| Important Safety Information |
| 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. |
| CONTRAINDICATIONS |
| 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: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
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: 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 1-833-Sancuso or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. |
| Please see full Prescribing information |
| CINV = chemotherapy-induced nausea and vomiting |
| References: |
| 1. |
Sancuso [package insert]. Bedminster, NJ, Cumberland Pharmaceuticals, Inc. |
|
| 2. |
Mason JW, Moon TE. Use and cardiovascular safety of transdermal and other granisetron preparations in cancer management, Cancer Manag Res. 2013;5:179-185. |
|
| 3. |
NCCN Clinical Practice Guidelines in Oncology. Antiemesis.V1.2023. |
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| © 2023 Cumberland Pharmaceuticals Inc. Nashville TN. All rights reserved. |
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