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SUSTOL—ROBUST SAFETY PROFILE IN CLINICAL TRIALS INVOLVING >2400 PATIENTS1-3
Adverse reactions in SUSTOL-treated patients
Injection site reactions (ISRs) following a single 10 mg SUSTOL dose
  • All reactions occurring at ≥3% in the SUSTOL group in either trial.
  • The placebo subcutaneous injection for Study 1 was normal saline and for Study 2 was a SUSTOL-matched control consisting of the polymer vehicle without active drug.
  • All groups received dexamethasone.
  • <1% of patients treated with SUSTOL discontinued due to treatment-related side effects in a multi-cycle study4
  • ISR reporting in Trial 1 used only investigator reporting, whereas Trial 2 included both investigator reporting and daily patient diaries (days 1-5)1
  • SUSTOL had no significant effect on any electrocardiogram interval, including QTc duration, in clinical trials1
Nearly half of patients (48%) reported no ISRs, 39% reported mild ISRs, 10% reported moderate ISRs, and 3% reported severe ISRs4
SUSTOL injection site reactions
Patients pooled across Phase 2-3 studies (N=1144).4
  • The most common ISR was bruising; other ISRs included pain/tenderness, erythema, nodule, swelling, and capillary bleeding4
    • Severity was mostly based on size/appearance rather than functional impairment; no Grade 4 ISRs were reported
  • Frequency and severity of most ISRs decreased in subsequent cycles4
  • In the multi-cycle trial (Trial 1), fewer than 1% of patients discontinued treatment due to ISRs3

ISRs are related to SUSTOL subcutaneous delivery and viscous formulation—it is the polymer that provides sustained release of granisetron for proven 5-day CINV prevention§1,5

§ SUSTOL is indicated for the prevention of CINV due to MEC and AC combination chemotherapy.1

Indication

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.

Important Safety Information

Contraindications

SUSTOL is contraindicated in patients with hypersensitivity to granisetron, any of the components of SUSTOL, or any other 5-HT3 receptor antagonist.

Warnings and Precautions

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.

Use in Specific Populations

Avoid SUSTOL in patients with severe renal impairment. In patients with moderate renal impairment, administer SUSTOL not more frequently than once every 14 days.

Adverse Reactions

Most common adverse reactions (≥3%) are injection site reactions, constipation, fatigue, headache, diarrhea, abdominal pain, insomnia, dyspepsia, dizziness, asthenia, and gastroesophageal reflux.

For more information about SUSTOL, please see full Prescribing Information.

References:
  1. SUSTOL [package insert]. Heron Therapeutics, Inc., Redwood City, CA; August 2016.
  2. Gabrail N, Yanagihara R, Spaczynski M, et al. Pharmacokinetics, safety, and efficacy of APF530 (extended-release granisetron) in patients receiving moderately or highly emetogenic chemotherapy: results of two phase II trials. Cancer Manag Res. 2015;7:83-92.
  3. Data on File [C2006-01]. Heron Therapeutics, Inc., Redwood City, CA.
  4. Data on File [Summary of Clinical Safety]. Heron Therapeutics, Inc., Redwood City, CA.
  5. Ottoboni T, Gelder MS, O’Boyle E. Biochronomer™ technology and the development of APF530, a sustained release formulation of granisetron. J Exp Pharmacol. 2014;6:15-21.




Indication

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.

Important Safety Information

Contraindications

SUSTOL is contraindicated in patients with hypersensitivity to granisetron, any of the components of SUSTOL, or any other 5-HT3 receptor antagonist.

Warnings and Precautions

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.

Use in Specific Populations

Avoid SUSTOL in patients with severe renal impairment. In patients with moderate renal impairment, administer SUSTOL not more frequently than once every 14 days.

Adverse Reactions

Most common adverse reactions (≥3%) are injection site reactions, constipation, fatigue, headache, diarrhea, abdominal pain, insomnia, dyspepsia, dizziness, asthenia, and gastroesophageal reflux.

For more information about SUSTOL, please see full Prescribing Information.