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oxaliplatin injection

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oxaliplatin injection Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

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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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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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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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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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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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5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

Serious and fatal hypersensitivity reactions, including anaphylaxis, can occur with Oxaliplatin within...

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6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in labeling:

  • Hypersensitivity Reactions [see

    6.1 Clinical Trials Experience

    ...
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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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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Based on its direct...

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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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11 DESCRIPTION

Oxaliplatin Injection, USP is a platinum-based drug with the molecular formula C8H14N2O4Pt and the chemical...

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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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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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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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15 REFERENCES

1. "OSHA Hazardous Drugs." OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

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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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17 PATIENT COUNSELING INFORMATION

Hypersensitivity Reactions

Advise patients of the potential risk of hypersensitivity and that...

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