When you trust the only commercially available FDA-approved blue dye indicated for sentinel lymph node mapping, the results are illuminating!
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.π
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%.¥
Efficacy profile highlights
Approximately 500,000 sentinel lymph node mapping procedures are performed in the United States every year.‡
Isosulfan Blue Injection 1% offers clinicians a ready-to-inject blue dye, with no reconstitution or dilution required prior to administration.π
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.π
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.§
- Trained personnel should be available to carry out emergency care, including resuscitation, for at least 60 minutes after administration.π
- Adverse skin reactions include transient or long-term blue coloration.π
- No drug interactions have been reported in the full Prescribing Information.π
Postmarketing cases report drug interactions with chronic preoperative use of angiotensin-converting enzyme inhibitors and angiotensin receptor blocking agents.π
Please see Indications and Important Safety Information† Lymphazurin is a registered trademark of Covidien LP, but this product is not currently commercially available.
‡ IMS Health Procedure Data (December 2015).
§ 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. (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).
¥ Purity of the active pharmaceutical ingredient as determined by high-performance liquid chromatography (HPLC).
π Isosulfan Blue 1% injection [package insert]. Rockford, IL: Mylan Institutional LLC; 2017.
