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
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/5 mL (8 mg/mL) indigotindisulfonate sodium as a dark blue or bluish-purple 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 Table 1.
Table 1. Adverse Reactions Reported at ≥1% of Patients Receiving BLUDIGO 5 mL Intravenously
4.2Postmarketing Experience
The following adverse reactions have been identified following the use of indigotindisulfonate sodium injection products.
Immune system disorders: anaphylactic reactions with hypotension, dyspnea, bronchospasm, urticaria, erythema
5DESCRIPTION
BLUDIGO (indigotindisulfonate sodium injection, USP) is a sterile deep blue or bluish-purple diagnostic dye for intravenous use.
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 (
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 Table 3.
Table 3. Summary of Proportion of Responders by Ureter and Reviewer or Surgeon in Patients Receiving BLUDIGO 5 mL
*responder: IC conspicuity score ≥ 3 and difference (IC – Saline) in conspicuity score ≥1, missing data is imputed as non-responder
** two-sided 95% confidence limits for the proportion of responder, calculated using the Clopper-Pearson (Exact) method
7HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
BLUDIGO (indigotindisulfonate sodium injection, USP) 40 mg/5 mL (8 mg/mL) is a dark blue or bluish-purple solution supplied in a carton of 5 single-dose amber glass ampules (NDC 81284-315-05).
Storage and Handling
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Store in original carton to protect from light.
Do not refrigerate or freeze.
Use immediately after opening ampule. Discard unused portion.
BLUDIGO (indigotindisulfonate sodium injection, USP) 40 mg/5 mL (8 mg/mL) is a dark blue or bluish-purple solution supplied in a carton of 5 single-dose amber glass ampules (NDC 81284-315-05).
Storage and Handling
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Store in original carton to protect from light.
Do not refrigerate or freeze.
Use immediately after opening ampule. Discard unused portion.
8PATIENT COUNSELING INFORMATION
Cardiovascular Reactions
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 (
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 (
Injection Site and Urine Discoloration
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 (
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 (
9PRINCIPAL DISPLAY PANEL - CARTON
Rx only NDC 81284-
Bludigo
indigotindisulfonate
sodium Injection, USP
indigotindisulfonate
sodium Injection, USP
5 AMPULES OF 5 ML
40 mg/5 mL (8 mg/mL)
Intravenous use only
5 mL - Single dose ampule
5 mL - Single dose ampule
Discard unused portion
Patented: US 10,927,258; US 11,499,050
PROVEPHARM
10PRINCIPAL DISPLAY PANEL - VIAL
NDC 81284-
Bludigo
indigotindisulfonate sodium
Injection, USP
indigotindisulfonate sodium
Injection, USP
40 mg/5 mL (8 mg/mL)
Intravenous use only
Single dose ampule
Rx only
Discard unused portion
Manufactured by Cenexi
Distributed by:
28069319
