Palonosetron
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
Renal Impairment Mild to moderate renal impairment does not significantly affect palonosetron pharmacokinetic parameters. Total systemic exposure increased by approximately 28% in severe renal impairment relative to healthy subjects. Dosage adjustment is not necessary in patients with any degree of renal impairment.
Dosing in liver impairment
Hepatic Impairment Hepatic impairment does not significantly affect total body clearance of palonosetron compared to the healthy subjects. Dosage adjustment is not necessary in patients with any degree of hepatic impairment.
Preparation and administration
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Instructions for Intravenous Administration Palonosetron Hydrochloride Injection is supplied ready for intravenous administration at a concentration of 0.05 mg/mL (50 mcg/ mL). Palonosetron Hydrochloride Injection should not be mixed with other drugs. The infusion line should be flushed with normal saline before and after administration of Palonosetron Hydrochloride Injection.
Parenteral drug products should be inspected visually for particulate matter and discoloration before administration, whenever solution and container permit.
| *Note different dosing units in pediatrics | ||
| Age | Dose* | Infusion Time |
| Adults | 0 . 2 5 mg x 1 | Infuse over 30 seconds beginning approx. 30 min before the start of chemo |
| Pediatrics (1 month to less than 17 years) | 2 0 micrograms per k ilogram (max 1.5 mg) x 1 | Infuse over 15 minutes beginning approx. 30 min before the start of chemo |
| *Note different dosing units in pediatrics | ||
| Age | Dose* | Infusion Time |
| Adults | 0 . 2 5 mg x 1 | Infuse over 30 seconds beginning approx. 30 min before the start of chemo |
| Pediatrics (1 month to less than 17 years) | 2 0 micrograms per kilogram (max 1.5 mg) x 1 | Infuse over 15 minutes beginning approx. 30 min before the start of chemo |
Drug interactions
Check palonosetron against a medication listLabel text (4 paragraphs)
Palonosetron is eliminated from the body through both renal excretion and metabolic pathways with the latter mediated via multiple CYP enzymes. Further in vitro studies indicated that palonosetron is not an inhibitor of CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2D6, CYP2E1 and CYP3A4/5 (CYP2C19 was not investigated) nor does it induce the activity of CYP1A2, CYP2D6, or CYP3A4/5. Therefore, the potential for clinically significant drug interactions with palonosetron appears to be low.
Serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular symptoms) has been described following the concomitant use of 5-HT 3 receptor antagonists and other serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs) [ see Warnings and Precautions ( 5.2 ) ]. Coadministration of 0.25 mg I.V. palonosetron and 20 mg I.V. dexamethasone in healthy subjects revealed no pharmacokinetic drug-interactions between palonosetron and dexamethasone. In an interaction study in healthy subjects where palonosetron 0.25 mg (I.V.
bolus) was administered on day 1 and oral aprepitant for 3 days (125 mg/80 mg/80 mg), the pharmacokinetics of palonosetron were not significantly altered (AUC: no change, C max : 15% increase). A study in healthy volunteers involving single-dose I.V. palonosetron (0.75 mg) and steady state oral metoclopramide (10 mg four times daily) demonstrated no significant pharmacokinetic interaction. In controlled clinical trials, Palonosetron Hydrochloride Injection has been safely administered with corticosteroids, analgesics, antiemetics /antinauseants, antispasmodics and anticholinergic agents.
Palonosetron did not inhibit the antitumor activity of the five chemotherapeutic agents tested (cisplatin, cyclophosphamide, cytarabine, doxorubicin and mitomycin C) in murine tumor models. The potential for clinically significant drug interactions with palonosetron appears to be low ( 7 )
Contraindications
Palonosetron Hydrochloride Injection is contraindicated in patients known to have hypersensitivity to the drug or any of its components. [ see Adverse Reactions ( 6.2 ) ]. Palonosetron Hydrochloride Injection is contraindicated in patients known to have hypersensitivity to the drug or any of its components ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for palonosetron. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Pregnancy Category B Risk Summary Adequate and well controlled studies with Palonosetron Hydrochloride Injection have not been conducted in pregnant women. In animal reproduction studies, no effects on embryo-fetal development were observed with the administration of oral palonosetron during the period of organogenesis at doses up to 1894 and 3789 times the recommended human intravenous dose in rats and rabbits, respectively. Because animal reproduction studies are not always predictive of human response, Palonosetron Hydrochloride Injection should be used during pregnancy only if clearly needed.
Animal Data In animal studies, no effects on embryo-fetal development were observed in pregnant rats given oral palonosetron at doses up to 60 mg/kg/day (1894 times the recommended human intravenous dose based on body surface area) or pregnant rabbits given oral doses up to 60 mg/kg/day (3789 times the recommended human intravenous dose based on body surface area) during the period of organogenesis.
Lactation
8.3 Nursing Mothers It is not known whether Palonosetron Hydrochloride Injection is present in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants and the potential for tumorigenicity shown for palonosetron in the rat carcinogenicity study [ see Nonclinical Toxicology ( 13.1 )] , a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Breastfeeding (LactMed)
No information is available on the use of palonosetron during breastfeeding. Until more data become available, palonosetron should be used with caution during breastfeeding. An alternate drug may be preferred. No information is available on the use of netupitant, which is the other component of the combination product Akynzeo, during breastfeeding. Because netupitant and its metabolites are more than 97% bound to plasma proteins, the amount in milk is likely to be low. Until more data become available, Akynzeo should be used with caution during breastfeeding. An alternate drug may be preferred.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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