palonosetron (Rx)

Brand and Other Names:Aloxi
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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

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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

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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 Category: B

            Lactation: unknown, discontinue drug or do not nurse

            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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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

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            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            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.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            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
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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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.