Deflux

Last updated on RxList: 10/25/2018
Deflux Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 10/25/2018

Deflux Injectable Gel (dextranomer microspheres in a carrier gel of non-animal stabilized hyaluronic acid) is a tissue bulking agent indicated for treatment of children with vesicoureteral reflux (VUR) grades II-IV. Common side effects of Deflux Injectable Gel include:

Deflux Injectable Gel is supplied in a glass syringe containing a 1 mL dose. Deflux Injectable Gel is to be administered only by qualified surgeons experienced in the use of a cystoscope and trained in the technique of subureteric and/or intraureteric injections. Deflux Injectable Gel may interact with other drugs. Tell your doctor all medications and supplements your child uses. Deflux Injectable Gel is intended for use in children and is unlikely to be used during pregnancy or while breastfeeding.

Our Deflux Injectable Gel (dextranomer microspheres in a carrier gel of non-animal stabilized hyaluronic acid) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Urinary Incontinence in Women: Types, Causes, and Treatments for Bladder Control See Slideshow
Deflux Professional Information

SIDE EFFECTS

Adverse Events

The safety of Deflux in the treatment of VUR is based on a pivotal randomized study in which 39 children were treated with Deflux, two nonrandomized supportive studies in which 170 children were treated with Deflux, and a nonrandomized post-approval study in which 165 children were treated with Deflux. Follow-up for the pivotal and supportive studies was 12 months; follow-up for the post-approval study was 5 years (5-year data available for 31 of the 165 enrolled subjects (18.8%) ). No patients died during the course of these studies.

A list of the treatment -related adverse events occurring in > 1% of patients in all four studies is presented in Table 1.

Table 1: List of Treatment-Related Adverse Events Occurring in > 1% of Patients in the Pivitol, Supportive and Post-Approval Studies

Adverse Event Category pivotal Study
(n=39 Deflux patients)
Supportive Studies
(n=170 Deflux patients)
post-Approval Study
(n=165 Deflux patients)
Urinary tract infection (UTI)(i) 6 (I5.4%)(ii, iii) 13 (7.6%)(ii, iii) 3 (1.8%)
Ureteral dilatation(iv) 1 (2.6%) 6 (3.5%) 0 (0%)
Nausea/Vomiting/Abdominal pain(v) 0 (0%) 2 (1.2%) 0 (0%)
Abdominal discomfort 0 (0%) 0 (0%) 2 (1.2%)
Dysuria 0 (0%) 0 (0%) 2 (1.2%)
Micturition urgency 0 (0%) 0 (0%) 2 (1.2%)
Pollakiuria 0 (0%) 0 (0%) 2 (1.2%)
Urinary incontinence 0 (0%) 0 (0%) 2 (1.2%)
Vesicoureteric reflux 0 (0%) 0 (0%) 2 (1.2%)
(i) Cases of UTI typically occurred in patients with persistent reflux.
(ii) Patients in the nonrandomized studies received antibiotic prophylaxis until the 3-month voiding cystourethrogram (VCUG). After that only those patients whose treatment had failed received further antibiotic prophylaxis. The patients in the randomized study received antibiotic prophylaxis 1 month post-treatment.
(iii) All UTI cases were successfully treated with antibiotics.
(iv) No case of ureteral dilatation required intervention and most cases resolved spontaneously.
(v) Both cases of nausea/vomiting/abdominal pain were resolved.

The following adverse events were associated with the use of Deflux from spontaneous post-marketing surveillance reporting or from clinical studies (occurring ≤ 1%) and include but are not limited to: ureteral obstruction with or without hydronephrosis (some cases requiring temporary placement of a ureteric stent, and rare cases of ureteral re-implant procedures), hematuria, urgency, frequency, pyelonephritis, foreign body reaction, calcification, pyrexia, hypertonic bladder, bladder irritation, and Henoch-Schonlein purpura.

Adverse events should be reported to:

Salix Product Information Call Center, Phone: 1-800-508-0024, Fax: 1-510-595-8183, E-mail: [email protected]

Read the entire FDA prescribing information for Deflux (Deflux Injection)

© Deflux Patient Information is supplied by Cerner Multum, Inc. and Deflux Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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