Bylvay
Bylvay (odevixibat) is a newly approved medication for the treatment of itching in children with a genetic liver condition called progressive familial intrahepatic cholestasis (PFIC). It's taken once per day by mouth, and is available in both capsules and pellets that can be mixed with soft foods.
What is Bylvay (odevixibat)?
What is Bylvay (odevixibat) used for?
- Itching in children 3 months and older with progressive familial intrahepatic cholestasis (PFIC)
How Bylvay (odevixibat) works
Bylvay (odevixibat) is an IBAT inhibitor. It's not exactly known how Bylvay (odevixibat) works to treat itching from PFIC, but it's thought to work by lowering the amount of bile acids your body absorbs.
Drug facts
Side effects of Bylvay (odevixibat)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Diarrhea (31%)
- Vomiting (17%)
- Liver damage (17%)
- Stomach pain (14%)
Less Common Side Effects
- Low vitamin A, D, and E levels
- Enlarged spleen
- Gallstones
- Dehydration
Bylvay (odevixibat) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Worsening liver problems or liver failure: swelling of your stomach, yellowing of your skin or the whites of your eyes, confusion, dark or brown urine
- Diarrhea and dehydration: dry mouth, sunken eyes, no tears while crying, fewer wet diapers than normal, sleepiness
The following Bylvay (odevixibat) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
- Dehydration—increased thirst, dry mouth, feeling faint or lightheaded, headache, dark yellow or brown urine
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Low vitamin A level—change in vision, dry eyes, dry skin, frequent infections
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
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Pros and cons of Bylvay (odevixibat)
Pros
- Can be used in children as young as 3 months old
- Taken once per day
- Contents from capsules and pellets can be sprinkled onto food for those who have trouble swallowing
- Dosing can be individualized based on weight
Cons
- Brand name only, which can be expensive
- Needs to be taken with food
- Can cause liver problems, diarrhea, and poor absorption of vitamins A, D, E, and K
Pharmacist tips for Bylvay (odevixibat)
- Before taking Bylvay (odevixibat), be sure to read the instructions for use and ask your provider or pharmacist if you have any questions.
- Give Bylvay (odevixibat) with soft food (e.g., apple sauce, oatmeal, banana, carrot puree, chocolate pudding, rice pudding) in the morning. Make sure the food is at or below room temperature. Don't mix Bylvay (odevixibat) with liquid.
- If your child is using the pellets: 1) Place a small amount of soft food (up to 30 mL (2 tablespoons)) in a bowl. 2) Open the shell containing the pellets and empty the contents into the bowl with the soft food. 3) Gently stir until the contents are mixed well. 4) Give the dose immediately. 5) After taking the dose, give your child a drink of water to help wash all of the medication down.
- The pellets (200 mcg and 600 mcg) shouldn't be swallowed whole. These should be opened and sprinkled onto soft food.
- If your child is using the capsules, have them swallow the capsules whole with a glass of water. Or, if your child is having trouble swallowing the capsules, open them and sprinkle the contents onto soft food. Then, give your child water to drink after taking the Bylvay (odevixibat) dose.
- The capsules shouldn't be crushed or chewed, since this could damage the medication.
- Be sure to take the dose right away. Don't store any food that's been mixed with Bylvay (odevixibat) for later use, since the medication might not work as well anymore.
- If your child is taking a bile acid medication, such as cholestyramine (Prevalite), colestipol (Colestid), or colesevelam (Welchol), give Bylvay (odevixibat) at least 4 hours before or 4 hours after the bile acid medication. This will keep the medications from interacting with each other and lowering the amount that's absorbed into the body.
- It's not known whether this medication is safe or works well in pregnant women. Some animal studies that looked at the use of Bylvay (odevixibat) during pregnancy showed that babies were harmed from the medication. If you're pregnant or thinking of becoming pregnant, talk with your provider about the risks and benefits of using Bylvay (odevixibat) during pregnancy.
Common questions about Bylvay (odevixibat)
The pellets are for children weighing less than 19.5 kg (43 lbs) and the capsules are for children weighing 19.5 kg (43 lbs) or more. The dose for Bylvay (odevixibat) is the same for both pellets and capsules. The shell of the pellets (200 mcg or 600 mcg) should be opened and the contents should be emptied into a bowl of soft food. The capsules (400 mcg or 1,200 mcg) can either be swallowed whole or opened and the contents should be emptied into a bowl of soft food.
Bylvay (odevixibat) should be taken once a day in the morning with a meal because that's the way it was studied in clincal studies. Food can affect how much medication is absorbed in the body and how the medication works.
In studies looking at how well the medication works, people started to see improvement in itching after about 1 month on the medication. Eventually, many people had very minimal or no scratching. Everyone responds to Bylvay (odevixibat) differently. If your child's itching isn't getting better after 3 months of taking Bylvay (odevixibat), contact their provider as they may raise the dose.
It isn't known if this medication is safe or works well in adults at this time. This medication has only been studied in people aged 3 months to 17 years. If you're an adult with PFIC, speak with your provider so they can help guide you to the best treatment options.
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Risks and warnings for Bylvay (odevixibat)
Bylvay (odevixibat) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Worsening liver problems and liver failure
- Risk factors: History of liver problems
Bylvay (odevixibat) can cause serious liver problems that can lead to liver failure. Your child will need to get blood tests to check their liver health before and during treatment to make sure their liver is working properly. Seek medical attention right away if you notice swelling of their stomach, stomach pain, yellowing of their skin or the whites of their eyes, stool changes (black, tarry, or bloody stools), nausea, vomiting, confusion, or dark or brown urine. Your child might need to stop using the medication to prevent further liver damage.
Diarrhea
Diarrhea is a common side effect of Bylvay (odevixibat). If your child gets diarrhea while taking Bylvay (odevixibat), make sure they're getting enough fluids. Monitor for signs and symptoms of dehydration, such as dry mouth, no tears while crying, sunken eyes, and fewer wet diapers than usual. Seek medical help right away if your child has any of these signs or symptoms of dehydration. If your child's diarrhea is persistent, let the provider know. In some cases, the provider might have your child stop Bylvay (odevixibat) until the diarrhea resolves.
Low levels of vitamins A, D, E, and K
Bylvay (odevixibat) can cause your child to absorb fewer amounts of vitamins A, D, E, and K, which can lower your child's blood levels of these vitamins. Your child's provider will likely check the levels of these vitamins before and during treatment with Bylvay (odevixibat). If their levels are low, your child's provider will prescribe supplements to help raise the levels of these vitamins.
Bylvay (odevixibat) dosage
Capsule| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 200mcg | 120 capsules | $29,197.93 | $243.32 |
| 400mcg | 150 capsules | $72,985.45 | $486.57 |
| 600mcg | 30 capsules | $20,857.45 | $695.25 |
| 1200mcg | 60 capsules | $87,581.29 | $1,459.69 |
Typical dosage for Bylvay (odevixibat)
The typical dose is 40 mcg/kg by mouth once per day in the morning with a meal. After 3 months, your child's provider might change the dose based on if it's helping your child's condition and if they're having side effects. The maximum dose is 120 mcg/kg, up to 6 mg, once per day.
