Solesta efficacy for patients with fecal incontinence who have failed conservative therapy
In the pivotal clinical trial, the most common adverse reactions (incidence >4%) were proctalgia, anorectal hemorrhage, injection site hemorrhage, pyrexia, injection site pain, diarrhea, and anorectal discomfort.
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With Solesta, people with fecal incontinence can achieve greater control for better quality of life1,2
Solesta is a biocompatible bulking agent in an injectable gel. Fecal incontinence is an underdiagnosed and underreported condition affecting millions of Americans. Solesta offers proven efficacy, improved quality of life, and a documented safety profile for patients with fecal incontinence.
Learn how to administer Solesta now
Solesta is administered in the physician’s office–find out how you can become certified to perform the Solesta procedure. Browse educational resources available for both doctors and patients.
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.
References: 1. Solesta [package insert].
Raleigh, NC: Salix Pharmaceuticals, Inc; 2011. 2. Graf W,
Mellgren A, Matzel KE, Hull T, Johansson C, Bernstein M; for the NASHA Dx Study
Group. Efficacy of dextranomer in stabilised hyaluronic acid for treatment of
fecal incontinence: a randomised, sham-controlled trial. Lancet. 2011;