FDA approves IV antiemetic Emend for chemo patients

ROCKVILLE, Maryland-A new formulation of Emend has entered oncology's antiemetic armamentarium. Emend (fosaprepitant dimeglumine, Merck) for Injection received US Food and Drug Administration approval in late January for use in combination with other antiemetic agents for the prevention of acute and delayed nausea and vomiting associated with initial and repeated courses of moderate- or high-emetogenic chemotherapies, including high-dose cisplatin.

The new product is an intravenous prodrug of oral Emend (aprepitant) that rapidly converts to aprepitant upon injection into the body.

The injectable form (115 mg) can be substituted for the oral 125 mg Emend capsule on day 1 of a 3-day antiemetic regimen. FDA approved Emend for Injection solely as a prevention agent for use with cancer chemotherapy; the drug is not intended for treating nausea and vomiting once they begin.

Chemotherapy-induced nausea and vomiting remains a major issue in oncology, disrupting patients' lives and sometimes their therapy.

"It's our patients' biggest fear, and it happens to a surprisingly large number of people," said Mark G. Kris, MD, chief of the thoracic oncology service at Memorial Sloan-Kettering Cancer Center. "I am really hopeful that this drug will get out to the tens of thousands of people who aren't getting it now."

Emend for Injection makes providing the drug easier for oncologists and this should result in greater use of its intravenous form, Dr. Kris told ONI. Although oral Emend won approval in 2003, it has received comparatively little use because oncology offices often don't stock or dispense oral medications, and some institutions bar patients from bringing in drugs from the outside.

Easier for oncologists

"Oncology offices are set up to give intravenous drugs," Dr. Kris said. "Having another IV product to give with IV chemotherapy is going to make it a lot easier for oncologists, and I think a lot more oncologists are going to be using Emend for Injection in their offices."

Biologically equivalent

FDA granted marketing approval to Emend for Injection on the basis of a trial in healthy volunteers that demonstrated that the 115 mg intravenous drug was biologically equivalent to 125 mg of oral Emend. In this study, adverse events, regardless of causality, included pain at the infusion site (7.6%), infusion site indurations (1.5%), and headache (3%).

Because the drug's efficacy results from its conversion to aprepitant, patients are likely to experience common side effects associated with oral Emend. These include fatigue, hiccups, constipation, diarrhea, and loss of appetite and hair.

When substituted for oral Emend, the injectable agent is administered over 15 minutes beginning 30 minutes prior to the initiation of chemotherapy. On the following 2 days, patients take 80 mg of oral Emend daily, accompanied by a corticosteroid and a 5-HT3 antagonist.