Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
granisetron (UNII: WZG3J2MCOL) (granisetron - UNII:WZG3J2MCOL)
Kyowa Kirin, Inc.
GRANISETRON
GRANISETRON 3.1 mg in 24 h
TRANSDERMAL
PRESCRIPTION DRUG
Sancuso® is indicated for the prevention of nausea and vomiting in adults 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 transdermal system [see Description (10)] . Risk Summary 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. In a published ex vivo human placental perfusion model, no transplacental passage of granisetron was detected at a concentration (5 ng/mL) that mimics the plasma concentration achieved following transdermal application of Sancuso. In animal reproduction studies, no adverse developmental effects were observed in pregnant rats and rabbits administered granisetron hydrochloride during organogenesis at intravenous doses up to 24 times and 16 times, respective
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.
New Drug Application
SANCUSO- GRANISETRON PATCH KYOWA KIRIN, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SANCUSO 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-3 (5-HT ) receptor antagonist indicated for the prevention of nausea and vomiting in adults receiving moderately and/or highly emetogenic chemotherapy for up to 5 consecutive days. (1) DOSAGE AND ADMINISTRATION 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. (2) DOSAGE FORMS AND STRENGTHS Transdermal System: 3.1 mg per 24 hours. (3) CONTRAINDICATIONS Known hypersensitivity to granisetron or to any of the components of the transdermal system (4) WARNINGS AND PRECAUTIONS Granisetron may mask a progressive ileus and/or gastric distention; consider before use in patients with abdominal surgery. Monitor for decreased bowel activity, particularly in patients with risk factors for gastrointestinal obstruction. (5.1) Serotonin syndrome has been reported with 5-HT 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. (5.2, 7.1) Mild application site reactions have occurred; remove Sancuso transdermal system if severe reactions or a generalized skin reaction occur. (5.3) Avoid exposing Sancuso transdermal system and surrounding area to direct external heat sources, such as heating pads (5.4). Avoid direct exposure of application site to natural or artificial Preberite celoten dokument