ISOSULFAN BLUE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]

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ISOSULFAN BLUE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]
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NDC 55150-240-05
Set ID 42f2d62a-c7f2-4706-87bc-64f3e72d63a9
Category Human Prescription Drug Label
Packager AuroMedics Pharma LLC
Generic Name
Product Class
Product Number
Application Number ANDA206831
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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use ISOSULFAN BLUE INJECTION safely and effectively. See full prescribing information for ISOSULFAN BLUE INJECTION.

    ISOSULFAN BLUE injection, for subcutaneous use only
    Initial U.S. Approval: 1981

    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 1% administration. Monitor patients closely for at least 60 minutes after administration of isosulfan blue 1% (5.1).
    •  The admixture of isosulfan blue 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 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 I.V. administration of a similar compound (6).

    To report SUSPECTED ADVERSE REACTIONS, contact AuroMedics Pharma LLC at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    DRUG INTERACTIONS

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

    USE IN SPECIFIC POPULATIONS

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

    See 17 for PATIENT COUNSELING INFORMATION.

    Revised: 3/2017

  • Table of Contents

    FULL PRESCRIBING INFORMATION: CONTENTS*

    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 Isosulfan Blue 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


    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.

  • 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.

  • 3 DOSAGE FORMS AND STRENGTHS

    1% aqueous solution (isosulfan blue)

  • 4 CONTRAINDICATIONS

    Isosulfan blue injection 1% 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 isosulfan blue 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 1%. Trained personnel should be available to administer emergency care including resuscitation.

    5.2 Precipitation of Isosulfan Blue 1% by Lidocaine


    The admixture of isosulfan blue 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 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.

    Isosulfan blue 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: Isosulfan blue 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 isosulfan blue 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 isosulfan blue 1% is administered to a nursing mother.


    8.4 Pediatric Use


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

  • 10 OVERDOSAGE


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

  • 11 DESCRIPTION


    The chemical name of isosulfan blue is N-[4-[[4-(diethylamino)phenyl] (2,5-disulfophenyl) methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxide, inner salt, sodium salt. Isosulfan blue is a greenish blue color hygroscopic powder. Its structural formula is:
    Isosulfan Blue Chemical structure
    Isosulfan blue injection 1% is a sterile, non-pyrogenic, aqueous dark blue color solution for subcutaneous administration. Phosphate buffer in water for injection 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

  • 12 CLINICAL PHARMACOLOGY

    12.2 Pharmacodynamics


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

  • 16 HOW SUPPLIED/STORAGE AND HANDLING


    Isosulfan blue injection 1% is a sterile, non-pyrogenic, aqueous dark blue color solution and is supplied as follows:

    Isosulfan blue injection 1%
    50 mg per 5 mL (10 mg / mL):
    5 mL Single Dose Vials
    in a Carton of 6                                                                      NDC 55150-240-05

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

    Discard Unused Portion.

    The vial stoppers are not made with natural rubber latex.

  • 17 PATIENT COUNSELING INFORMATION


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

    Distributed by:
    AuroMedics Pharma LLC
    279 Princeton-Hightstown Rd.
    E. Windsor, NJ 08520

    Manufactured by:
    Aurobindo Pharma Limited
    Hyderabad - 500038
    India

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1% [50 mg per 5 mL (10 mg / mL)] - Container Label

    Rx only                 NDC 55150-240-05
    Isosulfan Blue
    Injection 1%
    50 mg per 5 mL
    (10 mg / mL)
    For Lymphography
    For Subcutaneous Use Only
    5 mL                        Single Dose Vial

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1% [50 mg per 5 mL (10 mg / mL)] - Container Label

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1% [50 mg per 5 mL (10 mg / mL)] - Container-Carton (6 Vials)

    Rx only                        NDC 55150-240-05
    Isosulfan Blue
    Injection 1%
    50 mg per 5 mL
    (10 mg / mL)
    For Lymphography
    For Subcutaneous Use Only
    Sterile                                            6 X 5 mL
    Non-Pyrogenic                Single Dose Vials
    AUROMEDICS

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1% [50 mg per 5 mL (10 mg / mL)] - Container-Carton (6 Vials)

  • INGREDIENTS AND APPEARANCE
    ISOSULFAN BLUE 
    isosulfan blue injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55150-240
    Route of AdministrationSUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOSULFAN BLUE (UNII: 39N9K8S2A4) (ISOSULFAN BLUE INNER SALT - UNII:NS6Q291771) ISOSULFAN BLUE50 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
    POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55150-240-056 in 1 CARTON02/02/2016
    15 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20683102/02/2016
    Labeler - AuroMedics Pharma LLC (968961354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited918917662API MANUFACTURE(55150-240)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited650498244ANALYSIS(55150-240) , MANUFACTURE(55150-240)
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