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
More serious risks including infection and inflammation of the tissue in the anus may occur but are not
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.