Full Prescribing Information

  1. Full Prescribing Information


SANCUSO is a prescription medicine used to prevent nausea and vomiting in adults receiving anti-cancer (chemotherapy) treatment that causes moderate or severe vomiting.

SANCUSO is a skin patch (transdermal system) that slowly releases the medicine into your bloodstream while you wear the transdermal system.

It is not known if SANCUSO is safe and effective in children.

Who should not use SANCUSO?

Do not use SANCUSO if you are allergic to granisetron or any of the ingredients in SANCUSO. See the end of this page for a list of ingredients in SANCUSO.

What should I tell my healthcare provider before using SANCUSO?

  • Before using SANCUSO, tell your healthcare provider about all of your medical conditions, including if you:

    • have pain or swelling in your stomach area (abdomen).

    • are pregnant. It is not known if SANCUSO will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.

    • are breastfeeding or plan to breastfeed. It is not known if SANCUSO passes into your breast milk.

  • Tell your healthcare provide about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Other medicines may affect how SANCUSO works. SANCUSO may also affect how other medicines work. SANCUSO contains granisetron. Do not take other granisetron containing products with SANCUSO. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

    How should I use SANCUSO?

    Read the Instructions for Use that comes with SANCUSO transdermal system. Use SANCUSO exactly as your healthcare provider tells you to.

    What should I avoid while using SANCUSO?

  • Do not apply any heat source over or near the SANCUSO transdermal system

    • A heating pad or heat lamp should not be used where the transdermal system is applied.

    • You should avoid long periods of exposure to heat because heat can increase the amount of SANCUSO in your blood.

  • Avoid sunlight and artificial sunlight. The medicine in SANCUSO may not work as well and may affect your skin if exposed to direct sunlight or artificial sunlight from sunlamps or tanning beds.

    • Keep the transdermal system covered with clothing if you will be in direct sunlight or artificial sunlight.

    • Keep the skin where SANCUSO was applied covered for another 10 days after the transdermal system is taken off to protect from exposure to direct sunlight or artificial sunlight.

      What are the possible side effects of SANCUSO?

  • SANCUSO may cause serious side effects including:

    • Using SANCUSO may make it harder to identify certain stomach (abdomen) and bowl problems that are from other causes. Tell your healthcare provider if you have any abdominal pain or swelling while using SANCUSO.

    • Serotonin Syndrome. A potentially life-threatening problem called serotonin syndrome can happen if you use SANCUSO with certain medicines. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms of serotonin syndrome:

      • agitation

      • sweating

      • seeing or hearing things that are not real

      • flushing (hallucinations)

      • confusion

      • high body temperature (hyperthermia)

      • coma

      • shaking (tremors), stiff muscles, or muscle twitching

      • fast heart beat

      • loss of coordination

      • changes in blood pressure

      • seizures

      • dizziness

      • nausea, vomiting, diarrhea

    • Skin Reactions. Skin reactions can happen at the transdermal system application site or outside the transdermal system application site. Tell your healthcare provider if you get any redness, rashes, bumps, blisters or itching at or near the transdermal system application site, and especially if they spread outside the place where the transdermal system was applied or if they appear outside the transdermal system application site. You may need to stop using SANCUSO.

    • The most common side effect of SANCUSO is constipation.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of SANCUSO. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. See full patient information for SANCUSO.


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.


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

  • 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.