Version May 2024
Fecal incontinence (Solesta): Submucosal injection: 4 mL given as 4 x 1 mL injections in the anal canal in the following order: posterior, left lateral, anterior, and right lateral (maximum dose: 4 mL per treatment session); if inadequate response, may repeat ≥4 weeks after first injection with the point of injection made in between the initial injections, shifted one-eighth of a turn (eg, left posterolateral, left anterolateral, right anterolateral, and right posterolateral).
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
(For additional information see "Dextranomer and hyaluronic acid or derivatives: Pediatric drug information")
Fecal incontinence: Adolescents ≥18 years: Solesta: Submucosal injection: 4 mL total administered as 4 aliquots 1 mL injections in the anal canal in the following order: Posterior, left lateral, anterior, and right lateral (maximum dose: 4 mL per treatment session); if inadequate response, may repeat ≥4 weeks after first injection with the point of injection made in between the initial injections, shifted one-eighth of a turn (eg, left posterolateral, left anterolateral, right anterolateral, and right posterolateral).
Vesicoureteral reflux; grade II through V: Limited data available in patients with grade V (Ref):
Infants ≥2 months, Children, and Adolescents: Deflux: Submucosal injection: 0.5 to 1 mL single injection in the bladder near the ureteral orifice; if the ureteral orifice does not completely coapt with a single injection, a second more distal intra-ureteral injection or a sub-ureteral implantation can be performed. Safety and effectiveness of >6 mL (3 mL at each ureteral orifice) at the same treatment session have not been established.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults unless otherwise indicated.
>10%: Genitourinary: Urinary tract infection (children and adolescents: 2% to 15%)
1% to 10%:
Gastrointestinal: Abdominal distress (children, adolescents, adults: ≤1%), abdominal pain (children, adolescents, adults: ≤1%; including guarding/rigidity), anal hemorrhage (≤2%), bowel urgency (1%), constipation (≤1%), diarrhea (≤2%), nausea (children, adolescents, adults: ≤1%), proctitis (≤1%), rectal discharge (≤2%), rectal disease (prolapse: ≤1%), rectal hemorrhage (≤3%), rectal pain (≤9%; including anorectal discomfort), vomiting (children and adolescents: ≤1%)
Genitourinary: Bladder mucosa irritation (children and adolescents: ≤1%), dyspareunia (1%), dysuria (children and adolescents: 1%), genitourinary signs and symptoms (calcification: children and adolescents: ≤1%), hematuria (children and adolescents: ≤1%), pollakiuria (children and adolescents: 1%), ureteral obstruction (with/without hydronephrosis) (children and adolescents: ≤1%), urinary frequency (children and adolescents: ≤1%), urinary incontinence (children and adolescents: 1%), urinary tract dilation (ureter; children and adolescents: 3% to 4%), urinary urgency (children and adolescents: 1%)
Hematologic & oncologic: Henoch-Schönlein purpura (children and adolescents: ≤1%)
Local: Bleeding at injection site (2% to 3%), injection-site nodule (2%), pain at injection site (≤3%)
Nervous system: Chills (≤2%), foreign body reaction (children and adolescents: ≤1%)
Renal: Pyelonephritis (children and adolescents: ≤1%)
Miscellaneous: Fever (children, adolescents, adults: ≤4%)
<1%:
Dermatologic: Alopecia, dermatitis, diaphoresis
Gastrointestinal: Abdominal distention, abscess of rectum and/or perirectal area (including rectovaginal septum), anal fissure, fecal impaction, fecal incontinence, gastrointestinal motility disorder, gastrointestinal obstruction (rectum), gastrointestinal pain, gastrointestinal signs and symptoms (intestinal mass, mucosal excoriation, and rectal spasm), hemorrhoids, lower abdominal pain, painful defecation, pruritus ani
Genitourinary: Pelvic symptoms (genital prolapse), perineal pain, urinary retention, vaginal discharge, vaginal pain (vulvovaginal)
Hematologic & oncologic: C-reactive protein increased
Infection: Anal abscess, bacteremia (Escherichia coli)
Local: Cyst at injection site, injection-site reaction (including inflammation at injection site, irritation at injection site, pustules [injection site], swelling at injection site)
Nervous system: Fatigue, pain
Neuromuscular & skeletal: Back pain, musculoskeletal pain
Miscellaneous: Mass (pelvic)
Deflux: Non-functional kidneys; hutch diverticulum; ureterocele; active voiding dysfunction; ongoing UTI.
Solesta: Hypersensitivity to hyaluronic acid-based products, dextran, or any component of the formulation; active inflammatory bowel disease; immunodeficiency disorders or ongoing immunosuppressive therapy; prior pelvic radiation; significant mucosal or full thickness rectal prolapse; active anorectal conditions (eg, abscess, fissure, sepsis, bleeding, proctitis, infection); anorectal atresia, tumors, stenosis, or malformation; rectocele; rectal varices; existing anorectal implant (other than Solesta).
Concerns related to adverse effects:
• Bleeding: Bleeding risk at injection site is increased in patients with bleeding diathesis or in patients using anticoagulant or antiplatelet agents.
Disease-related concerns:
• Prostatic hyperplasia: Solesta: Avoid injection in the midline of the anterior rectal wall in men with enlarged prostate.
Other warnings/precautions:
• Administration: Do not administer intravascularly; injection into blood vessels may cause vascular occlusion.
• Appropriate use: Deflux: Treatment of duplex systems has not been prospectively studied. Ureters with grossly dilated orifices may render the patient unsuitable for treatment. Do not inject if the patient is known to be allergic to hyaluronic acid-based products or dextran.
• Appropriate use: Solesta: Safety and efficacy have not been investigated in patients with complete external sphincter disruption, significant chronic anorectal pain, rectal anastomosis <12 cm from anal verge, anorectal surgery within past 12 months, hemorrhoid treatment with rubber band within 3 months, anorectal implants and previous injection therapy, stapled transanal rectal resection, or stapled hemorrhoidectomy. Durability has not been studied past 36 months.
• Trained personnel: Should only be administered by a physician familiar with anorectal procedures and who has been trained and certified in the Solesta injection procedure or in the use of a cystoscope and trained in the technique of subureteric and/or intraureteric injections (with Deflux or other materials).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, gel:
Deflux: Dextranomer 50 mg and hyaluronic acid 15 mg per 1 mL (1 mL)
Solesta: Dextranomer 50 mg and sodium hyaluronate 15 mg per 1 mL (1 mL)
No
Gel (Solesta Injection)
50-15 mg/mL (1 mL): $1470.00
Disclaimer: The pricing data provided represent a median AWP and/or AAWP price for the brand and/or generic product, respectively. The pricing data should be used for benchmarking purposes only, and as such should not be used to set or adjudicate any prices for charging or reimbursement functions. Pricing data is updated monthly.
For submucosal injection; do not administer intravascularly (may cause vascular occlusion). Refer to product labeling for detailed preparation and administration instructions.
Solesta: Using an anoscope, inject slowly in the proximal part of the high pressure zone of the anal canal about 5 mm above the dentate line; avoid injection in midline of anterior wall of rectum in men with large prostates. After injection, the needle should be kept in position for 15 to 30 seconds to minimize leakage. Administer enema immediately prior to procedure to evacuate the anorectum and cleanse injection site with antiseptic. Use of prophylactic antibiotics is recommended. After injection, patient is to rest for ~1 hour (observe for bleeding or other treatment related symptoms). Confirming placement of gel by imaging may be of benefit.
Parenteral: For submucosal injection; do not administer intravascularly (may cause vascular occlusion). Refer to product labeling for detailed preparation and administration instructions.
Fecal incontinence: Solesta: Using an anoscope, inject slowly in the proximal part of the high pressure zone of the anal canal about 5 mm above the dentate line; avoid injection in midline of anterior wall of rectum in men with large prostates. Administer enema immediately prior to procedure to evacuate the anorectum and cleanse injection site with antiseptic. Use of prophylactic antibiotics is recommended. After injection, patient is to rest for ~1 hour (observe for bleeding or other treatment-related symptoms). Confirming placement of gel by imaging may be of benefit.
Vesicoureteral reflux: Deflux: Administration should be under general anesthesia and by trained specialist. Refer to product labeling for detailed preparation and administration instructions. In general, the bladder is semi-filled to allow for good visualization of the ureteral orifice(s) and to avoid tension within the submucosal layer of the ureter secondary to overdistension. Using a cystoscope, inject in the urinary bladder (close proximity to the ureteral orifice). A voiding cystourethrogram is suggested in the post treatment follow up to ascertain whether the reflux remains. If the original injection needs to be reinforced, further treatments may be administered. For previously treated patients, the injection sites from the previous procedure may still be visible; an augmentation of prior intraureteric injections can be performed or further enhanced with a subureteral injection.
Fecal incontinence (Solesta only): Treatment of fecal incontinence in patients ≥18 years of age who have failed to respond to conservative therapy (eg, diet, fiber therapy, antimotility medications).
Vesicoureteral reflux (Deflux only): Treatment of vesicoureteral reflux (VUR) grades II to IV in pediatric patients.
None known.
There are no known significant interactions.
Safety for use in pregnant women has not been established.
It is not known if dextranomer and hyaluronate derivatives are present in breast milk. Safety for use in breastfeeding women has not been established.
Excessive bleeding and pain (during and after treatment).
Fecal incontinence: Reduces frequency of fecal incontinence episodes; believed to work by building or bulking up tissue in the anal area to narrow the opening of the anus.
Dextranomer is a network of dextran-sucrose beads possessing a great many exposed hydroxy groups; when this network is applied to an exudative wound surface, the exudate is drawn by capillary forces generated by the swelling of the beads, with vacuum forces producing an upward flow of exudate into the network; sodium hyaluronate provides viscosity and facilitates injection of the dextranomer microspheres.
Vesicoureteral reflux: Injection in the urinary bladder creates increased tissue bulk thereby providing coaptation of the distal ureter during filling and contraction of the bladder; the dextranomer microspheres are gradually surrounded by host connective tissue.
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