Deflux safety information
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Europe
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Since 2001, Deflux has been used to treat vesicoureteral reflux (VUR) grades II-IV in children in the United States.
Deflux is the only injectable agent for VUR approved in the United States, Australia, Europe and New Zealand.
| Incidence of adverse events occurring >1% of patients1 | |||
| Adverse Event Category | Pivotal study N=39 |
Supportive Studies N=170 |
Post-Approval Study N=165 |
| UTI | 6 (15.4%) | 13 (7.6%) | 3 (1.8%) |
| Ureteral Dilatation | 1 (2.6%) | 6 (3.5%) | 0 (0%) |
| Nausea, Vomiting, or Abdominal Pain | 0 (0%) | 2 (1.2%) | 0 (0%) |
UTI = urinary tract infection
The following adverse events have been reported with Deflux (occurring ≤ 1%): ureteral obstruction (some cases requiring temporary placement of a ureteric stent), dysuria, hematuria, urgency, frequency, hydronephrosis, pyelonephritis, urinary tract infection, foreign body reaction, calcification and pyrexia.
The components used for the manufacturing of Deflux injectable gel are free from Latex.
Please see the product insert for full safety information.
1. Deflux prescribing information. Santa Barbara, CA: Palette Life Sciences, Inc.; 2019.
