Dosing and Administration
Dosing and Administration
DOSAGE AND ADMINISTRATION
The recommended dosage is a single transdermal system applied to the upper outer arm a minimum of 24 hours, up to a maximum of 48 hours, before chemotherapy. The transdermal system should be worn at minimum, 24 hours after chemotherapy is finished. The transdermal system can be worn for up to 7 days.
Application and Removal Instructions
Each transdermal system releases 3.1 mg of granisetron per 24 hours for up to 7 days.
Each transdermal system is packed in a pouch and should be applied directly after the pouch has been opened.
Only wear one transdermal system at any time. Do not cut the transdermal system.
Open the pouch and apply the transdermal system to clean, dry, nearly hairless, intact healthy skin on the upper outer arm.
Do not place Sancuso transdermal system on skin that is red, irritated, or damaged.
Do not apply a heat pad or heat lamp over or in vicinity of the transdermal system and avoid extended exposure to heat [see Warnings and Precautions (5.4)].
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 [see Warnings and Precautions (5.5)].
After the transdermal system is applied, wash hands thoroughly. Remove the transdermal system by peeling off gently from the skin.
Upon removal, fold the transdermal system in half with the sticky side together, and discard in the household trash in a manner that prevents accidental contact or ingestion by children, pets or others.
Sancuso contains granisetron. Do not use other granisetron-containing products with Sancuso.
3 DOSAGE FORMS AND STRENGTHS
Transdermal System: a 52 cm2 thin, translucent, rectangular-shaped transdermal system with rounded corners imprinted on one side with “Granisetron 3.1 mg/24 hours”. The transdermal system releases 3.1 mg of granisetron per 24 hours for up to 7 days
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.