Odevixibat

WHY is this medicine prescribed?

Odevixibat is used to treat pruritus (itching) in adults and children 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC; a liver disease in which the flow of bile from the liver is blocked). Odevixibat is also used to treat itching caused by Alagille syndrome (ALGS: an inherited condition in which bile builds up in the liver and causes liver damage) in adults and children 1 year of age and older. Odevixibat is in a class of medications called ileal bile acid transporter (IBAT) inhibitors. It works by decreasing the level of bile acids from the small intestine.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Odevixibat comes as a capsule and as pellets to take by mouth. It is usually taken once daily in the morning with a meal. Take odevixibat at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take odevixibat exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow capsules whole with a glass of water; do not chew or crush them. If you unable to swallow the capsules whole, you can open the capsule(s) and mix the contents with soft food or liquid using an oral syringe. Odevixibat pellets should be taken with soft foods or liquid using an oral syringe.

If you are taking the pellets or the contents of the capsules with soft food, place up to 2 tablespoons (30 mL) of soft food such as apple sauce, oatmeal, banana or carrot puree, or chocolate or rice pudding in a bowl; keep food at or below room temperature. Open the capsules or shell(s) containing the pellets and empty the entire contents into the bowl of soft food. Tap the shell(s) to ensure that all of the medication is in the food. Gently mix the food to disperse the medication and take the mixture immediately. Follow the dose by drinking water, baby formula, or breast milk. Do not store the mixture for future use.

If you are mixing the pellets or the contents of the capsule(s) with a liquid to use with an oral syringe, open the capsule(s) or shell(s) containing the pellets and empty the entire contents into an empty small cup, add 1 teaspoon (5 mL) of a liquid such as water, baby formula or breast milk, and allow the pellets to sit in the liquid for about 5 minutes. The pellets will not dissolve. Place the tip of the syringe into the dosing cup, pull the plunger up to withdraw the mixture into the syringe and gently push the plunger down to push the mixture back into the cup. Repeat this 2 or 3 times to make sure the pellets are mixed well. Withdraw the mixture into the syringe and slowly squirt the medication directly into your mouth or your child's mouth and toward the inside of their cheek. Slowly push the plunger all the way in to give the entire dose. Make sure the child has time to swallow the medication. Follow the dose by drinking water, baby formula, or breast milk. Do not store the mixture for future use.

If you are taking odevixibat for PFIC, your doctor may increase your dose if your symptoms do not improve after 3 months of treatment.

Your doctor may need to reduce your dosage or interrupt or discontinue your treatment if you experience certain side effects. Talk to your doctor about how you are feeling during your treatment.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking odevixibat,

• tell your doctor and pharmacist if you are allergic to odevixibat, any other medications, or any of the ingredients in odevixibat pellets and capsules. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• if you are taking a bile acid resin such as cholestyramine (Locholest, Prevalite), colesevelam (WelChol), or colestipol (Colestid), take odevixibat 4 hours after or 4 hours before you take a bile acid resin.

• tell your doctor if you have or have ever had liver problems.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking odevixibat, call your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Odevixibat may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• stomach pain
• vomiting
• decreased weight
• bruising

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• yellow eyes or skin; loss of appetite; dark urine; or pain or discomfort in right upper stomach area
• stomach swelling
• extreme thirst, dry mouth and/or skin, sunken eyes, or fast heartbeat

Odevixibat may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Dispose the empty capsule or pellets shell(s) into the household trash.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your body's response to odevixibat.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.