6. Radiation Recall

Total Page:16

File Type:pdf, Size:1020Kb

6. Radiation Recall Medical Journal of Zambia, Vol. 38, No. 1 (2011) CASE REPORT Radiation Recall; A Paediatric Case Report From University Teaching Hospital, Lusaka Caroline Allfrey¹, Cansu Mamurekli¹, Anjali Menon¹, Pauline Sambo², Kennedy Lishimpi³ ¹Foundation Year 2 Doctors, United Kingdom ² University Teaching Hospital, Lusaka, Zambia ³ Cancer Disease Hospital, Lusaka, Zambia ABSTRACT cause it (see table 1), the most common being the cytotoxic antibiotics (dactinomycin, doxorubicin, daunorubicin, and bleomycin), the taxanes Radiation Recall Dermatitis (RRD) is an acute 1 inflammatory reaction that develops within an area (paclitaxel. docetaxel), and methotrexate . Due to of previous irradiation, occurring after limited evidence and lack of knowledge regarding administering a chemotherapeutic agent. We present aetiology it is not possible to determine which the case of a 3-year-old Zambian girl with a patients will react to which drugs. 'There are no nephroblastoma who developed radiation recall identifiable characteristics of drugs, that cause after the administration of dactinomycin, radiation recall, and thus it must be kept in mind with the use of any drug after radiotherapy including new doxorubicin and vincristine. Our case attempts to 4 highlight the importance of this rare condition. drug classes' Given that radiotherapy and chemotherapy have such a close relationship in a multitude of cancers we Table 1 feel it increasingly important to further understand this phenomenon and specifically its associations Drugs Causing Radiation Recall Dermatitis Drug with certain drugs and susceptible individuals. To 5-fluoro uracil Hydroxycarbamide the best of our knowledge this is the first Bleomycin Hydroxyurea documented paediatric case of radiation recall from Cytarabine Interferon-á-2b Zambia. Cyclophosphamid e Lomustine Dacarbazine Melphalan BACKGROUND Dactinomycin Mercaptopurine Daunarubicin Me thotrexate Doxorubicin Oxaliplatin Radiation recall dermatitis was first described in Edatrexate Paclitaxel 3 1958 when it was observed with dactinomycin . As Etoposide Tamoxifen most information comes from case reports Gemcitabine pertaining to adults, it is not possible to determine the true incidence or prevalence The three manifestations of radiation recall are: The most frequent site of RRD is the skin but other 1. A mild reaction consisting of erythema, reported involved organs include mucous oedema and dry desquamation membranes, lungs, oesophagus, gastrointestinal 2. A moderate reaction with moist 1 desquamation, vesiculation, blister tract, central nervous system, bladder, and heart . A formation and erosion number of different drugs have been identified to 3. Severe necrotic ulcerative reactions that 1 Corresponding Author could result in skin hypopigmentation Anjali Menon Foundation Year 2 Doctors, United Kingdom Key Words: Radiation Recall Dermatitis, Doxorubicin, Email: [email protected] Dactinomycin 28 Medical Journal of Zambia, Vol. 38, No. 1 (2011) It has been proposed that the more-severe skin On day eight there was a significant turning point; an reactions, occur more frequently when the period erythematous patch of dry desquamation on the right between radiation and the recall-triggering drug is side of the back was noted correlating with the site of shorter 2. Our patient presented thirty days post radiation. The patient was treated symptomatically radiation and eight days post chemotherapy. with oral steroids and antihistamines. After However radiation recall dermatitis may present consulting the radio-oncologist, a working with a latency period of months to years 3. diagnosis of radiation recall was reached. This was largely due to the specific location (within the irradiated area), timing (after chemotherapy) and CASE PRESENTATION presentation (absence of any other cause or pre- existing skin pathology) of the dermatitis in this A three year old Zambian girl with no significant case. The patch of dry desquamation failed to past medical history and from an affluent respond to treatment and rapidly transformed into an background, presented in April 2011 to the area of ulcerative necrotic tissue. paediatric department at the University Teaching Hospital, Lusaka. She had a ten day history of a right Over the course of the next few weeks, her clinical sided abdominal mass, on a background of reduced state decompensated. She developed overwhelming appetite and non specific weight loss. Ultrasound sepsis secondary to immunosuppression induced by confirmed the presence of a capsulated abdominal chemotherapy and radiotherapy. It was thought by mass and a prompt subsequent intravenous the medical team that the area of necrosis was a pyelogram indicated a large right-sided hyperdense possible contributing factor to her sepsis. lesion, approximately 12.5 x 10cm with some mass effect. Unfortunately due to a combination of immunosuppression, sepsis and hepatorenal failure She went on to have an Magnetic Resonance the patient died six months after her initial Imaging (MRI), to establish the aetiology of the presentation. mass. A subsequent Vanillyl Mandelic Acid (VMA) test diagnosed a nephroblastoma, which was later DIFFERENTIAL DIAGNOSIS confirmed histologically. The nephroblastoma chemotherapy protocol was swiftly commenced, ten Radiation recall dermatitis could show clinical days after initial presentation. This consisted of: findings similar to those of acute radiation induced dactinomycin, vincristine and doxyrubicin. She dermatitis 1. tolerated this well and after six cycles a repeat MRI concluded that the mass had reduced in size. A Areas of skin irritation or infection can also become successful right nephrectomy was undertaken six further inflamed during the administration of a weeks after initial presentation. chemotherapeutic agent thereby making it difficult to differentiate between radiation recall dermatitis There were no post operative complications and and acute radiation induced dermatitis, which is three weeks later she was re-commenced on 1 related directly to radiotherapy . chemotherapy solely in the form of vincristine. After a total of ten cycles of chemotherapy, radiotherapy In our case, the initial medical report indicates that was commenced and finished three weeks later. The the patient had no skin abnormalities prior to subsequent second phase of chemotherapy began commencing radiotherapy. She presented with with the re-administration of all three original features of a mild radiation enhancement reaction, cytotoxic agents. crucially eight days post adjuvant chemotherapy. Both the location of the dermatitis and the natural Three days later she presented with fever, reduced history of when it occurred is in keeping with a appetite and drowsiness. Broad spectrum antibiotics diagnosis of radiation recall. were administered as a precautionary measure. Despite this, her clinical state was such that Camidge and Price have further defined the clinical chemotherapy was able to continue. entity and have made a clear separation between 29 Medical Journal of Zambia, Vol. 38, No. 1 (2011) radiation induced dermatitis and radiation recall administration of TAC chemotherapy, the irradiated dermatitis. They suggest designating any reaction skin started to show an erythema with a purplish occurring within seven days after administration of aspect. Since the indication of adjuvant drugs as sensitisation and not as radiation recall chemotherapy was considered to be crucial, she was dermatitis 2. In our case the interval was eight days encouraged to continue without doxorubicin. On post chemotherapy and thirty days post day 22 the second chemotherapy course was radiotherapy. This can, by the above definition, be administered consisting of TC and the skin reaction called radiation recall dermatitis. Although the did not re-occur. Subsequent courses could be interval of eight days can be considered relatively administered without reappearance of the recall 5 short, much longer intervals of up to 25 years have phenomena . been described 6. Despite the fact that the first documented case of TREATMENT radiation recall involved dactinomycin we were unable to find any current evidence to support how There are no proven interventions to relieve strong this link is. The same can be said with regards symptoms or to enhance recuperation. Once the to vincristine. radiation recall dermatitis has occurred almost all reports advice to discontinue the triggering drug 2. It is difficult to appreciate the total contribution that However, a re-challenge does not always result in the radiation recall dermatitis made in the days 2 leading up to this patient's death. It was clear that the occurrence of the skin reactions . severe sepsis was the major contributing factor to mortality. However, we were unable to establish the DISCUSSION exact site of this or a specific causative organism. We believe however that regardless of its direct role Dactinomycin and doxorubicin were the most likely in this patient's mortality, the diagnosis of radiation agents to have caused the radiation recall in our case recall should not be underplayed. 5. From literature that was reviewed we found no other reported cases involving dactinomycin, CONCLUSION doxorubicin and vincristine in the same treatment regime causing radiation recall. Most reports of In Zambia, dactinomycin, doxorubicin and radiation recall are in response to administration of a vincristine are commonly used in the treatment of single chemotherapeutic agent. However, there is no nephroblastoma.
Recommended publications
  • Targeting Fibrosis in the Duchenne Muscular Dystrophy Mice Model: an Uphill Battle
    bioRxiv preprint doi: https://doi.org/10.1101/2021.01.20.427485; this version posted January 21, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder. All rights reserved. No reuse allowed without permission. 1 Title: Targeting fibrosis in the Duchenne Muscular Dystrophy mice model: an uphill battle 2 Marine Theret1#, Marcela Low1#, Lucas Rempel1, Fang Fang Li1, Lin Wei Tung1, Osvaldo 3 Contreras3,4, Chih-Kai Chang1, Andrew Wu1, Hesham Soliman1,2, Fabio M.V. Rossi1 4 1School of Biomedical Engineering and the Biomedical Research Centre, Department of Medical 5 Genetics, 2222 Health Sciences Mall, Vancouver, BC, V6T 1Z3, Canada 6 2Department of Pharmacology and Toxicology, Faculty of Pharmaceutical Sciences, Minia 7 University, Minia, Egypt 8 3Developmental and Stem Cell Biology Division, Victor Chang Cardiac Research Institute, 9 Darlinghurst, NSW, 2010, Australia 10 4Departamento de Biología Celular y Molecular and Center for Aging and Regeneration (CARE- 11 ChileUC), Facultad de Ciencias Biológicas, Pontificia Universidad Católica de Chile, 8331150 12 Santiago, Chile 13 # Denotes Co-first authorship 14 15 Keywords: drug screening, fibro/adipogenic progenitors, fibrosis, repair, skeletal muscle. 16 Correspondence to: 17 Marine Theret 18 School of Biomedical Engineering and the Biomedical Research Centre 19 University of British Columbia 20 2222 Health Sciences Mall, Vancouver, British Columbia 21 Tel: +1(604) 822 0441 fax: +1(604) 822 7815 22 Email: [email protected] 1 bioRxiv preprint doi: https://doi.org/10.1101/2021.01.20.427485; this version posted January 21, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder.
    [Show full text]
  • Novartis R&D and Investor Update
    Novartis AG Investor Relations Novartis R&D and investor update November 5, 2018 Disclaimer This presentation contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, that can generally be identified by words such as “potential,” “expected,” “will,” “planned,” “pipeline,” “outlook,” “agreement to acquire,” or similar expressions, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this presentation, or regarding potential future revenues from such products, or regarding the proposed acquisition of Endocyte, Inc. (Endocyte) by Novartis including the potential outcome and expected timing for completion of the proposed acquisition, and the potential impact on Novartis of the proposed acquisition, including express or implied discussions regarding potential future sales or earnings of Novartis, and any potential strategic benefits, synergies or opportunities expected as a result of the proposed acquisition. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this presentation will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future.
    [Show full text]
  • Anticancer Drug Discovery from Microbial Sources: the Unique Mangrove Streptomycetes
    molecules Review Anticancer Drug Discovery from Microbial Sources: The Unique Mangrove Streptomycetes Jodi Woan-Fei Law 1, Lydia Ngiik-Shiew Law 2, Vengadesh Letchumanan 1 , Loh Teng-Hern Tan 1, Sunny Hei Wong 3, Kok-Gan Chan 4,5,* , Nurul-Syakima Ab Mutalib 6,* and Learn-Han Lee 1,* 1 Novel Bacteria and Drug Discovery (NBDD) Research Group, Microbiome and Bioresource Research Strength, Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, Bandar Sunway 47500, Selangor Darul Ehsan, Malaysia; [email protected] (J.W.-F.L.); [email protected] (V.L.); [email protected] (L.T.-H.T.) 2 Monash Credentialed Pharmacy Clinical Educator, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, 381 Royal Parade, Parkville 3052, VIC, Australia; [email protected] 3 Li Ka Shing Institute of Health Sciences, Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Shatin, Hong Kong, China; [email protected] 4 Division of Genetics and Molecular Biology, Institute of Biological Sciences, Faculty of Science, University of Malaya, Kuala Lumpur 50603, Malaysia 5 International Genome Centre, Jiangsu University, Zhenjiang 212013, China 6 UKM Medical Molecular Biology Institute (UMBI), UKM Medical Centre, Universiti Kebangsaan Malaysia, Kuala Lumpur 56000, Malaysia * Correspondence: [email protected] (K.-G.C.); [email protected] (N.-S.A.M.); [email protected] (L.-H.L.) Academic Editor: Owen M. McDougal Received: 8 October 2020; Accepted: 13 November 2020; Published: 17 November 2020 Abstract: Worldwide cancer incidence and mortality have always been a concern to the community. The cancer mortality rate has generally declined over the years; however, there is still an increased mortality rate in poorer countries that receives considerable attention from healthcare professionals.
    [Show full text]
  • Nurse-Led Drug Monitoring Clinic Protocol for the Use of Systemic Therapies in Dermatology for Patients
    Group arrangements: Salford Royal NHS Foundation Trust (SRFT) Pennine Acute Hospitals NHS Trust (PAT) Nurse-led drug monitoring clinic protocol for the use of systemic therapies in dermatology for patients with inflammatory dermatoses Lead Author: Dawn Lavery Dermatology Advanced Nurse Practitioner Additional author(s) N/A Division/ Department:: Dermatology, Clinical Support and Tertiary Medicine Applies to: (Please delete) Salford Royal Care Organisation Approving Committee Dermatology clinical governance committee Salford Royal Date approved: 13 February 2019 Expiry date: February 2022 Contents Contents Section Page Document summary sheet 1 Overview 2 2 Scope & Associated Documents 2 3 Background 3 4 What is new in this version? 3 5 Policy 4 Drugs monitored by nurses 4 Acitretin 7 Alitretinoin Toctino 11 Apremilast 22 Azathioprine 26 Ciclosporin 29 Dapsone 34 Fumaric Acid Esters – Fumaderm and Skilarence 36 Hydroxycarbamide 39 Hydroxychloroquine 43 Methotrexate 50 Mycophenolate moefetil 57 Nurse-led drug monitoring clinic protocol for the use of systemic therapies in dermatology for patients with inflammatory dermatoses Reference Number GSCDerm01(13) Version 3 Issue Date: 11/06/2019 Page 1 of 77 It is your responsibility to check on the intranet that this printed copy is the latest version Standards 67 6 Roles and responsibilities 67 7 Monitoring document effectiveness 67 8 Abbreviations and definitions 68 9 References 68 10 Appendices N/A 11 Document Control Information 71 12 Equality Impact Assessment (EqIA) screening tool 73 Group arrangements: Salford Royal NHS Foundation Trust (SRFT) Pennine Acute Hospitals NHS Trust (PAT) 1. Overview (What is this policy about?) The dermatology directorate specialist nurses are responsible for ensuring prescribing and monitoring for patients under their care, is in accordance with this protocol.
    [Show full text]
  • Cytostatics As Hazardous Chemicals in Healthcare
    REVIEW PAPER International Journal of Occupational Medicine and Environmental Health 2019;32(2):141 – 159 https://doi.org/10.13075/ijomeh.1896.01248 CYTOSTATICS AS HAZARDOUS CHEMICALS IN HEALTHCARE WORKERS’ ENVIRONMENT ANNA PAŁASZEWSKA-TKACZ, SŁAWOMIR CZERCZAK, KATARZYNA KONIECZKO, and MAŁGORZATA KUPCZEWSKA-DOBECKA Nofer Institute of Occupational Medicine, Łódź, Poland Department of Chemical Safety Abstract Cytostatics not only induce significant side-effects in patients treated oncologically but also pose a threat to the health of occupationally exposed healthcare workers: pharmacists, physicians, nurses and other personnel. Since the 1970s numerous reports from various countries have documented the contamination of working areas with cytostatics and the presence of drugs/metabolites in the urine or blood of healthcare employees, which di- rectly indicates the occurrence of occupational exposure to these drugs. In Poland the significant scale of occupational exposure to cytostatics is also confirmed by the data collected in the central register of occupational carcinogens/mutagens kept by the Nofer Institute of Occupational Medicine. The assessment of occupational exposure to cytostatics and health risks constitutes employers’ obligation. Unfortunately, the assessment of occu- pational risk resulting from exposure to cytostatics raises a number of concerns. Provisions governing the problem of workers’ health protection are not unequivocal because they derive from a variety of law areas, especially in a matter of hazard classification and safety data sheets for cytostatics. Moreover, no legally binding occupational exposure limits have been set for cytostatics or their active compounds, and analytical methods for these substances airborne and biological concentrations are lacking. Consequently, the correct assessment of occupational exposure to cytostatics, the eval- uation of health hazards and the development of the proper preventive strategy appear difficult.
    [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]
  • Investor Presentation
    Participants Company overview Pharmaceuticals Oncology Financial review Conclusion Appendix References Q1 2021 Results Investor presentation 1 Investor Relations │ Q1 2021 Results Participants Company overview Pharmaceuticals Oncology Financial review Conclusion Appendix References Disclaimer This presentation contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, that can generally be identified by words such as “potential,” “expected,” “will,” “planned,” “pipeline,” “outlook,” or similar expressions, or by express or implied discussions regarding potential new products, potential new indications for existing products, potential product launches, or regarding potential future revenues from any such products; or regarding the impact of the COVID-19 pandemic on certain therapeutic areas including dermatology, ophthalmology, our breast cancer portfolio, some newly launched brands and the Sandoz retail and anti-infectives business, and on drug development operations; or regarding potential future, pending or announced transactions; regarding potential future sales or earnings of the Group or any of its divisions; or by discussions of strategy, plans, expectations or intentions; or regarding the Group’s liquidity or cash flow positions and its ability to meet its ongoing financial obligations and operational needs; or regarding our collaboration with Molecular Partners to develop, manufacture and commercialize potential medicines for the prevention and treatment of COVID- 19 and our joining of the industry-wide efforts to meet global demand for COVID-19 vaccines and therapeutics by leveraging our manufacturing capacity and capabilities to support the production of the Pfizer-BioNTech vaccine and to manufacture the mRNA and bulk drug product for the vaccine candidate CVnCoV from CureVac.
    [Show full text]
  • Persistent Gestational Trophoblastic Disease Is Potentially Fatal, but the Majority of Patients Are Cured with Chemotherapy
    British Journal of Cancer (2000) 82(9), 1547–1552 © 2000 Cancer Research Campaign DOI: 10.1054/ bjoc.2000.1176, available online at http://www.idealibrary.com on Persistent gestational trophoblastic disease: results of MEA (methotrexate, etoposide and dactinomycin) as first-line chemotherapy in high risk disease and EA (etoposide and dactinomycin) as second-line therapy for low risk disease LS Dobson, PC Lorigan, RE Coleman and BW Hancock Gestational Trophoblastic Disease Centre, Weston Park Hospital, Sheffield, UK Summary Persistent gestational trophoblastic disease is potentially fatal, but the majority of patients are cured with chemotherapy. Any developments in treatment are therefore being directed towards maintaining efficacy and reducing toxicity. We evaluated efficacy and toxicity of methotrexate, etoposide and dactinomycin (MEA) as first-line therapy for high risk disease and etoposide and dactinomycin (EA) as second-line therapy for methotrexate-refractory low risk disease in a retrospective analysis of 73 patients (38 MEA, 35 EA) treated since 1986 at a supra-regional centre. The median follow-up period was 5.5 years and the median number of cycles received was 7. The overall complete response rate was 85% (97% for EA, 75% for MEA). Of eight patients who failed to respond, four have since died and four were cured with platinum-based chemotherapy. Alopecia was universal. Grade II or worse nausea, emesis, or stomatitis was observed in 29%, 30% and 37% respectively. Fifty-one per cent experienced grade II/III anaemia, 8% grade II or higher thrombocytopenia and 64% grade III or IV neutropenia; in six cases this was complicated by sepsis.
    [Show full text]
  • Dactinomycin
    Dactinomycin DRUG NAME: Dactinomycin 1 SYNONYM(S) : actinomycin D, actinomycin C1 COMMON TRADE NAME(S): COSMEGEN® CLASSIFICATION: antitumour antibiotic Special pediatric considerations are noted when applicable, otherwise adult provisions apply. MECHANISM OF ACTION: Dactinomycin is an antineoplastic antibiotic derived from Streptomyces parvullus.2 Stable complexes are formed with DNA through intercalation and DNA-dependent RNA synthesis is selectively inhibited.1-3 Protein and DNA synthesis are inhibited to a lesser extent.3 Dactinomycin is cell cycle phase-nonspecific1. Dactinomycin is an immunosuppressive agent.3 PHARMACOKINETICS: Oral Absorption poor3 Distribution rapid; high concentrations in bone marrow and nucleated cells3; extensively bound to body tissues cross blood brain barrier? <10% volume of distribution no information found plasma protein binding not highly protein bound Metabolism minimal active metabolite(s) none inactive metabolite(s)3 small amounts of monolactones have been recovered in urine Excretion rapidly cleared from plasma (85% within 2 min) urine 12-20% of dose recovered within 24 h, 15% of dose recovered unchanged after 1 week feces 50-90% of dose excreted in bile within 24 h, 15% of dose recovered after 1 week terminal half life 36 hours, possibly prolonged with hepatic dysfunction clearance no information found Adapted from standard reference2 unless specified otherwise. USES: Primary uses: Other uses: *Gestational trophoblastic tumour *Ewing’s sarcoma *Rhabdomyosarcoma Ovarian germ cell tumour3 *Wilms’ tumour Kaposi’s sarcoma4 5 Malignant melanoma 3,6 Testicular cancer *Health Canada approved indication BC Cancer Drug Manual© All rights reserved. Page 1 of 8 Dactinomycin This document may not be reproduced in any form without the express written permission of BC Cancer Provincial Pharmacy.
    [Show full text]
  • Dactinomycin for INJECTION, USP
    Dactinomycin FOR INJECTION, USP 10 DIGIT NDC STRENGTH SIZE WHOLESALE NUMBERS WEB LISTING 39822-2100-2 ABC 10229241 500 mcg 1 Cardinal 5557707 11 DIGIT NDC (0.5 mg) per vial vial McKesson 3975687 39822-2100-02 Morris Dickson 772301 OTHER INFORMATION PRESERVATIVE FREE LATEX FREE STOPPER CONTROLLED ROOM TEMPERATURE STORAGE - - - BARCODED FOR PATIENT SAFETY Dactinomycin FOR INJECTION, USP HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use • Regional Perfusion in Locally Recurrent and Locoregional Solid Malignancies: Dactinomycin for Injection safely and effectively. See full prescribing • Lower Extremity or Pelvis: The recommend dose is 50 mcg/kg once with information for Dactinomycin for Injection. melphalan. (2.6) ◦ Upper Extremity: The recommended dose is 35 mcg/kg once with melphalan. (2.6) Dactinomycin for Injection for intravenous use Initial U.S. Approval: 1964 DOSAGE FORMS AND STRENGTHS For injection: 500 mcg as a lyophilized powder in a single-dose vial. (3) RECENT MAJOR CHANGES • Dosage and Administration, Recommended Dosage for Wilms Tumor (2.1) CONTRAINDICATIONS 8/2018 None. (4) • Dosage and Administration, Recommended Dosage for Ewing Sarcoma (2.3) 8/2018 WARNINGS AND PRECAUTIONS • Secondary Malignancy or Leukemia: Increased risk of secondary malignancies INDICATIONS AND USAGE following treatment. (5.1) Dactinomycin for injection is an actinomycin indicated for the treatment of: • Veno-occlusive Disease: Can cause severe or fatal VOD. Monitor for elevations in • adult and pediatric patients with Wilms tumor, as part of a multi-phase, AST, ALT, total bilirubin, hepatomegaly, weight gain, or ascites. Consider delaying combination chemotherapy regimen. (1.1) next dose.
    [Show full text]
  • Cytostatics in Dutch Surface Water: Use, Presence and Risks To
    Cytostatics in Dutch surface water Use, presence and risks to the aquatic environment RIVM Letter report 2018-0067 C. Moermond et al. Cytostatics in Dutch surface water Use, presence and risks to the aquatic environment RIVM Letter report 2018-0067 C. Moermond et al. RIVM Letter report 2018-0067 Colophon © RIVM 2018 Parts of this publication may be reproduced, provided acknowledgement is given to: National Institute for Public Health and the Environment, along with the title and year of publication. DOI 10.21945/RIVM-2018-0067 C. Moermond (auteur/coördinator), RIVM B. Venhuis (auteur/coördinator),RIVM M. van Elk (auteur), RIVM A. Oostlander (auteur), RIVM P. van Vlaardingen (auteur), RIVM M. Marinković (auteur), RIVM J. van Dijk (stagiair; auteur) RIVM Contact: Caroline Moermond VSP-MSP [email protected] This investigation has been performed by order and for the account of the Ministry of Infrastructure and Water management (IenW), within the framework of Green Deal Zorg en Ketenaanpak medicijnresten uit water. This is a publication of: National Institute for Public Health and the Environment P.O. Box 1 | 3720 BA Bilthoven The Netherlands www.rivm.nl/en Page 2 of 140 RIVM Letter report 2018-0067 Synopsis Cytostatics in Dutch surface water Cytostatics are important medicines to treat cancer patients. Via urine, cytostatic residues end up in waste water that is treated in waste water treatment plants and subsequently discharged into surface waters. Research from RIVM shows that for most cytostatics, their residues do not pose a risk to the environment. They are sufficiently metabolised in the human body and removed in waste water treatment plants.
    [Show full text]
  • Pharmaceuticals As Environmental Contaminants
    PharmaceuticalsPharmaceuticals asas EnvironmentalEnvironmental Contaminants:Contaminants: anan OverviewOverview ofof thethe ScienceScience Christian G. Daughton, Ph.D. Chief, Environmental Chemistry Branch Environmental Sciences Division National Exposure Research Laboratory Office of Research and Development Environmental Protection Agency Las Vegas, Nevada 89119 [email protected] Office of Research and Development National Exposure Research Laboratory, Environmental Sciences Division, Las Vegas, Nevada Why and how do drugs contaminate the environment? What might it all mean? How do we prevent it? Office of Research and Development National Exposure Research Laboratory, Environmental Sciences Division, Las Vegas, Nevada This talk presents only a cursory overview of some of the many science issues surrounding the topic of pharmaceuticals as environmental contaminants Office of Research and Development National Exposure Research Laboratory, Environmental Sciences Division, Las Vegas, Nevada A Clarification We sometimes loosely (but incorrectly) refer to drugs, medicines, medications, or pharmaceuticals as being the substances that contaminant the environment. The actual environmental contaminants, however, are the active pharmaceutical ingredients – APIs. These terms are all often used interchangeably Office of Research and Development National Exposure Research Laboratory, Environmental Sciences Division, Las Vegas, Nevada Office of Research and Development Available: http://www.epa.gov/nerlesd1/chemistry/pharma/image/drawing.pdfNational
    [Show full text]