Dextranomer / Sodium Hyaluronate

Pronunciation: DEX-tran-NO-mer/SOE-dee-um HYE-a-loo-RON-ate
Class: Bulking agent

Trade Names

Solesta
- Injection, gel dextranomer 50 mg/mL/sodium hyaluronate 15 mg/mL

Pharmacology

A biocompatible bulking agent that contains dextranomer/sodium hyaluronate made up of biosynthesized polysaccharides of nonanimal origin. The exact mechanism is unknown.

Indications and Usage

Treatment of fecal incontinence in patients 18 y and older who have failed conservative therapy (eg, antimotility medications, diet, fiber therapy).

Contraindications

Active anorectal conditions, including abscess, bleeding, fissures, proctitis, sepsis, or other infections; active inflammatory bowel disease; allergy to hyaluronic acid–based products; anorectal atresia, malformation, stenosis, or tumors; immunodeficiency disorders or ongoing immunosuppressive therapy; presence of existing implant (other than dextranomer/sodium hyaluronate) in anorectal region; previous radiation treatment to the pelvic area; rectal varices; rectocele; significant mucosal or full-thickness rectal prolapse.

Dosage and Administration

Adults

Submucosal A total of 4 injections of 1 mL of dextranomer/sodium hyaluronate administered in the following order: posterior, left lateral, anterior, and right lateral at each treatment session (max, 4 mL). If the patient has an inadequate response, a reinjection may be performed no sooner that 4 weeks after the first injection.

General Advice

  • Adequate bowel preparation of the rectum using an enema is required immediately prior to the procedure to ensure evacuation of the anorectum; additional cleansing of the injection area is recommended.
  • Place patient in the left lateral position and insert a lubricated anoscope. Remove the obturator and withdraw the anoscope so the dentate line is identified.
  • Inject slowly in the deep submucosal layer in the proximal part of the high pressure zone of the anal canal about 5 mm above the dentate line.
  • Do not inject intravascularly; injection into blood vessels may cause vascular occlusion.
  • Stop injection if excessive bleeding or pain occurs.
  • After injection, the needle should be kept in position for 15 to 30 sec to minimize leakage of gel.
  • Re-treatment injections should be made in between the initial injections, shifted 1/8 of a turn.
  • A new needle should be used for each syringe and injection site.
  • Avoid injection in the anterior wall of the rectum in men with large prostates.
  • Do not mix dextranomer/sodium hyaluronate with other products.
  • Use of prophylactic antibiotics is recommended.
  • Confirming placement of the gel by imaging may be of benefit.

Storage/Stability

Store up to 77°F. Protect from sunlight and freezing.

Drug Interactions

Immunosuppressive agents (eg, cyclosporine, tacrolimus)

Coadministration of dextranomer/sodium hyaluronate with ongoing immunosuppressive therapy is contraindicated.

Adverse Reactions

CNS

Chills (2%); fatigue (1%); dizziness, malaise.

Dermatologic

Alopecia, cold sweat, dermatitis (1%).

GI

Proctalgia (17%); rectal hemorrhage (8%); anal hemorrhage, anorectal discomfort, diarrhea, rectal discharge (4%); proctitis (3%); anal prolapse, anal pruritus, constipation, rectal abscess (2%); abdominal discomfort, abdominal distension, abdominal pain, abdominal pain lower, abdominal rigidity, anal abscess, anal fissure, defecation urgency, fecal incontinence, feces hard, GI motility disorder, GI pain, hemorrhoids, intestinal mass, mucosal inflammation, nausea, painful defecation, pelvic mass, perineal pain, rectal lesion, rectal obstruction, rectal spasm (1%); hematochezia, perineal abscess, rectal prolapse, rectal tenesmus, rectovaginal septum abscess.

Genitourinary

Dyspareunia, genital prolapse, urinary retention, vaginal discharge, vulvovaginal pain (1%); genital discharge, hematospermia.

Local

Injection-site hemorrhage (8%); injection-site pain (5%); device dislocation, injection-site inflammation, irritation, nodule, pustule, or swelling (1%); injection-site abscess, discomfort, hematoma, or ulcer.

Musculoskeletal

Back pain, musculoskeletal pain (1%).

Miscellaneous

Pyrexia (7%); C-reactive protein increased, Escherichia coli bacteremia, pain (body aches) (1%).

Precautions

Monitor

Monitor for excessive bleeding or pain during and after treatment.


Pregnancy

Category undetermined .

Lactation

Has not been studied.

Children

Safety and effectiveness have not been established.

Special Risk Patients

Has not been studied in patients with complete external sphincter disruption or significant chronic anorectal pain, nor in patients with previous procedures, such as rectal anastomosis less than 12 cm from anal verge, anorectal surgery within previous 12 mo, hemorrhoid treatment with rubber band within previous 3 mo, anorectal implants and previous injection therapy, stapled transanal rectal resection, or stapled hemorrhoidectomy.

Bleeding

Patients with bleeding diathesis and patients using anticoagulants or antiplatelets agents may experience increased bleeding at injection sites.

Durability

Durability of dextranomer/sodium hyaluronate has not been studied longer than 12 mo.

Overdosage

Symptoms

None well documented.

Patient Information

  • Advise patients that this treatment is not effective for all patients with fecal incontinence and that repeat treatment may be required.
  • Instruct patients to rest at the clinic for approximately 60 min once the treatment is complete.
  • Inform patients that the implants may be detected during future anorectal examinations and radiographic imaging of the pelvis, and to inform all health care providers about the presence of the medication.
  • Advise patients that if there is need for surgery (eg, hemorrhoidectomy), the implant can be resected.
  • Instruct patients to avoid physical activity for 24 h, avoid sexual intercourse and strenuous activity for 1 wk (eg, horseback riding, bicycling, jogging), and avoid anal manipulation (eg, insertion of suppositories or enema, rectal temperature recording).
  • Inform patients that stool softeners may be used until the first defecation occurs; analgesics other than NSAIDs may also be prescribed if needed.
  • Inform patients about the risk of infection and bleeding.
  • Instruct patients to contact their health care provider immediately if the following symptoms occur: bloody diarrhea, fever, problems urinating, rectal bleeding, or tenesmus.
  • Advise patients to avoid taking hot baths during the first 24 h posttreatment.
  • Tell patients that antidiarrheal drugs should not be used for 1 wk after treatment.

Copyright © 2009 Wolters Kluwer Health.

Hide
(web3)