Odevixibat

Odevixibat helps relieve itching caused by progressive familial intrahepatic cholestasis in children who are at least 3 months old.

Odevixibat is also used to relieve itching caused by Alagille syndrome in children who are at least 1 year old.

Odevixibat might also be used for other reasons that are not mentioned in this medication guide.

Use only as directed. Inform your doctor if you are taking other medicines or have other medical conditions or allergies.

You should not use odevixibat if you are allergic to it.

Tell your child's doctor if the child has ever had:

• liver disease.

If you are pregnant, your name may be added to a pregnancy registry to monitor the effects of odevixibat on the baby.

It is not known if odevixibat will harm an unborn baby. Tell your doctor if you are pregnant or planning to become pregnant.

Ask a doctor if it is safe to breastfeed while using odevixibat.

Get emergency medical help if you have signs of an allergic reaction: hives, trouble breathing, swelling of your face, lips, tongue, or throat.

Call your doctor right away if your child has:

• new or worsening diarrhea; or
• liver problems--swelling in your midsection, pain in the upper right side of the stomach, loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of odevixibat may include:

• stomach pain, diarrhea, vomiting;
• weight loss;
• bruising;
• abnormal liver function tests; or
• low levels of vitamins A, D, E, or K.

This is not a complete list of side effects and others may happen. Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your child's dose. Use the medicine exactly as directed.

Give odevixibat capsule with each morning meal.

If your child is unable to swallow the medicine, read and carefully follow the instructions provided to you on how to prepare and use odevixibat. Ask a doctor or pharmacist if you do not understand these instructions.

Your child should swallow the capsule whole. Do not crush, chew, or break the capsule. If your child cannot swallow a capsule whole, open the capsule and mix the medicine with soft food or an age-appropriate liquid.

Odevixibat oral pellets come in a capsule that must be opened. Empty the pellets into a small amount of soft food such as applesauce, chocolate or rice pudding, oatmeal, or pureed bananas or carrots or an age-appropriate liquid (breast milk, infant formula, or water). Throw away the empty capsule.

Stir and give the mixture right away, then give the child a glass of water. Do not store the mixture for later use.

Let the oral pellets stay in the age-appropriate liquid for about 5 minutes to allow complete wetting, then give the oral pellets mixed in the liquid with an oral syringe.

Doses are based on weight. Your child's dose may change if the child gains or loses weight.

Your child will need blood test before and during treatment with odevixibat.

Call the doctor if your child's symptoms do not improve after 3 months.

Your doctor may recommend giving certain vitamin supplements to your child while using odevixibat. Avoid medication errors by using only the medicine your doctor prescribes.

Store at room temperature away from moisture and heat.

Call your doctor for instructions if you miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any limits on food, drinks, or activities.

Administer any of the following medications at least 4 hours before or 4 hours after giving odevixibat:

• cholestyramine;
• colesevelam; or
• colestipol.

Other drugs may affect odevixibat, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.