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东盟制药

Obetan OBETICHOLIC ACID 5 MG 30TABS Approval No. 10 L 0735/17 Expiration Date 06-8-2027

Obetan OBETICHOLIC ACID 5 MG 30TABS Approval No. 10 L 0735/17 Expiration Date 06-8-2027

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The following is the general instructions for obeticholic acid (Obeticholic Acid, trade name: Obetan). The actual drug instructions may be adjusted due to different manufacturers or regional regulations. Please refer to the instructions inside the drug packaging.

Drug instructions

Drug name <br>Generic name: Obeticholic acid Trade name: Obetan
English name: Obeticholic Acid

Pharmacological action and mechanism

Obeticholic acid is a semisynthetic bile acid derivative and a potent and selective agonist of the farnesoid X receptor (FXR). FXR is a key nuclear receptor for bile acid metabolism. By regulating bile acid synthesis and transport, obeticholic acid can reduce bile acid accumulation and reduce liver inflammation and fibrosis.

Indications

  1. Primary Biliary Cholangitis (PBC)
    • It is indicated for adult patients who have had an inadequate response to or cannot tolerate ursodeoxycholic acid (UDCA), usually used in combination with UDCA or alone.

Dosage

  1. Recommended dose
    • Initial dose: 5 mg, orally once a day.
    • Depending on efficacy and tolerability, the dose can be increased to 10 mg once daily after 3 months.
  2. Directions
    • Can be taken with or without food.
  3. Patients with impaired liver function
    • **Moderate (Child-Pugh B): **The starting dose is 5 mg once a week, which can be increased gradually to 5 mg twice a week or 10 mg once a week based on tolerability.
    • **Severe (Child-Pugh C): **The starting dose is 5 mg once a week, which can be gradually increased to 5 mg twice a week based on tolerance.

Contraindications

  • It is contraindicated in patients with complete biliary obstruction.

Precautions

  1. Liver function monitoring : Obeticholic acid may cause abnormal liver function. It is recommended to monitor liver function regularly before and during treatment.
  2. Itching : Itching symptoms may occur during treatment. Dose adjustment or symptomatic treatment may be adopted if necessary.
  3. Fat-soluble vitamin deficiency : Long-term treatment may affect the absorption of fat-soluble vitamins (such as vitamins A, D, E and K), which should be evaluated and supplemented regularly.
  4. Pregnancy and breast-feeding : The safety of obeticholic acid in pregnant women is not clear, and breast-feeding women need to weigh the benefits of drug treatment against the potential risks.
  5. Co-administration with other drugs : Bile acid sequestrants (such as cholestyramine) may affect the absorption of obeticholic acid. It is recommended that the two be taken at least 4 hours apart.

Adverse Reactions

  1. Common adverse reactions
    • Itching (most common)
    • fatigue
    • stomach ache
    • Joint pain
    • Thyroid dysfunction
  2. Serious adverse reactions
    • Worsening of liver function (especially in patients with severe liver impairment).

Drug interactions

  • Bile acid sequestrants : such as cholestyramine and colestipol, may reduce the absorption of obeticholic acid and need to be taken separately.
  • CYP450 enzymes : Obeticholic acid may slightly inhibit CYP1A2 and should be used with caution in combination with related substrate drugs.

Overdose

  • Symptoms: May cause severe itching, abnormal liver function, etc.
  • Treatment: Stop the drug immediately and treat symptomatically.

Storage conditions

  • Store below 25°C (within 15-30°C range) away from moisture and light.

Packing Specifications

5 mg 30 tablets,

Manufacturer

Laos ASEAN Pharmaceuticals.

Approval No.

10L 0735/17.

Note : This instruction manual is for reference only. Please read the actual drug instructions carefully and use it according to the doctor's instructions.

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