanes, platin derivates, bortezomib, and tha- treatment should be recommended. growth factors, neither prophylaxis nor specific lidomide. Little is known about synergistic neu- Possible new approaches for the management treatment is available, and only symptomatic rotoxicity caused by previously given chemo- of CIPN could be genetic susceptibility, as there treatment can be offered. therapies, or concomitant chemotherapies. The are some promising advances with vinca alka- CIPN are predominantly sensory, duration-of- role of pre-existent neuropathies on the develop- loids and taxanes. Eur Assoc Neurooncol Mag treatment-dependent neuropathies, which de- ment of a CIPN is generally assumed, but not 2012; 2 (1): 25–36. velop after a typical cumulative dose. Rarely mo- clear.
    [Show full text]
  • Chemotherapy Protocol
    Chemotherapy Protocol BREAST CANCER CYCLOPHOSPHAMIDE-DOCETAXEL-DOXORUBICIN (TAC) Regimen Breast Cancer – Cyclophosphamide-Docetaxel-Doxorubicin (TAC) Indication Adjuvant therapy for node positive early breast cancer WHO Performance status 0, 1, 2 Toxicity Drug Adverse Effect Cyclophosphamide Dysuria, haemorrhagic cystitis, taste disturbances Hypersensitivity, fluid retention, neuropathy, joint pains, nail Docetaxel changes, fatigue Doxorubicin Cardio toxicity, urinary discolourisation (red) The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Regimen FBC, U&E’s and LFT’s prior to each cycle. Ensure adequate cardiac function before starting treatment. Baseline LVEF should be measured, particularly in patients with a history of cardiac problems or in the elderly. Dose Modifications The dose modifications listed are for haematological, liver and renal function only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be re- escalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. Version 1.1 (Aug 2014) Page 1 of 8 Breast – Cyclophosphamide-Docetaxel-Doxorubicin (TAC) Please discuss all dose reductions / delays with the relevant consultant before prescribing if appropriate. The approach may be different depending on the clinical circumstances. The following is a general guide only. Haematological Prior to prescribing the following treatment criteria must be met on day one of treatment. Criteria Eligible Level Neutrophil equal to or more than 1x109/L Platelets equal to or more than 100x109/L Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL If counts on day one are below these criteria for neutrophils and/or platelets then delay treatment for seven days.
    [Show full text]
  • Docetaxel and Cyclophosphamide Chemotherapy Guide
    Docetaxel and cyclophosphamide chemotherapy guide For patients with breast cancer 1 Table of Contents What is chemotherapy? ..................................... 4 What should I discuss with my doctor before starting chemotherapy ....................................... 5 What are docetaxel and cyclophosphamide? ..... 9 How should I prepare for treatment? .................. 9 What can I expect during my treatment? .......... 10 What are the common side effects of docetaxel and cyclophosphamide treatment? .................. 12 How do I manage common side effects? ......... 13 Where can I get support? ................................. 32 2 Your health care team Oncologist: _______________________________ Pharmacist: _______________________________ Nurse: _______________________________ Dietitian: _______________________________ Social worker: ___________________________________ Medical Day Care: 416-864-5222 2 Donnelly Nursing Unit: 416-864-5099 3 What is chemotherapy? Chemotherapy is a type of treatment for cancer. Chemotherapy can be a single drug or it can be a few types of drugs at the same time. When used alone or along with surgery or radiation therapy, chemotherapy can often shrink a tumour or prevent its spread. How does it work? Chemotherapy kills cells that grow quickly. This is why it kills cancer cells. But it also affects healthy cells that grow fast. This includes cells in the mouth and stomach lining, bone marrow, skin and hair. This is why patients having chemotherapy treatment get side effects such as hair loss, nausea and low blood cell counts. As a rule, chemotherapy is given in cycles of treatment. There is a time of no treatment between cycles. This lets normal cells recover before the next cycle begins. 4 What should I discuss with my doctor before starting chemotherapy? Your health history • Tell your oncologist about any other health problems you have or had.
    [Show full text]
  • CYTOTOXIC and NON-CYTOTOXIC HAZARDOUS MEDICATIONS
    CYTOTOXIC and NON-CYTOTOXIC HAZARDOUS MEDICATIONS1 CYTOTOXIC HAZARDOUS MEDICATIONS NON-CYTOTOXIC HAZARDOUS MEDICATIONS Altretamine IDArubicin Acitretin Iloprost Amsacrine Ifosfamide Aldesleukin Imatinib 3 Arsenic Irinotecan Alitretinoin Interferons Asparaginase Lenalidomide Anastrazole 3 ISOtretinoin azaCITIDine Lomustine Ambrisentan Leflunomide 3 azaTHIOprine 3 Mechlorethamine Bacillus Calmette Guerin 2 Letrozole 3 Bleomycin Melphalan (bladder instillation only) Leuprolide Bortezomib Mercaptopurine Bexarotene Megestrol 3 Busulfan 3 Methotrexate Bicalutamide 3 Methacholine Capecitabine 3 MitoMYcin Bosentan MethylTESTOSTERone CARBOplatin MitoXANtrone Buserelin Mifepristone Carmustine Nelarabine Cetrorelix Misoprostol Chlorambucil Oxaliplatin Choriogonadotropin alfa Mitotane CISplatin PACLitaxel Cidofovir Mycophenolate mofetil Cladribine Pegasparaginase ClomiPHENE Nafarelin Clofarabine PEMEtrexed Colchicine 3 Nilutamide 3 Cyclophosphamide Pentostatin cycloSPORINE Oxandrolone 3 Cytarabine Procarbazine3 Cyproterone Pentamidine (Aerosol only) Dacarbazine Raltitrexed Dienestrol Podofilox DACTINomycin SORAfenib Dinoprostone 3 Podophyllum resin DAUNOrubicin Streptozocin Dutasteride Raloxifene 3 Dexrazoxane SUNItinib Erlotinib 3 Ribavirin DOCEtaxel Temozolomide Everolimus Sirolimus DOXOrubicin Temsirolimus Exemestane 3 Tacrolimus Epirubicin Teniposide Finasteride 3 Tamoxifen 3 Estramustine Thalidomide Fluoxymesterone 3 Testosterone Etoposide Thioguanine Flutamide 3 Tretinoin Floxuridine Thiotepa Foscarnet Trifluridine Flucytosine Topotecan Fulvestrant
    [Show full text]
  • TAXOTERE (DOCETAXEL) ) MDL No. 16-2740 PRODUCTS LIABILITY ) LITIGATION ) SECTION: “H” (5) ) This Document Relates To: ) Elizabeth Kahn, 16-17039 )
    Case 2:16-md-02740-JTM-MBN Document 11682 Filed 12/18/20 Page 1 of 23 UNITED STATES DISTRICT COURT EASTERN DISTRICT OF LOUISIANA IN RE: TAXOTERE (DOCETAXEL) ) MDL No. 16-2740 PRODUCTS LIABILITY ) LITIGATION ) SECTION: “H” (5) ) This document relates to: ) Elizabeth Kahn, 16-17039 ) ORDER AND REASONS Before the Court is a Motion for Summary Judgment Based on Preemption (Doc. 11020). The Court held oral argument on the Motion on October 7, 2020. For the following reasons, the Motion is GRANTED IN PART and DENIED IN PART. BACKGROUND Plaintiffs in this multidistrict litigation (“MDL”) are suing several pharmaceutical companies that manufactured and/or distributed a chemotherapy drug, Taxotere or docetaxel,1 that Plaintiffs were administered for the treatment of breast cancer or other forms of cancer. Among these companies are Defendants sanofi-aventis U.S. LLC and Sanofi U.S. Services Inc. (collectively, “Sanofi” or “Defendants”). Plaintiffs allege that the drug caused permanent alopecia—in other words, permanent hair loss. Plaintiffs bring claims of failure to warn, negligent misrepresentation, fraudulent misrepresentation, and more. The first bellwether trial was held in September 2019, and the second trial is set for 2021.2 1 Docetaxel is the generic version of Taxotere. 2 The second trial was continued due to the COVID-19 pandemic. Case 2:16-md-02740-JTM-MBN Document 11682 Filed 12/18/20 Page 2 of 23 Plaintiff Elizabeth Kahn, the second bellwether plaintiff, completed her Taxotere treatment in July 2008. In the instant Motion, Defendants move for summary judgment on the affirmative defense of preemption.
    [Show full text]
  • HIGHLIGHTS of PRESCRIBING INFORMATION These Highlights Do Not Include All the Information Needed to Use DOCETAXEL Safely And
    HIGHLIGHTS OF PRESCRIBING INFORMATION • HRPC: 75 mg/m2 with 5 mg prednisone twice a day continuously (2.3) • GC: 75 mg/m2 followed by cisplatin 75 mg/m2 (both on day 1 only) followed by fluorouracil 750 These highlights do not include all the information needed to use DOCETAXEL safely and 2 effectively. See full prescribing information for DOCETAXEL. mg/m per day as a 24-hr IV (days 1–5), starting at end of cisplatin infusion (2.4) • SCCHN: 75 mg/m2 followed by cisplatin 75 mg/m2 IV (day 1), followed by fluorouracil 750 DOCETAXEL injection, for intravenous use mg/m2 per day as a 24-hr IV (days 1–5), starting at end of cisplatin infusion; for 4 cycles (2.5) Initial U.S. Approval: 1996 • SCCHN: 75 mg/m2 followed by cisplatin 100 mg/m2 IV (day 1), followed by fluorouracil 1000 mg/m2 per day as a 24-hr IV (days 1–4); for 3 cycles (2.5) For all patients: • Premedicate with oral corticosteroids (2.6) WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY • Adjust dose as needed (2.7) REACTIONS, and FLUID RETENTION See full prescribing information for complete boxed warning. ———————————— DOSAGE FORMS AND STRENGTHS ———————————— • Treatment-related mortality increases with abnormal liver function, at higher doses, • Injection: One-vial Docetaxel: Single-dose vials 20 mg/mL, 80 mg/4 mL and 160 mg/8 mL (3) and in patients with NSCLC and prior platinum-based therapy receiving Docetaxel at 100 mg/m2 (5.1) ——————————————— CONTRAINDICATIONS ——————————————— • Hypersensitivity to docetaxel or polysorbate 80 (4) • Avoid use of Docetaxel if bilirubin > ULN, or if AST and/or ALT >1.5 × ULN 3 concomitant with alkaline phosphatase >2.5 × ULN.
    [Show full text]
  • Cancer Drug Counselling: a Guide for Pharmacists
    CANCER DRUG COUNSELLING: A GUIDE FOR PHARMACISTS CANCER DRUG COUNSELLING A Guide for Pharmacists 1st Edition, 2017 Pharmaceutical Services Division Ministry of Health, Malaysia Pharmaceutical Services Division, Ministry of Health Malaysia 1 DISCLAIMER This guide would serve as a handy reference for PHARMACIST ONLY and not as a complete drug information resource. It is NOT intended to replicate or replace the knowledge, skills and experience of trained oncology health professionals, nor is it a substitute for clinical judgement and advice. The nature of healthcare/drug information is that it is constantly evolving with ongoing research and clinical experience and is often subject to interpretation. While best effort has been made to ensure the accuracy of the information and recommendation presented, reader is advised that the contributors, editors, reviewers and publishers cannot be responsible for the continued updates of the information, of any errors or/and of any consequences arising from its application. ALL RIGHTS RESERVED This is a publication of the Pharmaceutical Services Division, Ministry of Health Malaysia (MOH). Enquiries are to be directed to the address below. Permission is hereby granted to reproduce information contained herein provided that such reproduction be given due acknowledgement and shall not modify the text. Pharmaceutical Services Division Ministry of Health Malaysia Lot 36, Jalan Universiti 46350 Petaling Jaya Selangor, Malaysia Tel: 603 - 7841 3200 Fax 603 - 7968 2222 Website: www.pharmacy.gov.my 2 Pharmaceutical Services Division, Ministry of Health Malaysia PREFACE Providing pharmaceutical care to patients through education and counselling can contribute towards enhancing patients’ adherence to cancer drug therapy as well as to reduce medication related problems.
    [Show full text]
  • Cancer Drug Costs for a Month of Treatment at Initial Food
    Cancer drug costs for a month of treatment at initial Food and Drug Administration approval Year of FDA Monthly Cost Monthly cost (2013 Generic name Brand name(s) approval (actual $'s) $'s) Vinblastine Velban 1965 $78 $575 Thioguanine, 6-TG Thioguanine Tabloid 1966 $17 $122 Hydroxyurea Hydrea 1967 $14 $97 Cytarabine Cytosar-U, Tarabine PFS 1969 $13 $82 Procarbazine Matulane 1969 $2 $13 Testolactone Teslac 1969 $179 $1,136 Mitotane Lysodren 1970 $134 $801 Plicamycin Mithracin 1970 $50 $299 Mitomycin C Mutamycin 1974 $5 $22 Dacarbazine DTIC-Dome 1975 $29 $125 Lomustine CeeNU 1976 $10 $41 Carmustine BiCNU, BCNU 1977 $33 $127 Tamoxifen citrate Nolvadex 1977 $44 $167 Cisplatin Platinol 1978 $125 $445 Estramustine Emcyt 1981 $420 $1,074 Streptozocin Zanosar 1982 $61 $147 Etoposide, VP-16 Vepesid 1983 $181 $422 Interferon alfa 2a Roferon A 1986 $742 $1,573 Daunorubicin, Daunomycin Cerubidine 1987 $533 $1,090 Doxorubicin Adriamycin 1987 $521 $1,066 Mitoxantrone Novantrone 1987 $477 $976 Ifosfamide IFEX 1988 $1,667 $3,274 Flutamide Eulexin 1989 $213 $399 Altretamine Hexalen 1990 $341 $606 Idarubicin Idamycin 1990 $227 $404 Levamisole Ergamisol 1990 $105 $187 Carboplatin Paraplatin 1991 $860 $1,467 Fludarabine phosphate Fludara 1991 $662 $1,129 Pamidronate Aredia 1991 $507 $865 Pentostatin Nipent 1991 $1,767 $3,015 Aldesleukin Proleukin 1992 $13,503 $22,364 Melphalan Alkeran 1992 $35 $58 Cladribine Leustatin, 2-CdA 1993 $764 $1,229 Asparaginase Elspar 1994 $694 $1,088 Paclitaxel Taxol 1994 $2,614 $4,099 Pegaspargase Oncaspar 1994 $3,006 $4,713
    [Show full text]
  • About Ewing Tumors What Is the Ewing Family of Tumors?
    cancer.org | 1.800.227.2345 About Ewing Tumors Overview and Types If you or your child have just been diagnosed with a Ewing tumor or are worried about it, you likely have a lot of questions. Learning some basics is a good place to start. ● What Is the Ewing Family of Tumors? Research and Statistics See the latest estimates for new cases of Ewing tumors in the US and what research is currently being done. ● Key Statistics for Ewing Tumors ● What’s New in Ewing Tumor Research and Treatment? What Is the Ewing Family of Tumors? Cancer starts when cells in the body begin to grow out of control. Cells in nearly any part of the body can become cancer, and can then spread to other areas of the body. To learn more about cancer and how it starts and spreads, see What Is Cancer?1 Ewing tumors (also known as Ewing sarcomas) are a group of cancers that start in the bones or nearby soft tissues and share some common features. These tumors can develop in people of any age, but they are most common in older children and teens. 1 ____________________________________________________________________________________American Cancer Society cancer.org | 1.800.227.2345 For information about the differences between childhood cancers and adult cancers, see Cancer in Children2. The main types of Ewing tumors are: ● Ewing sarcoma of bone: Ewing sarcoma that starts in a bone is the most common tumor in this family. This type of tumor was first described by Dr. James Ewing in 1921, who found it was different from the more common bone tumor, osteosarcoma3.
    [Show full text]