Safety profile highlights

Safety and risk features of Isosulfan Blue

  • Overall incidence of hypersensitivity reaction in approximately 2% of patients, including life-threatening anaphylactic reactionsπ
    • 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 administrationπ
  • Adverse skin reactions include transient or long-term blue colorationπ
  • No drug interactions have been reported in the full Prescribing Informationπ
    • Postmarketing cases report drug interactions with chronic preoperative use of angiotensin-converting enzyme inhibitors and angiotensin receptor blocking agentsπ

Please see Indications and Important Safety Information below.

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.

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