Palonosetron hydrochloride, a selective, second-generation inhibitor of type 3 serotonergic (5-HT3) receptors, is an antiemetic.1, 34, 35
Chemotherapy-induced Nausea and Vomiting
Palonosetron hydrochloride is used IV for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.1, 34, 35 The drug also is used IV for the prevention of acute nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy.1, 34, 35
Efficacy of a single IV dose of palonosetron hydrochloride for the prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults was established in 2 comparative studies with single-dose ondansetron hydrochloride or dolasetron mesylate.1, 24, 34, 35, 36 In the first study, complete responses (i.e., no emetic episodes and no rescue antiemetic therapy) at 0-24 or 24-120 hours were achieved in 81 or 74.1%, respectively, of patients receiving palonosetron (0.25 mg IV) and 68.6 or 55.1%, respectively, of patients receiving ondansetron (32 mg IV).24 In the second study, complete responses at 0-24 or 24-120 hours were achieved in 63 or 54%, respectively, of patients receiving palonosetron (0.25 mg IV) and 52.9 or 38.7%, respectively, of patients receiving dolasetron mesylate (100 mg IV).36 Concomitant corticosteroids were not used prophylactically in the first study, and such use occurred in 4.2-5.8% of patients in the second study.24, 36
Efficacy of a single IV dose of palonosetron hydrochloride for the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy in adults was established in a dose-ranging study and a comparative study with ondansetron hydrochloride.1, 34, 35, 37, 38 In the comparative study, complete responses (i.e., no emetic episodes and no rescue antiemetic therapy) at 0-24 hours were achieved in 59.2 or 57% of patients receiving palonosetron (0.25 mg IV) or ondansetron (32 mg IV), respectively.38 Corticosteroids were administered prophylactically in 67% of patients.38
Efficacy of a single IV dose of palonosetron hydrochloride for the prevention of acute nausea and vomiting associated with emetogenic cancer chemotherapy in pediatric cancer patients was established in a comparative study with multiple-dose IV ondansetron hydrochloride in 327 pediatric cancer patients (mean age 8.3 years; range: 2 months to 16.9 years) who were scheduled to undergo moderately or highly emetogenic chemotherapy.1, 34, 39 In this study, complete responses (i.e., no vomiting or retching and no rescue antiemetic therapy) in the first 24 hours after starting chemotherapy were achieved in approximately 59% of patients receiving either palonosetron (single IV dose of 20 mcg/kg prior to chemotherapy with a maximum of 1.5 mg) or ondansetron (0.15 mg/kg IV prior to chemotherapy, followed by 0.15 mg/kg 4 and 8 hours after the first dose with a maximum total dose of 32 mg), demonstrating noninferiority of palonosetron versus ondansetron.1, 34, 39 Concomitant corticosteroids were administered prophylactically in 55% of patients.1, 39
The American Society of Clinical Oncology (ASCO) guidelines on the use of antiemetics for prevention of chemotherapy-induced nausea and vomiting in adults recommend a 4-drug antiemetic regimen consisting of a neurokinin 1 (NK1) receptor antagonist, a type 3 serotonin (5-HT3) receptor antagonist, dexamethasone, and olanzapine for patients receiving high-emetic-risk agents (i.e., incidence of emesis exceeds 90% if no antiemetics are administered).400 A 3-drug combination (a NK1 receptor antagonist, a 5-HT3 receptor antagonist, and dexamethasone) is recommended in adults receiving carboplatin (target AUC ≥4 mg/mL per minute) and a 2-drug regimen (a 5-HT3 receptor antagonist and dexamethasone) is recommended in adults receiving other chemotheraoy of moderate emetic risk (i.e., incidence of emesis without antiemetics exceeds 30% but does not exceed 90%).400 For moderate-risk agents (e.g., cyclophosphamide, doxorubicin, oxaliplatin) with known delayed nausea and vomiting, dexamethasone may be used.400 A single dose of a 5-HT3 receptor antagonist or dexamethasone may be offered to adults receiving chemotherapy regimens with low-emetic risk (i.e., incidence of emesis without antiemetics exceeds 10% but does not exceed 30%).400 Routine antiemetic prophylaxis is not necessary in adults receiving chemotherapy with minimal antiemetic risk (i.e., incidence of emesis is less than 10% without antiemetics).400 For patients experiencing nausea and vomiting despite optimal antiemetic therapy, an antiemetic from a different therapeutic class may be used in addition to continuing the standard antiemetic regimen.400
Postoperative Nausea and Vomiting
Palonosetron hydrochloride is used IV for the prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery.1, 34 Efficacy of the drug beyond 24 hours has not been demonstrated.1, 34 The manufacturer states that, as with other antiemetics, routine prophylaxis with palonosetron is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively.1, 34 However, use of the drug is recommended for patients in whom nausea and/or vomiting must be avoided postoperatively, even when the anticipated incidence of such nausea and/or vomiting is low.1, 34
Efficacy of a single IV dose of palonosetron hydrochloride for the prevention of postoperative nausea for up to 24 hours following surgery was established in a randomized, double-blind clinical study.1, 34, 40 Patients (mean age of 38 years; range: 21-74 years) undergoing outpatient elective gynecologic or abdominal laparoscopic surgery received either a single IV dose of palonosetron (0.025, 0.05, or 0.075 mg) or placebo immediately prior to induction of anesthesia.1, 34, 40 The primary efficacy measures were complete response, defined as no emetic episode and no use of rescue drug, in the 0-24 hour postoperative period and the 24-72 hour postoperative period.1, 34, 40 The complete response rate (0-24 hours) was significantly higher in patients who received palonosetron 0.075 mg IV (42.8%) compared with those who received placebo (25.9%); however, the difference in complete response rate at 24-72 hours between palonosetron and placebo was not statistically significant (48.6 and 40.7%, respectively).1, 34 Palonosetron 0.075 mg IV also reduced the severity of nausea compared with placebo.1, 34
In a randomized, double-blind, dose-ranging study, the efficacy of IV palonosetron (administered at doses of 0.1, 0.3, 1, 3, or 30 mcg/kg) for the prevention of PONV following abdominal or vaginal hysterectomy was evaluated in 381 patients.1, 34 The primary efficacy measure was the proportion of patients with complete response in the first 24 hours following recovery from surgery.1, 34 Palonosetron 1 mcg/kg (approximately 0.075 mg) was the lowest effective dose in this study and resulted in a complete response rate of 44% compared with 19% for placebo.1, 34 Palonosetron 1 mcg/kg also substantially reduced the severity of nausea compared with placebo.1, 34
The Fourth Consensus Guidelines for the Management of PONV recommend identifying, and mitigating when possible, all baseline risk factors for PONV, administration of multimodal prophylaxis in patients with one or more risk factors, and providing treatment with antiemetic drugs to patients with PONV who did not receive prophylaxis or when prophylaxis failed.300 Drug therapies for the prevention and treatment of PONV primarily include 5-HT3 receptor antagonists, corticosteroids, NK1 receptor antagonists, and antidopaminergic agents; other drug therapies include antihistamines, anticholinergic agents, midazolam, or γ-aminobutyric acid (GABA) analogues (e.g., gabapentin, pregabalin).300
Experts recommend the use of multimodal prophylaxis, consisting of drugs from different classes, in patients with one or more risk factors for PONV based on concerns over inadequate prophylaxis as well as the availability of antiemetic safety data.300 The Fourth Consensus Guidelines for the Management of PONV provide examples of combination drug therapies for the prevention of PONV.300 Experts also recommend that patients receive PONV prophylaxis at the appropriate time, for example an NK1 receptor antagonist, dexamethasone, and/or amisulpride at induction of anesthesia and 5-HT3 receptor antagonists at the end of surgery.300
Palonosetron hydrochloride is administered IV.1
The commercially available 0.05 mg/mL injection does not need to be diluted prior to administration.1, 34 Do not mix palonosetron hydrochloride with other drugs.1, 34 Flush the IV line with 0.9% sodium chloride injection before and after administration.1, 34 Inspect the solution visually for particulate matter and discoloration before administration; discard if present.1, 34
Store palonosetron vials at 20-25°C (excursions permitted between 15-30°C).1, 34, 35 Protect from light, and do not freeze.1, 34, 35
For the prevention of chemotherapy-induced nausea and vomiting in adults, administer palonosetron hydrochloride as a single IV dose over 30 seconds approximately 30 minutes before the start of chemotherapy.1, 34
For the prevention of chemotherapy-induced nausea and vomiting in pediatric patients (1 month to <17 years of age), administer palonosetron as a single IV dose over 15 minutes, beginning approximately 30 minutes before chemotherapy.1, 34
For the prevention of postoperative nausea and vomiting (PONV) in adults, administer palonosetron as a single IV dose over 10 seconds immediately before the induction of anesthesia.1, 34
Dosage of palonosetron hydrochloride is expressed in terms of palonosetron.1, 34
Chemotherapy-induced Nausea and Vomiting
For the prevention of chemotherapy-induced nausea and vomiting in adults, a single dose of palonosetron 0.25 mg (administered IV over 30 seconds) is given beginning approximately 30 minutes before the start of chemotherapy.1, 34
Postoperative Nausea and Vomiting
For the prevention of PONV for up to 24 hours following surgery in adults, a single dose of palonosetron 0.075 mg (administered IV over 10 seconds) is given immediately before induction of anesthesia.1, 34
Chemotherapy-induced Nausea and Vomiting
For the prevention of chemotherapy-induced nausea and vomiting in pediatric patients 1 month to <17 years of age, a single dose of palonosetron 20 mcg/kg (up to a maximum of 1.5 mg) is administered IV over 15 minutes beginning approximately 30 minutes before the start of chemotherapy.1, 34
No dosage adjustment is required in patients with any degree of hepatic impairment.1, 34
No dosage adjustment is required in patients with any degree of renal impairment.1, 34
No dosage adjustment is required in geriatric patients.1, 34
Hypersensitivity reactions, including anaphylaxis and anaphylactic shock, have been reported in patients receiving palonosetron; these reactions have occurred in patients with or without known hypersensitivity to other type 3 serotonergic (5-HT3) receptor antagonists.1, 34 If a hypersensitivity reaction occurs, discontinue palonosetron and initiate appropriate medical management.1, 34 Do not re-initiate treatment with palonosetron in patients who have previously experienced hypersensitivity symptoms.1, 34
Development of serotonin syndrome has been reported in patients receiving 5-HT3 receptor antagonists.1, 34 Most of the cases have been associated with concomitant use of other serotonergic drugs (e.g., selective serotonin-reuptake inhibitors [SSRIs], serotonin- and norepinephrine-reuptake inhibitors [SNRIs], monoamine oxidase inhibitors (MAOIs), mirtazapine, fentanyl, lithium, tramadol, IV methylene blue).1, 34 Some of the reported cases of serotonin syndrome were fatal.1, 34 Serotonin syndrome occurring with overdosage of another 5-HT3 receptor antagonist alone has been reported.1, 34 The majority of reports of serotonin syndrome related to 5-HT3 receptor antagonist use have occurred in a post-anesthesia care unit or an infusion center.1, 34
Manifestations associated with serotonin syndrome may include mental status changes (e.g., agitation, hallucinations, delirium, coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), and seizures with or without GI symptoms (e.g., nausea, vomiting, diarrhea).1, 34
Patients receiving 5-HT3 receptor antagonists, including palonosetron, should be monitored for the emergence of serotonin syndrome, particularly with concomitant use of other serotonergic drugs.1, 34 If symptoms of serotonin syndrome occur, palonosetron should be discontinued, and supportive treatment should be initiated.1, 34
There are no available clinical data regarding the use of palonosetron in pregnant women to assess potential drug-related risks.1, 34 In animal studies, no harmful effects on embryo-fetal development were observed when pregnant rats were administered oral doses of palonosetron hydrochloride up to 60 mg/kg/day (equivalent to 1894 times the recommended human IV dose, adjusted for body surface area), or when pregnant rabbits were given oral doses up to 60 mg/kg/day (3789 times the human IV dose), during the organogenesis phase.1, 34
It is not known whether palonosetron is distributed into human milk or whether the drug has any effects on milk production or on the breastfed infant.1, 34 Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for palonosetron and any potential adverse effects on the nursing infant from the drug or underlying maternal condition.1, 34
The safety and effectiveness of palonosetron hydrochloride injection for the prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic chemotherapy have been established in pediatric patients 1 month to <17 years of age.1, 34 This indication is supported by evidence from a randomized clinical trial in 165 pediatric patients 2 months to <17 years of age who received a single dose of palonosetron hydrochloride injection 20 mcg/kg (maximum 1.5 mg) 30 minutes before chemotherapy.1, 34 The study demonstrated that pediatric patients require a higher dose than adults to achieve efficacy.1, 34 Adverse reactions in pediatric patients were generally consistent with those observed in adults.1, 34
Safety and efficacy of palonosetron hydrochloride injection have not been established in neonates <1 month of age for the prevention of chemotherapy-induced nausea and vomiting.1, 34
The safety and efficacy of palonosetron hydrochloride injection have not been established for the prevention of postoperative nausea and vomiting (PONV) in pediatric patients.1, 34 In a dose-finding trial with 150 pediatric surgical patients, no dose-response relationship was observed between palonosetron 1 mcg/kg and 3 mcg/kg.1, 34 In a randomized, double-blind, active-controlled, noninferiority study of 670 pediatric patients, palonosetron (1 mcg/kg; maximum, 0.075 mg) was compared to ondansetron for the prevention of PONV; the primary endpoint, complete response within 24 hours postoperatively, was achieved by 78.2% of palonosetron-treated patients versus 82.7% of ondansetron-treated patients.1, 34 The prespecified margin for noninferiority was not met.1, 34 Adverse reactions in pediatric patients were similar to those observed in adults.1, 34
Among 1374 adult cancer patients in clinical studies of palonosetron for chemotherapy-induced nausea and vomiting, 23% were 65 years of age or older and 5% were 75 years of age or older.1, 34 No overall differences in safety and effectiveness were observed between geriatric patients and younger adults in these studies, but increased sensitivity in older patients cannot be ruled out.1, 34
Among 1520 adult cancer patients in clinical studies of palonosetron for PONV, 5% were 65 years of age or older.1, 34 No overall differences in safety were observed between these older individuals and younger individuals in these studies; however, the possibility that some older patients may exhibit increased sensitivity to the drug cannot be ruled out.1, 34
A population pharmacokinetic analysis did not reveal any differences in palonosetron pharmacokinetics between cancer patients 65 years of age or older and younger cancer patients.1, 34 The manufacturer states that no dosage adjustment is required for geriatric patients receiving palonosetron.1, 34
Hepatic impairment does not substantially affect total body clearance of palonosetron compared with values in healthy individuals.1, 34 The manufacturer does not recommend any dosage adjustment in patients with any degree of hepatic impairment.1
Mild to moderate renal impairment does not substantially affect the pharmacokinetics of palonosetron.1, 34 Total systemic exposure was approximately 28% higher in patients with severe renal impairment relative to healthy individuals.1, 34 The manufacturer does not recommend any dosage adjustment in patients with any degree of renal impairment.1, 34
Adverse effects reported in ≥5% of adults receiving palonosetron for prevention of chemotherapy-induced nausea and vomiting include headache and constipation.1, 34
Adverse effects reported in ≥2% of adults receiving palonosetron for PONV include QT prolongation, bradycardia, headache, and constipation.1, 34
Palonosetron is metabolized principally by cytochrome P-450 (CYP) isoenzyme 2D6, and to a lesser extent by CYP3A4 and CYP1A2.1, 34
Palonosetron does not inhibit CYP1A2, 2A6, 2B6, 2C9, 2D6, 2E1, or 3A4/5; its effect on CYP2C19 activity is undetermined.1, 34 Palonosetron does not induce CYP1A2, 2D6, or 3A4/5.1, 34
Serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular symptoms) has been reported following concomitant use of type 3 serotonin (5-HT3) receptor antagonists and other serotonergic drugs, including selective serotonin-reuptake inhibitors (SSRIs), serotonin- and norepinephrine-reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs), mirtazapine, fentanyl, lithium, tramadol, and IV methylene blue.1, 34 Patients should be monitored for the emergence of serotonin syndrome, especially with concomitant use of palonosetron and other serotonergic drugs.1, 34 If symptoms of serotonin syndrome occur, palonosetron should be discontinued, and supportive treatment should be initiated.1, 34
In healthy individuals, concomitant administration of a single dose of palonosetron (0.25 mg IV on day 1) and oral aprepitant given for 3 days (125 mg on day 1 and 80 mg on days 2 and 3) did not substantially alter the pharmacokinetics of palonosetron.1, 34 The AUC of palonosetron was unchanged and peak plasma concentrations of the drug increased by 15%.1, 34
Concomitant administration of a single dose of palonosetron (0.25 mg IV) and dexamethasone (20 mg IV) in healthy individuals revealed no pharmacokinetic interactions between the 2 drugs.1, 34
In healthy individuals, concomitant administration of a single dose of palonosetron (0.75 mg IV) and steady-state oral metoclopramide (10 mg 4 times daily) revealed no clinically important pharmacokinetic interaction between the 2 drugs.1, 34
Palonosetron hydrochloride, a selective inhibitor of type 3 serotonergic (5-HT3) receptors, is an antiemetic.1, 7, 17 The drug is pharmacologically related to other 5-HT3 receptor antagonists (e.g., dolasetron, granisetron, ondansetron), but the 5-HT3 receptor antagonists differ structurally.1, 7, 13, 18 Palonosetron has high binding affinity for 5-HT3 receptors and little or no affinity for other receptors.1, 7 The antiemetic activity of palonosetron appears to be mediated both centrally and peripherally via inhibition of 5-HT3 receptors.7, 13
Current evidence suggests that chemotherapeutic agents produce acute nausea and vomiting by inducing degenerative changes in the GI tract (e.g., small intestine), thus increasing endogenous serotonin release from the enterochromaffin cells of the small intestine; serotonin then stimulates 5-HT3 receptors on vagal and splanchnic nerves that project to the medullary vomiting (emetic) center of the brain and also appears to stimulate 5-HT3 receptors in the area postrema.1, 2, 3, 4, 6, 18, 19, 20 Thus, 5-HT3 receptor antagonists appear to prevent or ameliorate acute chemotherapy-induced emesis by inhibiting visceral (from the GI tract) afferent stimulation of the emetic center probably indirectly at the level of the area postrema and by directly inhibiting serotonin activity within the area postrema and chemoreceptor trigger zone (CTZ).2, 3, 4, 6, 18, 19, 20
Alternative mechanisms appear to be principally responsible for delayed nausea and vomiting induced by emetogenic chemotherapy, since similar temporal relationships between serotonin and emesis beyond the first day after a dose have not been established, and 5-HT3 receptor antagonists generally have not appeared to be effective alone in preventing or ameliorating delayed effects.2, 3, 6, 7, 9, 10, 12, 13 In addition, other antiemetic drugs (e.g., aprepitant) that have no activity at 5-HT3 receptors effectively augment the activity of dexamethasone and ondansetron to inhibit both acute and delayed nausea and vomiting induced by highly emetogenic chemotherapy.15 Effective prevention of acute nausea and vomiting may decrease the risk of delayed nausea and vomiting in the same chemotherapy cycle.13, 20
Postoperative nausea and vomiting is influenced by a number of patient-, surgical-, and anesthesia-related factors and is triggered by a release of serotonin in a cascade of neuronal events involving both the CNS and the GI tract.1, 34
Following IV administration, palonosetron plasma levels initially decline rapidly, followed by slow systemic elimination.1, 34 Exposure (AUC) and mean peak plasma concentrations increase dose-proportionally across a 0.3-90 mcg/kg range.1, 34 Pharmacokinetics in surgical patients were comparable to those in cancer patients.1, 34 Palonosetron has approximately 62% plasma protein binding.1, 34
Palonosetron is eliminated through multiple pathways, with around 80% of an IV dose recovered in urine over 144 hours and 40% as unchanged drug.1, 34 The mean terminal elimination half-life is approximately 40 hours in adults.1, 34 Metabolism is primarily via cytochrome P450 (CYP) 2D6, with minor contributions from CYP3A4 and CYP1A2, generating two major metabolites with minimal activity.1, 34 In pediatric patients, mean AUC of palonosetron appears to increase in a dose-proportional manner over the dose range of 10 and 20 mcg/kg.1, 34 Peak plasma concentrations have been shown to be highly variable in pediatric patients and generally lower in children under 6 years of age compared with older children.1, 34 The median half-life of palonosetron across all pediatric age groups is 30 hours, with a range of 20 to 30 hours following administration of a 20 mcg/kg dose.1, 34
In Japanese patients, total body clearance of palonosetron was 25% higher than in white patients, though this was not clinically meaningful.1, 34 Pharmacokinetics of palonosetron are not substantially different between poor and extensive metabolizers of CYP2D6 substrates.1, 34
Additional Information
The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer's labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Parenteral | Injection, for IV use | 0.05 mg (of palonosetron) per mL* | Palonosetron Hydrochloride Injection | |
Posfrea | Avyxa Pharma | |||
0.125 mg (of palonosetron) per mL* | Palonosetron Hydrochloride Injection |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
AHFS® Drug Information. © Copyright, 1959-2025, Selected Revisions September 10, 2025. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, MD 20814.
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