DESCRIPTION SECTION

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 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.

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INDICATIONS & USAGE SECTION

Highlight: 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).

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.

DOSAGE & ADMINISTRATION SECTION

Highlight: 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).

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.

DOSAGE FORMS & STRENGTHS SECTION

Highlight: 1% aqueous solution (isosulfan blue) (3)

3 DOSAGE FORMS AND STRENGTHS

1% aqueous solution (isosulfan blue)

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CONTRAINDICATIONS SECTION

Highlight: Hypersensitivity to triphenylmethane or related compounds (4).

4 CONTRAINDICATIONS

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

WARNINGS AND PRECAUTIONS SECTION

Highlight: * 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).

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.

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DRUG INTERACTIONS SECTION

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

7 DRUG INTERACTIONS

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

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OVERDOSAGE SECTION

10 OVERDOSAGE

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

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INFORMATION FOR PATIENTS SECTION

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:
Eugia Pharma Specialities Limited
Hyderabad - 500032
India

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HOW SUPPLIED SECTION

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:

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** Isosulfan blue injection 1%**

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** 50 mg per 5 mL (10 mg / mL):**
5 mL Single-Dose Vials
in a Carton of 6 NDC 55150-240-05

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** 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.

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