Manufacturer:
Oceana Therapeutics, Inc.
Pharmacological Class:
Tissue bulking agent.
Active Ingredient(s):
Dextranomer microspheres 50mg/mL, sodium hyaluronate 15mg/mL; gel
for submucosal inj.
Indication(s):
Treatment of fecal incontinence in patients who have failed conservative therapy (eg, diet, fiber therapy, anti-motility drugs).
Pharmacology:
Solesta is a biocompatible tissue bulking agent, consisting of dextranomer microspheres and stabilized sodium hyaluronate.
While the exact mechanism of action has not been identified, it is hypothesized that Solesta may narrow the anal canal and allow for better sphincter control.
Clinical Trials:
Clinical data supporting the safety and effectiveness of Solesta are available from three clinical studies.
The main body of clinical evidence came from a multi-center, prospective, randomized, Sham(placebo) controlled study of the product’s effectiveness and safety.
The study included 206 patients (136 Solesta, 70 Sham) and consisted of a 6-month double-blinded phase followed by an open label phase in which patients originally randomized to Sham treatment were offered Solesta. The primary efficacy objective of the study required: 1) demonstrating a statistically significant
Solesta effect after 6 months of treatment; 2) meeting a pre-defined threshold for clinical significance; and 3) showing durability of the Solesta benefit up to 12 months after treatment. All three of these endpoints were met. Additionally, patients have been followed for over 2 years and the corresponding data showed no decline in effectiveness.
Legal Classification:
Rx
Adults:
See literature. Bowel preparation of rectum using enema required prior to injection.
Prophylactic antibiotics are recommended.
Inject slowly in deep submucosal layer in the proximal part of the high pressure zone of the anal canal about 5mm above the dentate line.
Four 1mL injections are to be given in the following order: posterior, left lateral, anterior, right lateral. Keep needle in place for 15–30 seconds to minimize leakage. A new needle should be used for each syringe and inj site. Post-treatment: Avoid hot baths and physical activity during first 24hrs, antidiarrheal drugs, sexual intercourse, strenuous physical activity for 1 week, anal manipulation for 1 month. Re-treatment: If needed, may repeat with max 4mL no sooner than 4 weeks after first injection. Point of injection should be made in between initial injections, shifted 1/8 of a turn.
Children:
<18yrs: not recommended.
Contraindication(s):
Active inflammatory bowel disease. Immunodeficiency disorders or ongoing immunosuppressive therapy. Previous radiation treatment to the pelvic area. Significant mucosal or full thickness rectal prolapse. Active anorectal conditions (eg, abscess, fissures, sepsis, bleeding, proctitis, other infections). Anorectal atresia,
tumors, stenosis or malformation. Rectocele. Rectal varices.
Presence of existing implant in anorectal region.
Warnings/Precautions:Should only be used by physicians experienced in anorectal procedures who have successfully completed training and a certification program in Solesta inj procedure. Do not inject intravascularly; may cause vascular occlusion. Avoid inj in midline of anterior wall of rectum in men with enlarged prostate. Complete external sphincter disruption. Significant chronic anorectal pain.
Previous anorectal procedures. Bleeding diathesis. Pregnancy.
Nursing mothers.
Interaction(s):
Concomitant anticoagulants, antiplatelets: increased risk of bleeding at inj site.
Adverse Reaction(s):
Anal hemorrhage, anorectal discomfort, chills, diarrhea, inj site hemorrhage, pain.
How Supplied:
Syringe (1mL)—4 (w. needles) |
