What is Lysodren®?

Lysodren® (Mitotane) is an adrenal cytotoxic active substance – an antineoplastic agent which suppresses production of adrenal cortex corticosteroid hormones. 1,2

Lysodren® role in ACC

Only FDA approved treatment of patients with inoperable, functional or nonfunctional, adrenocortical carcinoma (ACC) 1

WARNING: Patients treated with Lysodren are at an increased risk for developing ADRENAL CRISIS in the setting of shock, severe trauma or infection that may lead to death. If shock, severe trauma, or infection occurs or develops, temporarily discontinue Lyosdren and administer exogenous steroids. Montior patients closely for infections and instruct patients to contact their physician immediately if injury, infection, or any other concomitant illness occurs.

How Lysodren® works

Research on the mode of action of mitotane suggests two main biological effects:

  • A direct cytotoxic effect on adrenal cortical cells, mediated through mitochondrial alterations and inhibition of sterol-O-acyl transferase 1 (SOAT1) 2
  • Inhibition of corticosteroid synthesis by modifying the peripheral metabolism of cortisol and directly suppressing the production of corticosteroids from the adrenal cortex 1,4

Management of advanced ACC not amenable to radical resection

Practice Guidelines on the management of adrenocortical carcinoma in adults5

ACC: adrenocortical carcinoma: EDP: etoposide, doxorubicin, cisplatin
Adapted from Fassnacht M, et al. Eur J Endocrinol.2018;179(4):G1-G46.

Reference notes from Practice Guidelines

  1. Only in selected patients (with severe hormone excess)
  2. The following factors might guide the decision: site of disease involvement, tumor burden, symptoms, tumor grade/Ki67 index
  3. The following factors might guide the decision: site of disease involvement, tumor burden, symptoms, tumor grade/Ki67 index, and importantly kinetics of tumor growth
  4. Radiotherapy, radiofrequency ablation, cryo-ablation, microwave ablation, (chemo-) embolization
  5. Few panellists favored cisplatin + etoposide
  6. Contact specialized center

Lysodren® dosing and monitoring the therapeutic window

Lysodren® is available as 500 mg tablets.1 The total daily dose should be divided into three or four doses with food.1

The recommended treatment schedule is to start the patient at 2000 mg to 6000 mg orally, in three to four divided doses per day with food. Titrate LYSODREN to achieve a plasma level of 14 to 20 mg/L1

Time taken to reach target levels of Lysodren® and observe clinical benefits varies from patient to patient but typically requires a minimum of 4 months of continuous treatment. 6

Finding and maintaining the Lysodren® therapeutic window

Optimal Plasma Concentration Target

Mitotane Plasma Level Monitoring is to be performed on a regular and individual basis to reach/maintain an optimal therapeutic window.6


1. Lysodren® prescribing information.
2. Waszut U, Szyszka P, Dworakowska D. Understanding mitotane mode of action, J Physiol Pharmacol 2017; 68 (1):13-26.
3. Fassnacht M, Terzolo M, Allolio B, et al. Combination chemotherapy in advanced adrenocortical carcinoma, N Engl J Med 2012; 366(23):2189-97.
4. Ghataore L, Chakraborti I, Aylwin S, et al. Effects of mitotane treatment on human steroid metabolism: implications for patient management, Endocr Connect 2012; 1(11):37-47.
Fassnacht M, et al. European Society of Endocrinology Clinical Practice Guidelines on the management of adrenocortical carcinoma in adults, in collaboration with the European Network for the Study of Adrenal Tumors. Eur J Endocrinol. 2018;179(4):G1-G46.
6. Fassnacht M, Allolio B. Clinical management of adrenocortical carcinoma. Best Pract Res Clin Endocrinol Metab. 2009;23(2):273-89.

Lysodren Adverse Events1

Reported Adverse Reactions include:

  • Metabolism and nutrition disorders: Anorexia
  • Gastrointestinal disorders: Epigastric discomfort, nausea, vomiting, diarrhea
  • Nervous system disorders: Depression, dizziness, or vertigo
  • Confusion, headache, ataxia, mental impairment, weakness, dysarthria, paresthesia, polyneuropathy, movement disorder, balance disorder, dysgeusia
  • Skin and subcutaneous tissue disorders: Rash, pruritus, hypersensitivity reactions
  • Blood and lymphatic system disorders: Leukopenia, anemia, thrombocytopenia, prolonged bleeding time, hematuria, hemorrhagic cystitis
  • Endocrine: growth retardation, hypothyroidism
  • Eye disorders: maculopathy, visual blurring, diplopia, lens opacity, retinopathy
  • Hepatobiliary disorders: hepatitis, elevation of liver enzymes, liver injury (hepatocellular/cholestatic/mixed)
  • Reproductive system and breast disorders: gynecomastia, hypogonadism (in males)
  • Hypercholesterolemia, hypertriglyceridemia
  • Decreased plasma androstenedione, decreased plasma testosterone in females, increased sex hormone binding globulin in females and males, decreased blood free testosterone in males
  • Musculoskeletal disorders: muscular weakness, generalized aching
  • General disorders: fever
  • Renal and urinary disorders: Albuminuria/proteinuria
  • Vascular disorders: Hypertension, orthostatic hypotension, flushing
  • Infections: opportunistic infection

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