What is Solesta?
Solesta is a biocompatible bulking agent in an injectable gel
Solesta consists of dextranomer microspheres in stabilized hyaluronic acid. It is administered directly into the submucosal layer of the anal canal.
The Solesta procedure involves a total of 4 injections—administered in sequence at the posterior, left-lateral, anterior, and right-lateral sites.
The microspheres, or beads, of the compound work to provide a framework for fibrin and collagen synthesis. This eventually results in the formation of durable, tissue-like formations.1
Here, Solesta enters the submucosal layer.
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SOLESTA® is indicated for the treatment of fecal incontinence in patients 18 years and older who have failed conservative therapy (eg. diet, fiber therapy, anti-motility medications).
Important Safety Information about SOLESTA
SOLESTA® (hyaluronic acid/dextranomer) is contraindicated in patients with 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 (including abscess, fissures, sepsis, bleeding, proctitis, or other infections), anorectal atresia, tumors, or malformation, rectocele, rectal varices, presence of existing implant (other than SOLESTA) in anorectal region, or allergy to hyaluronic acid-based products.
SOLESTA must not be injected intravascularly as injection of SOLESTA into blood vessels may cause vascular occlusion. Injection in the midline of the anterior wall of the rectum should be avoided in men with an enlarged prostate.
SOLESTA should only be administered by physicians experienced in performing anorectal procedures and who have successfully completed a comprehensive training and certification program on the SOLESTA injection procedure.
The most common adverse reactions with SOLESTA (incidence >4%) in the clinical study were proctalgia, anorectal hemorrhage, injection site hemorrhage, pyrexia, injection site pain, diarrhea, and anorectal discomfort.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch/ or call 1-800-FDA-1088.
For product information, adverse event reports, and product complaint reports, please contact:
Salix Product Information Call Center
Please see complete Prescribing Information for SOLESTA.
Reference: 1.Stenberg A, Larsson E, Läckgren G. Endoscopic treatment with detranomer-hyaluronic acid for vesicoureteral reflux: histologic findings. J Urol. 2003;169(3):1109-1113.