LuciSelade___LUCIUS PHARMACEUTICALS

Drug Information Summary: Lucius Seladelpar (likely strengths: 50mg, 200mg)

Disclaimer: This is a synthesized summary based on the known pharmacological profile of Seladelpar and public information. This is not the official manufacturer's leaflet and does not replace professional medical advice. Seladelpar is a prescription drug with specific risks and must only be taken under the strict supervision of a specialist physician (hepatologist/gastroenterologist).

1. Brand and Generic Name

Generic Name: Seladelpar
Brand/Manufacturer: Lucius Pharmaceuticals (Laos) - Note: This is a generic/manufactured version. The original developer was CymaBay Therapeutics.

2. What is Seladelpar and what is it used for?

Seladelpar is a selective PPARδ (Peroxisome Proliferator-Activated Receptor Delta) agonist.
It is used for the treatment of Primary Biliary Cholangitis (PBC) in adults.
It is typically used in combination with Ursodeoxycholic Acid (UDCA) for patients who have not achieved an adequate biochemical response to UDCA alone, or as a monotherapy for those who cannot tolerate UDCA.

3. Before you take Lucius Seladelpar
Do NOT take if you:

Have known hypersensitivity to seladelpar or any of the excipients in the formulation.
Have decompensated cirrhosis (e.g., current or history of hepatic encephalopathy, clinically significant variceal hemorrhage, or ascites).
Have compensated cirrhosis with evidence of portal hypertension.
Have current or history of liver cancer (hepatocellular carcinoma).

Warnings and Precautions:
Talk to your doctor about:

Liver Function: Seladelpar affects liver metabolism. Your doctor will perform frequent blood tests (before starting, every month for the first 3 months, and periodically thereafter) to monitor liver enzymes (ALT, AST, Alkaline Phosphatase - ALP) and bilirubin. Report any symptoms of liver injury immediately (e.g., jaundice/yellowing of skin/eyes, dark urine, nausea, vomiting, abdominal pain).
Pregnancy and Breastfeeding: Seladelpar must not be used during pregnancy due to potential risk to the fetus. A pregnancy test is required before starting treatment. Patients who can become pregnant must use effective contraception during treatment and for at least 1 week after the last dose. It is not recommended while breastfeeding.
Drug Interactions: Inform your doctor about all other medicines you are taking, including:
- Other drugs known to cause liver injury.
- OATP1B1 and OATP1B3 substrates (e.g., statins like atorvastatin, rosuvastatin; anti-cancer drugs). Seladelpar may increase their concentration in the blood.
- BCRP substrates (e.g., rosuvastatin, methotrexate). Seladelpar may also increase their exposure.

4. How to take Lucius Seladelpar

Dosage: The recommended dosage is 5 mg orally, once daily. Based on tolerability and biochemical response, your doctor may increase the dose to 10 mg once daily.
How to take: Take the tablet with or without food. Swallow the tablet whole with water. Do not crush, chew, or break it.
Timing: Take it at approximately the same time each day to maintain consistent drug levels.
Missed Dose: If you miss a dose, take it as soon as you remember on the same day. If you remember the next day, skip the missed dose and take the next scheduled dose. Do not take a double dose to make up for a missed one.

5. Possible Side Effects
Common side effects may include:

Abdominal pain
Nausea
Diarrhea
Pruritus (itching) - often an improvement from pre-existing PBC-related pruritus
Fatigue
Rash
Increased weight

Your doctor will primarily monitor for biochemical responses (reduction in ALP) and the serious liver-related warnings mentioned above.

6. Storage

Store at or below 30°C (86°F).
Keep the tablets in their original container, tightly closed.
Protect from light and moisture.
Keep out of reach of children.

7. Packaging

The product is typically supplied in a high-density polyethylene (HDPE) bottle with a child-resistant closure.

Final Crucial Advice:
Seladelpar is a targeted therapy for a specific liver disease. Its use requires expert diagnosis and ongoing monitoring. Adherence to your doctor's instructions and scheduled blood tests is absolutely critical for safe and effective treatment. Always follow your hepatologist's specific guidance.

whatsapp:+852 61905607
wechat；yindu7689