Label: ISOSULFAN BLUE- isosulfan blue injection, solution 

  • NDC Code(s): 67457-220-00, 67457-220-05, 67457-259-00, 67457-259-05
  • Packager: Mylan Institutional LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 01/13

If you are a consumer or patient please visit this version.

  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use isosulfan blue injection 1% safely and effectively. See full prescribing information for isosulfan blue injection 1%.

    Isosulfan Blue Injection 1%
    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

    Isosulfan blue injection 1% 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

    Isosulfan blue injection 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 isosulfan blue injection 1% administration. Monitor patients closely for at least 60 minutes after administration of isosulfan blue injection 1% ( 5.1).
    The admixture of isosulfan blue injection 1% with local anesthetics results in an immediate precipitation of 4% to 9% drug complex. Use a separate syringe for anesthetics ( 5.2).
    Isosulfan blue injection 1% interferes with measurements in peripheral blood pulse oximetry. Arterial blood gas analysis may be needed ( 5.3).

    ADVERSE REACTIONS

    Hypersensitivity Reactions: Hypersensitivity reactions occur in 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 Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    DRUG INTERACTIONS

    No drug interactions have been identified for isosulfan blue injection 1% (7).

    USE IN SPECIFIC POPULATIONS

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

    See 17 for PATIENT COUNSELING INFORMATION.

    Revised: 1/2013

    Close
  • FULL PRESCRIBING INFORMATION: CONTENTS*
  • 1 INDICATIONS AND USAGE

    1.1 Lymphatic Vessel Delineation

    Isosulfan blue injection 1% 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.

    Close
  • 2 DOSAGE AND ADMINISTRATION

    2.1 Subcutaneous administration

    Isosulfan blue injection 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.

    Close
  • 3 DOSAGE FORMS AND STRENGTHS

    1% aqueous solution (isosulfan blue)

    Close
  • 4 CONTRAINDICATIONS

    Isosulfan blue injection 1% is contraindicated in those individuals with known hypersensitivity to triphenylmethane or related compounds.

    Close
  • 5 WARNINGS AND PRECAUTIONS

    5.1 Hypersensitivity Reactions

    Life threatening anaphylactic reactions (respiratory distress, shock, angio-edema) have occurred after isosulfan blue injection 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 isosulfan blue injection 1%. Trained personnel should be available to administer emergency care including resuscitation.

    5.2 Precipitation of Isosulfan Blue Injection 1% by Lidocaine

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

    5.3 Interference with Oxygen Saturation and Methemoglobin Measurements

    Isosulfan blue injection 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 4 hours after administration. Arterial blood gas analysis may be needed to verify decreased arterial partial pressure of oxygen.

    Isosulfan blue injection 1% may also cause falsely elevated readings of methemoglobin by arterial blood gas analyzer. Therefore, cooximetry may be needed to verify methemoglobin level.

    Close
  • 6 ADVERSE REACTIONS

    6.1 Post-Marketing 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: Isosulfan blue injection 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.

    Close
  • 7 DRUG INTERACTIONS

    No drug interactions have been identified with isosulfan blue injection 1%.

    Close
  • 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 isosulfan blue injection 1% is administered to a nursing mother.

    8.4 Pediatric Use

    Safety and effectiveness of isosulfan blue injection 1% in children have not been established.

    Close
  • 10 OVERDOSAGE

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

    Close
  • 11 DESCRIPTION

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

    ISOSULFAN BLUE

    Chemical Structure

    Isosulfan blue injection 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 to 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. Isosulfan blue injection 1% is a contrast agent for the delineation of lymphatic vessels.

    Close
  • 12 CLINICAL PHARMACOLOGY

    12.2 Pharmacodynamics

    Following subcutaneous administration, isosulfan blue injection 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 isosulfan blue injection 1% is excreted unchanged in the urine in 24 hours in humans.

    Close
  • 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 isosulfan blue injection 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 isosulfan blue injection 1%. It is not known whether isosulfan blue injection 1% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Isosulfan blue injection 1% should be given to a pregnant woman only if clearly needed.

    Close
  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    Isosulfan blue injection 1% is supplied as a 5 mL single-use vial, 1% aqueous solution in a phosphate buffer prepared by appropriate manufacturing to be sterile and pyrogen-free.

    Mylan Institutional LLC
    NDC 67457-220-05
    5 mL single-use vials

    NOVAPLUS®
    NDC 67457-259-05
    5 mL single-use vials

    N+ and NOVAPLUS are registered trademarks of Novation, LLC.

    Storage: Vials should be stored at 20° to 25°C (68° to 77°F). [See USP Con-
    trolled Room Temperature.] Avoid excessive heat.

    Close
  • 17 PATIENT COUNSELING INFORMATION

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

    Manufactured for:
    Mylan Institutional LLC
    Rockford, IL 61103 U.S.A.

    Manufactured by:
    Afton Scientific, LLC
    2020 Avon Court
    Charlottesville, VA 22902

    REVISED JANUARY 2013
    MI:ISOSIJ:R2

    Close
  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL - 50 mg/5 mL

    NDC 67457-220-05

    Isosulfan Blue
    Injection 1%

    50 mg/5 mL
    (10 mg/mL)

    For Lymphography

    For Subcutaneous Use Only

    Rx only     6 x 5 mL Single-Use Vials

    Sterile. Non-Pyrogenic. Single-Dose Container.
    Contains no preservatives.
    Not for Multiple-Use.
    Discard Unused Portion.

    Each mL contains:
    Isosulfan Blue . . . . . . . . . . . . . . . . . . . . . . . . . 10 mg
    Sodium monohydrogen phosphate. . . . . . . . 6.6 mg
    Potassium dihydrogen phosphate . . . . . . . . 2.7 mg

    Consult Accompanying Prescribing Information
    Before Administering Drug.

    Store at 20° to 25°C (68° to 77°F). [See USP
    Controlled Room Temperature.]

    Avoid excessive heat.

    MI:220:6C:R2

    Manufactured for:
    Mylan Institutional LLC
    Rockford, IL 61103 U.S.A.
    Made in U.S.A.

    Mylan.com

    Isosulfan Blue Injection 1 percent 50 mg/5 mL Single-Use Vial Carton Labels
    Close
  •  

    PRINCIPAL DISPLAY PANEL - 50 mg/5 mL

    NDC 67457-259-05

    Rx only

    Isosulfan Blue
    Injection 1%

    For Lymphography

    For Subcutaneous Use Only     6 x 5 mL Single-Use Vials

    50 mg per 5 mL (10 mg per mL)

    N+ and NOVAPLUS are registered trademarks of Novation, LLC.

    NOVAPLUS®

    Sterile. Non-Pyrogenic. Single Dose Container.

    Contains no preservatives.

    Not for Multiple-Use.

    Discard Unused Portion.

    Each mL contains:

    Isosulfan Blue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 mg

    Sodium monohydrogen phosphate . . . . . . . . . . . 6.6 mg

    Potassium dihydrogen phosphate . . . . . . . . . . . . 2.7 mg

    Consult Accompanying Prescribing Information Before

    Administering Drug.

    Store at 20° to 25°C (68° to 77°F). [See USP Controlled

    Room Temperature.]

    Avoid excessive heat.

    MI:259:6C:R2

    Manufactured for:
    Mylan Institutional LLC
    Rockford, IL 61103 U.S.A.

    Made in U.S.A.

    Isosulfan Blue Injection 1 percent 50 mg per 5 mL (10 mg per mL) Single-Use Vial Carton Labels
    Close
  • INGREDIENTS AND APPEARANCE
    ISOSULFAN BLUE 
    isosulfan blue injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:67457-220
    Route of Administration SUBCUTANEOUS DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ISOSULFAN BLUE (ISOSULFAN BLUE INNER SALT) ISOSULFAN BLUE 10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 6.6 mg  in 1 mL
    POTASSIUM PHOSPHATE, MONOBASIC 2.7 mg  in 1 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67457-220-05 6 in 1 CARTON
    1 NDC:67457-220-00 5 mL in 1 VIAL, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA090874 03/14/2013
    ISOSULFAN BLUE 
    isosulfan blue injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:67457-259
    Route of Administration SUBCUTANEOUS DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ISOSULFAN BLUE (ISOSULFAN BLUE INNER SALT) ISOSULFAN BLUE 10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 6.6 mg  in 1 mL
    POTASSIUM PHOSPHATE, MONOBASIC 2.7 mg  in 1 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67457-259-05 6 in 1 CARTON
    1 NDC:67457-259-00 5 mL in 1 VIAL, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA090874 03/14/2013
    Labeler - Mylan Institutional LLC (790384502)
    Close