FDA

Bludigo

Approved 8 Jul 2022IntravenousSolution

Indications

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.

( 1 )

Contraindications

BLUDIGO is contraindicated in patients with known hypersensitivity to indigotindisulfonate or any of its components [see Warnings and Precautions ( 5.2 )]. Known hypersensitivity to indigotindisulfonate or any of its components. ( 4 )

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. ( 5.1 ) 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. ( 5.2 ) Interference with Oximetry Measurements: Anesthesiologists should be aware of the potential for artifactual reduction in SpO 2 when anesthetized patients are administered BLUDIGO. ( 5.3 )

5.1Cardiovascular Reactions Severe

or life-threatening cardiovascular reactions including cardiac arrest, arrhythmia, asystole, second degree atrioventricular block, hypotension, elevation in blood pressure, bradycardia, and tachycardia have been reported generally within 60 minutes following administration of indigotindisulfonate sodium injection products and required urgent intervention [see Adverse Reactions ( 6.2 )]. Indigotindisulfonate may cause vasoconstriction by interference with vasodilation mediated by nitric oxide dependent mechanisms and by direct vasoconstriction.

Indigotindisulfonate may also cause hypotension. Patients with hypertension, heart rate and conduction disorders, or medications causing bradycardia may be at increased risk for elevated blood pressure, hypotension, and bradycardia. Closely monitor blood pressure and cardiac rhythm during and following the injection of BLUDIGO. Interrupt administration if reactions are observed.

At a glance

Brand name: Bludigo
Active substance: indigotindisulfonate sodium
Route: Intravenous
Dosage form: Solution
Applicant: Provepharm Sas
Status: Prescription
FDA approval: 8 Jul 2022
Application: NDA216264-001

Indications

( 1 )

Warnings and precautions

5.1Cardiovascular Reactions Severe

Adverse reactions

Clinically significant adverse reactions are described elsewhere in the labeling: Cardiovascular Reactions [see Warnings and Precautions ( 5.1 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.2 )] Adverse reactions (≥ 1%) are constipation, nausea, vomiting, abdominal pain, pyrexia, ALT increase, and dysuria. ( 6.1 ) 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.

6.1Clinical 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 [see Dosage and Administration ( 2.1 )] . The mean age of patients was 51 years and 35 (30%) patients were 65 years of age or older. The majority of patients were White 105 (89%) and female 87 (74%). 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 BLUDIGO 5 mL (N=60) n (%) 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)

6.2Postmarketing 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

Bludigo

Indications

Contraindications

Warnings and precautions

5.1Cardiovascular Reactions Severe

At a glance

Two medicines in one question?

Bludigo

Indications

Contraindications

Warnings and precautions

5.1Cardiovascular Reactions Severe

At a glance

Two medicines in one question?

5.2Hypersensitivity Reactions

5.3Interference with Oximetry Measurements

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience

Composition

Official product information