Granisetron Transdermal System

Sancuso is granisetron delivered via a transdermal patch system for the prevention of nausea and vomiting resulting from chemotherapy for cancer. Other formulations of granisetron (for example, Kytril) are administered by mouth or injection. Certain chemotherapeutic agents used for treating cancer stimulate the release of a neurotransmitter called serotonin from nerves in the brain. Neurotransmitters are chemicals that nerves use to communicate with one another. Released serotonin binds to other nerves in an area of the brain called the chemoreceptor trigger zone, causing nausea and vomiting. Granisetron, the active ingredient in Sancuso, prevents serotonin from binding to nerves in the chemoreceptor trigger zone thereby preventing nausea and vomiting. The FDA approved Sancuso in September 2008.

Dosage Forms And Strengths

Sancuso is a 52 cm² patch containing 34.3 mg of granisetron. The patch releases 3.1 mg of granisetron per 24 hours for up to 7 days.

Storage And Handling

Sancuso (Granisetron Transdermal System) is supplied as a 52 cm² patch containing 34.3 mg of granisetron. Each patch is printed on one side with the words “Granisetron 3.1 mg/24 hours”. Each patch is packaged in a separate sealed foil-lined plastic pouch.

Sancuso is available in packages of 1 (NDC 42747-726-01) patch.

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.

Manufactured by: 3M Drug Delivery Systems, St. Paul, MN 55107. Manufactured for: ProStrakan Inc., Bedminster, NJ 07921. Revised: Sep 2015

Granisetron blocks the actions of chemicals in the body that may cause nausea and vomiting.

Granisetron transdermal (skin patch) is used to prevent nausea and vomiting caused by cancer chemotherapy.

Granisetron may also be used for other purposes not listed in this medication guide.

You should not use this medication if you are allergic to granisetron.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using transdermal granisetron, tell your doctor if you have:

• a stomach or intestinal disorder;
• if you have recently had stomach or intestinal surgery; or
• if you have ever had an allergic reaction to any type of medicated skin patch.

FDA pregnancy category B. Granisetron is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether granisetron passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not use transdermal granisetron on anyone younger than 18 years old.

Avoid exposing the skin patch or your upper arm to sunlight, sunlamps, or tanning beds. Natural or artificial sunlight can cause a skin reaction where the granisetron skin patch is worn. This effect may last for up to 10 days after the patch is removed. Wear protective clothing over your arms while you are wearing the skin patch and for at least 10 days after you remove a patch.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The safety of Sancuso was evaluated in a total of 404 patients undergoing chemotherapy who participated in two double-blind, comparator studies with patch treatment durations of up to 7 days. The control groups included a total of 406 patients who received a daily dose of 2 mg oral granisetron, for 1 to 5 days.

Adverse reactions occurred in 8.7% (35/404) of patients receiving Sancuso and 7.1% (29/406) of patients receiving oral granisetron. The most common adverse reaction was constipation that occurred in 5.4% of patients in the Sancuso group and 3.0% of patients in the oral granisetron group.

Table 1 lists the adverse reactions that occurred in at least 3% of patients treated with Sancuso or oral granisetron.

Table 1: Incidence of Adverse Reactions in Double-Blind, Active Comparator Controlled Studies in Cancer Patients Receiving Chemotherapy (Events ≥ 3% in either group)

5-HT3 receptor antagonists, such as granisetron, may be associated with arrhythmias or ECG abnormalities. Three ECGs were performed on 588 patients in a randomized, parallel group, double-blind, double-dummy study: at baseline before treatment, the first day of chemotherapy, and 5 to 7 days after starting chemotherapy. QTcF prolongation greater than 450 milliseconds was seen in a total of 11 (1.9%) patients after receiving granisetron, 8 (2.7%) on oral granisetron, and 3 (1.1%) on the patch. No new QTcF prolongation greater than 480 milliseconds was observed in any patient in this study. No arrhythmias were detected in this study.

Adverse reactions reported in clinical trials with other formulations of granisetron include the following:

Gastrointestinal: abdominal pain, diarrhea, constipation, elevation of ALT and AST levels, nausea and vomiting

Cardiovascular: Hypertension, hypotension, angina pectoris, atrial fibrillation and syncope have been observed rarely

Central Nervous System: dizziness, insomnia, headache, anxiety, somnolence and asthenia

Hypersensitivity: rare cases of hypersensitivity reactions, sometimes severe (e.g. anaphylaxis, shortness of breath, hypotension, urticaria) have been reported

Other: fever; events often associated with chemotherapy have also been reported: leucopenia, decreased appetite, anemia, alopecia, thrombocytopenia.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Sancuso. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

General Disorders and Administration Site Conditions: Application site reactions (pain, pruritus, erythema, rash, irritation, vesicles, burn, discoloration, urticaria); patch non-adhesion)

Cardiac Disorders: bradycardia, chest pain, palpitations, sick sinus syndrome

Read the entire FDA prescribing information for Sancuso (Granisetron Transdermal System)

• Tell all of your health care providers that you take granisetron transdermal system. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid using a heating pad or other heating devices on the treated area.
• Avoid sun, sunlamps, and tanning beds. This medicine may not work as well or may cause skin irritation. Keep the patch covered with clothing. Keep the skin where the patch was used covered for 10 days after you take it off. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Hard stools (constipation).
• Headache.
• Feeling tired or weak.
• Loose stools (diarrhea).
• Dizziness.
• Not able to sleep.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about granisetron transdermal system, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about granisetron transdermal system. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using granisetron transdermal system.

Review Date: October 4, 2017