Solesta are natural materials formed into a gel that is similar to certain substances that occur naturally in your body. Solesta works by thickening the tissues in your anal canal.

Solesta is injected as an implant into your anal canal to treat fecal incontinence (loss of bowel control) in adults.

This medicine is usually given after diet changes and other medications have been tried without success.

Solesta may also be used for purposes not listed in this medication guide.

You should not receive Solesta if you have: rectal infection or bleeding, rectal fissure, rectal tumor, rectal malformation, rectal prolapse, an abnormal passageway between the rectum and vagina, stenosis (narrowing) of your anal canal, a rectal or anal implant (other than Solesta), congested blood vessels in the anus or rectum, inflammatory bowel disease, a history of radiation to your pelvic area, or a weak immune system.

A healthcare provider will give you Solesta in an outpatient clinic setting. Solesta is given as a set of 4 injections directly into the tissues of your anal canal.

You will be given an enema to clean out your rectum just before Solesta is injected.

You will receive the injections while lying on your side. A small tube called an anoscope will be gently inserted just a few inches into your rectum. This will help the doctor determine where to properly place the needle when injecting Solesta. You will be made to feel as comfortable as possible while the medicine is injected.

Tell your caregivers if you feel severe pain during the injections.

You will be able to get up after your injections are completed. However, you should remain resting for about 60 minutes before leaving the clinic. Your caregivers will check you for any immediate side effects the injections may cause.

Do not take a hot bath or engage in physical activity during the first 24 hours after your injection procedure.

You may use a stool softener to make your first bowel movement more comfortable after treatment. Do not continue using the stool softener unless your doctor tells you to.

Solesta injections can cause rectal bleeding or a rectal infection. Call your doctor if rectal bleeding is heavy or you have severe rectal irritation or signs of infection (pain, warmth, swelling, itching, or drainage).

You be given antibiotic medication to help prevent infection. Use the antibiotic for the full prescribed length of time, even if you have no symptoms of infection.

Solesta is not effective in every person and you may continue to have fecal incontinence. It also may take 3 to 6 months before you notice the full effects of this medicine. Tell your doctor if your symptoms do not begin to improve after 1 month.

You may need to receive more than one treatment with Solesta.

It is not known whether this medicine will continue to be effective for longer than 12 months.

You should not receive this medicine if you are allergic to dextranomer or sodium hyaluronate, or if you have:

• rectal infection, rectal bleeding or inflammation;

• a rectal fissure, rectal tumor, or genetic malformation of your rectum;

• a prolapsed rectum;

• an abnormal passageway between the rectum and the vagina;

• a narrowing (stenosis) of your anal canal;

• any type of implant (other than Solesta) in your anus or rectum;

• congested blood vessels in the anus or rectum;

• active inflammatory bowel disease;

• a history of radiation to your pelvic area; or

• a weak immune system (caused by disease or by using certain medicine).

To make sure Solesta is safe for you, tell your doctor if you have:

• an enlarged prostate;

• long-term rectal pain;

• a bleeding or blood clotting disorder such as hemophilia;

• a history of rectal or intestinal surgery, or hemorrhoid repair; or

• if you are pregnant or breast-feeding.

Since Solesta is given all at one time, it does not have a daily dosing schedule.

Since Solesta is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

For at least 1 week after your injections, avoid all strenuous activity including sexual intercourse, jogging, horseback riding, bicycling, or vigorous exercise.

For at least 1 month after injection, avoid inserting anything into your rectum (such as suppository, enema, or rectal thermometer).

Do not use anti-diarrhea medicine for at least 1 week after treatment with Solesta.

Ask your doctor before taking any medication to treat pain or swelling caused by your injection procedure. Avoid taking a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), diclofenac, indomethacin, meloxicam, and others.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Solesta may cause serious side effects. Call your doctor at once if you have:

• fever;

• sudden or constant urge to pass bowel movements, or feeling like you cannot completely empty your bowels;

• heavy rectal bleeding;

• diarrhea that is bloody;

• painful or difficult urination;

• severe rectal itching, swelling, pain, or drainage (pus);

• bulging tissue from your rectum; or

• sharp pain or stinging sensation during a bowel movement.

Common side effects of Solesta may include:

• constipation, diarrhea;

• pain where the medicine was injected;

• mild rectal bleeding;

• mild rectal itching or discomfort;

• dizziness, chills, cold sweat;

• stomach pain; or

• pain during sexual intercourse.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

It is not likely that other drugs you take orally or inject will have an effect on Solesta used in the anal canal. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.