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|Heron Therapeutics Announces Inclusion of SUSTOL® (Granisetron) Extended-Release Injection in NCCN® Antiemesis Guidelines|
- SUSTOL Granted Category 1 Recommendation for Use in Patients Receiving Highly or Moderately Emetogenic Chemotherapy (HEC or MEC)
- Identified as a “Preferred” Agent for Preventing CINV Following MEC
The NCCN has given SUSTOL a Category 1 recommendation, the highest level category of evidence and consensus, for use in the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) in patients receiving HEC or MEC regimens. Importantly, the guidelines identify SUSTOL as a “preferred” agent for preventing CINV following MEC. Further, the guidelines highlight the unique, extended-release formulation of SUSTOL.
“Unfortunately, CINV remains an all too common reality associated with
modern-day cancer treatment, and novel agents that can prevent or reduce
the severity of this debilitating chemotherapy side effect have the
potential to not only improve the quality of life of patients, but also
enable patients to complete potentially life-saving treatment,” said
Barry D. Quart, Pharm.D., Chief Executive Officer of
NCCN is a not-for-profit alliance that includes 27 of the world’s leading cancer institutions. The NCCN Guidelines document evidence-based, consensus-driven management to ensure that all patients receive preventive, diagnostic, treatment, and supportive services that are most likely to lead to optimal outcomes.
SUSTOL was approved by the
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.
Please see accompanying Full Prescribing Information at www.SUSTOL.com
About Chemotherapy-Induced Nausea and Vomiting (CINV)
While chemotherapy is one of the most effective and common used
therapies to help patients fight cancer, it is accompanied by
debilitating side effects, including varying degrees of nausea and
vomiting, often attributed as a leading cause of premature
discontinuation of cancer treatment. Delayed nausea and vomiting, which
occurs 2-5 days following chemotherapy treatment, is considered
particularly debilitating for patients. The National Comprehensive
Cancer Network (NCCN) and the
This news release contains "forward-looking statements" as defined by
the Private Securities Litigation Reform Act of 1995. Heron cautions
readers that forward-looking statements are based on management’s
expectations and assumptions as of the date of this news release and are
subject to certain risks and uncertainties that could cause actual
results to differ materially, including, but not limited to, those
associated with the potential market opportunity for SUSTOL and other
risks and uncertainties identified in the Company's filings with the
Heron Therapeutics, Inc.