Odevixibat Oral Capsules

What is this medication?

ODEVIXIBAT (OH de VIX i bat) is an ileal bile acid transporter (IBAT) inhibitor. It treats itchy skin in patients with progressive familial intrahepatic cholestasis (PFIC).

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:

• low levels of vitamin A, D, E, or K in the blood
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

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

Take products with bile acid binding resins in them at a different time of day than this medicine. Take this medicine 4 hours before or 4 hours after these products.

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

Talk to your health care provider about the use of this medicine in children. While it may be prescribed for children as young as 3 months 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?

• bile acid binding resins, such as 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 health care provider for regular checks on your progress. Tell your health care provider if your symptoms do not start to get better or if they get worse.

You should make sure you get enough vitamins while you are taking this medicine. Discuss the food you eat and the vitamins you take with your health care provider.

You may need blood work while you are taking this medicine.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)
• diarrhea
• liver injury (dark yellow or brown urine; general ill feeling or flu-like symptoms; loss of appetite, right upper belly pain; unusually weak or tired, yellowing of the eyes or skin)

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

• 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 medicine after the expiration date.

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

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, take the medicine out of the container. Mix the medicine 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.