Brand Name
Bludigo
Generic Name
Indigotindisulfonate
View Brand Information FDA approval date: September 06, 2022
Classification: Diagnostic Dye
Form: Injection
What is Bludigo (Indigotindisulfonate)?
BLUDIGO is 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 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.
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Brand Information
Bludigo (Indigotindisulfonate Sodium)
1INDICATIONS AND USAGE
BLUDIGO is 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.
2DOSAGE FORMS AND STRENGTHS
Injection: 40 mg per 5 mL (8 mg per mL) indigotindisulfonate sodium as a dark blue solution in a single-dose amber glass ampule.
3CONTRAINDICATIONS
BLUDIGO is contraindicated in patients with known hypersensitivity to indigotindisulfonate or any of its components
4ADVERSE REACTIONS
Clinically significant adverse reactions are described elsewhere in the labeling:
- Cardiovascular Reactions
- Hypersensitivity Reactions
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of BLUDIGO was evaluated in a randomized, intra-patient controlled, blind to dose of BLUDIGO, clinical trial. A total of 118 adult patients undergoing endoscopic urological or gynecological procedures were treated intravenously; 58 (49%) of these patients received one dose of BLUDIGO 2.5 mL and 60 (51%) of patients received one dose of BLUDIGO 5 mL. The 2.5 mL dose is not approved
The adverse reactions (≥1%) reported in the clinical trial are provided in
4.2Postmarketing Experience
The following adverse reactions have been identified following the use of indigotindisulfonate sodium injection products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
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
5DESCRIPTION
BLUDIGO (indigotindisulfonate sodium injection, USP) is a sterile deep blue diagnostic dye for intravenous use.
Each mL contains 8 mg indigotindisulfonate sodium (equivalent to 7.2 mg indigotindisulfonate) and may also contain citric acid and sodium citrate to adjust pH value between 3 and 6.5 and has an osmolality ≤0.05 osmol/kg. Indigotindisulfonate sodium is also known as indigo carmine.
The chemical name of indigotindisulfonate sodium is Disodium 3,3'-dioxo-[Δ
Indigotindisulfonate sodium
6CLINICAL STUDIES
The safety and efficacy of BLUDIGO were evaluated in a randomized intra-patient controlled, blind to dose of BLUDIGO, multi-center study (NCT04228445) in 118 adult patients undergoing endoscopic urological or gynecological surgical procedures including cystoscopic (58%), robotic (28%), and transvaginal (14%) approaches.
The majority of patients were white (89%), female (74%), and younger than 65 years of age (70%). Mean age was 51 years, and age ranged from 20 to 88 years.
Patients were randomized in a 1:1 ratio to receive 2.5 mL or 5 mL of BLUDIGO intravenously prior to the end of the surgical procedure. Each patient underwent cystoscopy and received 5 mL of sodium chloride injection 0.9% followed by the randomized BLUDIGO dose for visualization of urinary flow from the ureteral orifices. The 2.5 mL dose is not approved
The ureteral orifices and urine flow were observed and video recorded from 0 to 10 minutes post injection, with separate recordings made following sodium chloride injection and BLUDIGO. The conspicuity of the urine flow from the ureteral orifices was assessed in a randomized, blinded fashion by two independent central reviewers using a 5-point scale (1 = no urine flow observed; 2 = weak urine flow, little color contrast; 3 = Color contrast or significant urine flow; 4 = strong urine flow with good color contrast; and 5 = strong urine flow with striking contrast in color) once after sodium chloride injection and twice after BLUDIGO resulting in paired data. The surgeons also reviewed and scored conspicuity of the urine flow from the ureteral orifices.
The responder for a ureter is defined as the difference in conspicuity score between BLUDIGO and sodium chloride injection being at least one point difference and the conspicuity score following BLUDIGO alone being greater than or equal to three. The reviewer agreement with the responder endpoint is acceptable. The proportion of responders along with its 95% confidence interval by ureter and reviewer or surgeon is summarized in