Solesta

Solesta is a prescription medication used to treat fecal incontinence, the inability to control defecation. Solesta belongs to a group of drugs called biosynthesized polysaccharide tissue-bulking agents. These help to treat fecal incontinence by narrowing the anal canal and allowing for better control of the anal sphincter.

This medication is available in an injectable form to be given directly into the submucosal tissue of the anal canal by a healthcare professional, typically every 4 weeks as needed.

Common side effects of Solesta include injection site pain, bleeding, and fever.

Solesta is a prescription medication used to treat fecal incontinence, the inability to control defecation, in people over the age of 18 years who have failed diet, fiber therapy, and anti-motility medications.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Use this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your age

The recommended dose of Solesta for the treatment of fecal incontinence in people over the age of 18 years who have failed diet, fiber therapy, and anti-motility medications is four 1 mL submucosal injections every four weeks as needed.

Serious side effects have been reported with Solesta including the following:

Blockage of blood vessels. Solesta should never be injected into blood vessels.

Increased bleeding at injection sites. Consult with your physician before receiving treatment with Solesta if you have a bleeding diathesis or use anticoagulant or antiplatelet medications.

Infections of the anal canal. Be sure to follow your physician's instructions regarding enema usage prior to receiving Solesta injections.

Do not take Solesta if you:

• are allergic to Solesta or to any of its ingredients 
• have active inflammatory bowel disease
• have any immunodeficiency disorders or are receiving ongoing immunosuppressive therapy
• have had previous radiation treatment to your pelvic area
• have had rectal prolapse
• have active anorectal conditions including: abscess, fissures, sepsis, bleeding, proctitis, or any other infections
• have anorectal atresia, tumors, stenosis or malformation
• have a rectocele or rectal varices
• have an existing implant (other than Solesta) in your anorectal region

Serious side effects have been reported with Solesta. See the “Solesta Precautions” section.

Common side effects of Solesta include the following:

• injection site pain
• injection site bleeding
• injection site irritation and/or itching
• fever
• chills
• diarrhea

This is not a complete list of Solesta side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• lidocaine 
• benzalkonium chloride
• pramoxine 
• benzocaine
• cetylpyridinium
• menthol
• zinc chloride
• anticoagulant medications
• antiplatelet medications

This is not a complete list of Solesta drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Solesta has not yet been fully evaluated in this capacity for safety in use during pregnancy.

It is not known if Solesta crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Solesta.