Sancuso

What is Sancuso?

• Sancuso (granisetron transdermal system) is a serotonin-3 (5-HT3) receptor antagonist is used for the prevention of nausea and vomiting in adults receiving moderately and/or highly emetogenic chemotherapy for up to 5 consecutive days.

Granisetron structure

Granisetron3Dan

What are the uses of this medicine?

• Sancuso (granisetron transdermal system) 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.

How does this medicine work?

• Granisetron is a selective 5-hydroxytryptamine3 (5-HT3) receptor antagonist.
• 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.
• Binding to 5-HT3 receptors, granisetron blocks serotonin stimulation and subsequent vomiting after emetogenic stimuli such as cisplatin.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Known hypersensitivity to granisetron or to any of the components of the transdermal system.

What drug interactions can this medicine cause?

• Serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular symptoms) has been described following the concomitant use of 5-HT3 receptor antagonists and other serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs).
• No clinically relevant drug interactions have been reported in clinical studies with Sancuso.

Is this medicine FDA approved?

• Granisetron transdermal patch with the trade name Sancuso was approved by the US FDA on September 12, 2008.

How should this medicine be used?

Recommended dosage:

• 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.

Administration:

• 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.
• 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.
• 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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Transdermal System: 3.1 mg per 24 hours

This medicine is available in fallowing brand namesː

• Sancuso

What side effects can this medication cause?

The most common side effects of this medicine include:

• constipation

SANCUSO may cause serious side effects, including:

• Serotonin Syndrome
• Skin reactions

What special precautions should I follow?

• Sancuso may mask a progressive ileus and/or gastric distention. Monitor for decreased bowel activity, particularly in patients with risk factors for gastrointestinal obstruction.
• The development of serotonin syndrome has been reported with 5-HT3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs. If such symptoms occur, discontinue Sancuso and initiate supportive treatment. If concomitant use of Sancuso with other serotonergic drugs is clinically warranted, patients should be aware of a potential increased risk of serotonin syndrome.
• Mild application site reactions have occurred; remove Sancuso transdermal system if severe reactions or a generalized skin reaction occur.
• Prolonged exposure to heat results in increasing plasma concentrations of granisetron during the period of heat exposure. Avoid exposing Sancuso transdermal system and surrounding area to direct external heat sources, such as heating pads.
• Granisetron may be affected by direct natural or artificial sunlight, including sunlamps. Avoid direct exposure of application site to natural or artificial sunlight, including sunlamps, by covering with clothing throughout the period of wear and for 10 days after removal.

What to do in case of emergency/overdose?

Treatment of overdosage:

• There is no specific antidote for granisetron overdosage.
• In the case of overdosage, symptomatic treatment should be given.

Can this medicine be used in pregnancy?

• Available published data and postmarketing reports with granisetron use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Can this medicine be used in children?

• Safety and effectiveness of Sancuso have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• granisetron

Inactive ingredients:

• POLYESTER
• titanium dioxide
• HIGH DENSITY POLYETHYLENE

Who manufactures and distributes this medicine?

Manufactured by:

• 3M Drug Delivery Systems

Manufactured for:

• Kyowa Kirin, Inc.
• Bedminster, NJ

What should I know about storage and disposal of this medication?

• 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.

• Dailymed label info on Sancuso
• FDA Sancuso

Sancuso Resources
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