Adverse events associated with aprepitant pediatric bone cancer patients

被引:5
作者
Okumura, Lucas M. [1 ]
da Silva Ries, Sacha A. [1 ]
Meneses, Clarice F. [1 ]
Michalowski, Mariana B. [1 ]
Ferreira, Maria Angelica P. [1 ]
Moreira, Leila B. [1 ]
机构
[1] Hosp Clin Porto Alegre, Clin Pharm Div, 2350 Ramiro Barcelos St, BR-90035903 Porto Alegre, RS, Brazil
关键词
Antiemetics; aprepitant; bone cancer; nausea; vomiting; CHEMOTHERAPY-INDUCED NAUSEA; DOUBLE-BLIND; PREVENTION; CHILDREN;
D O I
10.1177/1078155218755547
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
An eight-year long case series follow-up study with pediatric bone cancer patients was conducted to compare the occurrence of adverse events associated with aprepitant with official sources of drug information (manufacturer's leaflet, clinical trials, and European Medicines Agency leaflet). All patients admitted were analyzed, representing 192 aprepitant cycles. Anorexia, febrile neutropenia, and headache were observed in frequencies over 43.8 per 100 patients, which was higher than previous estimates. Adverse events were classified as probable or possible, by using Naranjo score. The increased rates of adverse events, especially on the risk febrile neutropenia, warrant further safety studies on this population.
引用
收藏
页码:735 / 738
页数:4
相关论文
共 10 条
[1]   Aprepitant: drug-drug interactions in perspective [J].
Aapro, M. S. ;
Walko, C. M. .
ANNALS OF ONCOLOGY, 2010, 21 (12) :2316-2323
[2]  
[Anonymous], EM PACK INS
[3]   Aprepitant as an add-on therapy in children receiving highly emetogenic chemotherapy: a randomized, double-blind, placebo-controlled trial [J].
Bakhshi, Sameer ;
Batra, Atul ;
Biswas, Bivas ;
Dhawan, Deepa ;
Paul, Reeja ;
Sreenivas, Vishnubhatla .
SUPPORTIVE CARE IN CANCER, 2015, 23 (11) :3229-3237
[4]  
European Medicines Agency (EMA), APR
[5]   Aprepitant in Adolescent Patients for Prevention of Chemotherapy-Induced Nausea and Vomiting: A Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and Tolerability [J].
Gore, Lia ;
Chawla, Sant ;
Petrilli, Antonio ;
Hemenway, Molly ;
Schissel, Debra ;
Chua, Vickey ;
Carides, Alexandra D. ;
Taylor, Arlene ;
DeVandry, Suzanne ;
Valentine, Jack ;
Evans, Judith K. ;
Oxenius, Bettina .
PEDIATRIC BLOOD & CANCER, 2009, 52 (02) :242-247
[6]   Regulatory approvals of pediatric oncology drugs: Previous experience and new initiatives [J].
Hirschfeld, S ;
Ho, PTC ;
Smith, M ;
Pazdur, R .
JOURNAL OF CLINICAL ONCOLOGY, 2003, 21 (06) :1066-1073
[7]   Aprepitant for the prevention of chemotherapy-induced nausea and vomiting in children: a randomised, double-blind, phase 3 trial [J].
Kang, Hyoung Jin ;
Loftus, Susan ;
Taylor, Arlene ;
DiCristina, Cara ;
Green, Stuart ;
Zwaan, Christian Michel .
LANCET ONCOLOGY, 2015, 16 (04) :385-394
[8]   A METHOD FOR ESTIMATING THE PROBABILITY OF ADVERSE DRUG-REACTIONS [J].
NARANJO, CA ;
BUSTO, U ;
SELLERS, EM ;
SANDOR, P ;
RUIZ, I ;
ROBERTS, EA ;
JANECEK, E ;
DOMECQ, C ;
GREENBLATT, DJ .
CLINICAL PHARMACOLOGY & THERAPEUTICS, 1981, 30 (02) :239-245
[9]   Ethics Review of Pediatric Multi-Center Drug Trials [J].
Needham, Allison C. ;
Kapadia, Mufiza Z. ;
Offringa, Martin .
PEDIATRIC DRUGS, 2015, 17 (01) :23-30
[10]   EURAMOS-1, an international randomised study for osteosarcoma: results from pre-randomisation treatment [J].
Whelan, J. S. ;
Bielack, S. S. ;
Marina, N. ;
Smeland, S. ;
Jovic, G. ;
Hook, J. M. ;
Krailo, M. ;
Anninga, J. ;
Butterfass-Bahloul, T. ;
Bohling, T. ;
Calaminus, G. ;
Capra, M. ;
Deffenbaugh, C. ;
Dhooge, C. ;
Eriksson, M. ;
Flanagan, A. M. ;
Gelderblom, H. ;
Goorin, A. ;
Gorlick, R. ;
Gosheger, G. ;
Grimer, R. J. ;
Hall, K. S. ;
Helmke, K. ;
Hogendoorn, P. C. W. ;
Jundt, G. ;
Kager, L. ;
Kuehne, T. ;
Lau, C. C. ;
Letson, G. D. ;
Meyer, J. ;
Meyers, P. A. ;
Morris, C. ;
Mottl, H. ;
Nadel, H. ;
Nagarajan, R. ;
Randall, R. L. ;
Schomberg, P. ;
Schwarz, R. ;
Teot, L. A. ;
Sydes, M. R. ;
Bernstein, M. .
ANNALS OF ONCOLOGY, 2015, 26 (02) :407-414