Label: ISOSULFAN BLUE injection, solution
- NDC Code(s): 71288-805-05, 71288-805-06
- Packager: Meitheal Pharmaceuticals Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated October 12, 2021
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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
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)
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 4-9% 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).
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 Meitheal Pharmaceuticals Inc. at 1-844-824-8426 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
No drug interactions have been identified for isosulfan blue 1% (7).
USE IN SPECIFIC POPULATIONS
See 17 for PATIENT COUNSELING INFORMATION.
Table of Contents
FULL PRESCRIBING INFORMATION: CONTENTS*
- 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
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
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 4–9% 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
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.
- 10 OVERDOSAGE
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 Injection 1% is a sterile aqueous solution for subcutaneous administration. Phosphate buffer in sterile, nonpyrogenic 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 dibasic sodium phosphate, anhydrous and 2.7 mg monobasic potassium phosphate. The solution contains no preservative. Isosulfan Blue Injection 1% is a contrast agent for the delineation of lymphatic vessels.
12 CLINICAL PHARMACOLOGY
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.
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 dark blue aqueous solution in a phosphate buffer. It is supplied as follows:
NDC Isosulfan Blue Injection 1% Package Factor 71288-805-06 50 mg per 5 mL Single-Dose Vial 6 vials per carton
- 17 PATIENT COUNSELING INFORMATION
- PRINCIPAL DISPLAY PANEL – Isosulfan Blue Injection 1% 5 mL Vial Label
- PRINCIPAL DISPLAY PANEL – Isosulfan Blue Injection 1% 5 mL Carton
INGREDIENTS AND APPEARANCE
isosulfan blue injection, solution
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71288-805 Route of Administration SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength isosulfan blue (UNII: 39N9K8S2A4) (isosulfan blue inner salt - UNII:NS6Q291771) isosulfan blue 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength sodium phosphate, dibasic, anhydrous (UNII: 22ADO53M6F) potassium phosphate, monobasic (UNII: 4J9FJ0HL51) water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71288-805-06 6 in 1 CARTON 11/03/2021 1 NDC:71288-805-05 5 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA213130 11/03/2021 Labeler - Meitheal Pharmaceuticals Inc. (080548348) Establishment Name Address ID/FEI Business Operations Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. 421297554 MANUFACTURE(71288-805)