One dose helps prevent chemotherapy-related nausea and vomiting
MONTREAL, May 12 /CNW Telbec/ - Today Merck announced that Health Canada
has approved the new intravenous formulation of EMEND® IV (fosaprepitant dimeglumine). Used in combination with a 5-HT3 antagonist class of antiemetics and dexamethasone, fosaprepitant
dimeglumine is indicated for the prevention of acute and delayed nausea
and vomiting due to highly emetogenic cancer chemotherapy.1
The new EMEND® IV formulation is given on day one of chemotherapy. According to a
study published in the April 10, 2011 issue of Journal of Clinical Oncology, the new formulation was found to be as effective as the standard 3-day
oral course of aprepitant for preventing chemotherapy-induced nausea
and vomiting (CINV).2 The study also noted that the equally effective single dose formulation
could maintain overall therapeutic benefit for patients with greater
convenience and adherence.2
"Neurokinin 1 antagonists such as fosaprepitant are an important advance
in the prevention of delayed nausea and vomiting for patients
undertaking chemotherapy treatment," said Dr. Steven Grunberg,
University of Vermont Department of Medicine, lead author and initiator
of the study that led to the new EMEND® IV formulation. "The new single dose formulation benefits patients as
well as the medical staff. It is a convenient and reliable way of
administering this agent to protect our cancer patients from CINV, a
common side effect of chemotherapy. Our goal is to maintain the
highest quality of life for patients during chemotherapy".
The oral form of EMEND® remains available and is given as a series of oral doses (125 mg on day
1, 80 mg on day 2, and 80 mg on day 3 of chemotherapy) in combination
with a 5-HT3 antagonist class of antiemetics and dexamethasone. Emend® IV may prove to be ideal for patients who have difficulty swallowing,
and is a convenient way to deliver this novel anti-emetic.
Over the past ten years new treatments have been developed for control
of CINV, however CINV remains a significant problem in the context of
Consequences of chemotherapy-induced nausea and vomiting
Approximately 70 to 80 per cent of cancer patients can experience CINV.4 Patients who are beginning cancer treatment consistently list CINV as one of their greatest fears.5 Uncontrolled nausea and vomiting might even influence patients to
discontinue their treatment early.3
"Nausea and vomiting are among the most distressing side effects for
patients undergoing cancer chemotherapy," added Dr. Grunberg. "Cancer
patients might even consider sacrificing life expectancy to not
experience any nausea."
The burden that CINV places on patients with cancer and the healthcare
system can be considerable. In observational studies:
90 per cent of patients affected with both acute and delayed nausea or
vomiting due to chemotherapy reported an impact on their quality of
One in seven patients had a follow-up hospital visit associated with
CINV defined as outpatient hospital visit, emergency room visit or
hospitalization. Hospitalization was the most common type of visit for
Information about EMEND® IV
EMEND® IV (fosaprepitant dimeglumine), in combination with a 5-HT3 antagonist class of antiemetics and dexamethasone, is indicated for the
prevention of acute and delayed nausea and vomiting due to highly
emetogenic cancer chemotherapy.
EMEND® IV is contraindicated in patients who are hypersensitive to EMEND® IV, aprepitant, polysorbate 80, or to any ingredient in the formulation
and should not be used concurrently with pimozide, terfenadine,
astemizole, or cisapride. Inhibition of cytochrome P450 isoenzyme 3A4
(CYP3A4) by aprepitant could result in elevated plasma concentrations
of these drugs, potentially causing serious or life-threatening
Fosaprepitant is a prodrug* of aprepitant, and accordingly, its antiemetic effects are attributable
to aprepitant. Aprepitant has a unique mode of action; it is a
selective high affinity antagonist at human substance P neurokinin 1
EMEND® IV is for intravenous infusion only, upon reconstitution and dilution,
and for single use only.
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This news release includes "forward-looking statements" within the
meaning of the safe harbor provisions of the United States Private
Securities Litigation Reform Act of 1995. Such statements may include,
but are not limited to, statements about the benefits of the merger
between Merck and Schering-Plough, including future financial and
operating results, the combined company's plans, objectives,
expectations and intentions and other statements that are not
historical facts. Such statements are based upon the current beliefs
and expectations of Merck's management and are subject to significant
risks and uncertainties. Actual results may differ from those set forth
in the forward-looking statements.
The following factors, among others, could cause actual results to
differ from those set forth in the forward-looking statements: the
possibility that the expected synergies from the merger of Merck and
Schering-Plough will not be realized, or will not be realized within
the expected time period; the impact of pharmaceutical industry
regulation and health care legislation; the risk that the businesses
will not be integrated successfully; disruption from the merger making
it more difficult to maintain business and operational relationships;
Merck's ability to accurately predict future market conditions;
dependence on the effectiveness of Merck's patents and other
protections for innovative products; the risk of new and changing
regulation and health policies in the United States and internationally
and the exposure to litigation and/or regulatory actions. Merck
undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events or
otherwise. Additional factors that could cause results to differ
materially from those described in the forward-looking statements can
be found in Merck's 2009 Annual Report on Form 10-K and the company's
other filings with the Securities and Exchange Commission (SEC)
available at the SEC's Internet site (www.sec.gov).
EMEND® is a Registered Trademark of Merck Sharp & Dohme Corp., a subsidiary of
Merck & Co., Inc., Used under license.
1 EMEND® IV Product Monograph February 8, 2011.
2 Grunberg SG, et al. Single-dose fosprepitant for the prevention of
chemotherapy-induced nausea and vomiting associated with cisplatin
therapy: randomized double-blind study protocol. J Clin Oncol 2011; 29:11: 1495-1501.
3 Lachaine J, Yelle L, Kaizer L, Dufour A, et al. Chemotherapy-induced
emesis : quality of life and economic impact in the context of current
practice in Canada. Supportive Cancer Therapy 2005;2:181-7.
4 NCCN Clinical Practice Guidelines in Oncology; Antiemesis, Version
5 Viale PH. Integrating aprepitant and palonosertron into clinical
practice: a role for the new antiemetics. Clin J Oncol Nurs 2005; 9:77-84.
6 Ballatori E, Roila F. Ruggeri B, et al. The impact of
chemotherapy-induced nausea and vomiting on health-related quality of
life. Support Care Cancer 2007; 15:179-85
7 Burke TA, Wisniewski T, Ernst FR. Resource utilization and costs associated with chemotherapy-induced
nausea and vomiting (CINV) following highly or moderately emetogenic
chemotherapy administered in the US outpatient hospital setting. Support Care Cancer. 2011 Jan;19(1):131-40. Epub 2010 Jan 26
* A prodrug is inactive until the body's normal metabolic processes
converts into its active form.
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