SANCUSO (Page 4 of 5)

13.3 Phototoxicity

When tested for potential photogenotoxicity in vitro in a Chinese hamster ovary (CHO) cell line, at 200 and 300 mcg/mL, granisetron increased the percentage of cells with chromosomal aberration following photoirradiation [see Warnings and Precautions (5.5)].

Granisetron was not phototoxic when tested in vitro in a mouse fibroblast cell line. When tested in vivo in guinea-pigs, Sancuso transdermal system did not show any potential for photoirritation or photosensitivity. No phototoxicity studies have been performed in humans.

14 CLINICAL STUDIES

The effectiveness of Sancuso in the prevention of chemotherapy-induced nausea and vomiting (CINV) was evaluated in a randomized, parallel group, double-blind, double-dummy study conducted in the U.S. and abroad. The study compared the efficacy, tolerability and safety of Sancuso transdermal system with that of 2 mg oral granisetron once daily in the prevention of nausea and vomiting in a total of 641 patients receiving multi-day chemotherapy.

The population randomized into the trial included 48% males and 52% females aged 16 to 86 years receiving moderately emetogenic (ME) or highly emetogenic (HE) multi-day chemotherapy. Seventy-eight (78%) of patients were White, 12% Asian, 10% Hispanic/Latino and 0% Black.

Sancuso was applied 24 to 48 hours before the first dose of chemotherapy and kept in place for 7 days. Oral granisetron was administered daily for the duration of the chemotherapy regimen, 1 hour before each dose of chemotherapy. Efficacy was assessed from the first administration until 24 hours after the start of the last day’s administration of the chemotherapy regimen.

The primary endpoint of the trial was the proportion of patients achieving no vomiting and/or retching, no more than mild nausea and no rescue medication from the first administration until 24 hours after the start of the last day’s administration of multi-day chemotherapy. Using this definition, the effect of Sancuso was established in 60.2% of patients in the Sancuso arm and 64.8% of patients receiving oral granisetron (difference -4.89%; 95% confidence interval – 12.91% to +3.13%).

An assessment of transdermal system adhesion in 621 patients receiving either active or placebo transdermal system showed that less than 1% of transdermal systems became detached over the course of the 7 day period of transdermal system application.

16 HOW SUPPLIED/STORAGE AND HANDLING

Sancuso (granisetron transdermal system) is 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.

Each Sancuso transdermal system is packaged in a separate sealed foil-lined plastic pouch supplied in packages of 1 (NDC 42747-726-01) transdermal system.

Store at 20°-25°C (68°-77°F); excursions permitted between 15°-30°C (59°-86°F). [see USP Controlled Room Temperature].

Sancuso should be stored in the original packaging.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Progressive Ileus and Gastric Distention

Advise the patient to report new or worsening constipation to their healthcare provider and seek immediate medical care if symptoms of an ileus (pain or swelling in their abdomen) occur [see Warnings and Precautions (5.1)].

Serotonin Syndrome

Advise the patient of the possibility of serotonin syndrome with concomitant use of Sancuso and another serotonergic agent such as medications to treat depression and migraines. Advise the patient to seek immediate medical attention if the following symptoms occur: changes in mental status, autonomic instability, neuromuscular symptoms, with or without gastrointestinal symptoms [see Warnings and Precautions (5.2)].

Skin Reactions

Instruct the patient remove the transdermal system if they have a severe skin reaction, or a generalized skin reaction (e.g. allergic rash, including erythematous, macular, papular rash or pruritus) [see Warnings and Precautions (5.3)].

Increased Drug Exposure with Use of External Heat Sources

Advise the patient to avoid prolonged exposure to heat and not to apply a heat pad or heat lamp over or near the Sancuso transdermal system and avoid extended exposure to heat [see Warnings and Precautions (5.4)].

Phototoxicity with Ultraviolet Light Exposure

Advise the patient to avoid direct sunlight or exposure to sunlamps and to cover the application site of the transdermal system with clothing, if there is a risk of exposure to sunlight or sunlamps throughout the period of wear and for 10 days following its removal [see Warnings and Precautions (5.5)].

Application and Removal Instructions

Instruct the patient on how to apply and remove the transdermal system:

  • Only wear one transdermal system at any time.
  • Do not cut the transdermal system.
  • Apply the transdermal system to clean, dry, nearly hairless, intact healthy skin on the upper outer arm.
  • After the transdermal system is applied, wash hands thoroughly.
  • Remove the transdermal system by peeling off gently from the skin.
  • Upon removal, fold the used transdermal system in half with the sticky side together, and discard in 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 [see Dosage and Administration (2)].

Manufactured by:

Kindeva Drug Delivery L.P.
Northridge, CA 91324

Manufactured for:

Kyowa Kirin, Inc.
Bedminster, NJ 07921

Distributed by:

Cumberland Pharmaceuticals Inc.Nashville, TN 37203

Copyright © 2022, Kyowa Kirin, Inc. All rights reserved.

Sancuso and Kyowa Kirin are trademarks owned by the Kyowa Kirin group of companies.

This Patient Information has been approved by the U.S. Food and Drug Administration Revised: 12/2022
Patient Information SANCUSO® [san-KOO-so] (granisetron transdermal system) for transdermal use
Important: For skin use only.
Read the Patient Information that comes with SANCUSO before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. If you have any questions about SANCUSO, ask your healthcare provider.
What is SANCUSO? 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 leaflet 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 provider 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 bowel 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
  • seeing or hearing things that are not real (hallucinations)
  • confusion
  • coma
  • fast heart beat
  • changes in blood pressure
  • dizziness
  • sweating
  • flushing
  • high body temperature (hyperthermia)
  • shaking (tremors), stiff muscles, or muscle twitching
  • loss of coordination
  • seizures
  • 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 effects of SANCUSO include:
  • 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.
How should I store SANCUSO?
  • Store SANCUSO at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep SANCUSO in the original package it comes in.
Keep SANCUSO out of the reach of children.
General information about the safe and effective use of SANCUSO. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use SANCUSO for a condition for which it was not prescribed. Do not give SANCUSO to other people, even if they have the same symptoms that you have. It may harm them. This Patient Information leaflet summarizes the most important information about SANCUSO. You can ask your pharmacist or healthcare provider for information about SANCUSO that is written for health professionals.
Manufactured by:Kindeva Drug Delivery L.P.Northridge, CA 91324Manufactured for:Kyowa Kirin, Inc. Bedminster, NJ 07921Distributed by:Cumberland Pharmaceuticals Inc. Nashville, TN 37203For more information, go to www.sancuso.com or call 1-800-SANCUSO.Copyright © 2022, Kyowa Kirin, Inc. All rights reserved.Sancuso and Kyowa Kirin are trademarks owned by the Kyowa Kirin group of companies.

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