SANCUSO- granisetron patch

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

granisetron (UNII: WZG3J2MCOL) (granisetron - UNII:WZG3J2MCOL)

Fáanlegur frá:

Kyowa Kirin, Inc.

INN (Alþjóðlegt nafn):

GRANISETRON

Samsetning:

GRANISETRON 3.1 mg in 24 h

Stjórnsýsluleið:

TRANSDERMAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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

Vörulýsing:

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.

Leyfisstaða:

New Drug Application

Vara einkenni

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