Palonosetron hydrochloride

Palonosetron hydrochloride
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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Overview

Palonosetron hydrochloride is an antiemetic that is FDA approved for the prophylaxis of chemotherapy-Induced nausea and vomiting. Common adverse reactions include bradyarrhythmia,constipation,headache.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Prevention of Chemotherapy-Induced Nausea and Vomiting ALOXI Capsules are indicated for:

• Moderately emetogenic cancer chemotherapy - prevention of acute nausea and vomiting associated with initial and repeat courses.

Dosage

• One 0.5 mg capsule administered approximately one hour prior to the start of chemotherapy. ALOXI can be taken with or without food.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Palonosetron hydrochloride in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Palonosetron hydrochloride in adult patients.

DOSAGE FORMS AND STRENGTHS

• Capsules, 0.5 mg

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Palonosetron hydrochloride in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Palonosetron hydrochloride in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Palonosetron hydrochloride in pediatric patients.

Contraindications

• ALOXI is contraindicated in patients known to have hypersensitivity to the drug or any of its components.

Warnings

Hypersensitivity

Hypersensitivity reactions may occur in patients who have exhibited hypersensitivity to other 5-HT3 receptor antagonists. Hypersensitivity reactions have been very rarely reported post-marketing for intravenous palonosetron: dyspnea, bronchospasm, swelling/edema, erythema, pruritus, rash, urticaria. No hypersensitivity reactions have been reported for oral palonosetron.

Serotonin Syndrome

• The development of serotonin syndrome has been reported with 5-HT3 receptor antagonists. Most reports have been associated with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue). Some of the reported cases were fatal. Serotonin syndrome occurring with overdose of another 5-HT3 receptor antagonist alone has also been reported. The majority of reports of serotonin syndrome related to 5-HT3 receptor antagonist use occurred in a post-anesthesia care unit or an infusion center.

• Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g.,tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, with or without gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for the emergence of serotonin syndrome, especially with concomitant use of ALOXI and other serotonergic drugs. If symptoms of serotonin syndrome occur, discontinue ALOXI and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if ALOXI is used concomitantly with other serotonergic drugs.

Adverse Reactions

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.

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This image is provided by the National Library of Medicine.

The infrequently reported adverse reactions listed below, assessed by investigators as treatment-related or causality unknown/missing, occurred following administration of ALOXI 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.

• Musculoskeletal: <1%: joint stiffness,myalgia, pain in extremity.

• Nervous System: <1%: postural dizziness, dysgeusia.

• Psychiatric: <1%: insomnia.

• Respiratory System: <1%: dyspnea, epistaxis.

• Skin: <1%: generalized pruritus, erythema, alopecia.

• Very rare cases (<1/10,000) of hypersensitivity reactions have been reported for I.V. ALOXI from post-marketing experience.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Palonosetron hydrochloride in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Palonosetron hydrochloride in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Palonosetron hydrochloride during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Palonosetron hydrochloride with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Palonosetron hydrochloride with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Palonosetron hydrochloride with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Palonosetron hydrochloride with respect to specific gender populations.

Race

There is no FDA guidance on the use of Palonosetron hydrochloride with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Palonosetron hydrochloride in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Palonosetron hydrochloride in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Palonosetron hydrochloride in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Palonosetron hydrochloride in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Palonosetron hydrochloride in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Palonosetron hydrochloride in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Palonosetron hydrochloride in the drug label.

Pharmacology

There is limited information regarding Palonosetron hydrochloride Pharmacology in the drug label.

Mechanism of Action

Structure

File:Palonosetron hydrochloride01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Palonosetron hydrochloride in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Palonosetron hydrochloride in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Palonosetron hydrochloride in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Palonosetron hydrochloride in the drug label.

How Supplied

Storage

There is limited information regarding Palonosetron hydrochloride Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Palonosetron hydrochloride in the drug label.

Precautions with Alcohol

• Alcohol-Palonosetron hydrochloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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