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Overview: Bylvay is used to treat itching caused by progressive familial intrahepatic cholestasis (PFIC) or Alagille syndrome (ALGS), which are genetic conditions that can cause liver damage due to bile buildup. Bylvay works by reducing the amount of bile acid (a component of bile) circulating in the body. Common side effects include diarrhea, stomach pain, bleeding spots under the skin (hematoma), weight loss, abnormal liver test results, vomiting, and vitamin deficiency.

Uses

What is Bylvay used for?

Bylvay (odevixibat) is commonly used to treat itching caused by the following conditions:

  • Progressive familial intrahepatic cholestasis (PFIC), a genetic condition in which the liver can’t release bile (a fluid made in the liver that helps with digestion), which eventually leads to bile buildup and liver damage
  • Alagille syndrome (ALGS), a genetic condition linked to liver and heart problems due to abnormal bile ducts (the ducts that carry bile from the liver) and poor blood flow between the heart and the lungs

Bylvay may also be used for other conditions as determined by your health care provider.

How does Bylvay work (mechanism of action)?

Bylvay reduces the amount of bile acid (a component of bile) that is returned to your blood from your intestines. This reduces the amount of bile acid that moves between your blood and your liver, which may help manage the symptoms of PFIC and ALGS caused by bile buildup in the liver.

How is Bylvay supplied (dosage forms)?

Brands and other names

  • Bylvay

Dosage forms and strengths

  • 400 mcg and 1,200 mcg oral capsules
  • 200 mcg and 600 mcg oral pellets

How should I store Bylvay?

Bylvay should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when you’re transporting it. Store it in a cool, dry place.

Side Effects

What are the most common side effects of Bylvay?

The most common side effects of Bylvay are listed below. These side effects may vary, depending on the condition that is being treated. Tell your health care provider if you have any of these side effects that bother you.

  • Diarrhea (see below)
  • Abnormal liver test results (see below)
  • Vitamin deficiency (see below)
  • Stomach pain
  • Bleeding spots under the skin (hematoma)
  • Weight loss
  • Vomiting

There may be other side effects of Bylvay that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 )800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Bylvay?

While less common, the most serious side effects of Bylvay are described below, along with what to do if they happen.

Severe Allergic Reactions. Bylvay may cause allergic reactions, which can be serious. Stop taking Bylvay and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown, depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Abnormal Liver Test Results. Bylvay may be linked to abnormal liver test results. Elevated liver enzyme levels may be early signs of more serious liver problems that can happen if they’re not managed well. Your health care provider may perform regular liver tests to make sure that Bylvay is safe for you to take. Call your health care provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Diarrhea. Bylvay may cause diarrhea, which can last for several days. Persistent diarrhea can cause dehydration and may require treatment. Tell your health care provider if you get diarrhea that does not go away.

Vitamin Deficiency. Bylvay may cause a lack of vitamins A, D, E, and K because it affects how your body absorbs fat. Your health care provider may regularly check your vitamin levels and recommend or prescribe supplements. Follow all appointments you make with your health care provider and follow their advice on how to prevent vitamin deficiency.

Warnings & Precautions

Who should not use Bylvay?

Allergies to Ingredients. People who are allergic to any of the following should not take Bylvay.

  • Odevixibat
  • Bylvay
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in the specific Bylvay products they stock.

What should I know about Bylvay before using it?

Do not take Bylvay unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Bylvay with other people, even if they have the same condition as you. It may harm them.

Keep Bylvay out of the reach of children.

Bylvay oral pellets are supplied in capsules. These should be opened and the contents should be sprinkled onto a small amount of soft food or liquid (see below). The capsules containing the pellets should not be taken whole. Ask your pharmacist if you are not sure which Bylvay product has been dispensed to you.

Bylvay pellets may be mixed with a small amount (up to 30 mL, or two tablespoons) of soft food – such as applesauce, oatmeal, banana puree, carrot puree, chocolate pudding, or rice pudding – in a bowl. Take the mixture right away and do not store it for later use. Ask your health care provider if you are not sure about how much food to use. 

Bylvay pellets may also be mixed with liquid. Sprinkle the pellets into a small amount of liquid (5 mL, or one teaspoon) and let the pellets sit in the liquid for about five minutes. Use the provided syringe to draw up and push out the mixture two or three times to ensure complete mixing. (The pellets do not dissolve in the liquid.) Once mixed, use the syringe to take the medicine. Ask your health care provider if you are not sure about how much liquid to use. 

After taking a dose of Bylvay pellets (with either soft food or liquid), drink water or other liquid to make sure you have swallowed the entire dose.

Bylvay oral capsules (not pellets) should be swallowed whole with a glass of water. Do not chew or crush the non-pellet capsules.

What should I tell my health care provider before using Bylvay?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Bylvay is right for you.

In particular, make sure that you discuss any of the following.

Abnormal Liver Enzyme Levels. Tell your health care provider if you have had abnormal liver function test results. Bylvay may worsen your liver enzyme levels.

Vitamin Deficiency. Tell your health care provider if you have any vitamin deficiency. Bylvay may cause a vitamin A, D, E, or K deficiency to get worse.

Other Medicines and Supplements. Bylvay may interact with other medicines and supplements. Before taking Bylvay, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. It is not known if or how Bylvay could affect pregnancy or harm an unborn baby. Tell your health care provider if you are pregnant or plan to become pregnant. If you become pregnant while taking Bylvay, you can report the exposure to the drugmaker by calling 855-463-5127. The company is collecting safety information about the use of Bylvay during pregnancy.

Breastfeeding. It is not known if Bylvay passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should take Bylvay while breastfeeding.

How can I get more information about Bylvay?

For more information about Bylvay, you can visit the drugmaker’s website at www.bylvay.com or call them at 617-679-8500.

Interactions

Does Bylvay interact with foods or drinks?

Bylvay should be taken with the morning meal. 

It is unknown if drinking alcohol will affect Bylvay.

Does Bylvay interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any bile acid sequestrant, such as cholestyramine (Prevalite), colesevelam (Welchol), or colestipol (Colestid), which is a medicine to lower cholesterol. These medicines should be taken at least four hours before or four hours after taking Bylvay.

This may not be a complete list of medicines that can interact with Bylvay. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Bylvay?

If you or someone else has used too much Bylvay, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Bylvay?

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.