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FDA Approves Syndros for Chemo-Induced Nausea
Insys news release; 2016 Jul 5
The FDA has approved dronabinol oral solution (Syndros) for use in treating nausea and vomiting associated with cancer chemotherapy.
Indications: Syndros is approved for nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.
Dosage and administration: The recommended starting dosage is 4.2 mg/m2, administered 1 to 3 hours prior to chemotherapy, then every 2 to 4 hours after chemotherapy for a total of 4 to 6 doses per day.
Efficacy and safety: The effectiveness of Syndros has been established based on studies of dronabinol capsules for the treatment of nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.
Adverse reactions: Most common adverse reactions are dizziness, euphoria, paranoid reaction, somnolence, thinking abnormal, abdominal pain, nausea, and vomiting.
Insys Therapeutics Announces FDA Approval of Syndros [news release]. Phoenix, AZ: Insys Therapeutics Inc; July 5, 2016. https://www.pm360online.com/insys-therapeutics-announces-fda-approval-of-syndros/. Accessed July 22, 2016.
Syndros [package insert]. Chandler, AZ: Insys Therapeutics Inc 2016. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205525s000lbl.pdf. Accessed July 22, 2016.