Adult Dosing

Fecal incontinence [Solesta]

• Inject 1 mL x 4 injection at 4 sites (posterior, left lateral, anterior, right lateral) in the anal deep submucosal layer 5 mm proximal to the dentate line
• If no adequate response is observed after the first injection, perform a re-injection with a max of 4 mL, no sooner than 4 wks after the first injection

• Procedure may be performed without anesthesia in outpatient setting
• Evacuate the rectum with an enema and give prophylactic antibiotics prior to the procedure
• After injection, keep the needle in position for 15-30 seconds to avoid extrusion of the product
• Use separate needle for each syringe and injection site
• To be administered by physicians well trained and experienced in the treatment of anorectal conditions
• Advise the patient to rest in the clinic for approx 60 minutes after injection and allow him to leave only if there is no bleeding or other treatment related symptoms

Pediatric Dosing

• Safety and effectiveness of Solesta in pediatric patients have not been established
• Safety and effectiveness of Deflux in pediatric patients <1 yr have not been established

Vesicoureteral reflux [Deflux]

• Inject 0.5-1.0 mL in the bladder submucosa via cystoscope 2-3 mm below the refluxing ureteral orifice at 6 o’clock position, until a prominent bulge is seen and the orifice has assumed a crescent-like shape
• May repeat treatment, if the bulge needs to be reinforced

• Perform procedure under general anesthesia using common pediatric cystoscope
• After injection, keep the needle in position for 15-30 seconds to avoid extrusion of the product
• To be administered by qualified surgeons well trained and experienced in the use of cystoscope and subureteric injections

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of vesicoureteral reflux (VUR) grades II-IV in children [Deflux]
• Treatment of fecal incontinence in patients 18 yrs not responsive to conservative therapy [Solesta]

• Hypersensitivity to any of the ingredients of the product

Solesta

• Active IBD
• Immunodeficiency disorders
• Concurrent immunosuppressive therapy
• Prior radiation therapy to pelvic area
• Significant mucosal or full thickness rectal prolapse
• Active anorectal conditions: fissures, abscess, sepsis, bleeding, proctitis, infections
• Anorectal atresia, tumors, stenosis or malformation
• Rectocele
• Rectal varices
• Anorectal implants

Deflux

• Non-functional kidney(s)
• Hutch diverticulum
• Ureterocele
• Active voiding dysfunction
• UTI

• N/A

Renal Dose Adjustment

• Deflux
• Non-functional kidney(s): Contraindicated

• Solesta
• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Deflux
• Hepatic impairment: Dose adjustments not defined

• Solesta
• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• Avoid intravascular injection as it may cause vascular occlusion
• Do not re-sterilize, mix with other drugs, or use if syringe is damaged

Deflux

• Should be administered by qualified surgeons well trained and experienced in cystoscopic and subureteral injection procedures
• Patients with grossly dilated ureter orifices may not be suitable for treatment with Deflux
• Use necessary precautions to reduce the risk of infection and bleeding associated with the cystoscopic procedure used to inject Deflux
• Do not administer >3 mL of Deflux solution at each ureteral orifice in a single treatment session

Solesta

• Do not inject in the midline of the anterior rectal wall in men with enlarged prostate
• Should be administered by physicians well trained and experienced in performing anorectal procedures
• Patients with complete disruption of external sphincter or significant chronic anorectal pain may not be suitable for treatment with Solesta
• Safety and effectiveness of Solesta in patients with previous procedures involving the anorectal region such as rectal anastomosis <12 cm from anal verge, anorectal surgery within 12 months, hemorrhoid treatment with rubber band within 3 months, anorectal implants and previous injection therapy, stapled transanal rectal resection (STARR) or stapled hemorrhoidectomy have not been studied
• The safety and efficacy of Solesta have not been evaluated beyond two treatment sessions given four weeks apart. The durability of Solesta has not been evaluated beyond 12 months
• Increased bleeding at injection sites may occur in patients with bleeding diathesis or those using anticoagulant/antiplatelet drugs
• Treatment may need to be repeated to achieve a satisfactory level of improvement in incontinence
• Adequate bowel preparation of the rectum using enema and cleansing of the injection site with an antiseptic is recommended prior to injection; use of prophylactic antibiotics is also recommended
• Inject the gel slowly to avoid undue stress on the lock connection which could cause leakage
• Excessive pain may occur if the injection is given very close to the dentate line or very deep in the tissue. Discontinue treatment if excessive bleeding or pain occurs

Supplemental Patient Information

• Inform patients that repeat treatment might be required to achieve and maintain therapeutic effect
• Advise patients to inform future physicians regarding their treatment with Solesta
• Caution patients that the implants (Solesta) might be detected during future anorectal examinations

Pregnancy Category:NR

Breastfeeding: Safety unknown.

• CNS: Dizziness
• GI: Nausea, vomiting, abdominal pain, abdominal discomfort, abdominal distension, lower abdominal pain, anal abscess, anal fissure, anal hemorrhage, anal prolapse, anal pruritus, anorectal discomfort, constipation, defecation urgency, diarrhea, fecal incontinence, feces hard, GI motility disorder, GI pain, hematochezia, hemorrhoids, intestinal mass, perineal abscess, painful defecation, pelvic mass, perineal pain, proctalgia, proctitis, rectal abscess, rectal discharge, rectal hemorrhage, rectal lesion, rectal obstruction, rectal prolapse, rectal spasm, rectal tenesmus, rectovaginal septum abscess
• GU: UTI, ureteral dilatation, genital discharge, genital prolapse, urinary retention, vaginal discharge, vulvovaginal pain
• DERM: Alopecia, dermatitis
• REPRODUCTIVE: Dyspareunia, hematospermia
• LABTEST: Elevated C-reactive protein levels
• MUSC: Abdominal rigidity, back pain, musculoskeletal pain
• LOCAL: Injection site abscess, discomfort, hemorrhage, hematoma, inflammation, irritation, nodule, pain, pustule, swelling, ulcer
• MISC: Chills, cold sweat, device dislocation, escherichia bacteremia, fatigue, infection, malaise, mucosal inflammation, edema, pain, pyrexia

Dextranomer

• Hydrophilic dextran polymer; increases tissue bulk in anal region, thereby narrowing the anal canal and improving sphincter control. Also, increases tissue bulk in bladder submucosa, causing coaptation of the distal ureter during bladder filling and contraction of the bladder
• Metabolism: Unknown
• Excretion: Unknown
• Half-life: Unknown

Hyaluronate

• Viscosupplement; acts as a carrier that facilitates the injection of dextranomer microspheres
• Metabolism: Unknown
• Excretion: Unknown
• Half-life: Unknown

US Trade Name(s)

• Deflux
• Solesta

US Availability

Deflux (dextranomer/hyaluronic acid)

• INJ: [50 mg/15 mg]/mL (1 mL pre-filled syringe)

Solesta (dextranomer/hyaluronate)

• INJ: [50 mg/15 mg]/mL (1 mL pre-filled syringe)

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Urologic

Genitourinary Tract Agents;Miscellaneous