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Bylvay Dosage

Generic name: odevixibat 200ug
Dosage form: capsule, coated pellets
Drug class: Miscellaneous GI agents

Medically reviewed by Drugs.com. Last updated on Oct 26, 2022.

Recommended Dosage

  • The recommended dosage of BYLVAY is 40 mcg/kg once daily in the morning with a meal.
  • If there is no improvement in pruritus after 3 months, the dosage may be increased in 40 mcg/kg increments up to 120 mcg/kg once daily not to exceed a total daily dose of 6 mg.

Table 1 below shows the recommended weight-based total daily dosage needed for the recommended dosage at 40 mcg/kg once daily.

  • BYLVAY oral pellets are intended for use by patients weighing less than 19.5 kilograms.
  • BYLVAY capsules are intended for use by patients weighing 19.5 kilograms or above.
    Table 1. Recommended Dosage for 40 mcg/kg/day
    Body Weight (kg) Total Daily Dose (mcg)
    7.4 and below 200
    7.5 to 12.4 400
    12.5 to 17.4 600
    17.5 to 25.4 800
    25.5 to 35.4 1200
    35.5 to 45.4 1600
    45.5 to 55.4 2000
    55.5 and above 2400

Preparation and Administration Instructions

  • For patients taking bile acid binding resins, take BYLVAY at least 4 hours before or 4 hours after taking a bile acid binding resin [see Drug Interactions (7.1)].
  • Do not crush or chew capsules.
    Oral Pellets:
    • Mix the contents of the shell containing Oral Pellets into soft food or a liquid (as described below).
    • Discard the emptied shells. Do not let your child swallow the unopened shells containing the Oral Pellets.
      Administration Instructions for patients capable of swallowing soft food:
      1. Administer BYLVAY with the first morning meal.
      2. Place a small amount (up to 2 tablespoons [30 mL]) of soft food (apple sauce, oatmeal, banana or carrot puree, chocolate or rice pudding) in a bowl. Keep the soft food at, or cooler than, room temperature.
      3. Open the shell containing Oral Pellets and empty the contents into the bowl of soft food. Gently tap the Oral Pellet shell to ensure that all contents have been dispersed.
      4. If the dose requires more than one shell of Oral Pellets, repeat Step 2 and Step 3.
      5. Gently mix until well dispersed and administer the entire dose immediately.
      6. Follow the dose with breast milk, infant formula, or other age-appropriate liquid.
      7. Do not store the mixture for future use.
      8. For patients unable to swallow soft food, see the instructions below.
      Administration Instructions with liquids (Using an oral dosing syringe):
      1. Administer BYLVAY with the first morning meal.
      2. Open the shell containing Oral Pellets and empty the contents into a small mixing cup. Gently tap the shell containing Oral Pellets to ensure that all contents have been emptied into the mixing cup.
      3. Add 1 teaspoon (5 mL) of an age-appropriate liquid (for example, breast milk, infant formula, or water).
      4. If the dose requires more than one shell of Oral Pellets, repeat Step 2 and Step 3.
      5. Let the pellets sit in the liquid for approximately 5 minutes to allow complete wetting REMINDER: The Oral Pellets will not dissolve in the liquid.
      6. After 5 minutes, place the tip of the oral syringe completely into the mixing cup. Pull the plunger of the syringe up slowly to withdraw the liquid/pellet mixture into the syringe. Gently push the plunger down again to expel the liquid/pellet mixture back into the mixing cup. Do this 2 to 3 times to ensure complete mixing of the pellets into the liquid.
      7. Withdraw the entire contents into the oral syringe by pulling the plunger on the end of the syringe.
      8. Place the tip of the syringe into the front of the patient's mouth between the tongue and the side of the mouth, and then gently push the plunger down to squirt the liquid/pellet mixture between your child's tongue and the side of the mouth. Do not squirt liquid/pellet mixture in the back of the child's throat because this could cause gagging or choking.
      9. Do not administer via a bottle or "sippy cup" because the Oral Pellets will not pass through the opening. The oral pellets will not dissolve in liquid.
      10. Follow the dose with breast milk, infant formula, or other age-appropriate liquid.
      11. If any pellet/liquid mixture remains in the mixing cup, repeat Step 7 and Step 8 until the entire dose has been administered.
      12. Check the child's mouth to make sure all of the liquid/pellet mixture has been swallowed.
    Capsules:
    Administration Instructions:
    1. Take in the morning with a meal.
    2. Swallow the capsule whole with a glass of water.
    3. Alternatively, for patients unable to swallow the capsules whole, BYLVAY capsules may be opened, and sprinkled and mixed with a small amount of soft food, or mixed with an age-appropriate liquid. Follow directions above for oral pellets to prepare and administer such a mixture.

Dose Modification for Management of Adverse Events

Establish the baseline pattern of variability of liver tests prior to starting BYLVAY, so that potential signs of liver injury can be identified. Monitor liver tests (e.g., ALT [alanine aminotransferase], AST [aspartate aminotransferase], TB [total bilirubin], DB [direct bilirubin] and International Normalized Ratio [INR]) during treatment with BYLVAY. Interrupt BYLVAY if new onset liver test abnormalities occur or symptoms consistent with clinical hepatitis are observed [see Warnings and Precautions (5.1)].

Once the liver test abnormalities either return to baseline values or stabilize at a new baseline value, consider restarting BYLVAY at the lowest dose of 40 mcg/kg, and increase as tolerated if appropriate. Consider discontinuing BYLVAY permanently if liver test abnormalities recur.

Discontinue BYLVAY permanently if a patient experiences a hepatic decompensation event (e.g., variceal hemorrhage, ascites, hepatic encephalopathy).

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.