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Tom Ottoboni, Mary Rose Keller, Matt Cravets, Neil Clendeninn, Barry Quart
Introduction: Fosaprepitant, an intravenous (IV) aprepitant prodrug for chemotherapy-induced nausea and vomiting prophylaxis, is associated with systemic and infusion-site reactions attributed in part to its surfactant, polysorbate 80. HTX-019 is an IV aprepitant formulation free of polysorbate 80 and other synthetic surfactants. Materials and methods: This open-label, single-dose, randomized, two-way crossover bioequivalence study compared pharmacokinetics and safety of HTX-019 and fosaprepitant...
2018: Drug Design, Development and Therapy
Ciara C O'Sullivan, Holly K Van Houten, Lindsey R Sangaralingham, Alexis D Leal, Shivani Shinde, Hongfang Liu, David Ettinger, Charles L Loprinzi, Kathryn J Ruddy
Purpose: Prevention of chemotherapy-induced nausea and vomiting is essential to preserve quality of life in patients with cancer receiving highly emetogenic chemotherapy (HEC). Recently, new drugs (eg, fosaprepitant, and the newer neurokinin-1 receptor antagonists [NK1RAs] rolapitant and netupitant) and updated antiemetic guidelines have emerged. However, trends in real-world antiemetic use are understudied. Methods: We identified patients treated with an initial dose of HEC (either cisplatin or doxorubicin/cyclophosphamide) from January 2006 to June 2016 using administrative claims data from a US commercial insurance database (OptumLabs)...
March 2018: Journal of the National Comprehensive Cancer Network: JNCCN
Hidehito Horinouchi, Kaoru Kubota, Akihiko Miyanaga, Shinji Nakamichi, Masahiro Seike, Akihiko Gemma, Yuki Yamane, Futoshi Kurimoto, Hiroshi Sakai, Shintaro Kanda, Yutaka Fujiwara, Hiroshi Nokihara, Noboru Yamamoto, Tomohide Tamura, Yuichiro Ohe
Background: The aim of this trial was to evaluate the safety and efficacy of oral hydration as a substitute for intravenous hydration after cisplatin (CDDP) administration. Methods: The major eligibility criteria included patients with lung cancer, indications for a CDDP-based regimen at a dose of 60 mg/m2 or higher, an age of between 20 and 74 years and adequate renal function. Antiemetic prophylaxis consisted of an appropriate dose of palonosetron, aprepitant, dexamethasone and magnesium sulfate (8 mEq)...
2018: ESMO Open
Joseph Bubalo, Kelsey Mulverhill, Gabrielle Meyers, Brandon Hayes-Lattin, Richard Maziarz
The aim of this study was to evaluate the safety and efficacy of aprepitant when used prophylactically to prevent nausea and vomiting during cyclophosphamide-based conditioning regimens. The primary objective of this study was to determine if there was a difference in the number of emesis-free days in patients who received aprepitant as compared to those who received placebo. This prospective, randomized, double blind, placebo-controlled study was performed in 40 adult patients who received a cyclophosphamide-containing HSCT conditioning regimen...
February 20, 2018: Bone Marrow Transplantation
Dionne Okafor, Alan David Kaye, Rachel J Kaye, Richard D Urman
Postoperative nausea and vomiting (PONV) can be very debilitating for surgical patients, and effective management reduces potential morbidity, aiding in patient satisfaction, and minimizing the need for unintended hospital stays. Risk factors include female sex, nonsmoker, and having a previous history of motion sickness or PONV. Anesthetic risk factors include receiving opioids, not receiving a total intravenous anesthetic (TIVA), exposure to nitrous oxide, and extended length of anesthetic. Many treatments, including serotonin antagonists, dopamine antagonists, corticosteroids, inhaled isopropyl alcohol, and anticholinergics, as well as techniques such as TIVA, have been utilized over recent decades in an attempt to reduce PONV incidence...
October 2017: Journal of Anaesthesiology, Clinical Pharmacology
Lucas M Okumura, Sacha A da Silva Ries, Clarice F Meneses, Mariana B Michalowski, Maria Angelica P Ferreira, Leila B Moreira
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...
January 1, 2018: Journal of Oncology Pharmacy Practice
Samaneh Bayati, Elham Razani, Davood Bashash, Ava Safaroghli-Azar, Majid Safa, Seyed H Ghaffari
Genetic and laboratory studies have remodeled the conventional understanding of cancer pathogenesis by identifying different molecular alterations. Intrigued by the contribution of neurokinin-1 receptor (NK1R) network in cancer pathogenesis, we investigated the antileukemic effects of aprepitant, a nonpeptide antagonist of NK1R, in a panel of hematological cell lines. In this study, we found that aprepitant decreased the survival of all the tested cells; however, as compared with NB4, viability of the other cell lines was inhibited at higher concentrations...
January 31, 2018: Anti-cancer Drugs
Mayako Uchida, Tsutomu Nakamura, Kojiro Hata, Hiroyuki Watanabe, Yasuo Mori, Koji Kato, Kenjiro Kamezaki, Katsuto Takenaka, Motoaki Shiratsuchi, Keiko Hosohata, Toshihiro Miyamoto, Koichi Akashi
Background: Antiemetic effects and safety of granisetron or palonosetron alone and in combination with a corticosteroid against chemotherapy-induced nausea and vomiting (CINV) were retrospectively evaluated in patients with Hodgkin lymphoma receiving adriamycin, bleomycin, vinblastine, and dacarbazine (ABVD) therapy. Methods: A total of 39 patients were eligible for this study. Before ABVD therapy, granisetron or palonosetron was intravenously administered with or without a corticosteroid (dexamethasone or hydrocortisone) and aprepitant...
2018: Journal of Pharmaceutical Health Care and Sciences
Zhonghan Zhang, Yaxiong Zhang, Gang Chen, Shaodong Hong, Yunpeng Yang, Wenfeng Fang, Fan Luo, Xi Chen, Yuxiang Ma, Yuanyuan Zhao, Jianhua Zhan, Cong Xue, Xue Hou, Ting Zhou, Shuxiang Ma, Fangfang Gao, Yan Huang, Likun Chen, Ningning Zhou, Hongyun Zhao, Li Zhang
BACKGROUND: The current antiemetic prophylaxis for patients treated with highly emetogenic chemotherapy (HEC) included the olanzapine-based triplet and neurokinin-1 receptor antagonists (NK-1RAs)-based triplet. However, which one shows better antiemetic effect remained unclear. MATERIALS AND METHODS: We systematically reviewed 43 trials, involving 16,609 patients with HEC, which compared the following antiemetics at therapeutic dose range for the treatment of chemotherapy-induced nausea and vomiting: olanzapine, aprepitant, casopitant, fosaprepitant, netupitant, and rolapitant...
January 12, 2018: Oncologist
L C de Morais, A M Sousa, G F Flora, T R Grigio, G M N Guimarães, H A Ashmawi
BACKGROUND: Post-operative nausea and vomiting (PONV) is one of the most important causes of patient discomfort after laparoscopic surgeries despite the use of a multimodal pharmacological approach. This study assessed whether the addition of aprepitant to a multimodal regimen would further decrease the incidence of PONV in high-risk patients. METHODS: Apfel-score three or four patients, scheduled for laparoscopic procedures to treat abdominal or pelvic cancer, were randomized to receive oral starch (control group) or 80 mg of oral aprepitant (treatment group) before induction of anaesthesia in a double-blind study...
January 7, 2018: Acta Anaesthesiologica Scandinavica
Nikita Mehra, Prasanth Ganesan, Trivadi S Ganesan, Surendran Veeriah, Abirami Boopathy, Venkatraman Radhakrishnan, Manikandan Dhanushkodi, Swaminathan Rajaraman, Sevaluxmy Ganesharajah, Tenali Gnana Sagar
Chemotherapy-induced nausea-vomiting (CINV) compromises the quality of life of patients with cancer. We present data on the effectiveness of olanzapine after failure of aprepitant in patients receiving highly emetogenic chemotherapy (HEC). A single-center prospective study was conducted, where patients ≥ 18 years who failed aprepitant, palonosetron, dexamethasone (APD) received olanzapine, palonosetron and dexamethasone (OPD) in the subsequent cycle of HEC. Failure of APD was defined as occurrence of ≥ grade 2 acute and/or delayed nausea ± vomiting...
December 16, 2017: Medical Oncology
Constantinos K Zacharis, Elli Vastardi
In the research presented we report the development of a simple and robust liquid chromatographic method for the quantification of two genotoxic alkyl sulphonate impurities (namely methyl p-toluenesulfonate and isopropyl p-toluenesulfonate) in Aprepitant API substances using the Analytical Quality by Design (AQbD) approach. Following the steps of AQbD protocol, the selected critical method attributes (CMAs) were the separation criterions between the critical peak pairs, the analysis time and the peak efficiencies of the analytes...
December 7, 2017: Journal of Pharmaceutical and Biomedical Analysis
Alexandre Chan, Matin M Abdullah, Wan Zamaniah B Wan Ishak, Annielyn B Ong-Cornel, Antonio H Villalon, Ravindran Kanesvaran
A meeting of regional experts was convened in Manila, Philippines, to develop a resource-stratified chemotherapy-induced nausea and vomiting (CINV) management guideline. In patients treated with highly emetogenic chemotherapy in general clinical settings, triple therapy with a serotonin (5-hydroxytryptamine-3 [5-HT3]) antagonist (preferably palonosetron), dexamethasone, and aprepitant is recommended for acute CINV prevention. In resource-restricted settings, triple therapy is still recommended, although a 5-HT3 antagonist other than palonosetron may be used...
December 2017: Journal of Global Oncology
Louise Lönndahl, Mikael Holst, Maria Bradley, Hassan Killasli, Johan Heilborn, Martin A Hall, Elvar Theodorsson, Jadwiga Holmberg, Klas Nordlind
Atopic dermatitis (AD) is a chronic, itchy, inflammatory skin disorder that may worsen due to stress and anxiety. Tachykinins have been suggested to be involved in the inflammation in AD, as well as pruritus. Aprepitant is a NK-1 receptor antagonist. This open randomized trial evaluated the effect of aprepitant added to topical treatment in adult patients with moderate-severe AD. The treatment group (n = 19) received 80 mg/day aprepitant for 7 days as a supplement to standardized topical treatment with a moderately strong steroid and a moisturizer...
November 28, 2017: Acta Dermato-venereologica
Takeshi Ioroi, Junya Furukawa, Manabu Kume, Sachi Hirata, Yuko Utsubo, Naomi Mizuta, Hideaki Miyake, Masato Fujisawa, Midori Hirai
PURPOSE: This study aimed to determine the antiemetic efficacy and safety of palonosetron, aprepitant and dexamethasone in patients with testicular germ cell tumours (TGCTs) receiving 5-day cisplatin-based combination chemotherapy. METHODS: In this open-label, single-arm, single-centre study, the antiemetic therapy consisted of palonosetron 0.75 mg on day 1, aprepitant 125 mg on day 1 and 80 mg on days 2-7 and dexamethasone 6.6 mg on days 1-7. The primary endpoint was complete response (CR; no vomiting/retching or rescue medication) in the overall period (0-240 h), and secondary endpoints included complete protection (CP; defined as CR and no more than mild nausea) and total control (TC; defined as CR and no nausea)...
November 16, 2017: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
Bernardo L Rapoport, Karin Jordan, Cindy Weinstein
Chemotherapy-induced nausea and vomiting (CINV) remains a challenge in cancer care. Improved understanding of CINV pathophysiology has triggered the development of new antiemetic therapeutic options, such as selective neurokinin-1 (NK1) receptor antagonists (RAs), which effectively prevent CINV when added to a standard antiemetic regimen (serotonin-3 RA and dexamethasone). Aprepitant and its water-soluble prodrug, fosaprepitant dimeglumine, are the most widely used NK1 RAs, with extensive clinical use worldwide...
November 13, 2017: Future Oncology
Pankaj J Pasricha, Katherine P Yates, Irene Sarosiek, Richard W McCallum, Thomas L Abell, Kenneth L Koch, Linda Anh B Nguyen, William J Snape, William L Hasler, John O Clarke, Sameer Dhalla, Ellen M Stein, Linda A Lee, Laura A Miriel, Mark L Van Natta, Madhusudan Grover, Gianrico Farrugia, James Tonascia, Frank A Hamilton, Henry P Parkman
BACKGROUND & AIMS: There are few effective treatments for nausea and other symptoms in patients with gastroparesis and related syndromes. We performed a randomized trial of the ability of the neurokinin-1 receptor antagonist aprepitant to reduce symptoms in patients with chronic nausea and vomiting caused by gastroparesis or gastroparesis-like syndrome. METHODS: We conducted a 4-week multicenter, double-masked trial of 126 patients with at least moderate symptoms of chronic nausea and vomiting of presumed gastric origin for a minimum of 6 months...
October 28, 2017: Gastroenterology
L Zhang, S Lu, J Feng, A Dechaphunkul, J Chang, D Wang, S Chessari, C Lanzarotti, K Jordan, M Aapro
Background: Co-administration of multiple antiemetics that inhibit several molecular pathways involved in emesis is required to optimize CINV control in patients receiving highly emetogenic chemotherapy (HEC). NEPA, a fixed combination of a highly selective NK1 receptor antagonist (RA), netupitant (300 mg), and the pharmacologically distinct 5-HT3RA, palonosetron (PALO 0.50 mg), has shown superior CINV prevention compared to PALO in cisplatin and anthracycline/cyclophosphamide-based settings...
October 28, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
Joseph S Bubalo, Jon D Herrington, Marc Takemoto, Patricia Willman, Michael S Edwards, Casey Williams, Alan Fisher, Alison Palumbo, Eric Chen, Charles Blanke, Charles D Lopez
PURPOSE: Chemotherapy-induced nausea and vomiting (CINV) causes significant morbidity among colorectal cancer patients, receiving fluorouracil, oxaliplatin, and leucovorin (FOLFOX) chemotherapy even with standard antiemetic prophylaxis. The purpose of this study is to determine if the addition of aprepitant to standard antiemetic therapy improves CINV in these patients. METHODS: Patients receiving FOLFOX for colorectal cancer were given antiemetic prophylaxis with aprepitant 125 mg orally on day 1 and 80 mg on days 2 and 3...
October 31, 2017: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
Indira Nederpelt, Maria Kuzikov, Wilbert E A de Witte, Patrick Schnider, Bruno Tuijt, Sheraz Gul, Adriaan P IJzerman, Elizabeth C M de Lange, Laura H Heitman
An important question in drug discovery is how to overcome the significant challenge of high drug attrition rates due to lack of efficacy and safety. A missing link in the understanding of determinants for drug efficacy is the relation between drug-target binding kinetics and signal transduction, particularly in the physiological context of (multiple) endogenous ligands. We hypothesized that the kinetic binding parameters of both drug and endogenous ligand play a crucial role in determining cellular responses, using the NK1 receptor as a model system...
October 26, 2017: Scientific Reports
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