FDA approves Sustol (granisetron) for the prevention of chemotherapy-induced nausea and vomiting
The U.S. Food and Drug Administration (FDA) has approved Sustol (granisetron) extended-release injection. Sustol is a serotonin-3 (5-HT3) receptor antagonist indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens.
Sustol is an extended-release, injectable 5-HT3 receptor antagonist that utilizes Herons Biochronomer polymer-based drug delivery technology to maintain therapeutic levels of granisetron for 5 days, covering both the acute and delayed phases of chemotherapy-induced nausea and vomiting (CINV). The Sustol global Phase 3 development program was comprised of two, large, guideline-based clinical trials that evaluated Sustols efficacy and safety in more than 2,000 patients with cancer. Sustols efficacy in preventing nausea and vomiting was evaluated in both the acute phase (day 1 following chemotherapy) and the delayed phase (days 2-5 following chemotherapy).
The Sustol clinical trial populations and results are highly representative of cancer patients in our real-world clinical practice, said Jeffrey Vacirca, MD, FACP, Chief Executive Officer and Director of Clinical Research, North Shore Hematology Oncology Associates and Vice President, Community Oncology Alliance.
About Sustol (granisetron) extended-release injection
Sustol is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. Sustol is an extended-release, injectable 5-HT3 receptor antagonist that utilizes Herons Biochronomer polymer-based drug delivery technology to maintain therapeutic levels of granisetron for 5 days.
Important safety information for Sustol
Sustol is contraindicated in patients with hypersensitivity to granisetron, any of the components of Sustol, or any other 5-HT3 receptor antagonist.
Injection site reactions (ISRs), including infection, bleeding, pain and tenderness, nodules, swelling, and induration, have occurred with Sustol. Monitor for ISRs following Sustol injection. Inform patients that some ISRs may occur 2 weeks or more after Sustol administration. In patients receiving antiplatelet agents or anticoagulants, consider the increased risk of bruising or severe hematoma prior to the use of Sustol.
Monitor for constipation and decreased bowel activity and consider optimizing patients current bowel regimens used for managing preexisting constipation. Instruct patients to seek immediate medical care if signs and symptoms of ileus occur.
Hypersensitivity reactions have been reported and may occur up to 7 days or longer following Sustol administration and may have an extended course. If a reaction occurs, administer appropriate treatment and monitor until signs and symptoms resolve.
Serotonin syndrome has been reported with 5-HT3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs. Avoid Sustol in patients with severe renal impairment. In patients with moderate renal impairment, administer Sustol not more frequently than once every 14 days.
Most common adverse reactions (3%) are injection site reactions, constipation, fatigue, headache, diarrhea, abdominal pain, insomnia, dyspepsia, dizziness, asthenia, and gastroesophageal reflux.
Source: drugs.com
