What is the most important information I should know about odevixibat?
Follow all directions on the label and package. Use exactly as directed.
What is odevixibat?
Odevixibat is used to treat itching caused by progressive familial intrahepatic cholestasis (a genetic disorder) that causes progressive liver disease in children at least 3 months old.
Odevixibat may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before using odevixibat?
You should not give odevixibat to a child who is on a liquid diet.
Tell your child's doctor if the child has ever had cirrhosis.
How should I use odevixibat?
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 with each morning meal.
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. Stir and give the mixture to your child right away, then give the child a glass of water. Throw away the empty capsule.
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 as directed above for the oral pellets.
Do not mix odevixibat with liquids.
Doses are based on weight. Your child's dose may change if the child gains or loses weight.
Your child will need frequent blood tests to check his or her liver function.
Call your 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. Use only the types and amounts of vitamins your doctor prescribes.
Store at room temperature away from moisture and heat.
What happens if I miss a dose?
Skip the missed dose and give your child the next dose at the regular time. Do not use two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking odevixibat?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What are the possible side effects of odevixibat?
Get emergency medical help if your child has signs of an allergic reaction: hives; difficult breathing; swelling of the face, lips, tongue, or throat.
Call your doctor at once if your child has:
- severe or ongoing diarrhea, black or bloody stools;
- rapid weight gain, stomach pain and bloating;
- vomiting large amounts of blood;
- confusion, trouble concentrating, sleep problems, feeling anxious or irritable;
- slurred speech, problems with balance or coordination;
- uncontrolled muscle movement in the hands;
- increased thirst, decreased urination or sweating;
- a light-headed feeling;
- changes in mood or behavior; or
- new or worsening liver problems --loss of appetite, stomach pain (upper right side), tiredness, bruising or bleeding, increased itching, jaundice (yellowing of the skin or eyes).
Common side effects may include:
- stomach pain, diarrhea, vomiting;
- abnormal liver function tests; or
- deficiency in vitamins A, D, E, or K.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect odevixibat?
Give the odevixibat dose 4 hours before or 4 hours after giving any of the following:
- colesevelam; or
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.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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