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SUSTOL—advanced, extended-release technology designed to provide full 5-day CINV prevention*1
The problem
  • 5-HT3 RAs with shorter duration of action may not protect patients from both acute and delayed CINV2,3
  • Some patients rapidly clear 5-HT3 RAs and may therefore derive a shorter duration of benefit4,5
    • Although CINV risk is multifactorial, these patients may be particularly vulnerable to breakthrough CINV during the delayed phase (days 2-5)4
The SUSTOL solution
  • SUSTOL incorporates 10 mg granisetron into an advanced, extended-release polymer formulation1,6
  • After subcutaneous injection, the polymer undergoes controlled hydrolysis, resulting in a slow and sustained release of granisetron over a period of ≥5 days, covering both the acute and delayed phases of CINV1,6
After a single subcutaneous injection of SUSTOL, therapeutic levels of granisetron were maintained ≥5 days post-administration1
Plasma concentration of granisetron
* SUSTOL is indicated for the prevention of CINV due to MEC and AC combination chemotherapy.1
Based on pharmacokinetic data collected from SUSTOL clinical trials.1,6
Following a single subcutaneous injection of SUSTOL in 142 healthy volunteers, granisetron was released from the polymer depot by controlled hydrolysis and diffusion over a period of 5 or more days.

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. Aloxi [package insert]. Eisai Inc., Woodcliff Lake, NJ; December 2015.
  3. Zofran [package insert]. GlaxoSmithKline, Research Triangle Park, NC; September 2014.
  4. Bernard S, Neville KA, Nguyen AT, Flockhart DA. Interethnic differences in genetic polymorphisms of CYP2D6 in the U.S. population: clinical implications. Oncologist. 2006;11:126-135
  5. Belle DJ, Singh H. Genetic factors in drug metabolism. Am Fam Physician. 2008;77:1553-1560.
  6. 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.
  7. Howell J, Smeets J, Drenth HJ, Gill D. Pharmacokinetics of a granisetron transdermal system for the treatment of chemotherapy-induced nausea and vomiting. J Oncol Pharm Pract. 2009;15:223-231.




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.