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.

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IMPORTANT SAFETY INFORMATION

Isosulfan blue injection 1% is contraindicated in those individuals with known hypersensitivity to triphenylmethane or related compounds.

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.

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.

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

Isosulfan 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.

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INDICATION

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.