FDA Approves Emend (fosaprepitant dimeglumine) for Injection, Merck's New Intravenous Therapy

Jan 29, 2008 - Merck & Co., Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved EMEND(R) (fosaprepitant dimeglumine) for Injection, a new intravenous therapy for the prevention of chemotherapy-induced nausea and vomiting (CINV). EMEND for Injection is an intravenous prodrug of the oral formulation of EMEND(R) (aprepitant), which means that when EMEND for Injection is administered, fosaprepitant is rapidly converted in the body to aprepitant. EMEND for Injection is approved for use in combination with other antiemetic medicines for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic and highly emetogenic cancer chemotherapy, including high-dose cisplatin.

EMEND for Injection (115 mg) provides a new option for patients receiving an antiemetic on Day 1 of their chemotherapy. EMEND for Injection (115 mg) may be substituted for the 125 mg oral capsule of EMEND on Day 1 and is administered 30 minutes prior to the initiation of chemotherapy over a 15-minute period. The three-day antiemetic regimen includes EMEND for Injection (115 mg) or EMEND (125 mg orally) on Day 1; EMEND (80 mg orally) on Days 2 and 3; in addition to a corticosteroid and a 5-HT3 antagonist.

"Nausea and vomiting are among the top concerns that people have when they receive chemotherapy and, to an oncologist, are very important to control," said Lee Schwartzberg, M.D., clinical oncologist and professor of medicine at the University of Tennessee Health Science Center. "While the oral formulation of EMEND is appropriate for many patients, the approval of EMEND for Injection provides healthcare professionals and their patients with a new option in helping to prevent nausea and vomiting caused by chemotherapy."

The FDA approval for EMEND for Injection was based on a study that showed 115 mg of intravenous EMEND for Injection was biologically equivalent to 125 mg of oral EMEND. Adverse events reported in the study, regardless of causality, included infusion site pain (7.6 percent), infusion site induration (1.5 percent) and headache (3 percent). Because EMEND for Injection is converted to aprepitant, common side effects observed with oral EMEND might also be expected to occur with EMEND for Injection, including tiredness, nausea, hiccups, constipation, diarrhea, loss of appetite, headache and hair loss.