SANCUSO- granisetron patch

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GRANISETRON (UNII: WZG3J2MCOL) (GRANISETRON - UNII:WZG3J2MCOL)

Available from:

Physicians Total Care, Inc.

INN (International Name):

GRANISETRON

Composition:

GRANISETRON 3.1 mg in 24 h

Administration route:

TRANSDERMAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sancuso® (Granisetron Transdermal System) is indicated for the prevention of nausea and vomiting in patients receiving moderately and/or highly emetogenic chemotherapy regimens of up to 5 consecutive days duration. Sancuso is contraindicated in patients with known hypersensitivity to granisetron or to any of the components of the patch. Pregnancy Category B Reproduction studies with granisetron hydrochloride have been performed in pregnant rats at intravenous doses up to 9 mg/kg/day (54 mg/m2 /day, about 24 times the recommended human dose delivered by the Sancuso patch, based on body surface area) and oral doses up to 125 mg/kg/day (750 mg/m2 /day, about 326 times the recommended human dose with Sancuso based on body surface area). Reproduction studies have been performed in pregnant rabbits at intravenous doses up to 3 mg/kg/day (36 mg/m2 /day, about 16 times the human dose with Sancuso based on body surface area) and at oral doses up to 32 mg/kg/day (384 mg/m2 /day, about 167 times the human dose with San

Product summary:

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 54868-5985-0 ) 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.

Authorization status:

New Drug Application

Summary of Product characteristics

SANCUSO - GRANISETRON PATCH
PHYSICIANS TOTAL CARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SANCUSO (GRANISETRON TRANSDERMAL SYSTEM)
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SANCUSO.
SANCUSO (GRANISETRON TRANSDERMAL SYSTEM)
INITIAL U.S. APPROVAL: 2008
INDICATIONS AND USAGE
Sancuso is a serotonin subtype 3 (5-HT3) receptor antagonist indicated
for the prevention of nausea and vomiting in
patients receiving moderately and/or highly emetogenic chemotherapy
for up to 5 consecutive days. (1)
DOSAGE AND ADMINISTRATION
Apply a single transdermal system (patch) to the upper outer arm a
minimum of 24 hours before chemotherapy. The patch
may be applied up to a maximum of 48 hours before chemotherapy as
appropriate. Remove the patch a minimum of
24 hours after completion of chemotherapy. The patch can be worn for
up to 7 days depending on the duration of the
chemotherapy regimen. (2)
DOSAGE FORMS AND STRENGTHS
52 cm patch containing 34.3 mg of granisetron delivering 3.1 mg per 24
hours (3)
CONTRAINDICATIONS
Known hypersensitivity to granisetron or to any of the components of
the patch (4)
WARNINGS AND PRECAUTIONS
Granisetron may mask a progressive ileus and/or gastric distention
caused by the underlying condition. (5.1)
Mild application site reactions have occurred; remove patch if severe
reactions or a generalized skin reaction occur.
(5.2)
Avoid direct exposure of application site to natural or artificial
sunlight by covering with clothing while wearing the patch
and for 10 days after removing it. (5.3)
ADVERSE REACTIONS
The most common adverse reaction is constipation. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PROSTRAKAN INC. AT
1-800-SANCUSO AND
WWW.SANCUSO.COM, OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH_.
DRUG INTERACTIONS
No clinically relevant drug interactions have been reported in
clinical studies with Sancuso. (7)
USE IN SPECIFIC POPULATIONS
Use during pregnancy only if clearly needed. (8.1)
Use cauti