Pronunciation:

oh-de-VIX-i-bat

Brand Names:

• Bylvay

Dosage Forms:

• Capsule
• Pellet

Classifications:

Therapeutic—

Gastrointestinal Agent

Uses of This Medicine:

Odevixibat is used to treat pruritus (skin itching) in patients with progressive familial intrahepatic cholestasis (PFIC) and alagille syndrome (ALGS).

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of odevixibat in children younger than 3 months of age with progressive familial intrahepatic cholestasis (PFIC) and in children younger than 12 months of age with alagille syndrome (ALGS). Safety and efficacy have not been established.

Older adults—

Appropriate studies have not been performed on the relationship of age to the effects of odevixibat in geriatric patients. Safety and efficacy have not been established.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Fat-soluble vitamin ( vitamins A, D, E, and K) deficiency or
• Liver disease—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Take this medicine in the morning with food.

To use the capsule:

• 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 (eg, apple sauce, oatmeal, banana or carrot puree, chocolate or rice pudding) or liquid (eg, 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.

To use the oral pellets with soft food:

• Mix the medicine in a small amount of soft food (eg, 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.

To use the 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 (eg, 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.

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

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For cholestatic pruritus in patients in alagille syndrome (ALGS):
    • Adults and children 12 months of age and older weighing 19.5 kilograms or more—Dose is base on weight and must be determined by your doctor. The dose is usually 120 micrograms per kilogram (mcg/kg) of body weight once a day.
      • Weighing 55.5 kilograms (kg) or more—7200 micrograms (mcg) once a day. Your doctor may adjust your dose as needed and tolerated.
      • Weighing 45.5 kg to 55.4 kg—6000 mcg once a day. Your doctor may adjust your dose as needed and tolerated.
      • Weighing 35.5 kg to 45.4 kg—4800 mcg once a day. Your doctor may adjust your dose as needed and tolerated.
      • Weighing 25.5 kg to 35.4 kg—3600 mcg once a day. Your doctor may adjust your dose as needed and tolerated.
      • Weighing 19.5 kg to 25.4 kg—2400 mcg once a day. Your doctor may adjust your dose as needed and tolerated.
      • Weighing less than 19.5 kg—Use of oral pellets is recommended.
    • Children younger than 12 months of age—Use and dose must be determined by your doctor.
  • For pruritus in patients with progressive familial intrahepatic cholestasis:
    • Adults and children 3 months of age and older weighing 19.5 kilograms (kg) or more—Dose is base on weight and must be determined by your doctor. The dose is usually 40 micrograms per kilogram (mcg/kg) of body weight once a day.
      • Weighing 55.5 kilograms (kg) or more—2400 micrograms (mcg) once a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 6 milligrams (mg) per day.
      • Weighing 45.5 kg to 55.4 kg—2000 mcg once a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 6 mg per day.
      • Weighing 35.5 kg to 45.4 kg—1600 mcg once a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 6 mg per day.
      • Weighing 25.5 kg to 35.4 kg—1200 mcg once a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 6 mg per day.
      • Weighing 19.5 kg to 25.4 kg—800 mcg once a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 6 mg per day.
      • Weighing less than 19.5 kg—Use of oral pellets is recommended.
    • Children younger than 3 months of age—Use and dose must be determined by your doctor.

• For oral dosage form (pellets):
  • For cholestatic pruritus in patients in alagille syndrome (ALGS):
    • Adults and children 12 months of age and older weighing less than 19.5 kilograms (kg)—Dose is base on weight and must be determined by your doctor. The dose is usually 120 micrograms per kilogram (mcg/kg) of body weight once a day.
      • Weighing 17.5 kilograms (kg) to less than 19.5 kg—2400 micrograms (mcg) once a day. Your doctor may adjust your dose as needed and tolerated.
      • Weighing 12.5 kg to 17.4 kg—1800 mcg once a day. Your doctor may adjust your dose as needed and tolerated.
      • Weighing 7.5 kg to 12.4 kg—1200 mcg once a day. Your doctor may adjust your dose as needed and tolerated.
      • Weighing 7.4 kg or less—600 mcg once a day. Your doctor may adjust your dose as needed and tolerated.
    • Children younger than 12 months of age—Use and dose must be determined by your doctor.
  • For pruritus in patients with progressive familial intrahepatic cholestasis:
    • Adults and children 3 months of age and older weighing less than 19.5 kilograms (kg)—Dose is base on weight and must be determined by your doctor. The dose is usually 40 micrograms per kilogram (mcg/kg) of body weight once a day.
      • Weighing 17.5 kilograms (kg) to less than 19.5 kg—800 micrograms (mcg) once a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 6 milligrams (mg) per day.
      • Weighing 12.5 kg to 17.4 kg—600 mcg once a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 6 mg per day.
      • Weighing 7.5 kg to 12.4 kg—400 mcg once a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 6 mg per day.
      • Weighing 7.4 kg or less—200 mcg once a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 6 mg per day.
    • Children younger than 3 months of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for any unwanted effects.

This medicine may cause diarrhea. If you have any questions or if diarrhea continues or gets worse, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Clay-colored stools

confusion

dark urine

decreased urination

diarrhea

dizziness

dry mouth

fainting

fever

headache

increased heart rate

lightheadedness

loss of appetite

nausea

rapid breathing

skin rash

stomach pain, fullness, or tenderness

sunken eyes

swelling of the feet or lower legs

thirst

unusual tiredness or weakness

vomiting

wrinkled skin

yellow eyes or skin

Less common

Fracture

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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