Stability of an extemporaneous oral liquid aprepitant formulation

Dupuis, L. Lee; Lingertat-Walsh, Karen; Walker, Scott

doi:10.1007/s00520-008-0539-5

Cited by 23 publications

(16 citation statements)

References 13 publications

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“…A publication is available that reports stability of an extemporaneous preparation of aprepitant, however this remains a complicating factor that must be addressed when considering treatment for young patients. 13 A similar single-institution retrospective analysis described aprepitant use in 32 children; however, the youngest child was only 32 months. 9 We noted a positive experience in giving doses to children as young as 11 months and to 3 different children weighing less than 15 kg.…”

Section: Aprepitant and Fosaprepitant In Children And Adolescentsmentioning

confidence: 99%

Aprepitant and Fosaprepitant Use in Children and Adolescents at an Academic Medical Center

Shillingburg

Biondo

2014

The Journal of Pediatric Pharmacology and Therapeutics

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OBJECTIVE: To describe the use of aprepitant and fosaprepitant, a neurokinin 1 (NK-1) receptor inhibitor, in children and adolescents at a large academic medical center, for the prevention and management of chemotherapy-induced nausea and vomiting (CINV). METHODS: A retrospective chart review was conducted using an electronic medical record system to evaluate the use of aprepitant and fosaprepitant in all pediatric patients that were discharged from a single academic medical center between February 25, 2009 and May 25, 2012. RESULTS: Twenty-six patients were included in this review and received a total of 287 doses over the span of 114 cycles. Mean age was 10.1 years, with a range of 11 months to 17 years old. In 16 of 26 patients, aprepitant was used as the primary prophylaxis. Of those patients who received primary prophylaxis, 6 of 16 received it for highly emetogenic chemotherapy, and 10 of 16 received it for moderately emetogenic chemotherapy. Intravenous fosaprepitant was used in 7 of 26 patients, ages 13 to 17 (median 14) years old. No adverse effects attributable to aprepitant were reported. CONCLUSIONS: Use of aprepitant and fosaprepitant in pediatric patients appeared to be well tolerated. No currently published reports data using aprepitant in a patient younger than 32 months old, whereas we reported its use in patients as young as 11 months old.

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Section: Aprepitant and Fosaprepitant In Children And Adolescentsmentioning

confidence: 99%

Aprepitant and Fosaprepitant Use in Children and Adolescents at an Academic Medical Center

Shillingburg

Biondo

2014

The Journal of Pediatric Pharmacology and Therapeutics

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“…The commercially available oral aprepitant suspension has a short expiry of 72 hours after reconstitution. In jurisdictions where aprepitant oral suspension is not available, it can be prepared from capsules . CIV can affect up to 60% of patients receiving prophylactic anti‐emetics .…”

Section: Introductionmentioning

confidence: 99%

“…In jurisdictions where aprepitant oral suspension is not available, it can be prepared from capsules. 5 CIV can affect up to 60% of patients receiving prophylactic anti-emetics. 6,7 Prophylactic anti-emetic treatment with a neurokinin-1 (NK-1) antagonist in combination with a 5HT3 antagonist and/or dexamethasone is associated with a high frequency of CIV control in children than that with a 5HT3 antagonist alone or a 5HT3 antagonist and dexamethasone combination.…”

mentioning

confidence: 99%

Intravenous fosaprepitant for the prevention of chemotherapy‐induced vomiting in children: A double‐blind, placebo‐controlled, phase III randomized trial

Radhakrishnan

Joshi

Ramamoorthy

et al. 2018

Pediatric Blood & Cancer

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Background Fosaprepitant is a neurokinin‐1 receptor antagonist, approved for the prevention of chemotherapy‐induced nausea and vomiting. The data on the use of fosaprepitant in children are limited and therefore we conducted a phase III randomized controlled trial. Procedure Children aged 1‐12 years scheduled to receive moderately or highly emetogenic chemotherapy were randomly assigned to arm‐A (fosaprepitant) or arm‐B (placebo). Children recruited to arm‐A received intravenous ondansetron plus dexamethasone followed by fosaprepitant infusion. Children recruited to arm‐B received the same drugs as those given to children in arm‐A, except that fosaprepitant was substituted with a placebo. Ondansetron and dexamethasone were continued for 48 hours after completion of chemotherapy. The primary end point of the study was to determine the proportion of patients who achieved a complete response (CR), defined as no vomiting, no retching, and no use of rescue medication, during the 24‐120 hours (delayed phase) after administration of the last dose of chemotherapy. Secondary end points were the proportion of patients who achieved a CR during the acute phase (0‐24 hours) and overall after administration of the last dose of chemotherapy. Results One‐hundred‐sixty‐three patients were analyzed (81 in the fosaprepitant arm and 82 in the placebo arm). CR rates were significantly higher in the fosaprepitant arm compared to those in the placebo arm during the acute phase (86% vs 60%, P < 0.001), delayed phase (79% vs 51%, P < 0.001), and overall phase (70% vs 41%, P < 0.001). Three (4%) patients in the fosaprepitant arm and sixteen (20%) in the placebo arm required rescue anti‐emetics (P = 0.0017). Conclusion Addition of fosaprepitant to ondansetron and dexamethasone improved chemotherapy‐induced vomiting control in children treated with moderately or highly emetogenic chemotherapy.

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“…Aprepitant was administered based on patient weight and rounded to the nearest 20 mg (Table ) from a dosing table implemented based on practice at our institution assessed via retrospective review of prior aprepitant usage. Aprepitant was administered in the form on an oral solution or a capsule . Safety and tolerability of aprepitant was assessed daily by a study investigator and adverse event reporting was limited to adverse events which could be directly attributed to aprepitant systemic absorption.…”

Section: Methodsmentioning

confidence: 99%

Safety and efficacy of aprepitant for chemotherapy‐induced nausea and vomiting in pediatric patients: A prospective, observational study

Bodge

Shillingburg

Paul

et al. 2013

Pediatric Blood & Cancer

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Pediatric patients between the ages of 12 months and 17 years with a confirmed malignancy who were scheduled to receive aprepitant as part of triple therapy antiemetic prophylaxis for a cycle of moderately‐ or highly emetogenic chemotherapy were eligible for enrollment. Patients were evaluated for the incidence of nausea, episodes of emesis, interference with activities of daily living (ADLs), and appetite through utilization of a patient survey. Eleven patients were enrolled for a total of 20 patient encounters, mean age 9.55 ± 4.85 (range, 12 months–17 years). Aprepitant was well‐tolerated and complete response (CR) rate was 38.9%. Pediatr Blood Cancer 2014;61:1111–1113. © 2013 Wiley Periodicals, Inc.

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Stability of an extemporaneous oral liquid aprepitant formulation

Abstract: The extemporaneous aprepitant oral suspension formulation described is physically and chemically stable for at least 90 days when refrigerated. The bioavailability of this formulation is unknown.

Cited by 23 publications

References 13 publications

Aprepitant and Fosaprepitant Use in Children and Adolescents at an Academic Medical Center

Aprepitant and Fosaprepitant Use in Children and Adolescents at an Academic Medical Center

Intravenous fosaprepitant for the prevention of chemotherapy‐induced vomiting in children: A double‐blind, placebo‐controlled, phase III randomized trial

Safety and efficacy of aprepitant for chemotherapy‐induced nausea and vomiting in pediatric patients: A prospective, observational study

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