The Food and Drug Administration has issued an expanded indication for aprepitant (Emend) for the prevention of acute and delayed phases of chemotherapy-induced nausea and vomiting in patients 12-17 years old and in patients less than 12 years who weigh at least 66 lbs.
The approval is based on the results of a randomized, double-blind, active-comparator–controlled clinical study of 63 patients between 12 and 17 years of age, and 69 patients under the age of 12 years who weighed at least 66 pounds (30 kg). All patients were undergoing either highly or moderately emetogenic cancer chemotherapy and were put on a regimen of either ondansetron alone or ondensatron plus aprepitant, with intravenous dexamethasone administered at the physician’s discretion.
The primary outcome of no vomiting or retching and no use of rescue medication in the 25-120 hours following chemotherapy initiation was observed in 31 of 63 patients taking aprepitant plus ondensatron and in 13 of 69 patients taking ondensatron alone.
In the first 24 hours following chemotherapy initiation, 56% taking aprepitant plus ondensatron and 38% taking ondensatron alone achieved complete response. In the first 120 hours following chemotherapy initiation, 35% taking the combination and 13% taking ondensatron only had complete responses, according to a statement from Merck Research Laboratories.
Aprepitant is contraindicated for patients taking pimozide, as the CYP3A4 inhibitor in aprepitant can cause life-threatening, elevated plasma concentrations if taken with pimozide.
Serious adverse events associated with Emend should be reported to the FDA’s MedWatch program at 800-332-1088 or www.fda.gov/Safety/MedWatch/default.htm .
