Isosulfan Blue
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alara Ece Dagsali, M.D.[2]
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Overview
Isosulfan Blue is a {{{drugClass}}} that is FDA approved for the treatment of 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.. Common adverse reactions include {{{adverseReactions}}}.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
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.
1% aqueous solution (isosulfan blue)
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Safety and effectiveness of isosulfan blue 1% in children have not been established.
Off-Label Use and Dosage (Pediatric)
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, 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.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Isosulfan Blue Clinical Trials Experience in the drug label.
Postmarketing Experience
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
Drug Interactions
No drug interactions have been identified with isosulfan blue 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 1% is administered to a nursing mother.
Pediatric Use
Safety and effectiveness of isosulfan blue 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
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.
Monitoring
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.
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 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
There is limited information regarding Isosulfan Blue Structure in the drug label.
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.
Pharmacokinetics
Up to 10% of the subcutaneously administered dose of isosulfan blue 1% is excreted unchanged in the urine in 24 hours in human.
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.
Clinical Studies
There is limited information regarding Isosulfan Blue Clinical Studies in the drug label.
How Supplied
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
Storage
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Avoid excessive heat.
Images
Drug Images
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Package and Label Display Panel
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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 regarding 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.