Administering Solesta

A nonsurgical, in-office procedure1

The Solesta procedure, which requires no anesthesia, involves a total of four 1-mL injections in the anal canal. Solesta will work as a bulking agent directly in the anal canal to help treat the patient's fecal incontinence.

The injections are administered in sequence at the posterior, left-lateral, anterior, and right-lateral sites.

Solesta is administered about 5 mm into the submucosal layer of the anal canal, proximal to the dentate line (about 5 mm above) via anoscope. After injection, the needle should be kept in place for about 15 to 30 seconds to minimize gel extrusion.

Inject Solesta into the posterior, left-lateral, right-lateral, and anterior walls of the anal canal

BECOME CERTIFIED to administer Solesta, click here

BECOME CERTIFIED

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.

Reference: 1. Solesta [package insert]. Raleigh, NC: Salix Pharmaceuticals, Inc; 2011.