Palonosetron Hydrochloride .05 mg/mL
palonosetron hydrochloride · INJECTION, SOLUTION · Avenacy, Inc.
Palonosetron Hydrochloride is a injection, solution containing palonosetron hydrochloride at .05 mg/mL, taken intravenous. Manufactured by Avenacy, Inc..
Key Facts
- Brand Name
- Palonosetron Hydrochloride
- Generic Name
- palonosetron hydrochloride
- NDC Code (Product)
83634-777- Manufacturer
- Avenacy, Inc.
- Strength
- .05 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA202951
- Marketing Start
- 05/15/2024
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Palonosetron hydrochloride injection is indicated in adults for prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). acute nausea and vomiting associated with initial and repeat courses highly emetogenic cancer chemotherapy (HEC). 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, palonosetron hydrochloride injection is recommended even where the incidence of postoperative nausea and/or vomiting is low. Palonosetron hydrochloride injection is indicated in pediatric patients 1 month to less than 17 years of age for prevention of: acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy. Palonosetron hydrochloride injection is a serotonin-3 (5…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Chemotherapy-Induced Nausea and Vomiting ( 2.1 ) *Note different dosing units in pediatrics Age Dose* Infusion Time Adults 0.25 mg as a single dose Infuse over 30 seconds beginning approximately 30 minutes before the start of chemotherapy Pediatrics (1 month to less than 17 years) 20 micrograms per kilogram (maximum 1.5 mg) as a single dose Infuse over 15 minutes beginning approximately 30 minutes before the start of chemotherapy Postoperative Nausea and Vomiting ( 2.1 ) The recommended adult dosage is 0.075 mg as a single intravenous dose administered over 10 seconds immediately before the induction of anesthesia. 2.1 Recommended Dosage Prevention of Chemotherapy-Induced Nausea and Vomiting The recommended dosage of palonosetron hydrochloride injection for prevention of nausea and vomiting associated with HEC and MEC in adults and associated with emetogenic chemotherapy, including HEC in pediatric patients 1 month to less than 17 years of age is shown in Table 1 . Table 1: Recommended Dosage of Palonosetron Hydrochloride Injection for the Prevention of Nausea and Vomiting Associated with Chemotherapy in Adults and Pediatric Patients 1 Month to Less than…
Contraindications
4 CONTRAINDICATIONS Palonosetron hydrochloride injection is contraindicated in patients known to have hypersensitivity to palonosetron [see Warnings and Precautions ( 5.1 )] . Hypersensitivity to palonosetron or any of its components ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Serotonergic Drugs: Monitor for serotonin syndrome; if symptoms occur, discontinue palonosetron hydrochloride injection and initiate supportive treatment. ( 7.1 ) 7.1 Serotonergic Drugs Serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular symptoms) has been described following the concomitant use of 5-HT 3 receptor antagonists and other serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs). Monitor for the emergence of serotonin syndrome. If symptoms occur, discontinue palonosetron hydrochloride injection and initiate supportive treatment [see Warnings and Precautions ( 5.2 )] .
Adverse Reactions
6 ADVERSE REACTIONS Serious or otherwise clinically significant adverse reactions reported in other sections of labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Serotonin Syndrome [see Warnings and Precautions ( 5.2 )] Most common adverse reactions in chemotherapy-induced nausea and vomiting in adults (greater than or equal to 5%) are: headache and constipation ( 6.1 ) postoperative nausea and vomiting (greater than or equal to 2%) are: QT prolongation, bradycardia, headache, and constipation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Avenacy Inc. at 1-855-283-6229 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Chemotherapy-Induced Nausea and Vomiting Adults In double-blind randomized clinical trials for the prevention of nausea and vomiting induced by MEC or HEC, 1374 adult patients received a single dose of palonosetron hydrochloride injection, on…
Frequently Asked Questions
What is Palonosetron Hydrochloride used for?
Palonosetron Hydrochloride contains palonosetron hydrochloride. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Palonosetron Hydrochloride a controlled substance?
Palonosetron Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Palonosetron Hydrochloride?
The generic name for Palonosetron Hydrochloride is palonosetron hydrochloride. There are 5 other brand versions of palonosetron hydrochloride.
What is the NDC code for Palonosetron Hydrochloride .05 mg/mL?
The NDC (National Drug Code) for Palonosetron Hydrochloride .05 mg/mL is 83634-777, listed by Avenacy, Inc..