This site is managed by HRA Pharma, whose headquarters are located at 200 avenue de Paris, 92320, Chatillon, France.

Information provided

The product information provided on the site is intended only for residents in the United States.

While HRA Pharma makes every effort to ensure that all information provided on this website is accurate and reliable, some errors or omissions may occur. If you should come across any mistakes, please contact us to let us know and we will work to rectify the error. The content of this site may be corrected or changed without notice.

The information that appears on this site is published specifically to inform our current strategic partners, potential partners, potential employees and potential investors about our business. It is not intended to be, and should not be used as, a source of medical advice or opinion. Under no circumstances should any information provided on this site be used to establish a medical diagnosis, which can only be achieved by consulting a qualified doctor.

Under no circumstances will HRA Pharma be responsible for direct or indirect compensation, notably but not exclusively arising from the contents of this site, use of the site, access to this site or the impossibility of accessing the site, regardless of the nature of the claim.

Links to other sites

HRA Pharma is responsible for maintaining all links to other websites appearing on this website. However it cannot be held responsible for links appearing on these other websites. The Company is not responsible for the content of any external websites.

Commercial brands

A visit to or the use of this site confers no rights to the user.

Certain words, graphs or brands appearing on this website are the property of HRA Pharma or other parties. Any non-authorized use is strictly forbidden. All reproduction, modification, downloading, transmission, or distribution of any document or information appearing on this site, whether in part or in its entirety, requires prior written consent by HRA Pharma, with the exception of copies made for private and non-commercial use. These copies are under the governance of intellectual property rights and under all property rights if this work is referenced. The following notice “Copyright 2009 HRA Pharma, All Rights Reserved” must appear on all copies of any work, whether in whole or in part, contained within this site.

For further information on our policies please contact us.

Indication and Important Safety Information

LYSODREN® is an adrenal cytotoxic agent indicated for the treatment of inoperable, functional or nonfunctional, adrenal cortical carcinoma.

Warning/Adrenal crisis in the setting of shock or severe trauma:  In patients taking LYSODREN®, 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.

CNS Toxicity: CNS toxicity, including sedation, lethargy, and vertigo, occurs with LYSODREN® treatment. Mitotane plasma concentrations exceeding 20 mcg/mL are associated with a greater incidence of toxicity.
Adrenal Insufficiency: Treatment with LYSODREN® can cause adrenal insufficiency. Institute steroid replacement as clinically indicated.

Measure free cortisol and corticotropin (ACTH) levels to achieve optimal steroid replacement.
Embryo-Fetal Toxicity: LYSODREN® can cause fetal harm when administered to a pregnant woman. Abnormal pregnancy outcomes, such as preterm births and early pregnancy loss, can occur in patients exposed to mitotane during pregnancy. Advise females of reproductive potential to use effective contraception during treatment with LYSODREN® and after discontinuation of treatment for as long as mitotane plasma levels are detectable.
Ovarian Macrocysts in Premenopausal Women: Ovarian macrocysts, often bilateral and multiple, have been reported in premenopausal patients receiving LYSODREN®. Complications from these cysts, including adnexal torsion and hemorrhagic cyst rupture, have been reported. In some cases, improvement after mitotane discontinuation has been described.
Lactation: Mitotane is excreted in human milk; however, the effect of LYSODREN® on the breastfed infant, or effect on milk production is unknown.

Because of the potential for serious adverse reactions in the breastfed infant, advise nursing women that breastfeeding is not recommended during treatment with LYSODREN® and after discontinuation of treatment for as long as mitotane plasma levels are detectable.
Hepatic Impairment: Administer LYSODREN® with caution to patients with hepatic impairment.

Common adverse reactions (³15%) include: anorexia, nausea, vomiting and diarrhea; depression, dizziness or vertigo; and rash. LYSODREN® is a cytotoxic drug. Follow applicable special handling and disposal procedures.

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
© 2019 HRA Pharma | Lysodren is a registered trademark of HRA Pharma
Privacy Policy | Disclaimer
Last updated: June 2019; LYS – WEB – 0619 – US