Isosulfan Blue Injection 1% is the only commercially available FDA-approved blue dye indicated for sentinel lymph node mapping.


Isosulfan Blue Injection 1% is

  • FDA-approved as bioequivalent to Lymphazurin 1%
  • Isosulfan Blue injection 1% has been used in sentinel lymph node mapping for more then 30 years
  • Isosulfan Blue 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.π



Isosulfan Blue is an important part of Mylan’s growing oncology portfolio

  • Mylan now offers more than 40 therapies, from treatments for solid tumors and cancers of the blood to supportive care‡
Learn more about Mylan’s full health systems product portfolio

† Lymphazurin is a registered trademark of Covidien LP, but this product is not currently commercially available.

‡ IMS Health Procedure Data (January-December 2013).

§ In the study by Hirsch and colleagues, the 543 patients who received Isosulfan Blue 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; 2013.

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.

IMPORTANT SAFETY INFORMATION

Life-threatening anaphylactic reactions 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 or related compounds. Monitor patients closely for at least 60 minutes after administration and have trained personnel available to administer emergency care including resuscitation.

Do not mix isosulfan blue with local anesthetics in the same syringe as this results in immediate precipitation.

Isosulfan blue 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.

lsosulfan 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.

In post-marketing experience, hypersensitivity reactions have occurred in approximately 2% of patients. Transient or long-term (tattooing) blue coloration has been reported.

Click here for full Prescribing Information.

You are leaving Isosulfanblue.Mylan.com

You are arriving at a third-party site that contains content that is not controlled by Mylan.