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Adrenocortical Carcinoma
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Lysodren

mitotane
Adrenolytic Agent FDA Approved 1970 HRA Pharma
Route
Oral
Half-Life
18-159 days
FDA Approved
1970
Manufacturer
HRA Pharma
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1. Indications and Usage

Inoperable adrenocortical carcinoma.

2. Dosage and Administration

2-6 g/day divided. Target 14-20 ug/mL.

3. Dosage Forms and Strengths

Tablets: 500 mg

4. Contraindications

Hypersensitivity.

5. Warnings and Precautions
  • Adrenal Insufficiency: Steroid replacement.
  • CNS Toxicity: Monitor.
  • Embryo-Fetal Toxicity: Fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Nausea/Vomiting (78%), Adrenal Insufficiency (50%), Diarrhea (41%), CNS Depression (32%), Anorexia (33%), Lethargy (25%)

Nausea/Vomiting
78%
Adrenal Insufficiency
50%
Diarrhea
41%
CNS Depression
32%
Anorexia
33%
Lethargy
25%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

Strong CYP3A4 inducer.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Direct cytotoxic destruction of adrenal cortex.

Pharmacokinetics

Lipophilic. t1/2: 18-159 days.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
📋 All Lysodren Trials on ClinicalTrials.gov ↗ 📚 PubMed: Lysodren Clinical Trials ↗
FDA-Approved Tumor Types

Lysodren has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

Adrenocortical Carcinoma
External Resources
📋 DailyMed Label ↗ 🏛️ FDA Drugs@FDA ↗ 🔬 ClinicalTrials.gov ↗ 📚 PubMed Pivotal Trials ↗
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Lysodren. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Lysodren (mitotane) approved for?

Lysodren (mitotane) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Lysodren (mitotane) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Lysodren (mitotane) work?

Direct cytotoxic destruction of adrenal cortex.

What are the most common side effects?

Nausea/Vomiting (78%), Adrenal Insufficiency (50%), Diarrhea (41%), CNS Depression (32%), Anorexia (33%), Lethargy (25%) Nausea/Vomiting 78% Adrenal Insufficiency 50% Diarrhea 41% CNS Depression 32% Anorexia 33% Lethargy 25%

← All Therapies Full Prescribing Information ↗