Isosulfan blue

Isosulfan blue
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Turky Alkathery, M.D. [2]

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Overview

Isosulfan blue is {{{aOrAn}}} {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. Common adverse reactions include Hypersensitivity reactions occur and include life threatening anaphylactic reactions with respiratory distress, shock, angioedema, urticaria, pruritus.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

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

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.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Isosulfan blue in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Isosulfan blue in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Isosulfan blue FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Isosulfan blue in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Isosulfan blue in pediatric patients.

Contraindications

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

Warnings

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.

Adverse Reactions

Clinical Trials Experience

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.

Laboratory Tests: Isosulfan blue injection 1% interferes with measurements of oxygen saturation by pulse oximetry and of methemoglobin by gas analyzer.

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

Postmarketing Experience

There is limited information regarding Isosulfan blue Postmarketing Experience in the drug label.

Drug Interactions

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

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Isosulfan blue in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Isosulfan blue in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Isosulfan blue during labor and delivery.

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.

Pediatric Use

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

Geriatic Use

There is no FDA guidance on the use of Isosulfan blue in geriatric settings.

Gender

There is no FDA guidance on the use of Isosulfan blue with respect to specific gender populations.

Race

There is no FDA guidance on the use of Isosulfan blue with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Isosulfan blue in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Isosulfan blue in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Isosulfan blue in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Isosulfan blue in patients who are immunocompromised.

Administration and Monitoring

Administration

• Subcutaneous.

Monitoring

There is limited information regarding Isosulfan blue Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Isosulfan blue and IV administrations.

Overdosage

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

Pharmacology

There is limited information regarding Isosulfan blue Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Isosulfan blue Mechanism of Action in the drug label.

Structure

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:

This image is provided by the National Library of Medicine.

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.

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.

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.

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.

Clinical Studies

There is limited information regarding Isosulfan blue Clinical Studies in the drug label.

How Supplied

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.

Storage

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

Images

Drug Images

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Package and Label Display Panel

This image is provided by the National Library of Medicine.

This image is provided by the National Library of Medicine.

This image is provided by the National Library of Medicine.

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Patient Counseling Information

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

Precautions with Alcohol

Alcohol-Isosulfan blue interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Isosulfan blue Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Isosulfan blue Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.