Indication for DEFLUX
DEFLUX® is indicated for treatment of children with vesicoureteral reflux (VUR) grades II-IV.
Important Safety Information about DEFLUX
DEFLUX® (hyaluronic acid/dextranomer) is contraindicated in patients with any of the following conditions: non-functional kidney(s), hutch diverticulum, ureterocele, active voiding dysfunction, and ongoing urinary tract infection.
DEFLUX must not be injected intravascularly as injection into blood vessels may cause vascular occlusion.
DEFLUX should only be administered by qualified surgeons experienced in the use of a cystoscope and trained in subureteral injection procedures.
Safety and efficacy of treatment of duplex systems, use of more than 6 mL of DEFLUX (3 mL at each ureteral orifice) at the same treatment session, and treatment of children under 1 year of age have not been established.
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 cystoscopic procedure used to inject DEFLUX. The usual precautions associated with cystoscopy (e.g., sterile technique, proper dilation, etc.) should be followed.
The safety of DEFLUX in the treatment of VUR is based on a randomized study in which 39 children were treated with DEFLUX for VUR, and two nonrandomized studies in which 170 children were treated with DEFLUX for VUR. Treatment-related adverse events from the randomized and the nonrandomized studies were: urinary tract infection (UTI), ureteral dilation, and nausea/vomiting/abdominal pain.
Although vascular occlusion, ureteral obstruction, dysuria, hematuria/bleeding, urgency, and urinary frequency have not been observed in any of the clinical studies, they are potential adverse events associated with subureteral injection procedures. Following approval, rare cases of postoperative dilatation of the upper urinary tract with or without hydronephrosis leading to temporary placement of a ureteric stent have been reported.
Please see complete Prescribing Information for DEFLUX.
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