Solesta is an injectable outpatient product for the treatment of fecal incontinence in patients 18 years and older who have failed conservative therapy (eg. diet, fiber therapy, anti-motility medications).

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How to
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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.

Click here to find out how Solesta helps reduce fecal incontinence episodes.

When is the right time to consider Solesta for your patients with fecal incontinence? Click here.

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.  

Indication

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
Phone: 1-800-508-0024
Fax: 1-510-595-8183
Email: salix@medcomsol.com

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; 377(9770):997-1003