Sustol Approved for Preventing Chemotherapy-Induced Nausea and Vomiting
August 10, 2016 – The FDA approved Sustol® (granisetron) extended-release injection. Sustol, manufactured by Heron Therapeutics is indicated for preventing chemotherapy-induced nausea and vomiting (CINV) that occurs both immediately after chemo and persists for several days after the chemo session ends. This patented extended-release formulation maintains therapeutic blood levels for five days or longer. It is a member of the serotonin-3 (5-HT3) receptor inhibitor class, and it will be used in combination with other drugs that also help to prevent CINV including dexamethasone. Recommended dosing for adults is 10mg given subcutaneously on the first day of chemotherapy at least one-half hour before chemotherapy begins. It is packaged in pre-filled, single-dose syringes that should be administered by a healthcare professional. Because Sustol is thicker than most injectables, it can take up to 30 seconds to inject. Additionally, it may be more likely to cause injection site reactions such as bruises, pain and swelling, which may not appear until several days after the injection. No more than one dose should be given per week and Sustol should be used for no longer than six consecutive months. Heron Therapeutics expects Sustol to launch in the fourth quarter of 2016.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.