palonosetron (Rx)

Brand and Other Names:Aloxi

Dosing & Uses

AdultPediatric

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

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Interactions

Interaction Checker

and palonosetron

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 

            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)

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              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

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              Warnings

              Contraindications

              Hypersensitivity to drug, other selective 5-HT3 receptor antagonists (eg, granisetron), or any other component

              Coadministration with apomorphine; combination reported to cause profound hypotension and loss of consciousness

              Cautions

              Use caution in patients with congenital long QT syndrome or other factors that may prolong QT interval

              Serotonin syndrome reported with 5-HT3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs including SSRIs, SNRIs, MAO inhibitors, lithium, tramadol, methylene blue IV, and mirtazapine

              Hypersensitivity reactions, including anaphylaxis, reported with or without known hypersensitivity to other 5-HT3 receptor antagonists

              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

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              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.

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              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)

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              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

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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              palonosetron intravenous
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              0.25 mg/5 mL vial
              palonosetron intravenous
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              0.25 mg/5 mL solution
              palonosetron intravenous
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              0.25 mg/5 mL vial
              palonosetron intravenous
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              0.25 mg/2 mL vial
              palonosetron intravenous
              -
              0.25 mg/5 mL vial
              palonosetron intravenous
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              0.25 mg/5 mL vial
              palonosetron intravenous
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              0.25 mg/5 mL solution
              palonosetron intravenous
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              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.

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              Patient Handout

              Patient Education
              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.

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              Formulary

              FormularyPatient Discounts

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              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
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              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
              OR Other Restrictions
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.