Dosing & Uses
Dosage Forms & Strengths
injectable solution: single-use vials
- 0.05mg/mL
Prevention of Chemotherapy-induced Nausea & Vomiting
Indicated for prevention of acute N/V associated with moderately or highly emetogenic chemotherapeutic agents; also for delayed N/V associated moderately emetogenic chemotherapeutic agents
0.25 mg IV over 30 seconds x1, beginning 30 minutes before chemotherapy
Prevention of Postoperative Nausea & Vomiting
Indicated for prevention of PONV following surgery; efficacy beyond 24 hr has not been demonstrated
0.075 mg IV infused over 10 seconds immediately before anesthesia
Dosage Modifications
Renal or hepatic impairment: Dose adjustment not necessary
Dosage Forms & Strengths
injectable solution: single-use vials
- 0.05mg/mL
Prevention of Chemotherapy-induced Nausea & Vomiting
Indicated for prevention of acute N/V associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy
<1 month: Safety and efficacy not established
1 month to 17 years: 20 mcg/kg IV infused over 15 minutes x1, beginning 30 minutes before chemotherapy; not to exceed 1.5 mg/dose
Prevention of Postoperative Nausea & Vomiting
<18 years: Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (1)
- apomorphine
apomorphine, palonosetron. Mechanism: unspecified interaction mechanism. Contraindicated. Profound hypotension and loss of consciousness reported when 5HT3 antagonists are coadministered with apomorphine. .
Serious - Use Alternative (35)
- almotriptan
palonosetron, almotriptan. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.
- amitriptyline
palonosetron, amitriptyline. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.
- amoxapine
palonosetron, amoxapine. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.
- citalopram
palonosetron, citalopram. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.
- clomipramine
palonosetron, clomipramine. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.
- desipramine
palonosetron, desipramine. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.
- desvenlafaxine
palonosetron, desvenlafaxine. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.
- doxepin
palonosetron, doxepin. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.
- duloxetine
palonosetron, duloxetine. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.
- eletriptan
palonosetron, eletriptan. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.
- escitalopram
palonosetron, escitalopram. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.
- fluoxetine
palonosetron, fluoxetine. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.
- fluvoxamine
fluvoxamine and palonosetron both increase serotonin levels. Avoid or Use Alternate Drug.
- frovatriptan
palonosetron, frovatriptan. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.
- imipramine
palonosetron, imipramine. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.
- isocarboxazid
palonosetron, isocarboxazid. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.
- levomilnacipran
palonosetron, levomilnacipran. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.
- milnacipran
palonosetron, milnacipran. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.
- naratriptan
palonosetron, naratriptan. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.
- nortriptyline
palonosetron, nortriptyline. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.
- paroxetine
palonosetron, paroxetine. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.
- phenelzine
palonosetron, phenelzine. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.
- protriptyline
palonosetron, protriptyline. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.
- rasagiline
palonosetron, rasagiline. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.
- rizatriptan
palonosetron, rizatriptan. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.
- selegiline
palonosetron, selegiline. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.
- selegiline transdermal
palonosetron, selegiline transdermal. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.
- sertraline
palonosetron, sertraline. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.
- sumatriptan
palonosetron, sumatriptan. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.
- sumatriptan intranasal
palonosetron, sumatriptan intranasal. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.
- tedizolid
tedizolid, palonosetron. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. both increase serotonin levels; increased risk of serotonin syndrome.
- tranylcypromine
palonosetron, tranylcypromine. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.
- trimipramine
palonosetron, trimipramine. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.
- venlafaxine
palonosetron, venlafaxine. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.
- zolmitriptan
palonosetron, zolmitriptan. Either increases toxicity of the other by serotonin levels. Avoid or Use Alternate Drug.
Monitor Closely (3)
- dichlorphenamide
dichlorphenamide and palonosetron both decrease serum potassium. Use Caution/Monitor.
dichlorphenamide, palonosetron. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Both drugs can cause metabolic acidosis. - fenfluramine
palonosetron decreases effects of fenfluramine by pharmacodynamic antagonism. Use Caution/Monitor. Potent serotonin receptor antagonists may decrease fenfluramine efficacy. If coadministered, monitor appropriately.
- peginterferon alfa 2b
peginterferon alfa 2b, palonosetron. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.
Minor (0)
Adverse Effects
1-10%
Prolonged QT interval (up to 5%)
Anxiety
Dizziness
Headache
Weakness
Constipation
Diarrhea
Prutitus
Hyperkalemia
LFT's increased
<1%
First degree atrioventricular block
Second degree atrioventricular block
Frequency Not Defined
Immune hypersensitivity reaction (very rare)
Seizure
Dyskinesia
Infusion site pain
Allergic dermatitis, skin disorder
Postmarketing Reports
Serotonin syndrome
Dyspnea
Bronchospasm
Swelling/edema
Erythema
Pruritus
Rash
Urticaria
Warnings
Contraindications
Hypersensitivity to drug, other selective 5-HT3 receptor antagonists (eg, granisetron), or excipients
Cautions
Use caution in patients with congenital long QT syndrome or other factors that may prolong QT interval
For chemotherapy, the drug should follow a specific schedule, and not be administered as needed
Drug is not recommended in PONV if expectation for nausea or vomiting is very small; use only if the expectation is low or it is essential to avoid nausea and vomiting in the postoperative period
Hypersensitivity: Hypersensitivity reactions, including anaphylaxis and anaphylactic shock, reported with administration; these reactions occurred in patients with or without known hypersensitivity to other 5-HT3 receptor antagonists; if hypersensitivity reactions occur, discontinue therapy and initiate appropriate medical treatment; do not reinitiate therapy in patients who have previously experienced symptoms of hypersensitivity
Serotonin syndrome
- The development of serotonin syndrome reported with 5-HT3 receptor antagonists; most reports have been associated with concomitant use of serotonergic drugs (eg, 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-HT3 receptor antagonist alone also reported; the majority of reports of serotonin syndrome related to 5-HT3 receptor antagonist use occurred in post-anesthesia care unit or an infusion center
- Symptoms associated with serotonin syndrome may include mental status changes (eg, agitation, hallucinations, delirium, and coma), autonomic instability (eg, tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (eg, tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, with or without gastrointestinal symptoms (eg, nausea, vomiting, diarrhea)
- Patients should be monitored for emergence of serotonin syndrome, especially with concomitant use of other serotonergic drugs; if symptoms of serotonin syndrome occur, discontinue therapy and initiate supportive treatment
- Patients should be informed of increased risk of serotonin syndrome, especially if this drug is used concomitantly with other serotonergic drugs
Drug interactions overview
- Serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular symptoms) described following concomitant use of 5-HT3 receptor antagonists and other serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs); monitor for emergence of serotonin syndrome; if symptoms occur, discontinue therapy and initiate supportive treatment
- Coadministration with apomorphine; combination reported to cause profound hypotension and loss of consciousness
Pregnancy & Lactation
Pregnancy
There are no available data on palonosetron HCl use in pregnant women to inform a drug-associated risk
Animal data
- In animal reproduction studies, no effects on embryo-fetal development were observed with the administration of oral palonosetron HCl during the period of organogenesis at doses up to 1,894 and 3,789 times the recommended human intravenous dose in rats and rabbits, respectively
Lactation
There are no data on presence in human milk, effects on breastfed infant, or on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for drug and any potential adverse effect on breastfed infant from palonosetron or from underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Selective 5-HT3 receptor antagonist; palonosetron binds to 5-HT3 receptors both in peripheral and central nervous system with primary effects in GI tract
Pharmacokinetics
Half-life: 40 hr
Peak plasma: 5.6±5.5 ng/mL (dose-proportional)
AUC: 35.8±20.9 ng.hr/mL (dose-proportional)
Protein bound: 62%
Vd: 8.3±2.5 L/kg
Metabolism: CYP2D6, CYP3A and CYP1A2
Metabolites: N-oxide-palonosetron and 6-S-hydroxy-palonosetron (<1% parent activity)
Excretion: Urine (80-93%); feces (5-8%)
Clearance: 160±35 mL/hr/kg (total)
Administration
Pediatric administration
For a dose of 0.25 mg use either the single-dose vial or pre-filled syringe; do not use pre-filled syringe to administer a dose other than 0.25 mg
IV Incompatibilities
Do not mix with other drugs
IV Administration
Flush IV line with NS before and after administration
CINV: give IVP evenly over 30 sec (adults) or 15 min (children)
PONV: IVP over 10 sec
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| palonosetron intravenous - | 0.25 mg/5 mL vial |  | |
| palonosetron intravenous - | 0.25 mg/5 mL solution |  | |
| palonosetron intravenous - | 0.25 mg/2 mL vial |  | |
| palonosetron intravenous - | 0.25 mg/5 mL vial |  | |
| palonosetron intravenous - | 0.25 mg/5 mL vial |  | |
| palonosetron intravenous - | 0.25 mg/5 mL vial |  | |
| palonosetron intravenous - | 0.25 mg/5 mL vial |  | |
| palonosetron intravenous - | 0.25 mg/5 mL solution |  | |
| palonosetron intravenous - | 0.25 mg/5 mL vial |  | |
| palonosetron intravenous - | 0.25 mg/5 mL solution |  | |
| palonosetron intravenous - | 0.25 mg/5 mL vial |  | |
| palonosetron intravenous - | 0.25 mg/5 mL vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
palonosetron intravenous
PALONOSETRON - INJECTION
(PAL-oh-NOE-se-tron)
COMMON BRAND NAME(S): Aloxi
USES: This medication is used to prevent nausea and vomiting caused by cancer drug treatment (chemotherapy). It is also used to prevent nausea and vomiting after surgery. Palonosetron works by blocking one of the body's natural substances (serotonin) that causes vomiting.
HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using palonosetron and each time you get a refill. If you have any questions, ask your doctor or pharmacist.This medication is given by injection into a vein by a health care professional. It is given as directed by your doctor, usually 30 minutes before the start of chemotherapy or right before the start of surgery.The dosage is based on your medical condition and response to treatment. In children, the dosage is also based on weight.Tell your doctor if you vomit or feel nauseated.
SIDE EFFECTS: Pain, redness, or swelling at the injection site may occur. Headache, constipation, or diarrhea may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using palonosetron, tell your doctor or pharmacist if you are allergic to it; or to other anti-nausea serotonin blockers (such as ondansetron, granisetron); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/"ecstasy," St. John's wort, certain antidepressants (including SSRIs such as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine), among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Not applicable.
MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.
STORAGE: Not applicable. This medication is given in a clinic and will not be stored at home.
Information last revised August 2021. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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