Why is this medication prescribed?
Odevixibat is used to treat pruritus (itching) in children 3 months of age and older with progressive familial intrahepatic cholestasis (a liver disease in which the flow of bile from the liver is blocked). 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.
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, open and sprinkle the entire contents into 2 tablespoons (30 mL) of soft food such as applesauce and gently mix it. Do not mix the medication into a liquid. Swallow or eat this mixture right away. Do not store the mixture for future use.
If you are taking the pellets, 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. Do not use a liquid to mix with the odevixibat pellets. Open the 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 and medication and take the mixture immediately. Follow the dose by drinking a glass of water. Do not store the mixture for future use.
Your doctor may increase your dose if your symptoms do not improve after 3 months of treatment.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
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 (Questran), 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 medical conditions.
- 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 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 medication cause?
Odevixibat may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- stomach pain
- extreme thirst, dry mouth and/or skin, sunken eyes, or fast heartbeat
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
- black, tarry, or bloody stool
- stomach swelling
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.
In case of emergency/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 may order certain lab tests 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.