palonosetron hydrochloride
Pharmaranks rates Palonosetron Hydrochloride 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Palonosetron Hydrochloride is a serotonin-3 receptor antagonist.
Serotonin-3 Receptor Antagonist · by Mylan Institutional
Generic of Posfrea
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Palonosetron Hydrochloride
- Drug class
- Serotonin-3 Receptor Antagonist
- Form
- Injectable, Solution
- Strength
- Palonosetron Hydrochloride EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Mylan Institutional
- FDA application
- ANDA206416
What is Palonosetron Hydrochloride?
From the FDA label:Palonosetron hydrochloride injection contains palonosetron as palonosetron hydrochloride, an antiemetic and antinauseant agent. It is a serotonin-3 (5-HT 3 ) receptor antagonist with a strong binding affinity for this receptor. Chemically, palonosetron hydrochloride is: (3aS)-2-[(s)-1-azabicyclo[2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1H-benzo[de]isoquinoline hydrochloride. The molecular formula is C 19 H 24 N 2 O.HCl, with a molecular weight of 332.87. Palonosetron hydrochloride exists as a single isomer and has the following structural formula: Palonosetron hydrochloride, USP is a white to off-white crystalline powder. It is freely soluble in water, soluble in propylene glycol, and slightly soluble in ethanol and 2-propanol. Palonosetron hydrochloride injection is a sterile, clear, colorless, non-pyrogenic, isotonic, buffered solution for intravenous administration. Palonosetron hydrochloride injection is available as a 5 mL single-dose vial. Each 5 mL vial contains: 0.25 mg palonosetron (equivalent to 0.28 mg palonosetron hydrochloride), 207.5 mg mannitol, disodium edetate and citrate buffer in water for intravenous administration. The pH of the solution in the 5 mL vial is 4.5 to 5.5. Hydrochloric acid or sodium hydroxide may have been added to adjust pH. Palonosetron Hydrochloride Structural Formula
How to use
Palonosetron Hydrochloride is sold in more than one form (Injectable and Solution), and each is dosed differently. The instructions below come from the FDA label for application ANDA206416 — follow the label that came with the product you were actually 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 Pediatrics (1 month to less…
Side effects
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…
Warnings
Important safety information
Hypersensitivity reactions, including anaphylaxis and anaphylactic shock : reported in patients with or without known hypersensitivity to other selective 5-HT 3 receptor antagonists. If symptoms occur, discontinue palonosetron hydrochloride and initiate appropriate medical treatment. ( 5.1 ) • Serotonin syndrome : reported with 5-HT 3 receptor antagonists alone, but particularly with concomitant use of serotonergic drugs. ( 5.2 , 7.1 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis and anaphylactic shock, have been reported with administration of palonosetron hydrochloride injection [see Adverse Reactions (6.2) ] . These reactions occurred in patients with or without known hypersensitivity to other 5-HT 3 receptor antagonists. If hypersensitivity reactions occur, discontinue palonosetron hydrochloride injection and initiate appropriate medical treatment. Do not reinitiate palonosetron hydrochloride injection in patients who have previously experienced symptoms of hypersensitivity [see Contraindications (4) ] . 5.2 Serotonin Syndrome The development of serotonin syndrome has been reported with 5-HT 3 receptor antagonists. Most reports have been associated with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue). Some of the reported cases were fatal. Serotonin syndrome occurring with overdose of another 5-HT 3 receptor antagonist alone has also been reported. The majority of reports of serotonin syndrome related to 5-HT 3 receptor antagonist use occurred in a post-anesthesia care unit or an infusion center. Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, with or without gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for the emergence of serotonin syndrome, especially with concomitant use of palonosetron hydrochloride and other serotonergic drugs. If symptoms of serotonin syndrome occur, discontinue palonosetron hydrochloride and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if palonosetron hydrochloride is used concomitantly with other serotonergic drugs [see Drug Interactions (7.1) ] .
Who should not take Palonosetron Hydrochloride
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 )
Overdose — what happens if you take too much
There is no known antidote to palonosetron. Overdose should be managed with supportive care. Dialysis studies have not been performed, however, due to the large volume of distribution, dialysis is unlikely to be an effective treatment for palonosetron overdose. A single intravenous dose of palonosetron hydrochloride at 30 mg/kg (947 and 474 times the human dose for rats and mice, respectively, based on body surface area) was lethal to rats and mice. The major signs of toxicity were convulsions, gasping, pallor, cyanosis and collapse.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
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) ] .
Drug class
Dosage forms
Injectable and Solution
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- How is Palonosetron Hydrochloride rated?
- pharmaranks gives Palonosetron Hydrochloride a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Palonosetron Hydrochloride?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Palonosetron Hydrochloride. To pay less, Palonosetron Hydrochloride is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Palonosetron Hydrochloride?
- Palonosetron Hydrochloride is marketed by Mylan Institutional. You can see Mylan Institutional's full profile, rating, and other products on pharmaranks.
- Is Palonosetron Hydrochloride a brand-name or generic drug?
- Palonosetron Hydrochloride is a generic medication; its active ingredient is Palonosetron Hydrochloride. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Palonosetron Hydrochloride available over the counter?
- No. Palonosetron Hydrochloride is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Palonosetron Hydrochloride come in?
- Palonosetron Hydrochloride is currently marketed as injectable and solution, per the FDA's National Drug Code Directory.
- What class of drug is Palonosetron Hydrochloride?
- Palonosetron Hydrochloride is classified as serotonin-3 receptor antagonist, per the FDA's Established Pharmacologic Class.
- Is Palonosetron Hydrochloride FDA-registered?
- Palonosetron Hydrochloride is on record with the U.S. FDA under application number ANDA206416. You can verify this on its official FDA label.
- Has Palonosetron Hydrochloride been recalled by the FDA?
- Palonosetron Hydrochloride has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Palonosetron Hydrochloride safe?
- There's no single safe-or-not verdict. pharmaranks gives Palonosetron Hydrochloride a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Palonosetron Hydrochloride?
- Palonosetron Hydrochloride's side effects are taken directly from its FDA label. From the label: 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 vomit… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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palonosetron hydrochloride
70/100