Solesta

Solesta is made from natural materials that are turned into a gel, similar to some substances found in your body. Solesta helps 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 trying diet changes and other medications without success.

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

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

You will receive an enema to clean out your rectum just before the Solesta injections.

You will get the injections while lying on your side. A small tube called an anoscope will be gently inserted a few inches into your rectum. This will help the doctor find the right spot to place the needle for the Solesta injections. You will be made as comfortable as possible during the injections.

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

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

Do not take a hot bath or do 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 if you have severe rectal irritation or signs of infection (pain, warmth, swelling, itching, or drainage).

You will be given antibiotic medication to help prevent infection. Take the antibiotic for the full prescribed length of time, even if you do not have symptoms of infection.

Solesta is not effective in everyone, and you may continue to have fecal incontinence. It may also 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 more than one treatment with Solesta.

It is not known if this medicine will remain effective for longer than 12 months.

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.

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.

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

Solesta may cause serious side effects. Contact your doctor immediately if you experience:

• fever;
• sudden or constant urge to have bowel movements, or feeling like you cannot fully 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 during a bowel movement.

Common side effects of Solesta may include:

• constipation, diarrhea;
• pain at the injection site;
• 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 happen. Contact your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Since Solesta is given all at once, it does not require a daily dosing schedule.

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

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

For at least 1 month after injection, do not insert anything into your rectum (such as a 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 for pain or swelling from your injection procedure. Avoid taking a nonsteroidal anti-inflammatory drug (NSAID) like aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), diclofenac, indomethacin, meloxicam, and others.

It is not likely that other drugs you take by mouth or injection will affect Solesta when used in the anal canal. However, many drugs can interact with each other. Inform all your healthcare providers about every medicine you use, including prescription and over-the-counter medicines, vitamins, and herbal products.