
When you trust the only commercially available FDA-approved blue dye indicated for sentinel lymph node mapping, the results are illuminating!1,2

Isosulfan Blue injection 1% has been used in sentinel lymph node mapping for more than 30 years.*


Isosulfan Blue injection has exceptionally high purity of at least 99%.†
INDICATION: lsosulfan 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.

Efficacy profile highlights

Isosulfan Blue Injection 1% offers clinicians a ready-to-inject blue dye, with no reconstitution or dilution required prior to administration. For Subcutaneous Use Only.

Administration highlights
- 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.
- Overall incidence of hypersensitivity reaction in approximately 2% of patients, including life-threatening anaphylactic reactions.
In a study of 543 patients, <1% receiving Isosulfan Blue experienced an allergic reaction, all of whom recovered within 1 hour with no or minimal symptomatic therapy.31%>
- Trained personnel should be available to carry out emergency care, including resuscitation, for at least 60 minutes after administration.
- Adverse skin reactions include transient or long-term (tattooing) blue coloration.
- No drug interactions have been reported in the full Prescribing Information. Please see Indications and Important Safety Information
* Lymphazurin is a registered trademark of Covidien LP, but this product is not currently commercially available.
† Purity of the active pharmaceutical ingredient as determined by high-performance liquid chromatography (HPLC).
‡ In the study by Hirsch and colleagues, the 543 patients who received Isosulfan Blue (Lymphazurin®) were divided into 3 groups according to the clinical indication for the lymphangiogram. Group 1 (n=508) included patients with possible lymph node involvement by primary or secondary malignancy; group 2 (n=28) included patients with possible primary lymphatic disease; and group 3 (n=7) included patients with chyluria, chylous ascites or chylothorax. Inadequate identification of lymphatics occurred in 5, 9 and 0 patients in groups 1, 2 and 3, respectively.
References
1) Data on File. IMS DATA. July 2021.
2) Isosulfan Blue Injection, Prescribing Information, 2022. Mylan Pharmaceuticals Inc., Morgantown, WV.
3) Hirsch JI, Tisnado J, Cho SR, Beachley MC. Use of isosulfan blue for identification of lymphatic vessels: experimental and clinical evaluation. AJR Am J Roentgenol. 1982;139(6):1061-1064.