CINV still occurs despite established antiemetic treatment

~50% of patients experience a CINV event despite use of guideline-recommended antiemetic regimens1

Learn about 5-day efficacy

Data from a prospective observational study where 742 patients received guideline-adherent antiemetic treatment for single-day HEC or MEC at 4 oncology practice networks, all using EMR systems, in Georgia, Tennessee, and Florida.1

  • CINV event defined as emesis or clinically significant nausea on days 1-5.
  • Up to 50% of patients at 4 different community oncology practice networks across the US (n=742) still experienced a CINV event despite the use of guideline-recommended CINV regimens1
    • The guideline-recommended HEC regimen included a 5-HT3 RA + NK1 RA + dexamethasone; the MEC regimen included a 5-HT3 RA + dexamethasone1
    • 5-HT3 RA used: palonosetron (94%) or ondansetron (5%)1

Early control of CINV is important for future efficacy2

  • Patients with uncontrolled CINV at cycle 1 had 4 times the rate of anticipatory CINV prior to cycle 23
  • Antiemetics that provide broad coverage of acute and delayed CINV with proven efficacy should be preferred4
The high rates of CINV reveal the need for further improvements in 5-HT3 RAs
5-HT3 RA=5-hydroxytryptamine receptor antagonist; CINV=chemotherapy-induced nausea and vomiting; HEC=highly emetogenic chemotherapy; MEC=moderately emetogenic chemotherapy; NK1 RA=neurokinin 1 receptor antagonist.

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.

Report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Report side effects to Heron at 1-844-437-6611.

Please see full Prescribing Information, including Medication Guide.

References:
  1. Gilmore et al. J Oncol Pract. 2014.
  2. Schwartzberg et al. Am Health Drug Benefits. 2015.
  3. Aapro et al. Ann Oncol. 2006.
  4. Rapoport. Front Pharmacol. 2017.
  5. SUSTOL [prescribing information]. Heron Therapeutics, Inc., 2017.




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.

Report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Report side effects to Heron at 1-844-437-6611.

Please see full Prescribing Information, including Medication Guide.