Medical Information

Linaxibat is used to treat cholestatic itching in adult patients with primary biliary cholangitis (PBC). Standardizing the usage and dosage is the key to ensuring efficacy and safety.

1、 Recommended dosage and administration method

1. Standard dose

The recommended dose of linasibat is 40mg, taken orally twice a day, once in the morning and once in the evening.

2. Usage

(1) Tablets should be swallowed whole and should not be chewed, crushed, or broken apart.

(2) Suitable amount of water can be used for delivery.

3. Administration time

(1) It should be taken at least 30 minutes before eating or drinking any beverage other than water.

(1) This allows the medication to enter the gastrointestinal tract before consuming and releasing bile acids, which is beneficial for its effectiveness.

4. Take medication at a fixed time

It is recommended to take medication at similar times every day, such as before breakfast and dinner, to maintain a stable medication habit and reduce missed doses.

2、 Omission and Overtreatment

1. Principles for handling missed services

If one dose is missed, it should be taken as soon as possible and ensured to be taken at least 30 minutes before the next meal, and then the original dosing plan should be restored.

2. Approaching the next administration

If it is less than 6 hours before the next dose, the missed dose should be skipped and the next dose should be taken according to the original plan.

3. Prohibition of doubling

Double doses should not be taken at once to compensate for missed doses, in order to avoid increasing the risk of adverse reactions.

4. Overexpression

Excessive intake may lead to an increase in gastrointestinal adverse reactions, such as diarrhea, abdominal pain, nausea, etc.

5. Overtreatment

(1) There is currently no specific antidote available.

(2) If an overdose occurs, lenexibat should be discontinued, symptoms monitored, and general supportive treatment given.

3、 Combination medication and special adjustments

1. Combined with bile acid binding resin

Bile acid binding resins (such as colexamide and colervastatin) may bind to linacloprid in the intestine, inhibiting its therapeutic effect.

2. Medication interval

If bile acid binding resin needs to be used in combination, linacoxib should be taken at least 4 hours before or after taking the resin.

3. Combination with Ursodeoxycholic Acid

(1) Linaxibat can be used in combination with ursodeoxycholic acid.

(2) When used together, it does not affect the plasma concentration of ursodeoxycholic acid, but it can reduce the concentration of its bound metabolites, and no clinically significant increase in alkaline phosphatase was observed.

4. Adjustment of liver function impairment

(1) Mild liver dysfunction (Child Pugh A) patients do not require dose adjustment.

(2) Moderate to severe liver dysfunction (Child Pugh B and C) has not been evaluated and should be avoided.

5. decompensated cirrhosis

Patients with decompensated cirrhosis, or those who have had or currently have liver decompensation events, should avoid using linacoxib.

6. Adjustment of renal function impairment

(1) Patients with renal impairment do not need to adjust the dosage.

(2) Severe renal dysfunction (eGFR<30mL/min/1.73m ²), including hemodialysis patients, has not been studied.

7. Other groups of people

(1) The safety and efficacy of pediatric patients have not yet been established.

(2) Elderly patients do not require special dosage adjustments, but should be observed with caution.

(3) The use of medication during pregnancy and lactation should be weighed against the pros and cons, and the levels of fat soluble vitamins should be monitored.