Palonosetron Injection, Solution
Product Images NDC 68001-355

Palonosetron Hydrochloride Injection is a prescription medication administered by intravenous injection only in adults. It is available in single-dose sterile vial of 5 mL with 0.25 mg of palonosetron hydrochloride per 5 mL of aqueous solution. The solution also contains mannitol, disodium edetate, sodium acetate tinycrate, and water for injection. It is used to prevent nausea and vomiting caused by chemotherapy or radiation therapy. The instructions for dosage and administration are indicated on the package insert. It should be stored between 20°C to 25°C (68°F to 77°F) and protect it from freezing. This drug is manufactured by Dr. Reddy's Laboratories Ltd in India and distributed by BluePoint Laboratories.*

This text describes a pharmaceutical product called Palonosetron Hydrochloride Injection, which is administered intravenously for the prevention of nausea and vomiting caused by chemotherapy. The injection is stored in a controlled room temperature, protected from light and freezing. The product comes in a 0.25mg/5mL single-use sterile vial. The text includes instructions on how to administer the injection, and a warning that the product is for prescription use only. There are also symbols indicating temperature limits and the need to read additional information.*

This is a table showing the common adverse reactions in adults receiving chemotherapy. The table compares the percentage of patients who reported adverse reactions after receiving Palonosetron hydrochloride injection, Ondansetron 32mg intravenously, and Dolasetron 100mg intravenously. The adverse reactions listed include headache, constipation, diarrhea, dizziness, fatigue, abdominal pain, and insomnia. All adverse reactions were reported in less than 5% of patients.*

This table shows the pharmacokinetic parameters in pediatric cancer patients who received an infusion of 20 mcg/kg Palonosetron Hydrochloride Injection over 15 minutes. The table includes data for CT, AUC, Clearance, and Vss, for different age groups (2 to less than 6 years, 6 to less than 12 years, and 12 to less than 17 years), with the corresponding number of patients for each group.*

This text shows a table with the complete response rates of adults with nausea and vomiting associated with MEC or HEC. It includes data from three studies and shows the confidence interval, as well as the difference in complete response rates between palonosetron hydrochloride injection and the comparator. There is also a graph with data from moderately emetogenic and highly emetogenic patients.*

This text provides data on the prevention of delayed nausea and vomiting in adults undergoing chemotherapy treatment. The complete response rates for three different treatments, including palonosetron hydrochloride injection, are given with confidence intervals. The studies were designed for non-inferiority and used a lower bound of greater than -15% for demonstration. The currently recommended dose for one of the treatments, ondansetron, is not provided in this text.*

This is a table showing the efficacy of various medications in preventing overall nausea and vomiting associated with moderately emetogenic chemotherapy in adults. The complete response rates for each treatment option are listed, with Palonosetron hydrochloride injection at 0.25 mg intravenously showing the highest rate at 46%. Ondansetron was also used in the clinical trial, but the currently recommended dosage is different. The study was designed to show non-inferiority, with a lower bound greater than -15% being considered non-inferior between palonosetron hydrochloride and the comparator options.*

This is a table presenting information about the prevention of acute nausea and vomiting in pediatric patients undergoing emetogenic chemotherapy. The table shows the complete response rates of two drugs: Palonosetron hydrochloride injection and Ondansetron intravenous doses. The sample size for each drug is also given, along with the difference between the complete response rates for the two drugs, which is only 0.36% with confidence intervals ranging from -11.7% to 12.4%.*

The table compares the effectiveness of Palonosetron hydrochloride injection and a placebo in preventing postoperative nausea and vomiting in adults. The complete response rates are presented for two time periods, 0-24 hours and 24-72 hours after surgery. The Palonosetron hydrochloride injection had a higher complete response rate than the placebo within the 0-24 hour period (42.8% vs 25.9%) and a slightly higher complete response rate within the 24-72 hour period (48.6% vs 40.7%), but the difference was not significant.*