General Information

Sancuso is a transdermal elective 5-hydroxytryptamine3 (5-HT3) receptor antagonist with little or no affinity for other serotonin receptors. During chemotherapy that induces vomiting, mucosal enterochromaffin cells release serotonin, which stimulates 5-HT3 receptors. The 5-HT3 antagonists prevent serotonin from binding to 5-HT3 receptors, thus preventing nausea and vomiting.

Sancuso is specifically indicated for the prevention of nausea and vomiting in patients receiving moderately and/or highly emetogenic chemotherapy regimens of up to five consecutive days duration.

Mechanism of Action

Sancuso is a transdermal elective 5-hydroxytryptamine3 (5-HT3) receptor antagonist with little or no affinity for other serotonin receptors. During chemotherapy that induces vomiting, mucosal enterochromaffin cells release serotonin, which stimulates 5-HT3 receptors. The antiemetic effects of the antagonist are postulated to stem from blockade of these 5-HT3 receptors, which are located on the nerve terminals of the vagus in the periphery and centrally in the chemoreceptor trigger zone of the area postrema.

Side Effects

Adverse events associated with the use of Sancuso may include, but are not limited to, the following:

• abdominal pain
• diarrhea
• hypertension
• hypotension
• dizziness
• insomnia
• headache

Dosing/Administration

Sancuso is supplied as a patch containing 34.3 mg of granisetron; it releases 3.1 mg of granisetron per 24 hours for up to seven days. Sancuso is designed for transdermal application. The patch should be applied to the upper outer arm a minimum of 24 hours and maximum of 48 hours prior to chemotherapy. The patch should be removed a minimum of 24 hours following chemotherapy and may be worn for up to seven days, depending on the duration of the chemotherapy regimen.

Clinical Trial Results

FDA approval of Sancuso was based on the results of a phase 3 study. This randomized, parallel group, double-blind, double-dummy study enrolled 641 subjects receiving moderately (ME) or highly emetogenic (HE) multi-day chemotherapy, across international sites. The patch was applied 24 to 48 hours before the first dose of chemotherapy and kept in place for seven days. Oral granisetron (2 mg) was administered daily for the duration of the chemotherapy regimen one hour before each dose of chemotherapy. The primary endpoint was the proportion of subjects achieving no vomiting/retching, only mild nausea and no rescue medication from the first administration until 24 hours after the start of the last day’s administration of multi-day chemotherapy. Efficacy was established in 60.2 percent of subjects in the Sancuso arm and 64.8 percent of subjects receiving oral granisetron (difference -4.89 percent; 95 percent confidence interval -12.91 percent to +3.13 percent).