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.

• Salix Pharmaceuticals, Inc.

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.

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

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Solesta, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Solesta, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Solesta or to any of its ingredients
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed
• have active inflammatory bowel disease
• have rectal varices or a rectocele
• have an existing implant (other than Solesta) in your anorectal region
• have not previously used diet, fiber therapy, or medications to treat your fecal incontinence
• have had previous radiation treatment to your pelvic area
• have had significant mucosal or full thickness rectal prolapse
• have active anorectal conditions including: abscess, fissures, sepsis, bleeding, proctitis, or any other infections
• have any immunodeficiency disorders or are receiving ongoing immunosuppressive therapy
• have anorectal atresia, tumors, stenosis or malformation

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

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.

Use Solesta exactly as prescribed.

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.

To avoid infections, be sure to follow your physician's instructions regarding enema usage prior to receiving Solesta injections.

Inform all future physicians about the presence of Solesta in your body.

Post-injection care

• avoid taking hot baths during the first 24 hours post-injection
• contact the clinic or physician’s office immediately if symptoms of rectal bleeding, bloody diarrhea, fever, or problems with urinating occur
• anti-diarrheal drugs should not be used for one week after treatment
• stool softeners may be used until the first defecation occurs
• avoid physical activity for 24 hours
• avoid sexual intercourse and strenuous physical activity for one week (e.g., horse back riding, bicycling and jogging, etc.)
• avoid anal manipulation for one month (e.g., insertion of suppositories or enemas and rectal temperature recording

If you miss a dose, receive the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and receive your next dose at the regular time. 

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.

If Solesta is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.