Data from FDA - Curated by EPG Health - Last updated 18 December 2019

Indication(s)

1 INDICATIONS AND USAGE LYSODREN is indicated for the treatment of patients with inoperable, functional or nonfunctional, adrenal cortical carcinoma. LYSODREN is an adrenal cytotoxic agent indicated for the treatment of inoperable, functional or nonfunctional, adrenal cortical carcinoma. (1)

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Advisory information

contraindications
4 CONTRAINDICATIONS None. None (4)
Adverse reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: • Adrenal Crisis in the Setting of Shock or Severe Trauma [see Warnings and Precautions (5.1)] • CNS Toxicity [ see Warnings and Precautions (5.2)] • Adrenal Insufficiency [see Warnings and Precautions (5.3)] • Ovarian macrocysts [see Warnings and Precautions (5.5) ] The following adverse reactions associated with the use of LYSODREN were identified in clinical trials or postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. Common adverse reactions occurring with LYSODREN treatment include: •Anorexia, nausea, vomiting, and diarrhea (80%) •Depression, dizziness, or vertigo (15%-40%) •Rash (15%)•Neutropenia•Growth retardation, hypothyroidism •Confusion, headache, ataxia, mental impairment, weakness, dysarthria •Maculopathy•Hepatitis, elevation of liver enzymes•Gynecomastia • Hypercholesterolemia, hypertriglyceridemia • Decreased blood androstenedione and decreased blood testosterone in females, increased sex hormone binding globulin in females and males, decreased blood free testosterone in males. Less common adverse reactions include: visual blurring, diplopia, lens opacity, retinopathy, prolonged bleeding time, hematuria, hemorrhagic cystitis, albuminuria, hypertension, orthostatic hypotension, flushing, generalized aching, and fever. Common adverse reactions (≥15%) include: anorexia, nausea, vomiting and diarrhea; depression, dizziness or vertigo; and rash. (6) To report SUSPECTED ADVERSE REACTIONS, contact Direct Success Inc.at 844-597-6373 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION •Initial dose: 2 g to 6 g orally daily, in three or four divided doses. (2.1) •Increase dose incrementally to achieve a blood concentration of 14 to 20 mg/L, or as tolerated. (2.1) 2.1 Recommended Dose The recommended initial dose of LYSODREN is 2 g to 6 g orally, in three or four divided doses per day. Increase doses incrementally to achieve a blood concentration of 14 to 20 mg/L, or as tolerated. LYSODREN is a cytotoxic drug. Follow applicable special handling and disposal procedures. 2.2 Dose Modifications Adrenal Crisis in the Setting of Shock or Severe Trauma Discontinue LYSODREN until recovery [see Warnings and Precautions (5.1)]. Central Nervous System (CNS) Toxicity Discontinue LYSODREN until symptoms resolve. Seven to 10 days after symptoms resolve, restart at a lower dose (for example, decrease by 500-1000 mg) [see Warnings and Precautions (5.2)].
Use in special populations
8 USE IN SPECIFIC POPULATIONS •Lactation: Do not breastfeed. (8.2) •Hepatic Impairment: Administer LYSODREN with caution to patients with hepatic impairment. (8.6) 8.1 Pregnancy Risk Summary LYSODREN can cause fetal harm. Limited postmarketing cases report preterm births and early pregnancy loss in women treated with LYSODREN during pregnancy. Animal reproduction studies have not been conducted with mitotane. Advise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. 8.2 Lactation Risk Summary 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. 8.3 Females and Males of Reproductive Potential Contraception Females LYSODREN can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)]. Advise female patients of reproductive potential to use effective contraception during treatment with LYSODREN and after discontinuation of therapy for as long as mitotane plasma levels are detectable [see Clinical Pharmacology (12.3)]. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric Use Clinical studies of LYSODREN did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. 8.6 Hepatic Impairment Hepatic impairment may interfere with the metabolism of mitotane and the drug may accumulate. Administer LYSODREN with caution to patients with hepatic impairment.

Interactions

7 DRUG INTERACTIONS Adjust dosage of concomitant coumarin-type anticoagulants as needed. (7.2) 7.1 CYP3A4 Substrates Mitotane is a strong inducer of cytochrome P450 3A4 (CYP3A4). Monitor patients for a change in dosage requirements for the concomitant drug when administering LYSODREN to patients receiving drugs that are substrates of CYP3A4. 7.2 Warfarin When administering coumarin-type anticoagulants to patients receiving LYSODREN, monitor coagulation tests and adjust the anticoagulant dose as needed.

More information

Category Value
Authorisation number NDA016885
Agency product number 78E4J5IB5J
Orphan designation No
Product NDC 76336-080
Date Last Revised 13-02-2019
Type HUMAN PRESCRIPTION DRUG
RXCUI 207373
Marketing authorisation holder Laboratoire HRA Pharma
Warnings 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 [see Dosage and Administration (2.2) and Warnings and Precautions (5.1)]. WARNING: ADRENAL CRISIS IN THE SETTING OF SHOCK OR SEVERE TRAUMA See full prescribing information for complete boxed warning. 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. (2.2 , 5.1)