Label: OXALIPLATIN injection, solution

  • NDC Code(s): 60505-6132-6, 60505-6132-7, 60505-6132-8
  • Packager: Apotex Corp.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 13, 2023

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use OXALIPLATIN INJECTION safely and effectively. See full prescribing information for OXALIPLATIN INJECTION. OXALIPLATIN injection ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    WARNING: HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS

    Serious and fatal hypersensitivity adverse reactions, including anaphylaxis, can occur with oxaliplatin injection within minutes of administration and during any cycle. Oxaliplatin Injection is contraindicated in patients with hypersensitivity reactions to oxaliplatin and other platinum-based drugs [see Contraindications (4)]. Immediately and permanently discontinue oxaliplatin injection for hypersensitivity reactions and administer appropriate treatment for management of the hypersensitivity reaction [see Warnings and Precautions (5.1)].

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  • 1 INDICATIONS AND USAGE
    Oxaliplatin Injection USP, in combination with infusional fluorouracil and leucovorin, is indicated for:   adjuvant treatment of stage III colon cancer in patients who have undergone complete ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Recommended Dosage - Administer oxaliplatin injection in combination with fluorouracil and leucovorin every 2 weeks.   For adjuvant treatment, continue treatment for up to 12 cycles or ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Injection: 50 mg (5 mg/mL), 100 mg (5 mg/mL) or 200 mg (5 mg/mL) clear, colorless solution in a single-dose vial.
  • 4 CONTRAINDICATIONS
    Oxaliplatin Injection is contraindicated in patients with a history of a hypersensitivity reaction to oxaliplatin or other platinum-based drugs. Reactions have included anaphylaxis [see Warnings ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Hypersensitivity Reactions - Serious and fatal hypersensitivity reactions, including anaphylaxis, can occur with oxaliplatin injection within minutes of administration and during any cycle ...
  • 6 ADVERSE REACTIONS
    The following clinically significant adverse reactions are described elsewhere in labeling:   Hypersensitivity Reactions [ see Warnings and Precautions (5.1)]   Peripheral Sensory Neuropathy ...
  • 7 DRUG INTERACTIONS
    7.1 Drugs that Prolong the QT Interval - QT interval prolongation and ventricular arrhythmias can occur with oxaliplatin injection [see Warnings and Precautions (5.7)]. Avoid coadministration of ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Based on its direct interaction with DNA, oxaliplatin injection can cause fetal harm when administered to a pregnant woman. The available human data do not ...
  • 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 injection. Adverse reactions observed ...
  • 11 DESCRIPTION
    Oxaliplatin is a platinum-based drug with the molecular formula C8H14N2O4Pt and the chemical name of cis-[(1 R, 2 R)-1, 2-cyclohexanediamine-N, N'] [oxalato (2-)-O, O'] platinum. Oxaliplatin is ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Oxaliplatin undergoes nonenzymatic conversion in physiologic solutions to active derivatives via displacement of the labile oxalate ligand. Several transient reactive ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Long-term animal studies have not been performed to evaluate the carcinogenic potential of oxaliplatin. Oxaliplatin was not mutagenic ...
  • 14 CLINICAL STUDIES
    14.1 Adjuvant Treatment with Oxaliplatin Injection in Combination with Fluorouracil and Leucovorin - The efficacy of oxaliplatin injection in combination with fluorouracil (FU)/leucovorin (LV ...
  • 15 REFERENCES
    "OSHA Hazardous Drugs." OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Oxaliplatin Injection USP is supplied in clear, glass, single-dose vials with gray elastomeric stoppers and aluminum flip-off seals containing 50 mg, 100 mg or 200 mg of oxaliplatin as a clear ...
  • 17 PATIENT COUNSELING INFORMATION
    Hypersensitivity Reactions - Advise patients of the potential risk of hypersensitivity and that oxaliplatin injection is contraindicated in patients with a history of hypersensitivity reactions ...
  • Patient Information
    OXALIPLATIN (ox-Al-ah-platin) INJECTION USP -                                                                                      for ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    PRINCIPAL DISPLAY PANEL - 50 mg/10 mL Container - NDC 60505-6132-6 - Oxaliplatin Injection, USP - 50 mg/10 mL (5 mg/mL)
  • PRINCIPAL DISPLAY PANEL
    PRINCIPAL DISPLAY PANEL - 50 mg/10 mL Carton - NDC 60505-6132-6 - Oxaliplatin Injection USP - 50 mg/10 mL (5 mg/mL)
  • PRINCIPAL DISPLAY PANEL
    PRINCIPAL DISPLAY PANEL - 100 mg/20 mL Container - NDC 60505-6132-7 - Oxaliplatin Injection USP - 100 mg/20 mL (5 mg/mL)
  • PRINCIPAL DISPLAY PANEL
    PRINCIPAL DISPLAY PANEL - 100 mg/20 mL Carton - NDC 60505-6132-7 - Oxaliplatin Injection USP - 100 mg/20 mL (5 mg/mL)
  • PRINCIPAL DISPLAY PANEL
    PRINCIPAL DISPLAY PANEL - 200 mg/40 mL Container - NDC 60505-6132-8 - Oxaliplatin Injection USP - 200 mg/40 mL (5 mg/mL)
  • PRINCIPAL DISPLAY PANEL
    PRINCIPAL DISPLAY PANEL - 200 mg/40 mL Carton - NDC 60505-6132-8 - Oxaliplatin Injection USP - 200 mg/40 mL (5 mg/mL)
  • INGREDIENTS AND APPEARANCE
    Product Information