BLUDIGO
Generic: INDIGOTINDISULFONATE SODIUM
Basic Information
Manufacturer
Provepharm Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
73f246c4-b127-452e-856f-134b56cb8870
Indications & Usage
1 INDICATIONS 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.
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 )
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 )
Adverse Reactions
6 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.
6.1 Clinical 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) 6.2 Postmarketing 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
( 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 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) 6.2 Postmarketing 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