Sustol FDA Approval History
Last updated by Judith Stewart, BPharm on March 2, 2021.
FDA Approved: Yes (First approved August 9, 2016)
Brand name: Sustol
Generic name: granisetron
Dosage form: Extended-Release Injection
Company: Heron Therapeutics, Inc.
Treatment for: Nausea/Vomiting, Chemotherapy Induced
Sustol (granisetron) is a long-acting 5-HT3 antagonist indicated for the prevention of chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens.
Granisetron was first approved by the FDA in 1993 and is available generically in oral tablet and injection formulations.
Sustol injection is administered by a healthcare practitioner subcutaneously over 20 to 30 seconds. It is given in combination with dexamethasone at least 30 minutes before the start of chemotherapy, on the first day of the chemotherapy cycle. The long acting formulation is intended to last at least five days, covering both the acute and delayed phases of CINV.
Common side effects include injection site reactions (infections, bruising, pain, tenderness), constipation, fatigue, headache, diarrhea, abdominal pain, insomnia, dyspepsia, dizziness, asthenia, and gastroesophageal reflux.
Development timeline for Sustol
Further information
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