Health Canada approves EMEND IV formulation to prevent chemotherapy-induced nausea, vomiting

MERCKMay 12 2011

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.

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). The study also noted that the equally effective single dose formulation could maintain overall therapeutic benefit for patients with greater convenience and adherence.

"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 current practice.

Consequences of chemotherapy-induced nausea and vomiting
Approximately 70 to 80 per cent of cancer patients can experience CINV. Patients who are beginning cancer treatment consistently list CINV as one of their greatest fears. Uncontrolled nausea and vomiting might even influence patients to discontinue their treatment early.

"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 life
• 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 uncontrolled CINV.