Why is this medication prescribed?

Bylvay (odevixibat) is a medication used to treat a rare liver disorder called progressive familial intrahepatic cholestasis (PFIC). It works by reducing the amount of bile produced by the liver, which helps alleviate symptoms associated with PFIC such as severe itching and liver damage.

How should this medicine be used?

Here are some general guidelines on how Bylvay should be used:

• Prescription: Bylvay should only be used under the guidance and prescription of a qualified healthcare professional who is experienced in the treatment of PFIC.
• Dosage: The dosage of Bylvay will vary depending on factors such as the patient’s age, weight, severity of the condition, and response to treatment. It’s essential to follow the prescribed dosage instructions carefully.
• Administration: Bylvay is usually taken orally as a capsule or a liquid suspension. It can be taken with or without food, but it’s essential to take it consistently as directed by the healthcare provider.
• Monitoring: Regular monitoring by healthcare professionals is necessary while taking Bylvay to assess its effectiveness and monitor for any potential side effects or complications.
• Adherence: It’s crucial to adhere to the prescribed treatment regimen and not to miss any doses. If a dose is missed, it should be taken as soon as possible unless it’s almost time for the next scheduled dose, in which case the missed dose should be skipped.
• Side Effects: Like any medication, Bylvay can cause side effects. Common side effects may include diarrhea, abdominal pain, and fatigue. It’s essential to report any persistent or severe side effects to the healthcare provider.
• Other Medications and Supplements: Inform the healthcare provider about any other medications, supplements, or herbal products you are taking, as they may interact with Bylvay.
• Lifestyle Considerations: Patients taking Bylvay should also follow any lifestyle recommendations provided by their healthcare provider, such as dietary modifications or restrictions.
• Regular Follow-Up: Regular follow-up appointments with the healthcare provider are necessary to monitor the progress of treatment, adjust the dosage if needed, and address any concerns or questions.

It’s important to remember that Bylvay is specifically indicated for the treatment of PFIC and should not be used for other liver disorders or conditions without proper medical evaluation and guidance.

Other uses for this medicine

While Bylvay is primarily used for PFIC, researchers and healthcare professionals are continually exploring its potential for other conditions. However, it’s crucial to note that any off-label use should only be undertaken under the guidance and prescription of a qualified healthcare professional. Off-label use refers to using a medication for a purpose not approved by regulatory agencies based on the available evidence.

What special precautions should I follow?

Regarding special precautions for Bylvay:

• Pregnancy and Breastfeeding: It’s essential to inform your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding. The safety of Bylvay during pregnancy and breastfeeding has not been established, so the potential risks and benefits should be carefully considered.
• Liver Function Monitoring: Bylvay affects liver function, so regular monitoring of liver function tests may be necessary during treatment. Your healthcare provider will determine the appropriate monitoring schedule based on your individual circumstances.
• Drug Interactions: Bylvay may interact with other medications, supplements, or herbal products. Inform your healthcare provider about all the medications and supplements you are taking to avoid potential interactions.
• Pediatric Use: Bylvay is approved for use in pediatric patients with PFIC. However, special precautions may be necessary when administering the medication to children. Dosage adjustments and close monitoring may be required.
• Adverse Reactions: Be aware of potential adverse reactions associated with Bylvay, such as diarrhea, abdominal pain, and fatigue. Report any persistent or severe side effects to your healthcare provider.
• Compliance: It’s essential to adhere to the prescribed treatment regimen and not to miss any doses of Bylvay. If you have difficulty adhering to the treatment, discuss it with your healthcare provider for possible solutions.
• Medical History: Inform your healthcare provider about your medical history, especially if you have a history of liver disease or other significant medical conditions.

Always follow the guidance and instructions provided by your healthcare provider when using Bylvay or any other medication. They can provide personalized recommendations based on your individual health status and needs.

What special dietary instructions should I follow?

• Follow any specific dietary recommendations provided by your healthcare provider. These may include dietary adjustments to manage symptoms of PFIC or to optimize the effectiveness of Bylvay.
• Maintain a balanced and healthy diet, rich in fruits, vegetables, lean proteins, and whole grains.
• Limit intake of foods high in fat, cholesterol, and refined sugars, as these may exacerbate liver symptoms.
• Stay hydrated by drinking an adequate amount of water throughout the day unless otherwise instructed by your doctor.

What should I do if I forget a dose?

• If you forget to take a dose of Bylvay, take it as soon as you remember, unless it is almost time for your next scheduled dose. In that case, skip the missed dose and continue with your regular dosing schedule.
• Do not double up on doses to make up for a missed one.
• If you are unsure about what to do, contact your healthcare provider or pharmacist for guidance.

What side effects can this medication cause?

Bylvay (odevixibat) can cause various side effects, although not everyone will experience them. Common side effects may include:

• Diarrhea: This is one of the most commonly reported side effects of Bylvay. It may range from mild to severe. If diarrhea persists or becomes severe, inform your doctor.
• Abdominal Pain: Some individuals may experience abdominal discomfort or pain while taking Bylvay. This symptom should be reported to your healthcare provider if it persists or worsens.
• Nausea: Nausea or a feeling of queasiness is another potential side effect. If it becomes severe or persistent, notify your doctor.
• Vomiting: Some individuals may experience vomiting as a side effect of Bylvay. If vomiting occurs frequently or becomes severe, seek medical attention.
• Fatigue: Feeling tired or fatigued may occur in some individuals taking Bylvay. If fatigue is severe or persistent, discuss it with your healthcare provider.
• Headache: Headaches are another potential side effect of Bylvay. If headaches become severe or frequent, inform your doctor.
• Increased Liver Enzymes: Bylvay may cause an increase in liver enzyme levels in some individuals. Your doctor will monitor your liver function through regular blood tests.
• Upper Respiratory Tract Infection: Some people may experience symptoms of an upper respiratory tract infection, such as a sore throat, cough, or congestion.

It’s essential to report any side effects you experience while taking Bylvay to your healthcare provider. They can help determine whether the side effects are manageable or if adjustments to your treatment plan are necessary. Additionally, if you experience any severe or concerning symptoms, seek medical attention promptly.

What should I know about storage and disposal of this medication?

Storage and disposal of Bylvay:

Storage:

• Store Bylvay capsule at room temperature away from light and moisture.
• Keep the medication out of reach of children and pets.
• Do not store Bylvay in the bathroom or near the kitchen sink, as moisture and humidity can affect its stability.
• Follow any specific storage instructions provided by your pharmacist or healthcare provider.

Disposal:

• Dispose of any unused or expired Bylvay capsule according to local regulations or guidelines.
• Do not flush medications down the toilet or pour them into a drain unless instructed to do so by your pharmacist or local waste disposal authorities.
• Consult your pharmacist or healthcare provider for proper disposal methods if you are unsure.

In case of emergency/overdose

• In case of an emergency or suspected overdose of Bylvay, seek immediate medical attention or contact a poison control center.
• Be prepared to provide information about the amount of medication ingested and any symptoms experienced.
• Do not attempt to treat an overdose or suspected overdose on your own without medical supervision.

What other information should I know?

• Inform all healthcare providers involved in your care that you are taking Bylvay, including dentists and specialists.
• Attend all scheduled follow-up appointments with your healthcare provider for monitoring and dose adjustments if necessary.
• Do not share Bylvay with others, even if they have similar symptoms or conditions.
• Continue taking Bylvay as prescribed by your healthcare provider, even if you feel well, unless instructed otherwise.
• Follow any additional instructions provided by your healthcare provider or pharmacist regarding Bylvay therapy.

By following these guidelines, you can ensure the safe and effective use of Bylvay while minimizing the risk of adverse events or complications. If you have any questions or concerns about your medication, don’t hesitate to consult your healthcare provider or pharmacist for guidance.