"To address "continuing safety concerns" about severe neutropenia associated with the atypical antipsychotic clozapine (multiple brands), the US Food and Drug Administration (FDA) is making changes to requirements for monitoring, prescribing, disp"...
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 observed in practice. In clinical trials for the prevention of nausea and vomiting induced by moderately emetogenic chemotherapy, 693 adult patients received oral palonosetron in doses ranging from 0.25 mg to 0.75 mg. Following is a listing of drug related adverse reactions reported by ≥ 2% of patients from two clinical trials.
Table 1: Adverse Reactions ≥ 2% from Chemotherapy-Induced Nausea
and Vomiting Studies
|0.25 mg I.V.
|Headache||6 (3.8%)||6 (3.7%)||21 (5.6%)||14 (8.6%)|
|Constipation||1 (0.6%)||1 (0.6%)||9 (2.4%)||5 (3.1%)|
The infrequently reported adverse reactions listed below, assessed by investigators as treatment-related or causality unknown/missing, occurred following administration of ALOXI (palonosetron hcl capsules) Capsules to adult patients receiving concomitant cancer chemotherapy. Of these adverse events, fatigue (incidence 1%), was the only adverse event reported at an incidence of ≥ 1%. In general, adverse reactions were similar between oral and I.V. formulations.
Blood and Lymphatic System: <1%: anemia.
Cardiovascular: <1%: hypertension, transient arrhythmia, first degree atrioventricular block, second degree atrioventricular block, QTc prolongation.
Hearing and Labyrinth: <1%: motion sickness.
Eye: <1%: eye swelling.
Gastrointestinal System: <1%: gastritis, nausea, vomiting.
General: 1%: fatigue, <1%: chills, pyrexia.
Infections: <1%: sinusitis.
Liver: <1%: transient, asymptomatic increases in bilirubin.
Nutrition: <1%: anorexia.
Nervous System: <1%: postural dizziness, dysgeusia.
Psychiatric: <1%: insomnia.
Very rare cases (<1/10,000) of hypersensitivity reactions have been reported for I.V. ALOXI (palonosetron hcl capsules) from post-marketing experience.
Read the Aloxi Capsules (palonosetron hcl capsules) 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. 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.
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.
Concomitant administration of an antacid (Maalox® liquid 30 mL) had no effect on the oral absorption or pharmacokinetics of a single capsule of palonosetron 0.75 mg in healthy subjects.
In controlled clinical trials, ALOXI (palonosetron hcl capsules) Capsules have been safely administered with chemotherapeutic agents, systemic corticosteroids, analgesics, and drugs for gastrointestinal disorders including function gastrointestinal disorders, acid-related disorders, and antiemetics/antinauseants.
Palonosetron did not inhibit the antitumor activity of the five chemotherapeutic agents tested (cisplatin, cyclophosphamide, cytarabine, doxorubicin and mitomycin C) in murine tumor models.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 9/19/2008
Additional Aloxi Capsules Information
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