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Prescribing Information

Important Safety Information

 

Well-Established Safety Profile1,2

In the Bludigo® clinical trial, adverse reactions reported in ≥1% of patients receiving Bludigo® 5 mL intravenously.1a

Adverse Reactions
Bludigo® 5 mL (N=60)
Constipation
3 (5.0%)
Nausea
2 (3.3%)
Vomiting
2 (3.3%)
Abdominal Pain
2 (3.3%)
Pyrexia
2 (3.3%)
ALT Increase
2 (3.3%)
Dysuria
1 (1.7%)

Discussing Bludigo® with patients

Cardiovascular reactions1

Advise the patient of the possibility of developing elevated blood pressure, hypotension, bradycardia, tachycardia, or atrioventricular block during or after the administration of Bludigo® [see Warnings and Precautions (5.1)].

Injection site and urine discoloration1

Inform the patient that Bludigo® may cause a blue discoloration of injection site and urine and that the discoloration should resolve within 48 hours. Advise the patient to inform the healthcare provider if the discoloration of the injection site is associated with other symptoms [see Adverse Reactions (6.2)].

aAt least 1 TEAE was reported for 30.0% of subjects administered the indigo carmine high dose and 43.1% of subjects administered the low dose. No TEAE was reported following saline injection but prior to indigo carmine injection. Four subjects (3.4%) experienced SAEs, none of which were considered related to indigo carmine. No deaths or TEAEs leading to discontinuation of the study or study drug were reported.2

ALT=alanine aminotransferase; SAE=serious adverse event; TEAE=treatment-emergent adverse event.

BLUDIGO® (indigotindisulfonate sodium injection, USP)

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.

IMPORTANT SAFETY INFORMATION

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 clinical 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.

References: 1. Bludigo. Prescribing Information. Provepharm, Inc.; 2024. 2. Data on file. PVP-10ICO1 clinical study report. Newark, NJ: Provepharm, Inc.; 2024.