Efficacy

Efficacy

(Use Core Vis Aid Graphics and Language)

          1. Sancuso Keeps Them Covered: Consistent and Predictable Through 5 Days1,2

            [Graphic from vis aid]

            In the phase 3 trial, the primary endpoint was complete control, which is defined as no vomiting/retching, no more than mild nausea, and no rescue medication needed from first dose to 24 hours after last dose of chemotherapy.1

            Study Design: Phase 3 trial of 637 adult patients with cancer randomized to either SANCUSO patch applied 2 to 4 days prior to multiday moderately emetogenic (ME) or highly emetogenic (HE) chemotherapy + placebo oral capsule (capsule each day of ME/HE administration) or placebo patch + granisetron oral capsule (capsule each day of the ME/HE administration).

            Primary endpoint was the percentage of patients achieving complete control of CINV, defined as no vomiting and/or retching plus no more than mild nausea and no rescue medication from first administration until 24 hours after the last administration of ME/HE multiday chemotherapy.3

            Patients received moderately emetogenic chemotherapy and highly emetogenic chemotherapy multiday (3-5) regimens3

            71% of patients received platinum-based regimens (cisplatin)372% of patients were receiving chemotherapy for the first time3CINV=chemotherapy-induced nausea and vomiting.

          2. Sancuso Keeps Them Covered: Consistent and Predictable Through 5 Days4

            Bioavailability of Sancuso vs Oral Granisetron 2 mg Dosing4[Graphic from vis aid]

            Study design: Phase 1 pharmacokinetic study of 12 healthy white male subjects who were randomly assigned to a sequence of treatments, either oral granisetron (2 mg) for 5 days or the 52 cm2 transdermal patch (34.3 mg granisetron) for 5 days.4,5

            SANCUSO avoids the peak-trough fluctuations in blood levels seen with daily oral granisetron5

            Smooth daily granisetron levels vs daily variability with oral granisetron5Maintains steady control, even through hours 24 to 1205

            The most common adverse event in patients receiving SANCUSO is constipation (3.0%)1

          3. When Should You Consider Sancuso

            A Transdermal Option for Patients Who Are Unable to Take or Retain Daily Oral Antiemetics

            [Graphic from vis aid]

            Nausea and vomiting are 2 of the biggest fears of chemotherapy patients22

            Effective control of CINV during patients’ initial chemotherapy correlates with control of delayed emesis in subsequent cycles22

            If antiemetic failure occurs during patients’ initial chemotherapy, a patient is more likely to experience delayed emesis in the same cycle22

          4. NCCN Guideline Summary – HEC6

            SANCUSO may be used as the 5-HT3 RA in the preferred regimen [Graphic from vis aid]

          5. Patients with Breast and Ovarian Cancer Are at Particular Risk for CINV20

Rates of CINV in Breast Cancer Trials (% of patients)20

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Breast cancer patient with previous pregnancy nausea are at greater risk for emesis21

References

1. Sancuso [package insert], Bedminster, NJ; Kyowa Kirin, Inc. 2. Data on file. Kyowa Kirin, Inc. 3. Boccia RV, Gordan LN, Clark G, Howell JD, Grunberg SM; on behalf of the SANCUSO Study Group. Efficacy and tolerability of transdermal granisetron for the control of chemotherapy-induced nausea and vomiting associated with moderately and highly emetogenic multi-day chemotherapy: a randomized, double-blind, phase III study. Support Care Cancer. 2011;19(10):1609-1617. 4. Howell J, Mason JW, Guillory G, Donachie P. Cardiac safety of a granisetron transdermal system in the treatment of chemotherapy-induced nausea and vomiting. Poster presented at: the 8th Annual Conference of the Hematology/Oncology Pharmacy Association; March 21-24, 2012; Orlando, FL. 5. Mason JW, Moon TE. Use and cardiovascular safety of transdermal and other granisetron preparations in cancer management. Cancer Manag Res. 2013;5:179-185. 6. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Antiemesis. Version 2.2020. 7. Lalla RV, Bowen J, Barasch A, et al. MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy. Cancer. 2014;120:1453-1461. 8. Cawley MM, Benson LM. Current trends in managing oral mucositis. Clin J Oncol Nurs. 2005;9(5):584-592. 9. Di Lorenzo C, Youssef NN. Diagnosis and management of intestinal motility disorders. Semin Pediatr Surg. 2010;19:50-58. 10. Keller J, Layer P. Intestinal and anorectal motility and functional disorders. Best Pract Res Clin Gastroenterol. 2009;23:407-423. 11. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®), Head and Neck Cancer. Version 2.2020. 12. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Breast Cancer. Version 5.2020. 13. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Non-Small Cell Lung Cancer. Version 6.2020. 14. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Gastric Cancer. Version 2.2020. 15. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Cervical Cancer. Version 1.2020. 16. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Ovarian Cancer Including Fallopian Tube Cancer and Primary Peritoneal Cancer. Version 1.2020. 17. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Testicular Cancer. Version 3.2020. 18. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Colon Cancer. Version 4.2020. 19. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Rectal Cancer. Version 6.2020. 20. Booth CM, Clemmons M, Dranitsaris G, et al. Chemotherapy-induced nausea and vomiting in breast cancer patients:  a prospective observational study. J Support Oncol. 2007;5:374-380. 21. Warr DG, Street JC, Caridos AD. Evaluation of risk factors predictive of nausea and vomiting with current standard-of-care antiemetic treatment: analysis of phase 3 trial of aprepitant in patients receiving Adriamycin-cyclophosphamide-based chemotherapy. Support Care Cancer. 2011;19:807-813. 22. Schnell FM. Chemotherapy-induced nausea and vomiting: the importance of acute antiemetic control. Oncologist. 2003;8(2):187-198. 23. Weingart S,  Brown E,  Bach PB, et al. NCCN Task Force Report: Oral chemotherapy. J Natl Compr Canc Netw. 2008;6 (Suppl 3):S1-S14. 24. Navari RM. Treatment of breakthrough and refractory chemotherapy-Induced nausea and vomiting. Biomed Res Int. 2015;2015:595894. 25. Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005;353:487-497. 

INDICATIONS AND USAGE

SANCUSO® (granisetron transdermal system) is indicated for the prevention of nausea and vomiting in adults receiving moderately and/or highly emetogenic chemotherapy regimens of up to 5 consecutive days.


CONTRADICTIONS

Sancuso is contraindicated in patients with known hypersensitivity to granisetron or to any of the components of the transdermal system.


WARNINGS AND PRECAUTIONS
  • Progressive Ileus and Gastric Distention: Sancuso may mask a progressive ileus and/or gastric distention. This should be particularly considered before use of Sancuso in patients who have had recent abdominal surgery. Monitor for decreased bowel activity, particularly in patients with risk factors for gastrointestinal obstruction.
  • Serotonin Syndrome: The development of serotonin syndrome has been reported with 5-HT3 receptor antagonists. Patients should be monitored for the emergence of serotonin syndrome, especially with concomitant use of Sancuso and other serotonergic drugs.
  • If symptoms of serotonin syndrome occur, discontinue Sancuso and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if Sancuso is used concomitantly with other serotonergic drugs. Skin Reactions: In clinical trials with Sancuso, application site reactions were reported that were generally mild in intensity and did not lead to discontinuation of use. The incidence of reactions was comparable with placebo. If severe reactions, or a generalized skin reaction occur (e.g., allergic rash, including erythematous, macular, papular rash or pruritus), remove the Sancuso transdermal system.
  • Increased Drug Exposure with Use of External Heat Sources: Prolonged exposure to heat results in increasing plasma concentrations of granisetron during the period of heat exposure. Do not apply a heat pad or heat lamp over or in the vicinity of the Sancuso transdermal system and avoid extended exposure to heat.
  • Phototoxicity with Ultraviolet Light Exposure: Granisetron may be affected by direct natural or artificial sunlight, including sunlamps. An in vitro study using Chinese hamster ovary cells suggests that granisetron has the potential for photogenotoxicity. To avoid a potential skin reaction, advise patients to cover the application site of the transdermal system with clothing if there is a risk of exposure to direct natural or artificial sunlight throughout the period of wear and for 10 days following its removal.

Adverse Reactions

The most common adverse reaction (≥ 3%) is constipation.

You are encouraged to report suspected adverse reactions to Cumberland Pharmaceuticals Inc. at 1-800-Sancuso or FDA at 1-800-FDA-1088 or www.fda.gov/ medwatch.

See full Prescribing Information for SANCUSO.