Odevixibat Capsules (by Lucius) Patient Information Leaflet

Generic Name: Odevixibat
Manufacturer: Lucius
Therapeutic Class: Ileal Bile Acid Transporter (IBAT) Inhibitor

1. WHAT IS ODEVIXIBAT AND WHAT IS IT USED FOR?

Odevixibat is a prescription medicine used to treat itching (pruritus) caused by Progressive Familial Intrahepatic Cholestasis (PFIC) in patients 3 months of age and older.

PFIC is a rare genetic disorder that prevents the liver from releasing bile, leading to a buildup of bile acids in the blood, which causes severe itching and liver damage.

Odevixibat works by blocking the recycling of bile acids in the small intestine, reducing the amount of bile acids in the blood, which helps relieve the itching and protect the liver.

2. BEFORE YOU TAKE ODEVIXIBAT

Do NOT take Odevixibat if you are allergic to odevixibat or any of the other ingredients of this medicine.

Warnings and Precautions:
Talk to your doctor before or while taking Odevixibat about:

• Liver Problems: Your doctor will perform regular blood tests to monitor your liver function before and during treatment.

• Diarrhea: Diarrhea is a very common side effect. It can sometimes lead to dehydration, especially in children. Inform your doctor if you experience severe or persistent diarrhea.

• Fat-Soluble Vitamin (FSV) Deficiency: This medicine may affect the absorption of fat-soluble vitamins (A, D, E, and K). Your doctor will likely monitor your vitamin levels and may recommend supplements.

Pregnancy and Breast-feeding:
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and Using Machines:
Odevixibat is not expected to affect your ability to drive or use machines.

3. HOW TO TAKE ODEVIXIBAT

Always take this medicine exactly as your doctor has told you.

• Dosage: The recommended starting dose is 40 mcg per kilogram (kg) of body weight, taken once daily. Your doctor will calculate the exact dose based on the patient's weight.

• Dose Adjustment: After 24 weeks, if the response is insufficient and the medicine is well-tolerated, your doctor may increase the dose to a maximum of 120 mcg/kg once daily.

• Administration:

  • Take with food. Swallow the capsule whole with a drink (e.g., water).

  • For patients who cannot swallow capsules: The capsule can be opened, and the granules inside can be mixed with a small amount of soft food (e.g., apple sauce, yogurt, fruit puree) or expressed breast milk or infant formula. The mixture must be taken immediately (within 1 hour) and must not be stored for later use.

• If you miss a dose: Take the next dose at the usual time the next day. Do not take a double dose to make up for a forgotten dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very Common (may affect more than 1 in 10 people):

• Diarrhea

• Abdominal pain

• Vomiting

Common (may affect up to 1 in 10 people):

• Fever (pyrexia)

• Rash

• Decreased appetite

Monitoring:
Your doctor will test your blood regularly to check for:

• Increases in liver enzymes (transaminases)

• Increases in bilirubin

• Changes in fat-soluble vitamin levels

Reporting Side Effects:
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet.

5. HOW TO STORE ODEVIXIBAT

• Store in the original package to protect from moisture.

• Keep at room temperature (below 25°C or 77°F). Do not freeze.

• Keep this medicine out of the sight and reach of children.

• Do not use this medicine after the expiry date which is stated on the carton and blister after "EXP".

6. CONTENTS OF THE PACK AND OTHER INFORMATION

• Active substance: Odevixibat.

• Available strengths: 200 mcg and 400 mcg capsules.

• The capsules have an opaque body and cap.

Disclaimer for the Patient:
This information is a summary based on the typical characteristics of Odevixibat. It does not replace a consultation with your doctor. Your doctor is the best source of information for your specific medical condition and treatment.

For any questions, please contact your prescribing physician or pharmacist.