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oxaliplatin injection
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
oxaliplatin injection Quick Finder
Highlights
Boxed Warning
WARNING: HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS
Serious and fatal hypersensitivity adverse reactions, including anaphylaxis, can occur with Oxaliplatin within minutes of administration and...
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Indications and Usage
1 INDICATIONS AND USAGE
Oxaliplatin, in combination with infusional fluorouracil and leucovorin, is indicated for:
- adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
Administer Oxaliplatin in combination with fluorouracil and leucovorin every 2 weeks.
- For adjuvant...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Injection: 50 mg/10 mL or 100 mg/20 mL clear, colorless solution in a single-dose vial.
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Contraindications
4 CONTRAINDICATIONS
Oxaliplatin is contraindicated in patients with a history of a hypersensitivity reaction to oxaliplatin or other platinum-based drugs. Reactions have included anaphylaxis [see...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Reactions
Serious and fatal hypersensitivity reactions, including anaphylaxis, can occur with Oxaliplatin within...
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Adverse Reactions
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in labeling:
- Hypersensitivity Reactions [see Warnings and Precautions (5.1...
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Drug Interactions
7 DRUG INTERACTIONS
7.1 Drugs that Prolong the QT Interval
QT interval prolongation and ventricular arrhythmias can occur with Oxaliplatin [see...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on its direct...
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Overdosage
10 OVERDOSAGE
The maximum dose of oxaliplatin that has been administered in a single infusion is 825 mg. Several cases of overdoses have been reported with Oxaliplatin. Adverse reactions observed following an overdosage were...
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Description
11 DESCRIPTION
Oxaliplatin Injection, USP is a platinum-based drug with the molecular formula C8H14N2O4Pt and the chemical...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Oxaliplatin undergoes nonenzymatic conversion in physiologic solutions to active derivatives via displacement of the...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term animal studies have not been performed to evaluate the carcinogenic...
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Clinical Studies
14 CLINICAL STUDIES
14.1 Adjuvant Treatment with Oxaliplatin in Combination with Fluorouracil and Leucovorin
The efficacy of Oxaliplatin in combination with...
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References
15 REFERENCES
1. "OSHA Hazardous Drugs." OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
Concentrate for solution for infusion:
Oxaliplatin Injection, USP is supplied in clear, glass, single-dose...
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Hypersensitivity Reactions
Advise patients of the potential risk of hypersensitivity and that...
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Report Adverse Event
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:
*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(800) 438-1985.
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.
(800)-332-1088.