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Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates reported in practice.
In clinical trials for the prevention of nausea and vomiting induced by moderately or highly emetogenic chemotherapy, 1374 adult patients received palonosetron. Adverse reactions were similar in frequency and severity with ALOXI (palonosetron hydrochloride) and ondansetron or dolasetron. Following is a listing of all adverse reactions reported by ≥2% of patients in these trials (Table 1).
Table 1: Adverse Reactions from Chemotherapy-Induced Nausea and Vomiting Studies ≥2% in any Treatment Group
|Event||Aloxi 0.25 mg
32 mg IV
100 mg IV
|Headache||60 (9%)||34 (8%)||32 (16%)|
|Constipation||29 (5%)||8 (2%)||12 (6%)|
|Diarrhea||8 (1%)||7 (2%)||4 (2%)|
|Dizziness||8 (1%)||9 (2%)||4 (2%)|
|Fatigue||3 (<1%)||4 (1%)||4 (2%)|
|Abdominal Pain||1 (<1%)||2 (<1%)||3 (2%)|
|Insomnia||1 (<1%)||3 (1%)||3 (2%)|
In other studies, 2 subjects experienced severe constipation following a single palonosetron dose of approximately 0.75 mg, three times the recommended dose. One patient received a 10 mcg/kg oral dose in a postoperative nausea and vomiting study and one healthy subject received a 0.75 mg IV dose in a pharmacokinetic study.
In clinical trials, the following infrequently reported adverse reactions, assessed by investigators as treatment-related or causality unknown, occurred following administration of ALOXI (palonosetron hydrochloride) to adult patients receiving concomitant cancer chemotherapy:
Cardiovascular: 1%: non-sustained tachycardia, bradycardia, hypotension, < 1%: hypertension, myocardial ischemia, extrasystoles, sinus tachycardia, sinus arrhythmia, supraventricular extrasystoles and QT prolongation. In many cases, the relationship to ALOXI (palonosetron hydrochloride) was unclear.
Musculoskeletal: < 1%: arthralgia.
The following adverse reactions have been identified during postapproval use of ALOXI (palonosetron hydrochloride) . Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Very rare cases (<1/10,000) of hypersensitivity reactions and injection site reactions (burning, induration, discomfort and pain) were reported from postmarketing experience.
Read the Aloxi (palonosetron hydrochloride) Side Effects Center for a complete guide to possible side effects
Palonosetron is eliminated from the body through both renal excretion and metabolic pathways with the latter mediated via multiple CYP enzymes. 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.
A study in healthy volunteers involving single-dose IV palonosetron (0.75 mg) and steady state oral metoclopramide (10 mg four times daily) demonstrated no significant pharmacokinetic interaction.
In controlled clinical trials, ALOXI (palonosetron hydrochloride) injection has been safely administered with corticosteroids, analgesics, antiemetics/antinauseants, antispasmodics and anticholinergic agents.
Read the Aloxi Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 9/25/2007
This monograph has been modified to include the generic and brand name in many instances.
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