Solesta

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.

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 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.

Solesta is part of the drug class:

• Other cicatrizants

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. 

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.

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 dextranomer and sodium hyaluronate.

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.

• If you have an allergy to Solesta (dextranomer and sodium hyaluronate) or any part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Any anal or rectal problems like bleeding, growths, or infection; inflammatory bowel disease; or weak immune system.
• If you have ever had radiation to the pelvic area.
• If you are taking any drugs to suppress your immune system. This may be certain doses of steroids like prednisone. There are many drugs that can suppress your immune system. Ask your doctor or pharmacist if you are not sure.
• If you have another device where Solesta will be used.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Solesta with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine may not work for all people who use it. Talk with the doctor.
• Avoid hot baths and physical activity for 24 hours after getting Solesta. Avoid sex and exercise for 1 week after getting this medicine.
• Do not put anything in the rectum, like suppositories, enemas, or rectal thermometers, for 1 month after getting Solesta.
• Do not try to treat diarrhea with drugs for 1 week after getting this medicine unless your doctor tells you to.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Solesta while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Bleeding from rectum or rectal pain.
• Bloody loose stools (diarrhea).
• Fever.
• Trouble passing urine.

• If you need to store Solesta (dextranomer and sodium hyaluronate) at home, talk with your doctor, nurse, or pharmacist about how to store it.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Solesta or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Solesta. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017