Sancuso

What is Sancuso used for?

Sancuso is a prescription medicine that is used to prevent upset stomach and throwing up.

Description

Sancuso contains granisetron, which is a serotonin-3 (5-HT3) receptor antagonist. Chemically it is 1-methyl-N-[(1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide with a molecular weight of 312.4. Its empirical formula is C18H24N4O, while its chemical structure is:

Granisetron

Granisetron is a white to off-white solid that is insoluble in water. The inactive ingredients are acrylate-vinylacetate copolymer, polyester, titanium dioxide, polyamide resin and polyethylene wax. Sancuso is a 52 cm2 thin, translucent, matrix-type transdermal system that is rectangular- shaped with rounded corners, consisting of a backing (polyester), the drug matrix (acrylate- vinylacetate copolymer) and a release liner (siliconized polyester).

Mechanism of Action

Granisetron is a selective 5-hydroxytryptamine3 (5-HT3) receptor antagonist with little or no affinity for other serotonin receptors, including 5-HT1, 5-HT1A, 5-HT1B/C, 5-HT2; for alpha1-, alpha2-, or beta-adrenoreceptors; for dopamine-D2; or for histamine-H1; benzodiazepine; picrotoxin or opioid receptors.

Serotonin receptors of the 5-HT3 type are located peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone of the area postrema. During chemotherapy that induces vomiting, mucosal enterochromaffin cells release serotonin, which stimulates 5-HT3 receptors. This evokes vagal afferent discharge, inducing vomiting. Animal studies demonstrate that, in binding to 5-HT3 receptors, granisetron blocks serotonin stimulation and subsequent vomiting after emetogenic stimuli such as cisplatin. In the ferret animal model, a single granisetron injection prevented vomiting due to high-dose cisplatin or arrested vomiting within 5 to 30 seconds.

Before taking Sancuso, tell your doctor:

• If you are allergic to Sancuso; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Sancuso with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Sancuso?

• Tell all of your health care providers that you take Sancuso. 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, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is Sancuso best taken?

Use Sancuso as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Wash your hands before and after use.
• Put on clean, dry, healthy skin on the upper arm.
• Do not put on irritated skin.
• Do not put on skin where you have just used creams, oils, lotions, powder, or other skin products. The patch may not stick as well.
• Do not use patches that are cut or do not look right.
• If the patch loosens, put tape ONLY on the edges of the patch to hold it in place.
• You may bathe or shower while wearing the patch. Do not swim, use a hot tub, or sauna while wearing the patch.
• After you take off a skin patch, be sure to fold the sticky sides of the patch to each other. Throw away used patches where children and pets cannot get to them.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of Sancuso that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Chest pain or pressure.
• Fast or abnormal heartbeat.
• Very bad dizziness or passing out.
• Shortness of breath.
• Fever, chills, or sore throat.
• Stomach pain.
• Swelling of belly.
• A severe and sometimes deadly problem called serotonin syndrome may happen. The risk may be greater if you also take certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; severe diarrhea, upset stomach, or throwing up; or very bad headache.
• Very bad skin irritation.

What are some other side effects of Sancuso?

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:

• Headache.
• Feeling dizzy, tired, or weak.
• Diarrhea or constipation.
• Heartburn.
• Trouble sleeping.

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 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

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.

How do I store and/or throw out Sancuso?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Store patches in pouch until ready for use.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL – 3.1 MG/24 HOURS PATCH POUCH CARTON

• NDC 42747-726-01
• Sancuso®
  (Granisetron Transdermal System)
  3.1 mg/24 hours
• Rx Only
• 7 day patch
• Each 52 cm2 patch contains 34.3 mg of granisetron
  in an acrylate-vinylacetate copolymer adhesive
• 1 patch
• www.sancuso.com
• KYOWA KIRIN

SRC: NLM .