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palonosetron HCl injection

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palonosetron HCl injection Quick Finder

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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1 INDICATIONS AND USAGE

Palonosetron HCl Injection is indicated in adults for prevention of:

  • acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic...
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2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

Prevention of Chemotherapy-Induced Nausea...

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3 DOSAGE FORM AND STRENGTHS

Palonosetron HCl Injection is sterile, clear, and colorless solution:

  • 0.25 mg palonosetron in 5 mL (0.05 mg/mL) in a single-dose vial
  • 0.075 mg palonosetron in 1.5...
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5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis and anaphylactic shock, have been reported with...

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6 ADVERSE REACTIONS

Serious or otherwise clinically significant adverse reactions reported in other sections of labeling:

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7 DRUG INTERACTIONS

7.1 Serotonergic Drugs

Serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular symptoms) has been described...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

There are no available...

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10 OVERDOSAGE

There is no known antidote to palonosetron. Overdose should be managed with supportive care.

Dialysis studies have not been performed, however, due to the large volume of distribution, dialysis is...

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11 DESCRIPTION

Palonosetron HCl Injection is an antiemetic and antinauseant agent. It is a serotonin-3 (5-HT3) receptor antagonist with a strong binding affinity for this receptor. Chemically,...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Palonosetron is a 5-HT3 receptor antagonist with a strong binding affinity for this...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 104-week carcinogenicity study in CD-1 mice, animals were treated with oral...

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14 CLINICAL STUDIES

14.1 Prevention of Nausea and Vomiting Associated with MEC and HEC in Adults

Efficacy of a single intravenous dose of Palonosetron HCl Injection...

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16 HOW SUPPLIED/STORAGE AND HANDLING

Palonosetron HCl Injection is available as follows:

...
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17 PATIENT COUNSELING INFORMATION

Advise the patient or caregiver to read the FDA-approved patient labeling (Patient Information).

...

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Report Adverse Event
Pfizer Safety

To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at
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FDA Medwatch
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.