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Emend (Aprepitant) - Summary

 



EMEND SUMMARY

EMEND (aprepitant) is a substance P/neurokinin 1 (NK1) receptor antagonist.

EMEND, in combination with other antiemetic agents, is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy, including high-dose cisplatin (see DOSAGE AND ADMINISTRATION).


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NEWS HIGHLIGHTS

Media Articles Related to Emend (Aprepitant)

Low Installation Rates In Retail Pharmacies Across Europe Increase The Growth Potential Of The Pharmacy Automation Systems Market
Source: IT / Internet / E-mail News From Medical News Today [2010.09.02]
The pharmacy automation systems market in Europe is experiencing a tremendous growth spurt. Until recently, most pharmacies have been either without automation or have employed very basic automation systems...

Nausea and Vomiting
Source: MedicineNet Antiemetics Specialty [2008.04.29]
Title: Nausea and Vomiting
Category: Diseases and Conditions
Created: 1/31/2005 8:21:00 AM
Last Editorial Review: 4/29/2008

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Published Studies Related to Emend (Aprepitant)

Lack of effect of aprepitant or its prodrug fosaprepitant on QTc intervals in healthy subjects. [2009.08]
BACKGROUND: A single 115-mg dose of fosaprepitant, the IV prodrug of the NK(1) receptor antagonist aprepitant, is bioequivalent to a 125-mg dose of oral aprepitant. Thus far, fosaprepitant/aprepitant has not shown a meaningful effect on QTc intervals; in this study, we sought to confirm these findings... CONCLUSIONS: In subjects receiving fosaprepitant 200 mg, no clinically meaningful increases in QTc were seen at any timepoint, whereas after moxifloxacin 400 mg, increases were observed at the approximate T(max) of moxifloxacin and additional timepoints. The lack of QTc increase at this high dose of fosaprepitant and resulting aprepitant plasma exposures support the expectation that clinical doses of fosaprepitant or aprepitant will not be associated with significant QTc prolongation.

Aprepitant in adolescent patients for prevention of chemotherapy-induced nausea and vomiting: a randomized, double-blind, placebo-controlled study of efficacy and tolerability. [2009.02]
CONCLUSION: Aprepitant triple therapy was generally well tolerated; CR were greater with aprepitant, although not statistically significant. Pharmacokinetics suggest that the adult dosing regimen is appropriate for adolescents. (c) 2008 Wiley-Liss, Inc.

Cost-effectiveness analysis of aprepitant in the prevention of chemotherapy-induced nausea and vomiting in Belgium. [2008.08]
OBJECTIVES: Chemotherapy-induced nausea and vomiting (CINV) remains a major adverse effect of cancer chemotherapy which may increase morbidity, reduce quality of life and threaten the success of cancer therapy. Aprepitant is effective in preventing CINV, achieving higher complete response (no emesis and no rescue therapy) compared to standard prevention, in patients receiving either highly (HEC) or moderately emetogenic chemotherapy (MEC; absolute reduction = 11 and 13%, respectively). We assessed the cost effectiveness of aprepitant-based vs standard prevention in these indications in Belgium... CONCLUSIONS: In both approaches, the aprepitant-based strategy is more effective and less expensive compared to standard care.

Randomized, placebo-controlled, pilot study evaluating aprepitant single dose plus palonosetron and dexamethasone for the prevention of acute and delayed chemotherapy-induced nausea and vomiting. [2008.05.01]
BACKGROUND: The combination of palonosetron and aprepitant is safe and effective in the prevention of chemotherapy-induced emesis (CIE). The purpose of this pilot study was to ascertain the effectiveness of 1-day versus 3-day aprepitant in the prevention of acute and delayed nausea and vomiting in patients who were receiving highly emetogenic chemotherapy... CONCLUSIONS: From this pilot study of patients who were receiving palonosetron, aprepitant, and dexamethasone for highly emetogenic chemotherapy, a single dose of aprepitant displayed similar effectiveness compared with 3-day aprepitant.

A randomized, placebo-controlled, crossover, double-blind trial of the NK1 receptor antagonist aprepitant on gastrointestinal motor function in healthy humans. [2008.04.01]
BACKGROUND: Little is known about the role of tachykinins on human gastrointestinal motility and no data exist on the possible effect of an NK1 receptor antagonist. AIM: To examine the effect of an antiemetic dose of the selective NK1 receptor antagonist aprepitant on gastrointestinal propulsion in healthy humans... CONCLUSION: A 125-mg capsule of aprepitant followed by an 80-mg capsule of aprepitant each of the next 2-5 days did not induce major changes in the propulsive function of the gastrointestinal tract in the small number of healthy volunteers investigated.

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Clinical Trials Related to Emend (Aprepitant)

ONO-7436 Phase II Study in Japan [Completed]
The purpose of this study is to examine the efficacy and safety of ONO-7436 for the prevention of cancer chemotherapy-induced nausea and vomiting in patients with malignant tumor

A Study of Aprepitant (MK0869) and Fosaprepitant (MK0517) in Pediatric Patients Receiving Chemotherapy [Recruiting]
This study will determine the appropriate dosing regimen of aprepitant and fosaprepitant for the prevention of chemotherapy induced nausea and vomiting in pediatric patients from 6 months to 17 years of age.

Oral Aprepitant and Lower Dose Dexamethasone Versus Aprepitant Alone for Preventing Postoperative Nausea and Vomiting (PONV) After Elective Laparoscopic Surgeries [Not yet recruiting]
The combination of aprepitant and lower dose dexamethasone is superior to aprepitant alone with respect to the proportion of patients with a complete response (no vomiting and no use of rescue therapy) during 24 hours after the placement of last suture/staple.

Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) [Recruiting]
The study will test aprepitant for the prevention of CINV in patients receiving their initial cycle of MEC. Patients receiving more then one cycle of chemotherapy may opt to participate in an optional second cycle during which the patient will receive the same antiemetic regimen as cycle 1, except that an IV formulation of aprepitant will be given in place of the oral formulation on study day one. Study drug administration on subsequent days will be given orally as in cycle 1.

Effects of Treatment With Aprepitant (Emend®) in HIV Infected Individuals [Recruiting]
The investigators' in vitro data suggest that Neurokinin-1 receptor antagonists like aprepitant will decrease the expression of CCR5, an essential co-receptor in the life cycle of HIV, in the surface of macrophages and lymphocytes to levels at least similar to those observed in patients heterozygous for the CCR5 32 mutation. Together with a direct potential antiviral effect this could alter disease progression in patients with HIV infection.

The investigators' hypothesis is that aprepitant is safe, tolerable and has antiviral activity in HIV infected individuals.

This is randomized, placebo controlled, double blind study to determine the safety and antiviral activity of aprepitant by comparing the change in HIV RNA viral load after 2 weeks of aprepitant monotherapy.

27 HIV infected males and females ≥ 18 years old who have early infection with CD4 cell counts ≥ 350 cells/mm3. Subjects will be randomized 1: 1:1 to receive two different doses of aprepitant (Emend®) or placebo.

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Page last updated: 2010-09-02

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