What are the key points and detailed information in the instructions for use of Mitotane Tablets?

Mitotane is a targeted drug used to treat adrenocortical cancer (Adrenocortical Carcinoma, ACC). It is mainly used for patients with unresectable functional or non-functional adrenocortical cancer. It is currently one of the few drugs that has a certain effect on this rare malignant tumor. The following are the key contents and medical points in its instructions for use, which are suitable for patients, family members and clinical medical personnel as a normative reference.

1. Description of indications

Mitotan is approved for the treatment of adrenocortical cancer, particularly in advanced cases that cannot be surgically removed. Mitotane may be considered in patients with either functional (hormone-producing) or nonfunctional ACC, as long as there is a risk of progressive disease or recurrence. Its mechanism of action is to selectively destroy the adrenal cortex tissue and inhibit the synthesis of steroid hormones, thereby achieving dual anti-cancer and endocrine suppression effects.

2. Principles of usage and dosage

The recommended initial dose of mitotane is between 2000 mg and 6000 mg daily, taken orally in three or four divided doses. Dose adjustment needs to be based on the patient's tolerance and dynamic monitoring of plasma drug concentrations, with the goal of maintaining the plasma concentration of mitotane within the effective therapeutic range of 14 to 20 mg/L. If the patient can tolerate high doses at an early stage, the dose can be gradually increased to reach the therapeutic window faster, but potential toxic reactions must be guarded against.

3. Dosage methods and recommendations

Swallow the tablet whole: Mitotane tablets should not be chewed, crushed or broken to avoid affecting drug release and gastrointestinal irritation.

Take with food: It is recommended to take it with food, especially high-fat meals, which can significantly improve the absorption efficiency of the drug.

Take medication at a fixed time: The daily medication time should be consistent to enhance the stability of the drug effect and the controllability of the concentration in the body.

Do not take spoiled tablets: Avoid using tablets that are darkened in color, have a damaged surface, or have an odor to prevent unstable efficacy or toxic impurities.

4. Drug handling and operation safety

Because mitotane is cytotoxic, disposable gloves must be used when handling tablets to avoid inhalation or skin contact with the powder. If a tablet is broken or accidentally leaked, the contact area should be washed immediately and thoroughly with soap and plenty of water to avoid potential systemic reactions caused by drug absorption. Tablets should be stored out of the reach of children to avoid hot and humid environments that may affect stability.

5. Pre-medication assessment items

Before starting treatment, a series of basic checks are required to ensure the safety of medication:

Pelvic ultrasound (especially in premenopausal women): to evaluate ovarian tissue that may be affected by changes in hormone levels;

Liver function test: Because mitotane is metabolized in the liver, abnormal liver function may affect its clearance;

Complete blood count: to rule out potential risks of infection or myelosuppression.

6. Blood drug concentration monitoring

The efficacy of mitotane is highly correlated with its plasma concentration. It is clinically recommended to regularly monitor blood drug levels after medication to guide dosage adjustments to avoid low concentrations affecting efficacy, or high concentrations causing toxicity. If the blood concentration does not reach the target range after continuous use, a gradual increase in dose may be considered, but adverse reactions need to be closely observed.

7. Other precautions

Pregnancy should be avoided while taking the drug, as mitotane may be toxic to the embryo;

If severe gastrointestinal symptoms occur (such as persistent nausea, vomiting, diarrhea), you should seek medical treatment in time;

The drug may remain in the body for several weeks after the drug is stopped, so adverse effects may be delayed.

Reference materials:https://go.drugbank.com/drugs/DB00648