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Palonosetron

Generic Name
Palonosetron
Brand Names
Akynzeo, Aloxi, Palonosetron Accord
Drug Type
Small Molecule
Chemical Formula
C19H24N2O
CAS Number
135729-56-5
Unique Ingredient Identifier
5D06587D6R

Overview

Palonosetron (INN, trade name Aloxi) is an antagonist of 5-HT3 receptors that is indicated for the prevention and treatment of chemotherapy-induced nausea and vomiting (CINV). It is the most effective of the 5-HT3 antagonists in controlling delayed CINV nausea and vomiting that appear more than 24 hours after the first dose of a course of chemotherapy and is the only drug of its class approved for this use by the U.S. Food and Drug Administration. As of 2008, it is the most recent 5-HT3 antagonist to enter clinical use.

Background

Palonosetron (INN, trade name Aloxi) is an antagonist of 5-HT3 receptors that is indicated for the prevention and treatment of chemotherapy-induced nausea and vomiting (CINV). It is the most effective of the 5-HT3 antagonists in controlling delayed CINV nausea and vomiting that appear more than 24 hours after the first dose of a course of chemotherapy and is the only drug of its class approved for this use by the U.S. Food and Drug Administration. As of 2008, it is the most recent 5-HT3 antagonist to enter clinical use.

Indication

For the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy, as well as prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy. Also used for the prevention of postoperative nausea and vomiting for up to 24 hours post operation.

Associated Conditions

  • Nausea caused by Chemotherapy
  • Post Operative Nausea and Vomiting (PONV)
  • Acute chemotherapy-induced nausea and vomiting
  • Delayed chemotherapy-induced nausea and vomiting

FDA Approved Products

Palonosetron
Manufacturer:Apotex Corp.
Route:INTRAVENOUS
Strength:0.25 mg in 5 mL
Approved: 2020/06/28
NDC:60505-6193
Palonosetron Hydrochloride
Manufacturer:Sandoz Inc
Route:INTRAVENOUS
Strength:0.25 mg in 5 mL
Approved: 2022/10/13
NDC:0781-3312
Palonosetron Hydrochloride
Manufacturer:Sandoz Inc
Route:INTRAVENOUS
Strength:0.25 mg in 5 mL
Approved: 2022/10/13
NDC:0781-3415
Palonosetron Hydrochloride
Manufacturer:Baxter Healthcare Corporation
Route:INTRAVENOUS
Strength:0.25 mg in 5 mL
Approved: 2020/09/15
NDC:36000-326
Palonosetron hydrochloride
Manufacturer:Cipla USA Inc.
Route:INTRAVENOUS
Strength:0.25 mg in 5 mL
Approved: 2023/01/17
NDC:69097-439

Singapore Approved Products

PALONOSETRON-AFT SOLUTION FOR INJECTION 0.25MG/5ML
Manufacturer:QILU PHARMACEUTICAL (HAINAN), CO., LTD.
Form:INJECTION, SOLUTION
Strength:0.25mg/5ml
Online:Yes
Approved: 2024/02/20
Approval:SIN16959P
AKYNZEO CAPSULES 300MG/0.5MG
Manufacturer:Helsinn Birex Pharmaceuticals Ltd. (Intermediate Netupitant Tablets and final drug product), CATALENT PHARMA SOLUTIONS LLC (Intermediate Palonosetron softgels)
Form:CAPSULE, GELATIN COATED
Strength:0.50mg
Online:Yes
Approved: 2016/06/08
Approval:SIN15031P
ALOXI® Solution for Injection 50mcg/ml
Manufacturer:FAREVA PAU 1
Form:INJECTION, SOLUTION
Strength:50mcg/ml
Online:Yes
Approved: 2011/10/24
Approval:SIN14038P
Akynzeo® IV Concentrate for Solution for Infusion 235 mg/0.25 mg/vial
Manufacturer:Baxter Oncology GmbH
Form:INFUSION, SOLUTION CONCENTRATE
Strength:0.25 mg/vial
Online:Yes
Approved: 2023/11/28
Approval:SIN16899P

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