Odevixibat Oral Capsules

Odevixibat is used to treat pruritus (itching) in adults and children 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC; a liver disease in which the flow of bile from the liver is blocked). Odevixibat is also used to treat itching caused by Alagille syndrome (ALGS: an inherited condition in which bile builds up in the liver and causes liver damage) in adults and children 1 year of age and older. Odevixibat is in a class of medications called ileal bile acid transporter (IBAT) inhibitors. It works by decreasing the level of bile acids from the small intestine.

Odevixibat comes as a capsule and as pellets to take by mouth. It is usually taken once daily in the morning with a meal. Take odevixibat at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take odevixibat exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow capsules whole with a glass of water; do not chew or crush them. If you unable to swallow the capsules whole, you can open the capsule(s) and mix the contents with soft food or liquid using an oral syringe. Odevixibat pellets should be taken with soft foods or liquid using an oral syringe.

If you are taking the pellets or the contents of the capsules with soft food, place up to 2 tablespoons (30 mL) of soft food such as apple sauce, oatmeal, banana or carrot puree, or chocolate or rice pudding in a bowl; keep food at or below room temperature. Open the capsules or shell(s) containing the pellets and empty the entire contents into the bowl of soft food. Tap the shell(s) to ensure that all of the medication is in the food. Gently mix the food to disperse the medication and take the mixture immediately. Follow the dose by drinking water, baby formula, or breast milk. Do not store the mixture for future use.

If you are mixing the pellets or the contents of the capsule(s) with a liquid to use with an oral syringe, open the capsule(s) or shell(s) containing the pellets and empty the entire contents into an empty small cup, add 1 teaspoon (5 mL) of a liquid such as water, baby formula or breast milk, and allow the pellets to sit in the liquid for about 5 minutes. The pellets will not dissolve. Place the tip of the syringe into the dosing cup, pull the plunger up to withdraw the mixture into the syringe and gently push the plunger down to push the mixture back into the cup. Repeat this 2 or 3 times to make sure the pellets are mixed well. Withdraw the mixture into the syringe and slowly squirt the medication directly into your mouth or your child’s mouth and toward the inside of their cheek. Slowly push the plunger all the way in to give the entire dose. Make sure the child has time to swallow the medication. Follow the dose by drinking water, baby formula, or breast milk. Do not store the mixture for future use.

If you are taking odevixibat for PFIC, your doctor may increase your dose if your symptoms do not improve after 3 months of treatment.

Your doctor may need to reduce your dosage or interrupt or discontinue your treatment if you experience certain side effects. Talk to your doctor about how you are feeling during your treatment.

Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.