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Prescribing Lysodren

How to Prescribe Lysodren®1

<p>Lysodren<sup>®</sup> is available as 500 mg tablets.</p>

Lysodren® is available as 500 mg tablets.

<p>The recommended initial dose of Lysodren<sup>®</sup> is 2000 mg to 6000 mg orally, divided in 3 or 4 doses per day. Dosage may vary based on the medical needs of each patient.</p>

The recommended initial dose of Lysodren® is 2000 mg to 6000 mg orally, divided in 3 or 4 doses per day. Dosage may vary based on the medical needs of each patient.

<p>Lysodren<sup>®</sup> should be taken with food; administration with high-fat food enhances absorption. Timing of the dose relative to meals must be consistent.</p>

Lysodren® should be taken with food; administration with high-fat food enhances absorption. Timing of the dose relative to meals must be consistent.

Maximum recommended initial dose is 6000 mg. See dosing information below under “Monitoring Treatment.”
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Starting Lysodren®

Monitoring Treatment1

  • Monitor Lysodren® plasma levels and increase the dose based on patient tolerance and clinical response incrementally to achieve a Lysodren® plasma level of 14 to 20 mg/L, or as tolerated. Consider monitoring Lysodren® plasma levels every 2 weeks after starting treatment and after each dose adjustment
  • The target plasma level is usually reached within a period of 3 to 5 months, due to the long half-life of Lysodren® which ranges from 18 to 159 days and large distribution volume (fat).
  • Monitor Lysodren® plasma levels periodically (eg, monthly). Severe neurotoxicity may occur with levels >20 mg/L
  • In case of Lysodren® plasma levels above 20 mg/L without toxicities, consider reducing the dose by 50% to 75%

 

Safety Profile

Lysodren® has a well-documented safety profile. The most common adverse events include GI, nervous system, metabolism, or endocrine disorders.2

Specifically:

  • Loss of appetite
  • Epigastric discomfort
  • Nausea
  • Vomiting
  • Diarrhea
  • Depression
  • Dizziness/vertigo
  • Rash
  • Hypercholesterolemia
  • Hypertriglyceridemia
  • Hypothyroidism
  • Decreased blood free testosterone in males

For a full list of possible side effects, please see the Lysodren® Prescribing Information.

The Importance of Corticosteroid Replacement Therapy

Because of the adrenolytic effects of Lysodren®, glucocorticoid replacement (eg, hydrocortisone/cortisone acetate) is recommended in patients treated with Lysodren® (except those with functioning tumors with ongoing cortisol excess).3

Due to increased steroid clearance and increase in cortisol-binding globulin, at least twice the standard replacement dose is usually required.3

  • One possible strategy is to start concomitant treatment on day one of Lysodren® treatment with hydrocortisone 20 mg/day and increase to a typical total daily dose of 50 mg divided in 2 to 3 intakes.3
  • Doses of glucocorticoids should be titrated based on levels of cortisol suppression4
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  1. Lysodren®. US Prescribing information. ESTEVE.
  2. Shirley M. Mitotane in adrenocortical carcinoma: a profile of its use. Drugs Ther Perspect. 2022;38:508-519. doi:10.1007/s40267-022-00958-y
  3. Fassnacht M, Dekkers OM, Else T, 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):1-46. doi:10.1530/EJE-18-0608
  4. Kiseljak-Vassiliades K, Bancos I, Hamrahian A, et al. American association of clinical endocrinology disease state clinical review on the evaluation and management of adrenocortical carcinoma in an adult: a practical approach. Endocr Pract. 2020;26(11):1366-1383. doi:10.4158/DSCR-2020-0567
INDICATION AND IMPORTANT SAFETY INFORMATION FOR LYSODREN©
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Warning/Adrenal crisis in the setting of shock, severe trauma or infection: Patients treated with LYSODREN are at 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 LYSODREN and administer exogenous steroids. Monitor patients closely for infections and instruct patients to contact their physician immediately if injury, infection, or any other concomitant illness occurs.
LYSODREN® is an adrenal cytotoxic agent indicated for the treatment of patients with inoperable, functional or nonfunctional, adrenocortical carcinoma (ACC).

Warning/Adrenal crisis in the setting of shock, severe trauma or infection: Patients treated with LYSODREN are at 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 LYSODREN and administer exogenous steroids. Monitor patients closely for infections and instruct patients to contact their physician immediately if injury, infection, or any other concomitant illness occurs.

Adrenal Insufficiency and Adrenal Crisis: Temporarily withhold LYSODREN during shock; trauma, infection or adrenal insufficiency. Steroid replacement may be necessary.

Central Nervous System (CNS) Toxicity: Monitor behavioral and neurologic assessments and mitotane plasma levels at regular intervals. Mitotane plasma levels exceeding 20 mg/L are associated with a greater incidence of toxicity. Advise patients not to drive or operate hazardous machinery if experiencing CNS adverse reactions.

Ovarian Macrocysts in Premenopausal Women: Monitor pelvic ultrasound at baseline and at regular intervals. Withhold, reduce the dose, or permanently discontinue LYSODREN based on severity.

Hematologic Toxicity: Monitor complete blood counts prior to starting LYSODREN, during dose titration and as clinically indicated. Withhold, reduce the dose or permanently discontinue based on severity.

Prolonged Bleeding Time: Prolonged bleeding time has occurred in patients treated with mitotane and this should be taken into account when surgery is considered.

Embryo-Fetal Toxicity: LYSODREN can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective nonhormonal contraception.

Lactation: Advise not to breastfeed.

Hepatic Impairment: LYSODREN is not recommended for patients with severe hepatic impairment. In patients with mild to moderate hepatic impairment, monitor mitotane plasma levels frequently and modify the dosage as needed.

Renal Impairment: LYSODREN® is not recommended for patients with severe renal impairment. In patients with mild or moderate renal impairment, monitor mitotane plasma levels frequently and modify the dosage as needed.

Most common adverse reactions include: anorexia, epigastric discomfort, nausea, vomiting diarrhea, depression, dizziness, vertigo, rash, hypercholesterolemia, hypertriglyceridemia, hypothyroidism and decreased blood free testosterone in males. LYSODREN is a hazardous drug. Advise caregivers to wear disposable gloves when handling LYSODREN tablets.

Avoid concomitant use with spironolactone, certain CYP3A substrates, hormonal contraceptives and warfarin.

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.

Link to US Prescribing Information including Boxed Warning.

ESTEVE.
Passeig de la Zona Franca, 109, 4a planta, 08038 Barcelona
Tel: +34 93 446 60 00 / Fax: +34 93 347 39 44
©2025 ESTEVE.
Lysodren a registered trademark of ESTEVE
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Last updated: October 2025; 0097-10/2026@ESTEVE

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