ALOXI- palonosetron hydrochloride injection

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

palonosetron hydrochloride (UNII: 23310D4I19) (palonosetron - UNII:5D06587D6R)

זמין מ:

MGI PHARMA

INN (שם בינלאומי):

palonosetron hydrochloride

טופס פרצבטיות:

INJECTION

הרכב:

0.25 mg in 5 mL

מסלול נתינה (של תרופות):

INTRAVENOUS

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

ALOXI is indicated for: • Moderately emetogenic cancer chemotherapy -- prevention of acute and delayed nausea and vomiting associated with initial and repeat courses • Highly emetogenic cancer chemotherapy -- prevention of acute nausea and vomiting associated with initial and repeat courses ALOXI is indicated for: • Prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated. As with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and vomiting must be avoided during the postoperative period, ALOXI is recommended even where the incidence of postoperative nausea and/or vomiting is low. ALOXI is contraindicated in patients known to have hypersensitivity to the drug or any of its components. [see Adverse Reactions (6.2 )] Teratogenic Effects: Category B Teratology studies have been perfo

leaflet_short:

NDC # 58063-797-25, ALOXI Injection 0.25 mg/5 mL (free base) single-use vial individually packaged in a carton. NDC # 58063-797-37, ALOXI Injection 0.075 mg/1.5 mL (free base) single-use vial packaged in a carton containing 5 vials. Storage • Store at controlled temperature of 20-25°C (68°F-77°F). Excursions permitted to 15-30°C (59-86°F). • Protect from freezing. • Protect from light.

מאפייני מוצר

ALOXI- PALONOSETRON HYDROCHLORIDE INJECTION
MGI PHARMA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
ALOXI (PALONOSETRON HCL) INJECTION FOR INTRAVENOUS USE
RECENT MAJOR CHANGES
Indications and Usage, Postoperative and Postdischarge Nausea and
Vomiting (1.2) 02/2008
Dosage and Administration, Recommended Dosing (2.1) 02/2008
Warnings and Precautions, QTc Intervals (5.2) - Deletion 02/2008
INDICATIONS AND USAGE
ALOXI is a serotonin subtype 3 (5-HT ) receptor antagonist indicated
for:
• Moderately emetogenic cancer chemotherapy -- prevention of acute
and delayed nausea and vomiting associated with
initial and repeat courses (1.1)
• Highly emetogenic cancer chemotherapy -- prevention of acute
nausea and vomiting associated with initial and repeat
courses (1.1)
• Prevention of postoperative nausea and vomiting (PONV) for up to
24 hours following surgery. Efficacy beyond 24 hours
has not been demonstrated (1.2)
DOSAGE AND ADMINISTRATION
Chemotherapy Induced Nausea and Vomiting (2.1)
• Adult Dosage: a single 0.25 mg I.V. dose administered over 30
seconds. Dosing should occur approximately 30 minutes
before the start of chemotherapy.
Postoperative Nausea and Vomiting (2.1)
• Adult Dosage: a single 0.075 mg I.V. dose administered over 10
seconds immediately before the induction of anesthesia.
DOSAGE FORMS AND STRENGTHS
0.25 mg/5ml (free base) single-use vial (3)
0.075 mg/1.5ml (free base) single-use vial (3)
CONTRAINDICATIONS
ALOXI is contraindicated in patients known to have hypersensitivity to
the drug or any of its components (4)
WARNINGS AND PRECAUTIONS
• Hypersensitivity reactions may occur in patients who have
exhibited hypersensitivity to other selective 5-HT receptor
antagonists (5.1)
ADVERSE REACTIONS
The most common adverse reactions in chemotherapy-induced nausea and
vomiting (incidence ≥ 5%) are headache and
constipation (6.1)
The most common adverse reactions in postoperative nausea and vomiting
(incidence ≥ 2%) are QT prolongation,
bradycardia, headache, and constipation.
DRUG INTERACTIONS