Bylvay (Odevixibat)
Complete patient guide for uses, dosage, side effects, and safety information
Prescription RequiredQuick Facts
What Is Bylvay Used For?
Bylvay is a specialized medication that helps remove excess bile acids from your body to treat a rare liver condition.
Primary Uses
Bylvay is used to treat progressive familial intrahepatic cholestasis (PFIC) in patients aged 6 months or older. PFIC is a liver disease caused by build-up of bile acids that gets worse over time and is often accompanied with severe itching.
How It Works
Bylvay increases the removal of bile acids from the body. It blocks the mechanism that returns bile acids to the blood after they have done their job in the gut, allowing them to pass out of the body in the stool instead of building up in the liver.
Good to know: This medicine helps reduce the severe itching that often comes with PFIC by removing excess bile acids from your system.
How to Take Bylvay
Your doctor will calculate the exact dose based on your weight. The capsules can be swallowed whole or opened and sprinkled on soft food.
Dosage Instructions
The recommended starting dose is 40 micrograms per kilogram of body weight once daily. If not working well enough after 3 months, your doctor may increase the dose to 120 micrograms per kilogram (up to a maximum of 7,200 micrograms once daily). Take once daily in the morning with or without food. Larger capsules (200 and 600 micrograms) are intended to be opened and sprinkled on soft food like yogurt, applesauce, or pudding. Smaller capsules (400 and 1200 micrograms) are intended to be swallowed whole but may also be opened if needed.
What If You Miss a Dose?
Take Bylvay regularly at the same time each morning. If it’s almost time for your next dose, skip the missed dose and take the next dose when you’re supposed to. Do not take a double dose to make up for the missed one.
Important: Never take a double dose to make up for a missed dose. Treatment must be started and supervised by a doctor experienced in managing progressive liver disease.
Available Tablet Strengths
Side Effects
Like all medications, this medicine can cause side effects. Most are mild and temporary, but some require medical attention.
Common Side Effects
These side effects occur relatively frequently and usually don’t require emergency care:
- Diarrhea (including diarrhea with bloody stool)
- Soft stools
- Abdominal (belly) pain
- Enlarged liver
Seek immediate medical attention if you experience:
- Severe diarrhea leading to dehydration
- Bloody stools
- Signs of liver problems
Important Warnings
There are several important conditions and situations where Bylvay should not be used or requires special monitoring.
Who Should Not Take Bylvay
Do not use Bylvay if you are allergic to odevixibat or any of the ingredients. It is not recommended for babies under 6 months because safety and effectiveness have not been established in this age group.
Medical Conditions to Discuss
Tell your doctor if you have: complete absence or lack of function of bile salt export pump protein, severely reduced liver function, reduced stomach or bowel motility, or reduced circulation of bile acids between liver, bile and small intestine due to medicines, surgical procedures or diseases other than PFIC (as these may reduce the effect of odevixibat).
Pregnancy and Breastfeeding
Bylvay is not recommended during pregnancy. Use barrier contraceptive methods since oral contraceptives may be affected by odevixibat. It is not known if odevixibat passes into breast milk. Your doctor will help you decide whether to stop breastfeeding or avoid Bylvay treatment.
Liver Monitoring Required: Your doctor will assess liver function before starting treatment and may recommend more frequent monitoring if you have elevated liver function test results.
Drug Interactions
Bylvay may affect how your body absorbs certain vitamins and medications, including oral contraceptives.
Vitamin Monitoring: Your doctor may recommend blood tests to check Vitamin A, D, and E levels, as Bylvay may impact absorption of these fat-soluble vitamins.
- Fat-soluble vitamins (Vitamin A, D, and E)
- Oral contraceptives
- Other medicines (consult your doctor about all medications you’re taking)
Alcohol & Driving
Bylvay is not known to affect your ability to drive or operate machinery, but be cautious until you know how it affects you.
Alcohol
No specific alcohol interactions are mentioned, but consult your doctor about alcohol use while taking Bylvay.
Driving and Operating Machinery
Bylvay is not known to influence the ability to drive or use machinery. However, be careful before you drive or use any machines or tools until you know how Bylvay affects you.
Storage
Keep Bylvay in its original container in a cool, dry place where the temperature stays below 25°C. Store away from moisture, heat, or sunlight. Do not store in the bathroom, near a sink, in the car, or on window sills. Keep out of reach of children.
Overdose Information
If you think you or your child may have taken too much Bylvay, seek urgent medical attention immediately. Call the Poisons Information Centre (13 11 26), contact your doctor, or go to the nearest hospital Emergency Department. Symptoms may include diarrhea and stomach and bowel problems.
Frequently Asked Questions
If the medicine is not working well enough after 3 months, your doctor may increase the dose. If there’s no improvement after 6 months of continuous daily treatment, your doctor may recommend an alternative treatment.
Yes, Bylvay capsules should be taken once daily in the morning with or without food. The larger capsules can be opened and sprinkled on soft foods like yogurt, applesauce, or pudding.
Diarrhea is a common side effect. Make sure to drink enough fluids like water or juice to avoid becoming dehydrated. Talk to your doctor if diarrhea becomes severe or concerning.
Do not stop taking Bylvay or lower the dosage without first discussing with your doctor. Your doctor needs to monitor your condition and determine the best approach for any changes to your treatment.
Yes, all capsules can be opened and sprinkled on soft food. The larger capsules (200 and 600 micrograms) are specifically intended to be opened, while smaller ones (400 and 1200 micrograms) are meant to be swallowed whole but can be opened if needed.
Yes, your doctor may recommend blood tests to check your liver function and levels of fat-soluble vitamins (A, D, and E). They may also monitor blood clotting values before and during treatment.
Bylvay is approved for patients aged 6 months or older. It is not recommended for babies under 6 months because safety and effectiveness have not been established in this age group.
Important Disclaimer
This information is intended for general educational purposes only and should not be considered medical advice. Always consult your healthcare provider or pharmacist before starting, stopping, or changing any medication.
If you think you may have a medical emergency, call your doctor or emergency services immediately.