Important Safety Information

Important Safety Information about DEFLUX®

DEFLUX is indicated for treatment of children with vesicoureteral reflux (VUR) grades II-IV. Patients should not receive DEFLUX (hyaluronic acid/dextranomer) if they have any of the following conditions: kidneys that don’t work (non-functional kidney[s]), bulging or herniation in the skin of the bladder (hutch diverticulum), swelling at the bottom of the ureter (ureterocele), a disorder in eliminating urine (active voiding dysfunction), and ongoing urinary tract infection.

Do not injection DEFLUX intravascularly. Injection of DEFLUX into the blood vessels may cause vascular occlusion. Do not inject DEFLUX if the patient is known to be allergic to hyaluronic acid-based products or dextran.

DEFLUX should only be administered by qualified surgeons experienced performing urologic procedures.

Treatment of duplex systems has not been prospectively studied. Ureters with grossly dilated orifices may render the patient unsuitable for treatment.

There is a risk of infection and bleeding that is associated with the cystoscopy procedure used to inject DEFLUX.

The safety and effectiveness of the use of more than 6 mL of DEFLUX (3 mL at each ureteral orifice) at the same treatment session have not been established.

The safety and effectiveness of DEFLUX in the treatment of children under 1 year of age have not been established.

In clinical studies, the most common side effects associated with DEFLUX (occurring > 1%) were: urinary tract infection (UTI), ureteral dilation, and nausea/vomiting/abdominal pain.

The following adverse events have been reported with DEFLUX (occurring < 1%): blockage of the ureters (some cases require temporary placement of a ureteric stent), painful urination, blood in the urine, urgency of urination, frequency of urination, swelling of the kidneys, inflammation of the kidneys, urinary tract infection, foreign body reaction, calcification, and fever.

You are encouraged to report negative side effects of DEFLUX to the FDA. Visit fda.gov/medwatch or call 1-800-FDA-1088.

 

For product information, adverse event reports, and product complaint reports, contact:

Palette Life Sciences
Medical Information Department
T: 844.350.9656
F: 510.595.8183
E: palettemc@dlss.com