Odevixibat (oh-de-VIX-i-bat)

Treats skin itching in patients with progressive familial intrahepatic cholestasis (PFIC) and alagille syndrome (ALGS).

Brand Name(s):

Bylvay

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule, Pellet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• It is best to take this medicine with food or milk. Take this medicine in the morning.
• Capsules:
  • Swallow the capsule whole with a glass of water. Do not chew or crush it.
  • If you are not able to swallow the capsule whole, you may open, sprinkle, and mix it with a small amount of soft food (including apple sauce, oatmeal, banana or carrot puree, chocolate or rice pudding) or liquid (including breast milk, infant formula, or water).
  • Take the mixture right away and drink water. Do not store for future use.
• You may mix the oral pellets into soft food or liquid. Do not swallow the capsule shell whole.
• Oral pellets with soft food:
  • Mix the medicine in a small amount of soft food (including apple sauce, oatmeal, banana or carrot puree, chocolate or rice pudding).
  • Place a small amount (at least 2 tablespoons) of soft food in a bowl. Keep it at room temperature or cooler.
  • Open the shell and empty the contents into the bowl of soft food. Gently mix it with a spoon.
  • Take the mixture right away and drink water, breast milk, or infant formula. Do not store for later use.
• Oral pellets with liquid:
  • Open the shell and empty the contents into a small mixing cup.
  • Add 1 teaspoon or 5 milliliters (mL) of liquid (including breast milk, infant formula, or water). Let the pellets sit in the liquid for 5 minutes to allow complete wetting.
  • Measure the mixture with the oral dosing syringe.
  • Place the tip of the oral syringe in the mouth between the tongue and the side of the mouth. Swallow the mixture and drink water, breast milk, or infant formula.
  • Do not squirt the mixture in the back of the throat to avoid gagging or choking. Do not give using a bottle or sippy cup.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Take this medicine at least 4 hours before or 4 hours after using bile acid sequestrants (including cholestyramine, colesevelam, colestipol).

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease or fat-soluble vitamin (vitamins A, D, E, and K) deficiency.
• This medicine may cause diarrhea.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dark urine, pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Severe diarrhea

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088