Provepharm receives FDA approval for BLUDIGO™ (indigotindisulfonate sodium, USP) Injection

2022-07-17

Marseille, France - Collegeville, PA 

 

BLUDIGOTM  is the first and only indigotindisulfonate sodium injection, USP, drug product approved by the FDA.

 

Provepharm, a French company with operations in the United States of America, specializing in the development of pharmaceutical applications, today announced that it has received FDA New Drug Approval for the marketing of its injectable BLUDIGO™ (indigotindisulfonate sodium) Injection. 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.

 

Provepharm filed its application for approval with the FDA in September 2021 and with this new approval, its US affiliate, Provepharm Inc., will market the product directly in the United States of America. Frederick Girard, Provepharm’s Chief Medical Officer, said: “BLUDIGOTM is the second product to be granted market authorization by the FDA from Provepharm’s R&D group. This new success validates Provepharm’s strategy based on a high level of investment in research and development aimed at improving patients’ lives and health care professionals’ work on a daily basis”.

 

In addition, Mary Jane Helenek, Executive VP and COO of Provepharm, Inc., said: “Provepharm is immensely proud of this accomplishment and approval by the FDA. We will soon make this important product available to clinicians in the US.”

 

Eighty-two percent of ureter injuries occur during pelvic surgery, and 75% of urinary tract injuries are due to gynecologic surgery [1]. Current estimates of urinary tract injury incidence with all types of gynecologic surgery range from 0.2 to 15 per 1,000 cases [2]. If the damage is not identified during the surgical procedure, it may lead to severe post-surgical complications, notably obstruction fistulae and sepsis, with potential impact on the functional prognosis of the kidney and sometimes on the vital prognosis. These complications lead also to the need for reintervention, sometimes in an emergency. Hence, screening for potential iatrogenic ureteral damage during the initial procedure can provide the surgeons with an opportunity of repairing the damage immediately, which may significantly contribute to the reduction of post-surgical complications.

BLUDIGO™ (Indigotindisulfonate Sodium Injection, USP) INDICATION AND IMPORTANT SAFETY INFORMATION

 

INDICATION AND USAGE

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.

 

CONTRAINDICATIONS

BLUDIGO™ is contraindicated in patients with known hypersensitivity to indigotindisulfonate or any of its components.

 

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.

 

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.

 

Interference with Oximetry Measurements: Anesthesiologists should be aware of the potential for artifactual reduction in SpO2 when anesthetized patients are administered BLUDIGO™.

 

USE IN SPECIFIC POPULATIONS

Renal Impairment: BLUDIGO™ is not recommended for use in patients with eGFR<30 mL/min.

 

Pediatric Use: The safety and effectiveness of BLUDIGO™ have not been established in pediatric patients.

 

Pregnancy and Lactation: Please consult the Full Prescribing Information before using BLUDIGO™ in a patient that is lactating, pregnant, or may be pregnant.

 

RECOMMENDED DOSAGE

The recommended dose for BLUDIGO™ is 5 mL given intravenously over 1 minute.

 

IMPORTANT ADMINISTRATION INSTRUCTIONS

  • Monitor blood pressure and cardiac rhythm during and following the injection.
  • Use immediately after opening ampule.
  • Withdraw the contents of the ampule through a 5 micron or smaller filter straw/filter needle to ensure that the withdrawn solution contains no particulates.
  • The withdrawn solution should be inspected visually for particulate matter and discoloration prior to administration.
  • Do not administer with infusion assemblies used with other diluents or drugs.
  • Discard any unused portion.

 

ADVERSE REACTIONS

Clinical Trial Experience: The most common adverse reactions (≥ 1%) associated with BLUDIGO™ in clinical trials were: constipation, nausea, vomiting, abdominal pain, pyrexia, ALT increase, and dysuria.

 

Postmarketing Experience: The following adverse reactions have been identified following the use of indigotindisulfonate sodium injection products:

  • 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

 

Please see the full Prescribing Information for additional important safety information.

 

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.

 

About Provepharm

Provepharm Life Solutions is a privately held, global pharmaceutical company based in Marseille, France, specializing in molecule revitalization. Its long-standing expertise in fine chemistry and high investment in R&D allows it to improve the purity of active pharmaceutical ingredients to the highest standards for the development of drug products and medical devices. Provepharm’s strategy has already proven successful through the patented development and approval of Provayblue® (methylene blue injection, USP) notably in the European Union and the United States of America.

 

References:

1. Lee, J.S.,Urologic Complications Following Obstetric and Gynecologic Surgery, Korean J Urol 2012;53:795-799, AAGL Advancing minimally invasive gynecology worldwide.

2. AAGL Advancing minimally invasive gynecology worldwide. AAGL Practice Report: Practice Guidelines for Intraoperative Cystoscopy in Laparoscopic Hysterectomy. Journal of Minimally Invasive Gynecology 2012; 19(4): 407-411

 

For more information, please visit www.us-provepharm.com.

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