Odevixibat Capsules

What is this medication?

ODEVIXIBAT (OH de VIX i bat) treats itching caused by liver disease. It works by decreasing the amount of bile acids in the body, which reduces itching.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Bylvay

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Have or have had bleeding from swollen veins in the stomach
• Have or have had confusion caused by liver problems
• Have or have had fluid buildup or swelling in the stomach area
• Low levels of vitamin A, D, E, or K in the blood
• An unusual or allergic reaction to odevixibat, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the capsules whole. Take it with food. You may open the capsule and put the contents in up to 2 tablespoons of soft food or a small amount of liquid. Swallow the mixture right away. Do not chew. Keep taking it unless your care team tells you to stop.

Take bile acid binding resins, such as cholestyramine, colesevelam, and colestipol at a different time of day than this medication. Take this medication 4 hours before or 4 hours after these products.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

Talk to your care team about the use of this medication in children. While it may be given to children for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

• Cholestyramine
• Colesevelam
• Colestipol

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. You may need blood work while you are taking this medication.

You should make sure you get enough vitamin A, D, E, and K while you are taking this medication. Discuss the food you eat and the vitamins you take with your care team.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• Dehydration—increased thirst, dry mouth, feeling faint or lightheaded, headache, dark yellow or brown urine
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low vitamin A level—change in vision, dry eyes, dry skin, frequent infections

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Diarrhea
• Stomach pain
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.