TOP

ALOXI(palonosetron hydrochloride) injection

2015-03-13 19:38:05 来源: 作者: 【大中小】浏览:354次评论:0条

HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ALOXI safely and effectively. See full prescribing information for ALOXI. ALOXI® (palonosetron HCl) Injection for Intravenous Use Initial U.S. Approval: 2003
RECENT MAJOR CHANGES
Indications and Usage, Postoperative Nausea and Vomiting (1.2)02/2008 Dosage and Administration, Recommended Dosing (2.1)02/2008 Warnings and Precautions, QTc Intervals (5.2) - Deletion02/2008
INDICATIONS AND USAGE
ALOXI is a serotonin subtype3 (5-HT3) 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 24hours following surgery. Efficacy beyond 24hours has not been demonstrated (1.2)
DOSAGE AND ADMINISTRATION
Chemotherapy-Induced Nausea and Vomiting (2.1) Adult Dosage: a single 0.25mg I.V. dose administered over 30seconds. Dosing should occur approximately 30minutes before the start of chemotherapy. Postoperative Nausea and Vomiting (2.1) Adult Dosage: a single 0.075mg I.V. dose administered over 10seconds immediately before the induction of anesthesia.
DOSAGE FORMS AND STRENGTHS
0.25mg/5mL (free base) single-use vial (3) 0.075mg/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-HT3 receptor antagonists (5.1)
ADVERSE REACTIONS
The most common adverse reactions in chemotherapy-induced nausea and vomiting (incidence ≥5%) are and constipation (6.1) The most common adverse reactions in postoperative nausea and vomiting (incidence ≥2%) are QT prolongation, bradycardia, headache, and constipation. To report SUSPECTED ADVERSE REACTIONS, contact EISAI at 1-888-422-4743 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
The potential for clinically significant drug interactions with palonosetron appears to be low (7)
USE IN SPECIFIC POPULATIONS
Safety and effectiveness in patients below the age of 18years have not been established (8.4)
See 17 for PATIENT COUNSELING INFORMATION
Revised: 09/2008

Back to Highlights and Tabs

FULL PRESCRIBING INFORMATION: CONTENTS*

*Sections or subsections omitted from the full prescribing information are not listed

RECENT MAJOR CHANGES

1INDICATIONS AND USAGE

1.1Chemotherapy-Induced Nausea and Vomiting

1.2Postoperative Nausea and Vomiting

2DOSAGE AND ADMINSTRATION

2.1Recommended Dosing

2.2Instructions for I.V. Administration

3DOSAGE FORM AND STRENGTHS

4CONTRAINDICATIONS

5WARNINGS AND PRECAUTIONS

5.1Hypersensitivity

6ADVERSE REACTIONS

6.1Chemotherapy-Induced Nausea and Vomiting

6.2Postoperative Nausea and Vomiting

6.3Postmarketing Experience

7DRUG INTERACTIONS

8USE IN SPECIFIC POPULATIONS

8.1Pregnancy

8.2Labor and Delivery

8.3Nursing Mothers

8.4Pediatric Use

8.5Geriatric Use

8.6Renal Impairment

8.7Hepatic Impairment

8.8Race

10OVERDOSAGE

11DESCRIPTION

12CLINICAL PHARMACOLOGY

12.1Mechanism of Action

12.2Pharmacodynamics

12.3Pharmacokinetics

13NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility

14CLINICAL STUDIES

14.1Chemotherapy-Induced Nausea and Vomiting

14.2Postoperative Nausea and Vomiting

16HOW SUPPLIED/STORAGE AND HANDLING

17PATIENT COUNSELING INFORMATION

17.1Instructions for Patients

17.2FDA-Approved Patient Labeling

PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

1INDICATIONS AND USAGE

1.1Chemotherapy-Induced Nausea and Vomiting

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

1.2Postoperative Nausea and Vomiting

ALOXI is indicated for:

Prevention of postoperative nausea and vomiting (PONV) for up to 24hours following surgery. Efficacy beyond 24hours 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.