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Bylvay (Pellets)
Bylvay (odevixibat) is a prescription medication used to treat progressive familial intrahepatic cholestasis (PFIC), a rare genetic liver disorder that causes bile buildup in the liver, leading to liver damage. Bylvay is a bile acid transport inhibitor that works by reducing the amount of bile acids in the body, which helps to alleviate the symptoms of cholestasis, such as itching and liver damage. The pellet form is designed for young children who may have difficulty swallowing capsules.
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Frequently Asked Questions
How long does it take for Bylvay to start working?
How long does it take for Bylvay to start working? Bylvay may begin to reduce itching (pruritus) and improve bile acid levels within a few weeks, but it can take several months to see the full benefits. Regular follow-up with the healthcare provider is important to monitor progress.
Can Bylvay cure PFIC?
No, Bylvay is not a cure for PFIC. It helps manage symptoms like itching and bile acid buildup, but it does not reverse the underlying genetic condition.
What should I do if my child misses a dose of Bylvay?
If a dose is missed, give it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and give the next one at the regular time. Do not double the dose to make up for a missed dose.
Can Bylvay cause weight loss?
Significant diarrhea, a possible side effect of Bylvay, may lead to weight loss if the child loses fluids or nutrients. Caregivers should monitor the child’s weight and contact the healthcare provider if there are concerns.
Does Bylvay interact with food?
Bylvay pellets can be mixed with food or liquid, making it easier for young children to take. However, it’s important to follow the healthcare provider’s instructions for preparation to ensure the child gets the full dose.
Comprehensive Drug Guide
How Does Bylvay (Pellets) Work?
Bylvay works by inhibiting the ileal bile acid transporter (IBAT) in the intestines. This blocks the reabsorption of bile acids into the bloodstream, thereby reducing their accumulation in the liver. Lower bile acid levels help prevent liver damage and reduce the intense itching (pruritus) commonly experienced by patients with cholestatic liver diseases like PFIC.
What is Bylvay (Pellets) Used For?
Progressive Familial Intrahepatic Cholestasis (PFIC): To treat itching and manage the bile acid buildup associated with this rare liver disease in patients aged 3 months and older.
Common Dosages
Bylvay is available by prescription only and is not classified as a controlled substance. It comes in pellet form for easy administration to young children who cannot swallow pills.
Administration: Bylvay pellets are administered orally. The pellets can be mixed with soft food (like applesauce) or liquid and given to the child once daily, preferably in the morning. It is important to give the medication at the same time each day to maintain consistent bile acid levels.
Duration of Use: Bylvay is often used as a long-term treatment for managing symptoms of PFIC. Regular follow-ups with the healthcare provider are important to monitor liver function and symptom control.
Typical Dosing
FDA Approved Indications
Bylvay is available in pellet form for younger children who cannot swallow pills. The typical dosage depends on the child’s weight:
- For patients under 19.5 kg: The recommended starting dose is 40 mcg/kg once daily.
- For patients 19.5 kg and above: The recommended starting dose is 120 mcg/kg once daily.
The dosage may be adjusted based on the patient's response and tolerability.
Off-Label Uses
Who Shouldn't Take Bylvay (Pellets)?
Bylvay is contraindicated in patients with:
- Complete Biliary Obstruction: Bylvay cannot be used in patients with total blockage of bile flow, as its mechanism of action relies on bile acid transport.
- Hypersensitivity to odevixibat or any of the ingredients in the formulation.
Advice From The Pharmacist
Caregivers administering Bylvay should be advised to:
- Follow the healthcare provider’s instructions carefully, especially when mixing the pellets with food or liquid. Ensure the child consumes the entire mixture to receive the full dose.
- Store Bylvay pellets at room temperature, away from moisture and heat.
- Monitor for side effects, particularly diarrhea or abdominal pain, which may indicate that the medication is affecting bile acid transport too strongly.
- Contact the healthcare provider if symptoms of pruritus (itching) do not improve or if new symptoms arise.
Side Effects of Bylvay (Pellets)
Common Side Effects
- Diarrhea
- Abdominal pain or discomfort
- Bloating or gas
- Elevated liver enzymes (as seen in blood tests)
Uncommon/Severe Side Effects
- Severe Diarrhea: This may lead to dehydration, especially in young children. Symptoms include dry mouth, reduced urination, and lethargy.
- Liver Function Abnormalities: Although rare, liver enzyme levels should be monitored regularly as the medication can sometimes affect liver function.
Risks and Warnings of Bylvay (Pellets)
Severe Diarrhea and Dehydration: Bylvay can cause significant diarrhea, which can lead to dehydration. Caregivers should monitor their child for signs of dehydration, such as reduced urination, dry mouth, or drowsiness, and seek medical attention if these symptoms occur.
Monitoring Liver Function: Regular monitoring of liver function is necessary, as Bylvay is used to manage a liver condition. Liver enzyme levels should be checked periodically to ensure the medication is working without causing additional liver damage.
Long-term Safety: The long-term effects of Bylvay in young children are still being studied, so ongoing monitoring by healthcare providers is essential.
Interactions with Bylvay (Pellets)
Common Drug Interactions
Bylvay may interact with other medications, particularly those that affect bile acid metabolism. These include:
- Cholestyramine or Colestipol: These bile acid sequestrants can reduce the effectiveness of Bylvay by preventing its absorption.
- Fat-Soluble Vitamins (A, D, E, K): Long-term use of Bylvay may affect the absorption of fat-soluble vitamins. Patients may need vitamin supplements under the guidance of a healthcare provider.
Caregivers should inform the healthcare provider of all medications and supplements the child is taking to avoid potential interactions.
Alternatives to Bylvay (Pellets)
Alternative treatments for PFIC and related liver conditions include:
- Ursodeoxycholic Acid (UDCA): A bile acid used to improve bile flow in certain liver diseases.
- Liver Transplant: For severe cases of PFIC that do not respond to medical treatment, liver transplantation may be necessary.
- Surgical Interventions: In some cases, procedures to improve bile drainage may be performed.
The choice of treatment depends on the severity of the condition and the patient’s response to medications.
