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The Food and Drug Administration (FDA) has approved Bludigo™ (indigotindisulfonate sodium, USP) as 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.
Indigotindisulfonate is a dye excreted by the kidney through tubular secretion that enhances visualization of the ureteral orifices by its deep blue color. The approval was based on data from a randomized, intrapatient controlled, blind to dose, multicenter phase 3 study (ClinicalTrials.gov Identifier: NCT04228445), which evaluated the efficacy and safety of Bludigo in 118 adults undergoing endoscopic urological or gynecological surgical procedures including cystoscopic (58%), robotic (28%), and transvaginal (14%) approaches.
Patients were randomly assigned (1:1) to receive Bludigo 2.5mL or 5mL intravenously prior to the end of the surgical procedure. Each patient underwent cystoscopy and received 5mL of sodium chloride injection 0.9% followed by the randomized Bludigo dose for visualization of urinary flow from the ureteral orifices.
The conspicuity of the urine flow from the ureteral orifices was assessed in a blinded fashion by 2 independent central reviewers using a 5-point scale. Surgeons also reviewed and scored conspicuity of the urine flow. The responder for a ureter was defined as the difference in conspicuity score between Bludigo and sodium chloride being at least 1 point difference and the conspicuity score after Bludigo alone being greater than or equal to 3.
Results demonstrated that the following proportion of patients who received Bludigo 5mL were responders for the left and right ureter, respectively:
- Reviewer 1: 63% (95% CI, 48-77); 76% (95% CI, 61-87).
- Reviewer 2: 78% (95% CI, 63-88); 82% (95% CI, 68-91).
- Surgeon: 71% (95% CI, 57-83); 82% (95% CI, 68-91).
Bludigo is not recommended for use in patients with an estimated glomerular filtration rate less than 30mL/min. The most common adverse reactions reported with Bludigo were constipation, nausea, vomiting, abdominal pain, pyrexia, ALT increase, and dysuria.
Bludigo is supplied in a single-dose ampule containing 40mg/5mL (8mg/mL) of indigotindisulfonate sodium. According to Provepharm, the product is expected to be available in the US soon.
References
- Provepharm announces that it has received FDA approval for BludigoTM (indigotindisulfonate sodium, USP) Injection. News release. Provepharm Inc. Accessed July 12, 2022. https://www.prnewswire.com/news-releases/provepharm-announces-that-it-has-received-fda-approval-for-bludigotm-indigotindisulfonate-sodium-usp-injection-301584954.html
- Bludigo. Package insert. Provepharm Inc.; 2022. Accessed July 12, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216264s000lbl.pdf
