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

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 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
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/5 mL vial | ![]() | |
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 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.
Formulary
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.
Adding plans allows you to:
- 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.