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About Lysodren (Mitotane)
Lysodren (Mitotane) was approved by the U.S. Food and Drug Administration (FDA) in 1970 for the treatment of Adrenocortical Carcinoma (ACC) and was listed as an orphan drug by the European Medicines Agency (EMA) in 2004.

Lysodren (Mitotane) was originally produced by Bristol Myers Squibb SpA in the United States, and then transferred to the French HRA Company in Europe. At present, the French Laboratoire HRA Company is the only global production licensee of Lysodren (Mitotane) tablets, and there is only one production company in the world.

What is Adrenocortical Carcinoma (ACC)?
Adrenocortical carcinoma (ACC) is a rare malignancy of the adrenal cortex. ACC is a cancer of the adrenal glands, which are two small triangular-shaped glands that sit on top of each kidney. The outside of these glands is called the adrenal cortex. The adrenal cortex makes important hormones that help your body control water balance, blood pressure, stress response, and cause the body to have male or female traits. ACCs form in the adrenal cortex.

An ACC may be functioning, which means it makes more hormone than normal, or non-functioning, which means it has no effect on hormone production. A functioning ACC tumor often makes too much of the hormones cortisol, aldosterone, testosterone, or estrogen.
Lysodren (Mitotane)

Introduction of Drug Information

【Product Name】 Lysodren
【General Name】 Mitotane
【Specification】 Tablets: 500 mg
【Manufacturer】 HRA Pharma
【Indications】 Lysodren (Mitotane) is an adrenal cytotoxic agent indicated for the treatment of inoperable, functional or nonfunctional, adrenal cortical carcinoma.
【Dosage and Administration】 The recommended initial dose of Lysodren (Mitotane) is 2 g to 6 g orally, in three or four divided doses per day.
Increase doses incrementally to achieve a blood concentration of 14 to 20 mg/L, or as tolerated.
【Dose Modifications】 (1) Adrenal Crisis in the Setting of Shock or Severe Trauma: Discontinue Lysodren (Mitotane) until recovery;
(2) Central Nervous System (CNS) Toxicity: Discontinue Lysodren (Mitotane) until symptoms resolve. Seven to 10 days after symptoms resolve, restart at a lower dose (for example, decrease by 500-1000 mg).
【Precautions】 (1) Adrenal Crisis in the Setting of Shock or Severe Trauma:
In patients taking Lysodren (Mitotane), adrenal crisis occurs in the setting of shock or severe trauma and response to shock is impaired. Administer hydrocortisone, monitor for escalating signs of shock, and discontinue LYSODREN until recovery.
(2) Central Nervous System (CNS) Toxicity:
CNS toxicity, including sedation, lethargy, and vertigo, occurs with Lysodren (Mitotane) treatment. Mitotane plasma concentrations exceeding 20 mcg/mL are associated with a greater incidence of toxicity.
(3) Adrenal Insufficiency:
Treatment with Lysodren (Mitotane) can cause adrenal insufficiency. Institute steroid replacement as clinically indicated. Measure free cortisol and corticotropin (ACTH) levels to achieve optimal steroid replacement.
(4) Embryo-Fetal Toxicity:
Can cause fetal harm. Advise women of reproductive potential of the potential risk to a fetus and use of effective contraception.
(5) Ovarian Macrocysts in Premenopausal Women:
Advise women to seek medical advice if they experience gynecological symptoms such as vaginal bleeding and/or pelvic pain.
Lysodren Plasma Concentration Monitoring and Dosage Adjustment
A number of studies have shown that the efficacy and adverse reactions of Lysodren are related to the plasma concentration.
The use of Lysodren treatment requires adjustment of the drug dose on the basis of regular monitoring of the plasma concentration.
Applicable Population All ACC patients treated with Lysodren should undergo Therapeutic Drug Monitoring (TDM), and the dose of Lysodren should be adjusted according to the monitoring results.
Goal Maintain the plasma concentration within 14-20 mg/L.
Plasma concentrations of Lysodren >14 mg/L significantly prolong patient survival, while plasma concentrations above 20 mg/L are associated with symptoms of reversible neuromuscular toxicity.
Monitoring Frequency For patients whose plasma concentration has not yet reached a steady state level of >14 mg/L, it is recommended to perform TDM assessment every 3 to 4 weeks; when the plasma concentration of Lysodren is >14 mg/L, assessment is performed every 6 to 12 weeks . It usually takes several weeks (sometimes months) for the plasma concentration of Lysodren to be more than 14 mg/L, so as long as the plasma concentration of Lysodren is less than 14 mg/L and the patient can tolerate it, it is recommended to continue to increase the dose.
For most patients, the dose of Lysodren can be reduced or maintained when the plasma concentration of Lysodren is greater than 14 mg/L. With the prolongation of treatment time, the best tolerated dose of Lysodren can be determined, while the plasma concentration is maintained within 14-20 mg/L.
Precautions Lysodren is a strong inducer of CYP3A4. For patients taking CYP3A4 substrate drugs at the same time, attention should be paid to the interaction of Lysodren-related drugs, monitoring the patient's response to changes in the dose of concomitant drugs, and combining clinical symptoms and TDM result, adjust the drug regimen in time.
Dosage Adjustment (一) A low-dose starting regimen, that is, the starting dose of Lysodren is 1.0 g/d. If the patient is well tolerated by the gastrointestinal tract, it will start on the 4th day and increase mitotane by 0.5 g every 3 days until the total dose reaches 3.0 ~4.0g/d, start to monitor the plasma concentration of Lysodren after 2 to 3 weeks of treatment, and then adjust the dose according to the plasma concentration to achieve the therapeutic plasma concentration (14 to 20 mg/L) or the maximum tolerance.
Note: If the patient is not well tolerated by the gastrointestinal tract, reduce the dose of Lysodren or delay escalation and treat gastrointestinal symptoms.
Dosage Adjustment (二) High-dose starting regimen, the initial dose of Lysodren was 1.5 g/d, and if the patient had good gastrointestinal tolerance, the dose was increased to 2-3 g/d on the second day, 4.5 g/d and 6 g/d on the third and fourth days.
In this treatment regimen, the plasma concentration of Lysodren was monitored after 2 to 3 weeks of treatment, and then the dose was adjusted according to the plasma concentration to achieve the therapeutic plasma concentration (14 to 20 mg/L) or the maximum tolerance.
Prevention and Treatment of Adverse Reactions
Due to the numerous, severe and high incidence of adverse reactions of Lysodren, regular monitoring of adverse reactions is recommended (eg, every 3-4 weeks within 6 months of initial treatment, and every 6-12 weeks thereafter);
In the event of CNS grade 2 (moderate) or gastrointestinal grade 3 (serious but not life-threatening) adverse reactions, it is recommended to reduce the dose of mitotane by 1 to 1.5 g/d.
CNS grade 3 (serious but not life-threatening) or grade 4 (life-threatening), or gastrointestinal grade 4 (life-threatening) adverse reactions, or liver enzymes increase >5 times the baseline value, should be discontinued With mitotane, re-administer 50% to 75% of the last dose after clinically significant improvement.
Others: assessment of thyroid hormone status, assessment of testosterone and sex hormone binding globulin levels, etc.

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