ADEPT^® [4% Icodextrin Adhesion Reduction Solution]

ADEPT^® Adhesion Reduction Solution is indicated for use intraperitoneally as an adjunct to good surgical technique for the reduction of post-surgical adhesions in patients undergoing gynecological laparoscopic adhesiolysis.

Important Safety Information

ADEPT^® is for direct intraperitoneal administration only. NOT for intravenous (IV) administration. ADEPT^® is contraindicated in patients with known or suspected allergy to cornstarch based polymers e.g. icodextrin, or with maltose or isomaltose intolerance, or with glycogen storage disease. ADEPT^® is contraindicated in laparotomy, in cases involving bowel resection or repair, or appendectomy and in surgical cases with frank abdomino-pelvic infection.

There have been rare reports of sterile peritonitis following the use of icodextrin. Leakage of ADEPT^® from port sites may lead to wound healing complications; meticulous fascial closure may reduce leakage through laparoscopic port sites post-operatively. There have been rare reports of hypersensitivity reactions, pulmonary edema, pulmonary effusion and arrhythmia. Anaphylaxis has been reported in a few patients. Maltose metabolites of icodextrin may interfere with blood glucose measurement in diabetic patients who use rapid blood glucose systems that are not glucose specific.

In the pivotal study, the most frequently occuring treatement-related adverse events between surgeries were post procedural leaking from port sites, labial, vulvar or vaginal swelling and abdominal distention.

RX Only: For safe and proper use of this device, please refer to full device Instructions for Use.