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General Information

Syndros is an orally administered liquid formulation of the pharmaceutical cannabinoid dronabinol, a pharmaceutical version of tetrahydrocannabinol ("THC"). Dronabinol has complex effects on the CNS, including central sympathomimetic activity. Cannabinoid receptors have been discovered in neural tissues. These receptors may play a role in mediating the effects of dronabinol.

Syndros is specifically indicated for 1) anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (AIDS); and 2) nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.

Syndros is supplied as a solution for oral administration. The recommended dose is as follows:

Anorexia Associated with Weight Loss in Adult Patients with AIDS:

Starting Dosage: The recommended adult starting dosage of Syndros is 2.1 mg orally twice daily, one hour before lunch and one hour before dinner. In elderly patients, consider initiating Syndros at 2.1 mg once daily one hour before dinner or at bedtime to reduce the risk of central nervous system (CNS) symptoms. Dosing later in the day may reduce the frequency of CNS adverse reactions.

Dosage Titration: If tolerated and further therapeutic effect is desired, the dosage may be increased gradually to 2.1 mg one hour before lunch and 4.2 mg one hour before dinner. Increase the dose of Syndros gradually in order to reduce the frequency of dose-related adverse reactions. Most patients respond to 2.1 mg twice daily, but the dose may be further increased to 4.2 mg one hour before lunch and 4.2 mg one hour before dinner, as tolerated to achieve a therapeutic effect. The maximum dosage is 8.4 mg twice daily.

Nausea and Vomiting Associated with Cancer Chemotherapy in Adult Patients Who Failed Conventional Antiemetics:

Starting Dosage: The recommended starting dosage of Syndros is 4.2 mg/m2 orally administered 1 to 3 hours prior to chemotherapy and then every 2 to 4 hours after chemotherapy for a total of 4 to 6 doses per day. In elderly patients, consider initiating Syndros at 2.1 mg/m2 once daily 1 to 3 hours prior to chemotherapy to reduce the risk of CNS symptoms. Because food delays the absorption of Syndros, administer the first dose on an empty stomach at least 30 minutes before eating. Subsequent doses can be taken without regard to meals. Because food can substantially change the systemic exposure to dronabinol and its active metabolite, the timing of dosing in relation to meal times should be kept consistent for each chemotherapy cycle, once the dosage has been determined from the titration process.

Dosage Titration: The dosage can be titrated to clinical response during a chemotherapy cycle or subsequent cycles, based upon initial effect, as tolerated to achieve a clinical effect, in increments of 2.1 mg/m2 . The maximum dosage is 12.6 mg/m2 per dose for 4 to 6 doses per day. Monitor patients for adverse reactions and consider decreasing the dose to 2.1 mg once daily 1 to 3 hours prior to chemotherapy to reduce the risk of CNS adverse reaction.

Clinical Results

FDA Approval

The effectiveness of Syndros has been established based on studies of dronabinol capsules for the treatment of anorexia associated with weight loss in patients with AIDS and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.