Mitotane is an oral cytotoxic agent for adrenal cells, and its mechanism of action is not fully understood. It mainly exerts pharmacological effects by regulating the peripheral metabolism of steroids and directly inhibiting the adrenal cortex.

1、 Drug name

1. Common name: Mitotane

2. Product Name: LYSODREN ®

2、 Indications

Used for the treatment of inoperable, functional or non functional adrenal cortical carcinoma (ACC).

3、 Specifications and characteristics

1. Specification: 500mg per tablet.

2. Appearance: White, round.

4、 Main components

1. Active ingredient: Mitotane.

5、 Usage and dosage

1. The recommended initial dose is 2000-6000mg per day, divided into 3-4 oral doses.

2. The blood concentration of mitoxan should be monitored, with a target therapeutic concentration of 14-20mg/L, usually achieved within 3-5 months.

3. Should be taken with food, high-fat foods can increase absorption.

4. The tablet must be swallowed whole and should not be crushed, chewed, or divided.

6、 Dose adjustment

1. If adverse reactions occur, it is recommended to reduce the daily dose by 500-1000mg.

2. When the blood concentration of mitoxan exceeds 20mg/L, a reduction of 50-75% should be considered.

3. If shock, severe trauma, infection, or adrenal crisis occurs, medication should be suspended and restarted at a lower dose or permanently discontinued after recovery.

4. For specific adverse reactions (such as neurological toxicity, hepatotoxicity, hematological toxicity, etc.), medication should be paused, reduced, or discontinued according to the severity.

7、 Medication precautions

1. Taking with food: It is recommended to take with high-fat foods to enhance absorption, and the medication time should be relatively fixed.

2. Omission treatment: If missed once, the regular dose should be taken at the next scheduled time, and double the dose should not be taken.

3. Vomiting management: If vomiting occurs after taking medication, the regular dose should still be taken at the next scheduled time.

4. Tablet breakage: Do not consume broken or crushed tablets. When handling tablets, nursing staff should wear disposable gloves to avoid contact with debris.

5. Driving and operating machinery: If there are adverse central nervous system reactions such as drowsiness, fatigue, dizziness, etc., driving or operating dangerous machinery should be avoided.

8、 Medication for special populations

1. Pregnant women: Mitotan may cause harm to the fetus, and it is recommended that pregnant women refrain from using it. Women of childbearing age should use effective non hormonal contraceptive measures during treatment and after discontinuing medication until blood drug concentration cannot be detected.

2. Breastfeeding women: Mitotan can enter breast milk. It is recommended to stop breastfeeding during treatment and after stopping the medication until the blood drug concentration cannot be detected.

3. Children's medication: Safety and efficacy have not been established yet, and may have negative effects on neuropsychological development.

4. Elderly medication: The dosage should be carefully selected, usually starting from the lower limit of the dosage range.

5. Patients with liver and kidney dysfunction: Mild to moderate liver and kidney dysfunction requires more frequent monitoring of blood drug concentration and adjustment of dosage; Not recommended for individuals with severe liver and kidney dysfunction.

9、 Adverse reactions

1. Common adverse reactions include loss of appetite, upper abdominal discomfort, nausea, vomiting, diarrhea, depression, dizziness, vertigo, rash, hypercholesterolemia, hypertriglyceridemia, hypothyroidism, and decreased male free testosterone.

2. Serious adverse reactions include: adrenal insufficiency/crisis, central nervous system toxicity, giant ovarian cysts (in premenopausal women), hepatotoxicity, hematological toxicity, prolonged bleeding time, etc.

10、 Contraindications

There are no known absolute contraindications.

11、 Drug interactions

1. Avoid co administration with spironolactone as it may block the action of mitoxan.

2. Avoid co administration with certain CYP3A substrate drugs, as mitoxan is a potent CYP3A inducer that may lower the blood drug concentration of co administered drugs.

3. Avoid using hormonal contraceptives in combination, as mitoxan may reduce its effectiveness.

4. Avoid co administration with warfarin, as mitotan may induce its metabolism and reduce its anticoagulant effect.

12、 Storage method

1. Store below 25 ° C (77 ° F).

2. Keep out of reach of children.

Mitotaneinformation