VA Class:GA605
ATC Class:A04AA
Palonosetron hydrochloride, a selective, second-generation inhibitor of type 3 serotonergic (5-HT3) receptors, is an antiemetic.1, 17, 28
Palonosetron hydrochloride is used IV for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy.1 Palonosetron hydrochloride also is used IV for the prevention and treatment of postoperative nausea and vomiting.1
Cancer 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 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
To prevent chemotherapy-induced nausea and vomiting associated with highly emetogenic chemotherapy regimens (including an anthracycline plus cyclophosphamide), the American Society of Clinical Oncology (ASCO) currently recommends a 3-drug antiemetic regimen consisting of a neurokinin-1 (NK1) receptor antagonist (e.g., either oral aprepitant or IV fosaprepitant dimeglumine), a type 3 serotonin (5-HT3) receptor antagonist (e.g., dolasetron, granisetron, ondansetron, palonosetron, ramosetron [not commercially available in the US], tropisetron [not commercially available in the US]), and dexamethasone.28, 29 ASCO states that the oral, fixed-combination of netupitant and palonosetron plus dexamethasone is an additional antiemetic treatment option in this setting.29
For patients receiving moderately emetogenic chemotherapy regimens, ASCO recommends a 2-drug antiemetic regimen preferably consisting of palonosetron and dexamethasone.28, 29 If palonosetron is not available, a first-generation 5-HT3 receptor antagonist (preferably granisetron or ondansetron) may be substituted.28 Limited evidence suggests that aprepitant may be added to this regimen; in such cases, ASCO states that any of the 5-HT3 receptor antagonists is appropriate.28
For patients receiving chemotherapy regimens with a low emetogenic risk , ASCO recommends administration of a single dose of dexamethasone prior to chemotherapy.28
In patients receiving chemotherapy regimens with a minimal emetogenic risk , antiemetics should not be routinely administered prior to or following chemotherapy.28
Efficacy and safety 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 were established in 2 comparative studies with single-dose ondansetron hydrochloride or dolasetron mesylate.1 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%, respectively, of patients receiving palonosetron (0.25 mg IV) and 69 or 55%, respectively, of patients receiving ondansetron (32 mg IV).1 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 53 or 39%, respectively, of patients receiving dolasetron mesylate (100 mg IV).1 Concomitant corticosteroids were not used prophylactically in the first study, and such use occurred in 4-6% of patients in the second study.1
Efficacy and safety of a single IV dose of palonosetron hydrochloride for the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy in adults were established in a dose-ranging study and a comparative study with ondansetron hydrochloride.1 In the comparative study, complete responses (i.e., no emetic episodes and no rescue antiemetic therapy) at 0-24 hours were achieved in 59 or 57% of patients receiving palonosetron (0.25 mg IV) or ondansetron (32 mg IV), respectively.1 Corticosteroids were administered prophylactically in 67% of patients.1
Efficacy and safety 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 were established in a comparative study with multiple-dose IV ondansetron hydrochloride in 327 pediatric cancer patients (mean age of 8.3 years; range: 2 months-16.9 years).1 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 pediatric patients receiving either palonosetron (single dose of 20 mcg/kg prior to chemotherapy; maximum of 1.5 mg IV) or ondansetron (0.15 mg/kg IV prior to chemotherapy and 4 and 8 hours after the first dose; maximum total dose of 32 mg).1 Concomitant corticosteroids were administered prophylactically in 55% of patients.1
Postoperative Nausea and Vomiting
Palonosetron hydrochloride is used IV for the prevention of postoperative nausea and vomiting for up to 24 hours following surgery.1 Efficacy of the drug beyond 24 hours has not been demonstrated.1 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 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
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 Outpatients (mean age of about 38 years; range: 21-74 years) undergoing 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 The primary efficacy measures were complete response (i.e., no emetic episode and no use of rescue drug in the 0-24 and in the 24-72 hour periods postoperatively).1 The complete response rate (0-24 hours) was higher in patients who received palonosetron 0.075 mg IV (42.8%) compared with those who received placebo (25.9%).1 Palonosetron 0.075 mg IV also reduced the severity of nausea compared with placebo.1
In a randomized, double-blind, dose-ranging study, the efficacy of 5 IV palonosetron doses (0.1, 0.3, 1, 3, and 30 mcg/kg) for the prevention of postoperative nausea and vomiting following abdominal or vaginal hysterectomy was evaluated in 381 patients.1 The primary efficacy measure was proportion of patients with complete response in the first 24 hours following recovery from surgery.1 Palonosetron 1 mcg/kg (approximately 0.075 mg) was the lowest effective dose in this study and had a complete response rate of 44% compared with 19% for placebo.1 Palonosetron 1 mcg/kg also substantially reduced the severity of nausea compared with placebo.1
Palonosetron hydrochloride is administered IV.1 The solution should be inspected visually for particulate matter and discoloration prior to administration.1 Palonosetron hydrochloride should not be mixed with other drugs, and the IV line should be flushed with 0.9% sodium chloride injection before and after administration of the drug.1
Dosage of palonosetron hydrochloride is expressed in terms of palonosetron.1
Cancer Chemotherapy-induced Nausea and Vomiting
For the prevention of cancer chemotherapy-induced nausea and vomiting in adults, a single palonosetron dose of 0.25 mg (administered IV over 30 seconds) is given approximately 30 minutes before the start of chemotherapy.1
For the prevention of cancer chemotherapy-induced nausea and vomiting in pediatric patients 1 month to less than 17 years of age, a single palonosetron dose of 20 mcg/kg (maximum dose of 1.5 mg) administered IV over 15 minutes is given approximately 30 minutes before the start of chemotherapy.1 The manufacturer states that a clinical study in pediatric patients 2 months to less than 17 years of age demonstrated that pediatric patients require a higher dose of palonosetron to prevent cancer chemotherapy-induced nausea and vomiting compared with adults.1
Postoperative Nausea and Vomiting
For the prevention of postoperative nausea and vomiting in adults, a single palonosetron dose of 0.075 mg (administered IV over 10 seconds) is given immediately before induction of anesthesia.1
No dosage adjustment is required in patients with any degree of hepatic impairment.1 (See Hepatic Impairment under Warnings/Precautions: Specific Populations, in Cautions.)
No dosage adjustment is required in patients with any degree of renal impairment.1 (See Renal Impairment under Warnings/Precautions: Specific Populations, in Cautions.)
No dosage adjustment is necessary in geriatric patients.1 (See Geriatric Patients under Warnings/Precautions: Specific Populations, in Cautions.)
Known hypersensitivity to palonosetron hydrochloride or any ingredient in the formulation.1 (See Sensitivity Reactions under Cautions: Warnings/Precautions.)
Hypersensitivity reactions, including anaphylaxis, 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, 32, 33 (See Advice to Patients.)
Other Warnings and Precautions
Development of serotonin syndrome has been reported in patients receiving 5-HT3 receptor antagonists.1 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 [MAO] inhibitors, mirtazapine, fentanyl, lithium, tramadol, IV methylene blue).1 Some of the reported cases of serotonin syndrome were fatal.1 Serotonin syndrome occurring with overdosage of another 5-HT3 receptor antagonist alone (ondansetron) also has been reported.1, 31 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
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
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 If symptoms of serotonin syndrome occur, palonosetron should be discontinued, and supportive treatment should be initiated.1 (See Drug Interactions: Serotonergic Agents and also see Advice to Patients.)
Category B.1 (See Users Guide.)
Not known whether palonosetron is distributed into milk.1 Discontinue nursing or the drug, taking into account the importance of the drug to the woman.1
Safety and efficacy of IV palonosetron have not been established in neonates younger than 1 month of age for prevention of chemotherapy-induced nausea and vomiting.1 (See Clinical Experience under Uses; Cancer Chemotherapy-induced Nausea and Vomiting.)
Safety and efficacy of IV palonosetron have not been established in pediatric patients for the prevention of postoperative nausea and vomiting.1
In the clinical studies for palonosetron in chemotherapy-induced nausea and vomiting, 23% of adult cancer patients were 65 years of age or older and 5% were 75 years of age or older.1 No overall differences in safety and effectiveness were observed between these geriatric patients and younger adults in these studies, but increased sensitivity cannot be ruled out.1 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 (18-64 years of age).1 The manufacturer states that no dosage adjustment or special monitoring is required for geriatric patients receiving palonosetron.1
In the clinical studies for palonosetron in postoperative nausea and vomiting, 5% of adult patients were 65 years of age or older.1 No overall differences in safety were observed between these older individuals and younger individuals in these studies, although the possibility that some older patients may exhibit increased sensitivity to the drug cannot be ruled out.1
No differences in efficacy were observed in geriatric patients for the chemotherapy-induced nausea and vomiting indication and none are expected for geriatric postoperative nausea and vomiting patients.1 However, efficacy of palonosetron in geriatric patients has not been adequately evaluated to date.1
Hepatic impairment does not substantially affect total body clearance of palonosetron compared with values in healthy individuals.1 The manufacturer states that dosage adjustment is not necessary in patients with any degree of hepatic impairment.1
Mild to moderate renal impairment does not substantially affect the pharmacokinetics of palonosetron.1 Total systemic exposure was approximately 28% higher in patients with severe renal impairment relative to healthy individuals.1 The manufacturer states that dosage adjustment is not necessary in patients with any degree of renal impairment.1
Adverse effects reported in 1% or more of adults receiving palonosetron for prevention of chemotherapy-induced nausea and vomiting include headache,1 constipation,1 diarrhea,1 dizziness,1 nonsustained tachycardia,1 bradycardia,1 hypotension,1 weakness,1 hyperkalemia,1 and anxiety.1
Adverse effects reported in 2% or more of adults receiving palonosetron for postoperative nausea and vomiting include QT-interval prolongation,1 bradycardia,1 headache,1 and constipation.1
Drugs Affecting or Affected by Hepatic Microsomal Enzymes
Clinically important pharmacokinetic interactions unlikely.1 Metabolized principally by cytochrome P-450 (CYP) isoenzyme 2D6, but pharmacokinetics of palonosetron are not substantially different between poor and extensive metabolizers of isoenzyme 2D6 substrates.1 Metabolized to a lesser extent by isoenzymes 3A and 1A2.1 Does not inhibit activity of isoenzymes 1A2, 2A6, 2B6, 2C9, 2D6, 2E1, or 3A4/5; effect on isoenzyme 2C19 activity undetermined.1 Does not induce activity of isoenzymes 1A2, 2D6, or 3A4/5.1
Serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular symptoms) has been reported following the 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 (MAO) inhibitors, mirtazapine, fentanyl, lithium, tramadol, and IV methylene blue.1 Patients should be monitored for the emergence of serotonin syndrome, especially with concomitant use of palonosetron and other serotonergic drugs.1 If symptoms of serotonin syndrome occur, palonosetron should be discontinued, and supportive treatment should be initiated.1 (See Serotonin Syndrome under Warnings/Precautions: Other Warnings and Precautions, in Cautions and also see Advice to Patients.)
Pharmacologic interaction unlikely.1 Palonosetron did not inhibit antineoplastic activity of cisplatin, cyclophosphamide, cytarabine, doxorubicin, or mitomycin in animal tumor models.1
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 The area under the concentration-time curve (AUC) of palonosetron was unchanged and peak plasma concentrations of the drug increased by 15%.1
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 (See Drug Interactions: Other Drugs.)
In healthy individuals, concomitant administration of a single dose of palonosetron (0.75 mg IV on day 1) and steady-state oral metoclopramide (10 mg 4 times daily) revealed no clinically important pharmacokinetic interaction between the 2 drugs.1
Palonosetron has been administered safely in controlled studies with corticosteroids (see Drug Interactions: Dexamethasone), analgesics, antiemetics, antispasmodics, and anticholinergic agents.1
Palonosetron hydrochloride, a selective inhibitor of type 3 serotonergic (5-HT3) receptors, is an antiemetic.1, 7, 17, 27 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, 11, 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, 5, 6, 8, 11, 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, 5, 6, 8, 11, 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, 5, 6, 7, 8, 9, 10, 11, 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.14, 15, 16 Effective prevention of acute nausea and vomiting may decrease the risk of delayed nausea and vomiting in the same chemotherapy cycle.13, 20 Although efficacy of a 5-HT3 receptor antagonist appears to depend more on its interaction at the receptor than its plasma half-life, it has been hypothesized that palonosetron's potency and long plasma half-life (i.e., 4-5 times longer than those of other commercially available 5-HT3 receptor antagonists) may contribute to its observed efficacy in preventing delayed nausea and vomiting caused by moderately emetogenic cancer chemotherapy. 7, 11, 17, 21
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
Approximately 80% of a single IV dose of palonosetron is recovered in urine within 144 hours following administration; about 40% of the dose is recovered in urine as unchanged drug.1 Following single-dose IV administration in healthy individuals, palonosetron appears to have a mean terminal elimination half-life of about 40 hours.1
Importance of reading the palonosetron hydrochloride patient information provided by the manufacturer before beginning therapy and rereading it each time the preparation is given.1
Importance of informing patients that hypersensitivity reactions, including anaphylaxis, have been reported in patients receiving palonosetron.1 Clinicians should advise patients to seek immediate medical attention if any signs or symptoms of a hypersensitivity reaction occur while receiving the drug.1
Importance of informing patients of the possibility of serotonin syndrome, particularly with concomitant use of palonosetron and another serotonergic agent such as antidepressants and antimigraine agents.1 Clinicians should advise patients to seek immediate medical attention should they experience any of the following serotonin syndrome symptoms: changes in mental status, autonomic instability, neuromuscular symptoms, or seizures with or without GI symptoms.1
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.1, 26
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1, 26
Importance of informing patients of other important precautionary information.1, 26 (See Cautions.)
Additional Information
Overview® (see Users Guide). For additional information on this drug until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.
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.
AHFS® Drug Information. © Copyright, 1959-2025, Selected Revisions March 4, 2019. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, MD 20814.
1. Eisai, Inc. Aloxi® (palonosetron hydrochloride) injection prescribing information. Woodcliff, NJ; 2014 Sep.
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9. De Mulder PHM, Seynaeve C, Vermorken JB et al. Ondansetron compared with high-dose metoclopramide in prophylaxis of acute and delayed cisplatin-induced nausea and vomiting: a multicenter, randomized, double-blind, crossover study. Ann Intern Med . 1990; 113:834-40. [PubMed 2146911]
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11. Donnerer J, Beubler E. 5-HT3 receptor antagonists in antiemetic therapy. In: Donnerer J (ed.): Antiemetic therapy. Basel: Karger; 2003: 22-32.
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14. Merck. Emend® (aprepitant) capsules prescribing information. Whitehouse Station, NJ; 2003 Mar.
15. Sorbera LA, Castaner J, Bayes M at al. Aprepitant and L758298. Drugs Fut . 2002; 27:211-22.
16. Merck. Emend® (aprepitant) product information form for the American Hospital Formulary Service. 2003.
17. Eglen RM, Lee CH, Smith WL at al. Pharmacological characterization of RS 25259-17, a novel and selective 5-HT3 receptor antagonist, in vivo. Br J Pharmacol . 1995; 114:860-6 [PubMed 7773547][PubMedCentral]
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21. MGI Pharma. Aloxi® (palonosetron hydrochloride) injection. Overview. Bloomington, MN; [2003 Aug 28]. From MGI Pharma web site ([Web]).
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23. Clark RD, Miller AB, Berger J et al. 2 (Quinuclidin-3-yl) pyrido [4,3-b]indol-1-ones and isoquinolin-1-ones. Potent conformationally restricted 5-HT3 receptor antagonists. J Med Chem . 1993; 36:2645-57. [PubMed 8410977]
24. Gralla R, Lichinitster M, Van Der Vegt S et al. Palonosetron improves prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy: results of a double-blind randomized phase III trial comparing single doses of palonosetron with ondansetron. Ann Oncol . 2003; 14:570-7. [PubMed 12649103]
25. MGI Pharma, Bloomington, MN: Personal communication.
26. MGI Pharma. Aloxi® (palonosetron hydrochloride) patient information. Bloomington, MN. Undated. Available at: [Web]. Accessed 2006 Dec 6.
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