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Aloxi (Palonosetron Hydrochloride) - Summary

 
 



ALOXI SUMMARY

ALOXI® (palonosetron HCl) injection for Intravenous

ALOXI1 (palonosetron hydrochloride) is an antiemetic and antinauseant agent. It is a selective serotonin subtype 3 (5-HT3) receptor antagonist with a strong binding affinity for this receptor.

ALOXI is indicated for:

  1. the prevention of acute nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy, and
  2. the prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.


See all Aloxi indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Aloxi (Palonosetron)

Nausea and Vomiting
Source: MedicineNet Cholera Specialty [2012.04.24]
Title: Nausea and Vomiting
Category: Diseases and Conditions
Created: 1/31/2005 8:21:00 AM
Last Editorial Review: 4/24/2012 12:00:00 AM

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Published Studies Related to Aloxi (Palonosetron)

Anti-emetic effect of ondansetron and palonosetron in thyroidectomy: a prospective, randomized, double-blind study. [2012]
high-risk patients receiving i.v. PCA after thyroidectomy... CONCLUSIONS: Palonosetron is more effective than ondansetron for high-risk

Three palonosetron regimens to prevent CINV in myeloma patients receiving multiple-day high-dose melphalan and hematopoietic stem cell transplantation. [2011.04]
BACKGROUND: Explore safety and efficacy of three palonosetron-containing regimens for emesis prevention over 7 days in multiple myeloma (MM) patients receiving melphalan (100 mg/m(2)) and hematopoietic stem cell transplantation (HSCT)... CONCLUSIONS: Palonosetron with dexamethasone was safe and effective in preventing emesis in MM patients receiving melphalan and HSCT. This pilot study with a limited number of patients suggests that multiple doses of palonosetron could be more effective than a single dose in making patients emesis free without need for rescue medication. However, even multiple doses of palonosetron resulted in only 20% of patients being emesis free without rescue medication, suggesting that further improvement will require development of more effective combination antiemetic therapy. (c) The Author 2010. Published by Oxford University Press on behalf of the European Society for Medical Oncology.

Randomized, double-blind, crossover study of palonosetron compared with granisetron for the prevention of chemotherapy-induced nausea and vomiting in a Chinese population. [2011.03]
The objective of this study was to compare the efficacy and tolerability of palonosetron and granisetron in a Chinese population receiving highly emetogenic cisplatin-based chemotherapy or moderately emetogenic chemotherapy. Patients were stratified by chemotherapy with cisplatin (yes/no) and then randomly assigned to receive either palonosetron (0.25 mg i.v.) in the first cycle followed by granisetron (3 mg i.v.) in the second cycle or vice versa...

A Randomized Controlled Trial of Two Different Interventions for the Prevention of Postoperative Nausea and Vomiting: Total Intravenous Anaesthesia using Propofol and Remifentanil versus Prophylactic Palonosetron with Inhalational Anaesthesia using Sevoflurane-Nitrous Oxide. [2011]
Total intravenous anaesthesia (TIVA) can reduce the risk of postoperative nausea and vomiting (PONV) almost as much as a single antiemetic. This study compared TIVA (using propofol and remifentanil) with prophylactic palonosetron (a 5-hydroxytryptamine type 3 receptor antagonist) combined with inhalation anaesthesia using sevoflurane in 50% nitrous oxide, for the prevention of PONV...

Daily palonosetron is superior to ondansetron in the prevention of delayed chemotherapy-induced nausea and vomiting in patients with acute myelogenous leukemia. [2010.12.15]
BACKGROUND: Nausea and vomiting in patients with acute myelogenous leukemia (AML) can be from various causes, including the use of high-dose cytarabine... CONCLUSIONS: The daily assessments of emesis did not show significant differences between the study arms. Patients receiving palonosetron on Days 1 to 5 had significantly less severe nausea and experienced significantly less impact of CINV on daily activities on Days 6 and 7. Cancer 2010. (c) 2010 American Cancer Society.

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Clinical Trials Related to Aloxi (Palonosetron)

Palonosetron in Sarcoma Patients Receiving Chemotherapy With Adriamycin and Ifosfamide (AI) [Recruiting]
The goal of this clinical research study is to compare 2 treatment schedules of Aloxi (palonosetron) in patients with sarcoma who are receiving chemotherapy with adriamycin and ifosfamide. The safety of the drug and schedules will be studied. The effect of palonosetron on patients' quality of life (QOL) will also be studied.

Intravenous Palonosetron With Radiotherapy and Concomitant Temozolomide [Recruiting]
1. Purpose and objective:

1. To determine the safety and tolerability of palonosetron in the prevention of radiation induced nausea and vomiting (RINV) in primary glioma patients receiving radiation (RT) and concomitant temozolomide (TMZ).

2. To determine the efficacy of palonosetron in primary glioma patients receiving six weeks of RT and concomitant TMZ

3. To evaluate the effect s of palonosetron on the quality of life of primary glioma patients receiving six weeks of RT and Concomitant TMZ.

2. Study activities and Population group: We will conduct a phase II single arm trial of Palonosetron (PALO) for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ). All eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0. 25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks. Forty subjects with gliomas will participate.

3. Data analysis and risk/safety issues: The frequency of toxicity will be summarized by type and the most severe grade experienced. The complete response rate, defined as the proportion of patients with no emetic episode or use of rescue medication while receiving radiation and concomitant temozolomide, will be estimated with a 95% confidence interval. Logistic regression will be used to explore the effect of age, sex, the use of glucocorticoids and anti convulsants, on the complete response rate.

Efficacy and Safety of Palonosetron Intravenous in Prevention of Chemotherapy Induced Nausea and Vomiting in Pediatric Patients [Recruiting]
The primary objective is to evaluate the efficacy of two different doses of IV palonosetron in the prevention of chemotherapy induced nausea and vomiting in MEC and HEC patients through 120 hours after start of chemotherapy in single and repeated chemotherapy cycles. The secondary objectives are to evaluate the safety and tolerability of IV palonosetron in pediatric patients and evaluate the pharmacokinetics of IV palonosetron in a subset of pediatric CINV patients.

Palonosetron for the Treatment of Nausea and Vomiting in Terminally Ill Patients [Recruiting]
The primary objective of this study is to determine the complete response (no vomiting and no need for other medications to treat nausea) in terminally ill patients suffering from nausea and/or vomiting, who are treated with palonosetron. Another objective is to determine the partial response (relief of nausea and vomiting to the extent that the patient wishes to continue treatment with palonosetron) after being treated with palonosetron. Palonosetron is currently approved by the FDA to prevent nausea and vomiting associated with chemotherapy. The investigators are testing this medication to see if it can help to relieve nausea and vomiting not associated with chemotherapy.

Aloxi for Prevention of Acute and Delayed Chemotherapy Induced Nausea and Vomiting (CINV) in Malignant Glioma (MG) Patients Receiving Irinotecan With Bevacizumab [Recruiting]

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Reports of Suspected Aloxi (Palonosetron) Side Effects

Abdominal Pain (2)Weight Decreased (2)Tachycardia (2)Polyneuropathy (2)Malaise (2)DRY Mouth (2)Anaphylactoid Reaction (2)Onychoclasis (2)Blood Creatinine Increased (2)Muscle Spasms (2)more >>


Page last updated: 2013-02-10

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