Safety

Important Safety Information

Indication
Deflux is indicated for treatment of children with vesicoureteral reflux (VUR) grades II-IV.

Contraindications
Deflux is contraindicated in patients with any of the following conditions: non-functional kidney(s), hutch diverticulum, ureterocele, active voiding dysfunction, ongoing urinary tract infection.

Warnings
Do not inject Deflux intravascularly. Injection of Deflux into blood vessels may cause vascular occlusion.

Precautions

• Deflux should only be administered by qualified surgeons experienced in the use of a cystoscope and trained in subureteral injection procedures.
• Treatment of duplex systems has not been prospectively studied.
• Ureters with grossly dilated orifices may render the patient unsuitable for treatment.
• The risks of infection and bleeding are 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 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.
• Deflux is supplied prefilled in a 1 mL syringe with a luer lock fitting, and is intended for single use only. Carefully examine the unit to verify that neither the contents nor the package has been damaged in shipment. DO NOT USE if damaged.
• Deflux is supplied sterile. Do not re-sterilize, as this may damage or alter the product.
• Deflux is supplied in a syringe ready for use. Never mix Deflux with other products.
• Deflux is stored up to 25 C (77 F), and used prior to the expiration date printed on its label. Do not expose Deflux to either sunlight or freezing, as this may damage or alter the product. Do not use Deflux after its expiration date.
• Deflux is packaged in a glass syringe. Glass is subject to breakage under a variety of unavoidable conditions. Care should be taken with the handling of the glass syringe and with disposing of broken glass to avoid laceration or other injury.
• After use, syringes and needles should be handled as potential biohazards. Disposal should be in accordance with accepted medical practice and applicable local, state and federal requirements.

Adverse Events
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. Follow-up for all three studies was 12 months. No patients died during the course of these studies.

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 Package Insert.