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).
SOLESTA is a biocompatible tissue bulking agent, injected in the submucosal layer of the anal canal, consisting of a viscous combination of stabilized hyaluronic acid and dextranomer-linked beads. While the exact mechanism of action has not been identified, it is hypothesized that the SOLESTA injections may narrow the anal canal, allowing for better sphincter control.1
Indication for SOLESTA
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 for Patients (SOLESTA)
It is important for you to know that SOLESTA® (hyaluronic acid/dextranomer) does not work for everyone and you may not benefit from SOLESTA treatment. It is also important for you to know that you may not experience immediate improvement after your first treatment with SOLESTA and the full effects of SOLESTA may not be apparent until 3 to 6 months after treatment.
People who have an infection or who are currently experiencing bleeding in the rectum or anus should not receive SOLESTA. People who have problems in the rectum or anus, such as tumor, abnormal anatomy, large dilated blood vessels (hemorrhoids), or cracks in the tissue (anal fissures) should not receive SOLESTA. People who have active inflammation of their bowels (Crohn's disease or ulcerative colitis) should not receive SOLESTA. People who have trouble fighting off infection (immunodeficiency disorder such as HIV/AIDS) or who take medication to suppress the immune system, such as those used in cancer or organ transplant patients, should not receive SOLESTA. If you already have a device or material placed in your rectum or anus, or if you have had radiation treatments in your pelvic area before, you should not receive SOLESTA. You should tell your doctor if you have any allergies or if you had problems with your rectum or anus in the past.
The most common risks of treatment with SOLESTA are mild or moderate pain or discomfort in the rectum or anus, and minor to moderate bleeding or spotting from the rectum following treatment. Some patients experience fever, stomach problems such as diarrhea or constipation, and infection after treatment.
More serious risks including infection and inflammation of the tissue in the anus may occur but are not common.
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.
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Reference: 1. SOLESTA [package insert]. Edison, NJ: Oceana Therapeutics (US), Inc; 2011.
The information contained on this page is intended for US residents, healthcare providers, and pharmacists only.