Bylvay

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Read the Instructions for Use leaflet if available from your pharmacist before you start using odevixibat and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with food as directed by your doctor, usually once daily with the morning meal. This medication comes in 2 dosage forms: a capsule to swallow or a capsule that contains pellets to sprinkle on food or liquid.

If you are using the capsules that contain pellets, you must open the capsules and sprinkle the pellets onto soft food or liquid as directed. Do not swallow these capsules whole. For mixing in soft food, place up to 2 tablespoonsful (30 milliliters) of soft food in a container. Keep food at or below room temperature. Some recommended soft foods include: apple sauce, oatmeal, banana or carrot puree, or chocolate or rice pudding. Gently mix the prescribed dose in the soft food (the pellets will not dissolve) and give all of the dose right away. Do not store the mixture for later use. Drink some liquid after the dose is taken. For mixing in liquid (such as water, breast milk, formula), empty the pellets in a mixing cup. Place 1 teaspoonful (5 milliliters) of liquid into the cup and let the pellets sit in the liquid for about 5 minutes (the pellets will not dissolve). Follow instructions on how to mix and give the liquid mixture using the oral syringe. Drink some liquid after the dose is taken. Throw away the empty capsule shell(s) in the trash.

If you are using the capsules to swallow, swallow the capsule(s) with a glass of water. Do not chew or crush the capsules. If you have trouble swallowing the capsule(s), you may open the capsule and sprinkle the contents onto soft food or liquid as directed, using the same instructions as the capsules that contain pellets.

The dosage is based on your medical condition, weight, and response to treatment. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

If you are also taking bile acid-binding resins such as cholestyramine, colesevelam, or colestipol, take this medication at least 4 hours before or at least 4 hours after taking these medications. These medications can bind to odevixibat, preventing your body from fully absorbing the drug.

Tell your doctor if your condition does not get better or if it gets worse.

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Do not share this medication with others.

Lab and/or medical tests (such as liver function, fat-soluble vitamin levels) should be done before starting this medication and while you are taking it. Keep all medical and lab appointments.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Diarrhea, abdominal pain, or vomiting may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Vomiting/diarrhea that doesn't stop may result in dehydration. Contact your doctor promptly if you notice any symptoms of dehydration, such as unusual decreased urination, unusual dry mouth/thirst, fast heartbeat, or dizziness/lightheadedness.

Tell your doctor right away if you have any serious side effects, including: easy bleeding/bruising.

Although this medication is used to treat liver problems, it may sometimes cause other serious liver problems. Tell your doctor right away if you have new or worsening symptoms of liver problems such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, or dark urine.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking odevixibat, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other liver problems (such as ascites, encephalopathy, variceal bleeding).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using odevixibat. Odevixibat may harm an unborn baby. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.