Princeton, New Jersey, January 4, 2017– Sandoz today announced the U.S. market introduction of aprepitant capsules, 40mg, 80mg, and 125mg, a generic version of Emend®1 by Merck Sharp & Dohme Corp.
Aprepitant is prescribed for patients 12 years of age and older, in combination with other antiemetic agents to help prevent nausea and vomiting caused by certain chemotherapy medicines. It is also prescribed for adults to prevent nausea and vomiting after surgery. Aprepitant is not used for established nausea and vomiting. Aprepitant is not for chronic continuous administration.
“Sandoz is the first company to offer a generic of Emend capsules, which demonstrates our passion for bringing high-quality generic medicines to patients and health care professionals,” said Peter Goldschmidt, President of Sandoz Inc. “This launch complements our portfolio of medicines that address the side effects of cancer therapy, while offering cost savings to patients and health systems.”
According to IMS Health, U.S. sales for Emend were approximately USD 62m for the 12 months ending in Oct 2016.
Important Safety Information
Aprepitant is contraindicated in patients who are allergic to the any component of the drug, and for those patients who are concurrently taking pimozide. Before taking aprepitant, patients should tell their healthcare provider if they have liver problems, are pregnant or plan to become pregnant, breastfeeding or planning to breastfeed, or if they take birth control medicines containing hormones to prevent pregnancy.
Side-effects include (in adults taking aprepitant to prevent nausea and vomiting caused by chemotherapy) tiredness, diarrhea, weakness, indigestion, stomach (abdominal) pain, hiccups, decrease in white blood cell count, dehydration, and changes in liver function tests. In adults taking aprepitant to prevent nausea and vomiting after surgery, the most common side effects include constipation and low blood pressure (hypotension).
Full prescribing information is available at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=696f9e80-9cae-403b-de9e- 078343ce4713
You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
