The usage and dosage of Pimitesib should strictly follow medical advice, and medication for special populations should be adjusted according to individual circumstances. The following provides a detailed explanation from three aspects: standard usage, dosage adjustment, and precautions for special populations.

1. Standard usage and dosage

(1) Administration method

The whole tablet of Pimetib should be swallowed, and should not be cut, crushed, or chewed. It is recommended to have a fixed daily medication time, which can be taken with food or alone, and maintain consistent dosing intervals.

(2) Treatment cycle

The principle of continuous medication until disease progression or intolerable toxicity occurs is similar to the treatment strategy of targeted drugs such as pitobutinib.

Principle of dose adjustment

(1) Adverse reaction management

When a toxic reaction of grade 3 or above occurs, the administration should be suspended, and the dosage should be gradually reduced according to the dose gradient after recovery. The initial reduction can be adjusted by referring to a 30% reduction in the amount of bimetinib.

(2) Remedial measures for missed services

If it is more than 12 hours before the next dose, it can be taken immediately, and if it is less than 12 hours, it can be skipped. Double dose compensation is strictly prohibited, which is consistent with the management requirements of pirfenidone.

3. Medication for special populations

(1) Pregnancy and lactation period

Pregnant women are prohibited from using contraception, and women of childbearing age should use contraception for one week after the last dose. Breastfeeding should be suspended during lactation, following the lactation risk management plan for pratinib.

(2) Liver and kidney dysfunction

Patients with moderate to severe liver damage should reduce their dosage by 50%, while patients with end-stage renal disease should avoid using it. The adjustment principle is similar to the liver and kidney dose adjustment strategy of pirfenidone.

(3) Elderly patients

The incidence of adverse reactions increases in patients over 65 years old, but there is no need to adjust the preset dosage and monitoring needs to be strengthened.

(4) Pediatric patients

The population under 18 years old lacks safety data, and when necessary, the dosage should be calculated based on body surface area and growth and development indicators should be closely monitored.