LYMPHAZURIN (ISOSULFAN BLUE) INJECTION, SOLUTION [UNITED STATES SURGICAL CORPORATION]

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LYMPHAZURIN (ISOSULFAN BLUE) INJECTION, SOLUTION [UNITED STATES SURGICAL CORPORATION]
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NDC 63261-250-21
Set ID cbee4532-238b-4f91-86ae-f8c0c1b6d7da
Category HUMAN PRESCRIPTION DRUG LABEL
Packager UNITED STATES SURGICAL CORPORATION
Generic Name
Product Class
Product Number
Application Number NDA018310
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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use LYMPHAZURIN safely and effectively. See full prescribing information for LYMPHAZURIN.

    LYMPHAZURIN injection, solution for subcutaneous use
    Initial U.S. Approval: 1981

    RECENT MAJOR CHANGES

    Warnings and Precautions, Interference with Oxygen Saturation and Methemoglobin Measurements (5.3). 10/2007

    INDICATIONS AND USAGE

    Lymphazurin™ 1% (isosulfan blue) upon subcutaneous administration, delineates the lymphatic vessels draining the region of injection. It is an adjunct to lymphography in: primary and secondary lymphedema of the extremities; chyluria, chylous ascites or chylothorax; lymph node involvement by primary or secondary neoplasm; lymph node response to therapeutic modalities (1.1).

    DOSAGE AND ADMINISTRATION

    Lymphazurin™ 1% is to be administered subcutaneously, one-half (1/2) ml into three (3) interdigital spaces of each extremity per study. A maximum dose of 3 ml (30 mg) isosulfan blue is, therefore, injected (2.1).

    DOSAGE FORMS AND STRENGTHS

    1% aqueous solution (isosulfan blue) (3)

    CONTRAINDICATIONS

    Hypersensitivity to triphenylmethane or related compounds (4).

    WARNINGS AND PRECAUTIONS

    • Life-threatening anaphylactic reactions have occurred after Lymphazurin 1% administration. Monitor patients closely for at least 60 minutes after administration of Lymphazurin 1% (5.1).
    • The admixture of Lymphazurin 1% with local anesthetics results in an immediate precipitation of 4-9% drug complex. Use a separate syringe for anesthetics (5.2). 
    • Lymphazurin 1% interferes with measurements in peripheral blood pulse oximetry. Arterial blood gas analysis may be needed (5.3).

    ADVERSE REACTIONS

    Hypersensitivity reactions: Hypersensitivity reactions occurring approximately 2% of patients and include life-threatening anaphylactic reactions with respiratory distress, shock, angioedema, urticaria, pruritus. A death has been reported following IV administration of a similar compound (6).

    To report SUSPECTED ADVERSE REACTIONS, contact U.S. Surgical at 1-800-522-0263 option 5 and website or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

    DRUG INTERACTIONS

    No drug interactions have been identified for Lymphazurin 1% (7).

    USE IN SPECIFIC POPULATIONS

    • Caution should be exercised when Lymphazurin 1% is administered to nursing mothers (8.3).
    • Safety and effectiveness of Lymphazurin 1% in children has not been established (8.4).

    See 17 for PATIENT COUNSELING INFORMATION.

    Revised: 1/2012

  • Table of Contents

    FULL PRESCRIBING INFORMATION: CONTENTS*

    RECENT MAJOR CHANGES

    1 INDICATIONS AND USAGE

    1.1 Lymphatic Vessel Delineation

    2 DOSAGE AND ADMINISTRATION

    2.1 Subcutaneous administration

    3 DOSAGE FORMS AND STRENGTHS

    4 CONTRAINDICATIONS

    5 WARNINGS AND PRECAUTIONS

    5.1 Hypersensitivity Reactions

    5.2 Precipitation of Lymphazurin 1% by Lidocaine

    5.3 Interference with Oxygen Saturation and Methemoglobin Measurements

    6 ADVERSE REACTIONS

    6.1 Postmarketing Experience

    7 DRUG INTERACTIONS

    8 USE IN SPECIFIC POPULATIONS

    8.3 Nursing Mothers

    8.4 Pediatric Use

    10 OVERDOSAGE

    11 DESCRIPTION

    12 CLINICAL PHARMACOLOGY

    12.2 Pharmacodynamics

    12.3 Pharmacokinetics

    13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

    13.2 Teratogenic Effects

    16 HOW SUPPLIED/STORAGE AND HANDLING

    17 PATIENT COUNSELING INFORMATION

    *
    Sections or subsections omitted from the full prescribing information are not listed.
  • 1 INDICATIONS AND USAGE


    1.1 Lymphatic Vessel Delineation

    Lymphazuirn™ 1% (isosulfan blue) upon subcutaneous administration, delineates lymphatic vessels draining the region of injection. It is an adjunct to lymphography in: primary and secondary lymphedema of the extremities; chyluria, chylous ascites or chylothorax; lymph node involvement by primary or secondary neoplasm; and lymph node response to therapeutic modalities.

  • 2 DOSAGE AND ADMINISTRATION


    2.1 Subcutaneous administration

    Lymphazurin™ 1% is to be administered subcutaneously, one-half (1/2) ml into three (3) interdigital spaces of each extremity per study. A maximum dose of 3 ml (30 mg) isosulfan blue is, therefore, injected.

  • 3 DOSAGE FORMS AND STRENGTHS

    1% aqueous solution (isosulfan blue)

  • 4 CONTRAINDICATIONS

    Lymphazurin™ 1% (isosulfan blue) is contraindicated in those individuals with known hypersensitivity to triphenylmethane or related compounds.

  • 5 WARNINGS AND PRECAUTIONS


    5.1 Hypersensitivity Reactions

    Life-threatening anaphylactic reactions (respiratory distress, shock, angioedema) have occurred after Lymphazurin 1% administration. Reactions are more likely to occur in patients with a history of bronchial asthma, allergies, drug reactions or previous reactions to triphenylmethane dyes. Monitor patients closely for at least 60 minutes after administration of Lymphazurin 1%. Trained personnel should be available to administer emergency care including resuscitation.

    5.2 Precipitation of Lymphazurin 1% by Lidocaine

    The admixture of Lymphazurin 1% (with local anesthetics (i.e. lidocaine)) in the same syringe results in an immediate precipitation of 4 – 9% drug complex. Use a separate syringe to administer a local anesthetic.

    5.3 Interference with Oxygen Saturation and Methemoglobin Measurements

    Lymphazurin 1% interferes with measurements of oxygen saturation in peripheral blood by pulse oximetry and can cause falsely low readings. The interference effect is maximal at 30 minutes and minimal generally by four hours after administration. Arterial blood gas analysis may be needed to verify decreased arterial partial pressure of oxygen.

    Lymphazurin 1% may also cause falsely elevated readings of methemoglobin by arterial blood gas analyzer. Therefore, co-oximetry may be needed to verify methemoglobin level.

  • 6 ADVERSE REACTIONS


    6.1 Postmarketing Experience

    Hypersensitivity Reactions: Case series report an overall incidence of hypersensitivity reactions in approximately 2% of patients. Life-threatening anaphylactic reactions have occurred. Manifestations include respiratory distress, shock, angioedema, urticaria, pruritus. A death has been reported following administration of a similar compound employed to estimate the depth of a severe burn. Reactions are more likely to occur in patients with a personal or family history of bronchial asthma, significant allergies, drug reactions or previous reactions to triphenylmethane dyes [see Warnings and Precautions (5)].

    Laboratory tests: Lymphazurin 1% interferes with measurements of oxygen saturation by pulse oximetry and of methemoglobin by gas analyzer [see Warnings and Precautions (5)].

    Skin: transient or long-term (tattooing) blue coloration.

  • 7 DRUG INTERACTIONS

    No Drug Interactions have been identified with Lymphazurin 1%.

  • 8 USE IN SPECIFIC POPULATIONS


    8.3 Nursing Mothers

    It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Lymphazurin™ 1% (isosulfan blue) is administered to a nursing mother.

    8.4 Pediatric Use

    Safety and effectiveness of Lymphazurin™ 1% (isosulfan blue) in children have not been established.

  • 10 OVERDOSAGE

    Do not exceed indicated recommended dosage as overdosage levels have not been identified for Lymphazurin 1%.

  • 11 DESCRIPTION

    The chemical name of Lymphazurin 1% (isosulfan blue) is N-[4-[[4-(diethylamino)phenyl] (2,5-disulfophenyl) methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylehananamunium hydroxide, inner salt, sodium salt. Its structural formula is:

    Chemical Structure

    Lymphazurin 1% is a sterile aqueous solution for subcutaneous administration. Phosphate buffer in sterile, pyrogen free water is added in sufficient quantity to yield a final pH of 6.8-7.4. Each ml of solution contains 10 mg Isosulfan blue, 6.6 mg sodium monohydrogen phosphate and 2.7 mg potassium dihydrogen phosphate. The solution contains no preservative. Lymphazurin 1% is a contrast agent for the delineation of lymphatic vessels.

  • 12 CLINICAL PHARMACOLOGY


    12.2 Pharmacodynamics

    Following subcutaneous administration, Lymphazurin 1% binds to serum proteins and is picked up by the lymphatic vessels. Thus, the lymphatic vessels are delineated by the blue dye.

    12.3 Pharmacokinetics

    Up to 10% of the subcutaneously administered dose of Lymphazurin 1% is excreted unchanged in the urine in 24 hours in human.

  • 13 NONCLINICAL TOXICOLOGY


    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

    Long-term studies in animals have not been performed to evaluate the carcinogenic potential of Lymphazurin 1%. Reproduction studies in animals have not been conducted and, therefore, it is unknown if a problem concerning mutagenesis or impairment of fertility in either males or females exists.

    13.2 Teratogenic Effects

    Pregnancy Category C. Animal reproduction studies have not been conducted with Lymphazurin 1%. It is not known whether Lymphazurin 1% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Lymphazurin 1% should be given to a pregnant woman only if clearly needed.

  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    Lymphazurin 1% is supplied as a 5 ml single dose vial, 1% aqueous solution in a phosphate buffer prepared by appropriate manufacturing to be sterile and pyrogen-free.

  • 17 PATIENT COUNSELING INFORMATION

    Inform patients that urine color may be blue for 24 hours following administration of Lymphazurin 1%.

  • PRINCIPAL DISPLAY PANEL

    D.I.N. 00592358
    NDC 63261-250-21 LYM-100
    LYMPHAZURIN* 1%
    (isosulfan blue) Single Dose Vial 5 ml.

    Mfd. for United States Surgical, a division of
    Tyco Healthcare Group LP,
    Norwalk, CT 06856 USA.

    by Ben Venue Labs, Inc., Bedford, OH 44146 USA

    Distributed in Canada by: Tyco Healthcare
    Montreal, Quebec
    Canada, H9R 5H8

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    LYMPHAZURIN 
    isosulfan blue injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63261-250
    Route of AdministrationSUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOSULFAN BLUE (UNII: 39N9K8S2A4) (ISOSULFAN BLUE - UNII:39N9K8S2A4) ISOSULFAN BLUE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63261-250-215 mL in 1 VIAL, SINGLE-USE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01831001/12/2012
    Labeler - UNITED STATES SURGICAL CORPORATION (044680650)
    Establishment
    NameAddressID/FEIBusiness Operations
    BEN VENUE LABORATORIES, INC.004327953manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    SIGMA-ALDRICH CO LTD397924143api manufacture
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