Source: DGNews  |  Posted 4 years ago

WHITEHOUSE STATION, NJ -- January 29, 2008 -- 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 3-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.

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%), infusion site induration (1.5%) and headache (3%). 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.

New packaging for Emend capsules
In addition to the current three-dose oral regimen tri-pack containing one 125 mg capsule and two 80 mg capsules, a new two-dose bi-pack has been developed containing two 80 mg oral capsules of Emend. Emend for Injection will be packaged separately as a single-dose vial.

About Emend and Emend for Injection
Outside the United States, fosaprepitant dimeglumine is approved for use in the European Union and Australia, with marketing applications under review by a number of other regulatory agencies.

Emend and Emend for Injection belong to a class of medications called substance P/neurokinin 1 (NK-1) receptor antagonists and are believed to work through a novel mechanism, which primarily blocks nausea and vomiting signals to the brain. Emend (aprepritant) oral capsules are currently recommended as one part of standard antiemetic regimens to prevent the acute or delayed nausea and vomiting caused by specified chemotherapies by major clinical oncology treatment guidelines, including the American Society of Clinical Oncology (ASCO), the European Society for Medical Oncology (ESMO), the Multinational Association of Supportive Care in Cancer (MASCC) and the National Comprehensive Cancer Network (NCCN).

Emend(R) for Injection is a registered trademark of Merck & Co., Inc.

SOURCE: Merck & Co., Inc.