The Fast and Reliable Visualization of Bludigo® in Action
Urine jet post-Bludigo® application1
Surgeons rated their overall satisfaction with Bludigo® 5 mL
Overall satisfaction with indigo carmine (score of 1 or 2) was 89.8% with the high dose1,a |
|
| Physician's Response to Statement: "Compared to the saline treatment, my ability to assess ureter patency was improved after the addition of indigo carmine." | 5 mL (high dose) (N=49) |
| 1 Strongly agree | |
| 2 Agree | |
| 3 Neither agree nor disagree | |
| 4 Disagree | |
| 5 Strongly disagree | |
| Overall satisfaction (score of 1 or 2) | |
Nearly 9 out of 10 physicians reported overall satisfaction with Bludigo® visualization improvement1
These results are not included in the approved Bludigo® package insert.
aSatisfaction was based on a scale 1-5 of agreement that indigo carmine improved the ability to assess ureteral patency (1=strongly agree and 2=agree).1
Time to Visualization Varies Between Dyes
| Bludigo® | |||||||
| Methylene Blue | Used off-label3 | ||||||
| Phenazopyridine | Used off-label4 | ||||||
| Sodium fluorescein | Used off-label5 | ||||||
| Indocyanine Green | Used off-label6 |
| FDA indication for cystoscopy during urological and gynecological surgery | Used off-label3 | Used off-label4 | Used off-label5 | Used off-label6 |
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| Route of admin | |||||
| Time to visualization | |||||
| Half-life | |||||
| Metabolism/ excretion | |||||
| CI in patients with G6PD deficiency | |||||
| Black-box warning |
Provepharm does not endorse the use of any product beyond its approved labeling.
CI=contraindication; FDA=US Food and Drug Administration; G6PD=glucose-6-phosphate dehydrogenase; IV=intravenous; PO=by mouth.
aIndigo carmine, which was originally grandfathered by the FDA, now has an FDA indication with the launch of Bludigo®.
bNot studied in patients with estimated glomerular filtration rate <30 mL/min/m2 and not recommended for use in these patients.
cBased on a range of 9-20 min (mean: 14.4 minutes) when using near infrared imaging (NIR) of the ureter.
dBased on recommendations that methylene blue be administered 45 min prior to cystoscopy.
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 Sagent Pharmaceuticals at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
References: 1. Data on file. PVP-10ICO1 clinical study report. Newark, NJ: Provepharm, Inc.; 2025. 2. Bludigo. Prescribing Information. Provepharm, Inc.; 2024. 3. ProvayBlue. Prescribing Information. Provepharm, Inc.; 2016. 4. Phenazopyridine. Prescribing Information. Graxell Pharmaceuticals; 2020. 5. Fluorescite. Prescribing Information. Alcon, Inc., 2006. 6. IC-GREEN™ (Indocyanine Green for Injection, USP) NDA 11-525-S-017. 7. Boytim M, Jones MJ, Bart AS, Svintozelskiy P, Albala DM. Comparison of methods for ureteral patency visualization. Rev Urol. 2024;23(1):e67-e74. 8. Yeung TM, Volpi D, Tullis ID, Nicholson GA, Buchs N, et al. Identifying ureters in situ under fluorescence during laparoscopic and open colorectal surgery. Ann Surg. 2016;Jan;263(1):e1-2. doi:10.1097/SLA.0000000000001513. 9. Luketic L, Murji A. Options to evaluate ureter patency at cystoscopy in a world without indigo carmine. J Minim Invasive Gynecol. 2016;Sep-Oct;23(6):878-85. doi:10.1016/j.jmig.2016.06.009. 10. Manen L, Handgraaf H, Diana M, et al. A practical guide for the use of indocyanine green and methylene blue in fluorescence guided abdominal surgery. J Surg Oncol. 2018 Jun 24;118(2):283-300. doi: 10.1002/jso.25105.
