Palonosetron is a serotonin-3 receptor antagonist sold in the U.S. under 3 brand and generic names. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Palonosetron Hydrochloride (application ANDA206416). Other palonosetron products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Chemotherapy-Induced Nausea and Vomiting ( 2.1 ) Age Dose Note different dosing units in pediatrics Infusion Time Adults 0.25 mg as a single dose Infuse over 30 second s 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 17 Years Age Dose Note different dosing units in pediatrics Infusion Time Adults 0.25 mg as a single dose Infuse over 30 seconds beginning approximately 30 minutes before the start of chemotherapy…
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 (≥ 5%) are: headache and constipation. ( 6.1 ) • postoperative nausea and vomiting (≥ 2%) are: QT prolongation, bradycardia, headache, and constipation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) 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, ondansetron (Studies 1 and 3) or dolasetron (Study 2) administered 30 minutes prior to chemotherapy [see Clinical Studies (14.1) ] . Adverse reactions were similar in frequency and severity in all 3 treatment groups. Common adverse reactions reported…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 68/100 | Prescription | Injectable | — | — | View → | |
| 2 | Not yet rated | Prescription | Injectable | — | — | View → |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Palonosetron hydrochloride 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 )
Serotonergic Drugs : Monitor for serotonin syndrome; if symptoms occur, discontinue palonosetron hydrochloride 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 and initiate supportive treatment [see Warnings and Precautions (5.2) ] .
| 3 | Not yet rated | Prescription | Injectable | — | — | View → |