Solesta

What is Solesta?

Solesta is a prescription medicine that is used to help with controlling bowel movements.

Description

Solesta consists of dextranomer microspheres, 50 mg/mL, and stabilized sodium hyaluronate, 15 mg/mL, in phosphate-buffered 0.9% sodium chloride solution.

Solesta is a sterile, viscous, biocompatible bulking agent contained in a disposable 1 mL assembled glass syringe with a standard Luer-lock fitting. The syringe is equipped with a plunger stopper, a plunger rod and a finger grip. The labeled syringe is packed in a pouch and terminally sterilized by moist heat. The final product consists of a carton containing four pouches with syringes, four sterile needles ( SteriJect®, 21G x 4 ¾ inches, 0.80 x 120 mm), patient record labels and a package insert. The product is for single use.

Both the dextranomer and sodium hyaluronate are made up of biosynthesized polysaccharides of non-animal origin. The dextranomer component consists of microspheres of dextran chains cross-linked into a three-dimensional network. The stabilized sodium hyaluronate accounts for the viscous properties of Solesta and acts as a carrier that facilitates the injection of the dextranomer microspheres.

Before taking Solesta, tell your doctor:

• If you are allergic to Solesta; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• 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.

What are some things I need to know or do while I take Solesta?

• Tell all of your health care providers that you take Solesta. 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 Solesta.
• 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 Solesta unless your doctor tells you to.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is Solesta best taken?

Use Solesta as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of Solesta that I need to call my doctor about immediately?

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, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Bleeding from rectum or rectal pain.
• Bloody diarrhea.
• Fever.
• Trouble passing urine.

What are some other side effects of Solesta?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

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.

How do I store and/or throw out Solesta?

• If you need to store Solesta at home, talk with your doctor, nurse, or pharmacist about how to store it.

SRC: NLM .