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Bludigo™ (indigotindisulfonate sodium injection, USP)

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the bludigo dye inside its Provepharm box packaging

Introducing Bludigo™ (indigotindisulfonate sodium injection, USP) the first and only FDA-approved injectable indigo carmine diagnostic dye.

a video of bludigo dye being injected inside urinary system
Urine Jet post - Bludigo™ application
a group of doctors surrounding an operating room table

Not just any blue dye.

Bludigo™ is a diagnostic dye indicated for use as a visualization aid in the cystoscopic assessment of the integrity of the ureters in adults following urological and gynecological open, robotic, or endoscopic surgical procedures.

Bludigo™ has a deep blue color that significantly aids visualization when assessing ureter patency.

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83% of the ureter patency assessments in the Bludigo™ clinical trial were reported as visualizing good or striking color contrast in the ureter jet stream.
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In 90% of urologic and gynecologic surgical procedures (N=49) in the Bludigo™ clinical trial, physicians agreed that their ability to assess ureteral patency was improved following the use of Bludigo™ compared to saline.

Data on file PVP-19ICO1 clinical study report.

Fast detection. Bludigo™ is excreted in the urine quickly.

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After injection, the blue color at the ureteral orifices is detectable within 4–9 minutes.

Prescribing Information

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Learn more about Bludigo™ (indigotindisulfonate sodium injection, USP)

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BLUDIGO™ (indigotindisulfonate sodium injection, USP)
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATIONS AND USAGE

BLUDIGO™ is a diagnostic dye indicated for use as a visualization aid in the cystoscopic assessment of the integrity of the ureters in adults following urological and gynecological open, robotic, or endoscopic surgical procedures.

CONTRAINDICATIONS

BLUDIGO™ is contraindicated in patients with known hypersensitivity to indigotindisulfonate or any of its components.

WARNINGS AND PRECAUTIONS

Cardiovascular Reactions: Severe or life-threatening cardiovascular reactions including cardiac arrest, arrhythmia, asystole, atrioventricular block second degree, hypotension, elevation in blood pressure, bradycardia, and tachycardia have been reported. Closely monitor blood pressure and cardiac rhythm during and following the BLUDIGO™ injection. Interrupt administration if reactions are observed.

Hypersensitivity Reactions:
Serious anaphylactic reactions with hypotension, dyspnea, bronchospasm, urticaria, or erythema have been reported. Monitor patients for anaphylactic reactions and have emergency equipment and trained personnel readily available.

Interference with Oximetry Measurements: Anesthesiologists should be aware of the potential for artifactual reduction in SpO2 when anesthetized patients are administered BLUDIGO™.

USE IN SPECIFIC POPULATIONS

Renal Impairment: BLUDIGO™ is not recommended for use in patients with eGFR<30 mL/min.

Pediatric Use: The safety and effectiveness of BLUDIGO™ have not been established in pediatric patients.

Pregnancy and Lactation: Please consult the Full Prescribing Information before using BLUDIGO™ in a patient that is lactating, pregnant, or may be pregnant.

RECOMMENDED DOSAGE

The recommended dose for BLUDIGO™ is 5 mL given intravenously over 1 minute.

IMPORTANT ADMINISTRATION INSTRUCTIONS
  • Monitor blood pressure and cardiac rhythm during and following the injection.
  • Use immediately after opening ampule.
  • Withdraw the contents of the ampule through a 5 micron or smaller filter straw/filter needle to ensure that the withdrawn solution contains no particulates. The withdrawn solution should be inspected visually for particulate matter and discoloration prior to administration.
  • Do not administer with infusion assemblies used with other diluents or drugs.
  • Discard any unused portion.
ADVERSE REACTIONS

Clinical Trial Experience: The most common adverse reactions (≥ 1%) associated with BLUDIGO™ in clincal trials were: constipation, nausea, vomiting, abdominal pain, pyrexia, ALT increase, and dysuria.

Postmarketing Experience: The following adverse reactions have been identified following the use of indigotindisulfonate sodium injection products:

  • Cardiovascular disorders: cardiac arrest, arrhythmia, asystole, atrioventricular block second degree, hypotension, elevation in blood pressure, bradycardia, tachycardia.
  • General disorders and administration site conditions: injection site discoloration.
  • Immune system disorders: anaphylactic reactions with hypotension, dyspnea, bronchospasm, urticaria, erythema. Please see the full Prescribing Information for additional important safety information.

To report SUSPECTED ADVERSE REACTIONS, contact PROVEPHARM Inc at 1–833-727-6556 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

© 2022 Provepharm, Inc., All rights reserved. Bludigo is a trademark of Provepharm Life Solutions.