BLUDIGO (indigotindisulfonate sodium)

The pharmacokinetic properties of BLUDIGO are presented in Table 2. Table 2. Pharmacokinetics of Indigotindisulfonate in Healthy Adults Following Intravenous Administration of BLUDIGO 5 mL (40 mg) BLUDIGO 5 mL (40 mg) General Information C max (CV%), μg/mL 6.33 (58.4) AUC 0-INF (CV%), μg·h/mL 1.15 (36.4)

DistributionMean (CV%) Volume of Distribution, L 10.7 (36.1) Protein Binding, in vitro About 90%

EliminationMean (CV%)

EliminationHalf-life, minutes 12 (34.1) Mean (CV%) Clearance, L/hour Uri...

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 surgi...

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. 6.1 Clinical Trials Experience Becaus...

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 )

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, bronc...