Mitotane, as a therapeutic drug for adrenal cortical cancer, requires individualized adjustment of its usage and dosage. Special attention should be paid to pregnancy contraindications and liver function monitoring when using it in special populations. The following provides a detailed explanation from three aspects: standard usage, dosage adjustment, and precautions for special populations.

1. Standard usage and dosage

The initial dose is usually 2-6g/day, taken orally 3-4 times, gradually increasing to the therapeutic dose of 9-10g/day based on tolerance. The maintenance dose is 2-4g/day, and regular monitoring of blood drug concentration is required to maintain it within the therapeutic window of 14-20mg/L.

Principle of dose adjustment

2.1 Abnormal liver function

Mild to moderate damage patients need to reduce their dosage by 25% -50%, and severe liver function damage is prohibited. During the treatment period, ALT/AST should be monitored monthly, and medication should be suspended when the ULN increases by more than 3 times.

2.2 Drug Interaction Adjustment

When used in combination with CYP3A4 inducers, an increase of 20% -30% in the dose of mitoxan is required; When used in combination with inhibitors, the dosage should be reduced by 15% -20%.

3. Medication for special populations

3.1 Pregnancy period

It has clear embryonic toxicity and is absolutely prohibited for pregnant women. Women of childbearing age need to confirm that they are not pregnant before treatment, and efficient contraception should be taken during the treatment period and within 3 months after discontinuation of medication.

3.2 Breastfeeding period

Animal data shows milk secretion, while human data is lacking. It is recommended to suspend breastfeeding during the treatment period and within one month after discontinuing the medication.

3.3 Child patients

The safety data for children under 14 years old is limited, and the dosage needs to be adjusted based on body surface area. Suggest starting the dosage at 40mg/kg/day and taking it in divided doses.

3.4 Elderly patients

The clearance rate of patients over 65 years old decreases, and it is recommended to reduce the starting dose by 25%. Need to strengthen monitoring of neurological toxicity.