isosulfan blue dye

Action and Spectrum

Actions and spectrum: 

isosulfan blue dye is a diagnostic agent used in medicine. It is commonly used as a lymphatic mapping agent during surgical procedures to identify and visualize lymph nodes draining a specific area of the body, such as in cancer staging and sentinel lymph node biopsy.

The dye is injected near the tumor or affected area, and it travels through the lymphatic system, allowing surgeons to identify the sentinel lymph nodes for further examination and treatment. isosulfan blue dye has a specific affinity for lymphatic tissue, aiding in its diagnostic utility. 

Drug Interaction

Adverse Reaction

Frequency defined 

1-10% 

Hypersensitivity reaction (2%) 

Pruritus (2%) 

Local swelling (2%)  

<1% 

skin discoloration 

Black Box Warning

Black Box Warning: 

There is no black box warning associated with the use of isosulfan blue dye. 

Contraindication / Caution

Contraindication/Caution: 

Contraindication: 

• Hypersensitivity: isosulfan blue dye should not be used in individuals with a known hypersensitivity or allergic reaction to the dye or any of its components. 
• Lymphatic Disorders: It is contraindicated in patients with pre-existing lymphatic disorders or a history of lymphatic obstruction, as it may exacerbate the condition. 
• Concomitant Use with Certain Medications: There may be interactions between isosulfan blue dye and specific medications. Patients should inform their healthcare providers about all the medications they are taking before undergoing any procedures involving this dye. 
• Cardiovascular Disorders: isosulfan blue dye may cause transient changes in heart rate and blood pressure. It should be used cautiously in patients with cardiovascular disorders or a history of arrhythmias. 
• Pediatric Use: The safety and efficacy of isosulfan blue dye have not been well-established in pediatric populations, and its use in children should be carefully evaluated.

Caution: 

• Allergic Reactions and Hypersensitivity: isosulfan blue dye may cause allergic reactions in some individuals. It is essential to screen patients for any history of hypersensitivity to dyes or other medications before using isosulfan blue. Emergency measures should be readily available in case of an allergic reaction. 
• Injection Site Reactions: isosulfan blue dye is administered as an injection. Localized reactions, such as pain, swelling, or redness at the injection site, may occur. Monitoring the injection site and providing appropriate care is necessary to manage these reactions. 
• Skin Discoloration: After injection, isosulfan blue dye may temporarily cause skin discoloration, typically in the form of a blue or green hue. This discoloration is temporary and will resolve over time. Patients should be informed about this side effect to prevent unnecessary concern. 
• Lymphatic Disorders: isosulfan blue dye is primarily used in sentinel lymph node mapping and lymphatic mapping procedures. However, in patients with pre-existing lymphatic disorders or lymphatic obstruction, the dye’s migration to lymph nodes may be affected. Caution is needed when using isosulfan blue dye in such patients.

Comorbidities: 

• Renal Impairment: Patients with existing renal impairment or kidney diseases may experience delayed excretion of isosulfan blue dye, leading to its accumulation in the body. Careful consideration and dose adjustments may be required in such patients. 
• Pregnancy and Breastfeeding: The safety of isosulfan blue dye during pregnancy and breastfeeding has not been extensively studied. Its use should be carefully evaluated, considering the potential risks to the mother and fetus or infant. 
• Liver Dysfunction: Patients with liver dysfunction may experience altered metabolism or excretion of isosulfan blue dye, leading to potential complications. Caution and close monitoring are necessary in such individuals. 
• Pulmonary Disorders: Patients with respiratory conditions may experience respiratory distress or allergic reactions after isosulfan blue dye administration. Adequate respiratory support should be available when using the dye in these individuals. 
• Bleeding Disorders: isosulfan blue dye is commonly used in surgical procedures, including lymph node mapping. Patients with bleeding disorders may be at an increased risk of bleeding complications during surgery involving the dye. 
• Neurological Conditions: isosulfan blue dye may rarely cause neurological symptoms such as dizziness or seizures. Patients with a history of neurological disorders should be closely monitored during dye administration. 

Pregnancy / Lactation

Pregnancy consideration: pregnancy category C 

Lactation: excreted into human milk: unknown  

Pregnancy category: 

• Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester. 
• Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women. 
• Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.   
• Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits. 
• Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women. 
• Category N: There is no data available for the drug under this category. 

Pharmacology

Pharmacology: 

isosulfan blue dye, also known as methylene blue or Lymphazurin, is a synthetic triarylmethane dye with a deep blue color. It is used in medicine for diagnostic and surgical purposes, particularly in cancer surgeries.

The pharmacology of isosulfan blue dye involves its selective absorption into the lymphatic vessels, where it is carried by the lymphatic fluid to the sentinel lymph node to receive drainage from the tumor site.

This property allows surgeons to identify and remove the sentinel lymph node during surgical procedures like sentinel lymph node biopsy and lymphatic mapping. The dye is minimally metabolized and primarily eliminated from the body through the kidneys via urine.  

Pharmacodynamics: 

• The pharmacodynamics of isosulfan blue dye involve its specific action on the lymphatic system. When injected into the tissues, the dye is taken up by the lymphatic vessels and transported through the lymphatic system. It has a high affinity for the lymphatic tissues and tends to accumulate in the sentinel lymph node to receive drainage from the area around the tumor. 
• This selective uptake and accumulation of isosulfan blue dye in the sentinel lymph node allow surgeons to identify and remove it during cancer surgeries, particularly in cases of breast cancer and melanoma. By mapping the lymphatic drainage pathway using the blue dye, surgeons can determine if the cancer has spread to the lymph nodes and make more informed decisions regarding further treatment. 
• The pharmacodynamics of isosulfan blue dye are important for its diagnostic and therapeutic applications in cancer management, enabling more precise and targeted surgical interventions. Additionally, the dye’s rapid clearance from the body and low systemic toxicity contribute to its safety and utility as a lymphatic mapping agent.

Pharmacokinetics: 

Absorption 

isosulfan blue dye is usually administered intradermally or subcutaneously at the site of interest, such as the tumor site or injection near the tumor. Once injected, the dye is absorbed into the lymphatic vessels and carried by the lymphatic fluid to the sentinel lymph node to receive drainage from the tumor site. 

Distribution 

The dye travels through the lymphatic system to the sentinel lymph node, providing a visual pathway for surgeons to identify and remove the node during surgery. The distribution of isosulfan blue dye is primarily limited to the lymphatic system and sentinel lymph node. 

Metabolism 

isosulfan blue dye is not extensively metabolized in the body. It is primarily eliminated from the body unchanged through the renal route. Only a small portion of the dye may undergo minor metabolic transformations. 

Elimination and excretion 

The main route of elimination for isosulfan blue dye is through the kidneys. After the dye has served its purpose in lymphatic mapping or sentinel lymph node identification, it is eventually filtered by the kidneys and excreted in the urine. 

Adminstartion

Administration: 

isosulfan blue dye is typically administered as an injection directly into the affected area or tumor site. The dye is commonly used for lymphatic mapping in surgical procedures, especially for breast cancer and melanoma cases, to identify the sentinel lymph node and assess if cancer has spread to the lymphatic system. 

The administration of isosulfan blue dye is typically performed by a surgeon or radiologist. The dye is injected either intradermally (within the skin layers) or subcutaneously (under the skin) near the tumor or biopsy site. The dye then travels through the lymphatic vessels and is taken up by the sentinel lymph node to receive drainage from the area surrounding the tumor. 

By tracking the movement of the blue dye, the surgeon can identify the sentinel lymph node and assess its involvement in cancer spread. This information guides the surgical procedure, allowing the surgeon to remove the affected lymph node for further evaluation and determine the stage of cancer. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: isosulfan blue dye 

Pronounced: (eye-so-SUL-fan blue dye)  

Why do we use isosulfan blue dye? 

• Sentinel Lymph Node Mapping: isosulfan blue dye is injected near the tumor or the sentinel lymph node to receive drainage from the area around the tumor. The dye helps surgeons locate and assess the involvement of the sentinel lymph node in cancer spread. 
• Staging of Cancer: By identifying and evaluating the sentinel lymph node, the surgeon can determine if cancer has spread to the lymphatic system. This information is crucial for staging the cancer and planning the appropriate treatment. 
• Biopsy Guidance: isosulfan blue dye is used to guide the biopsy of lymph nodes during surgical procedures, helping ensure accurate sampling and diagnosis.