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Privacy Policy

Any data collected by HRA Pharma from the users through this website are solely used to generate statistics on the frequency of website use and how the site is used. Personal data related to patients (for the purpose of ordering our pharmaceutical products through our distributor) are not collected through this website.

The following data are collected through the use of this website:

  • The domain and server (host) from which the user accessed the website on the Internet
  • In cases of failure, the address of the website from which the user accessed our site (www.hra-pharma.com)
  • The date, time and length of visits to the website, and details of which pages were accessed
  • The user’s internet protocol (IP) address
  • The operating system of the user’s computer and details of the user’s web browser

With respect to collecting anonymous traffic data, we may use third parties to collect such data on our behalf. To disable or limit the use of cookies, please refer to the options provided by your Internet browser. If you do so, however, some pages or features (such as customised products/services or user preferences) on this Web site may not work properly.

However, with the express consent of the user, some personal data such as forename, surname, e-mail address, and place of work may be collected by HRA Pharma in order to permit HRA Pharma to meet its requirements for providing information and/or services by mail or e-mail. HRA Pharma will not share, sell or rent your personal data collected through this website and takes all reasonable action to maintain the protection of such data.

In compliance with the “Informatique et Libertés” law (computers and freedom of expression) dated January 6th 1978, the user has the right to access, modify, rectify and delete all data concerning themselves (article 34 of this same law). To exercise this right, please contact dataprivacy@HRA-PHARMA.COM. You can find all details related to the law “Informatique et Libertés” on the web site for CNIL.

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
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Last updated: June 2019; LYS – WEB – 0619 – US