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ABOUT LYSODREN®


What is Lysodren®?

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

Lysodren® role in ACC

Lysodren® is indicated for the treatment of patients with inoperable, functional or non-functional, adrenal cortical carcinoma (ACC) 1

Lysodren® is the only drug approved for the treatment of ACC and can be used: 1,3

  • alone
  • combined with cytotoxic chemotherapy as adjuvant therapy (post-surgery)

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

References

  1. Lysodren® prescribing information, July 2018.
  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.

IMPORTANT SAFETY INFORMATION


What should you know about Lysodren®?

  • In patients taking Lysodren®, adrenal crisis occurs in the setting of 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
  • Administer Lysodren® with caution to patients with hepatic impairment
  • Lysodren® can cause fetal harm when administered to pregnant women.
  • Lysodren® is excreted in human milk.  However, the effect of Lysodren® on the breastfed infant, or effect on milk production is unknown.
  • Ovarian maccroscysts, often bilateral and multiple, have been reported in premenopausal patients receiving Lysodren®.

Additional possible serious side effects of Lysodren® are:

  • CNS toxicity, including sedation, lethargy, and vertigo
  • Adrenal insufficiency

Common Lysodren® adverse reactions include:

  • Anorexia
  • Nausea
  • Vomiting and diarrhea
  • Depression
  • Dizziness or vertigo
  • Rash

Please see full Prescribing Information, including BOXED WARNING, for LYSODREN® (mitotane) tablets.

To report SUSPECTED ADVERSE REACTIONS, contact Direct Success Pharmacy, Inc. at 1-844-LYSODREN (1-844-597-6373) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

HRA Pharma, 200 avenue de Paris, 92320, Chatillon, FRANCE
Tel: +33 (0) 1 40 33 11 30 / Fax: +33 (0) 1 40 33 12 31
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Last updated: June 2019; LYS – WEB – 0619 – US