Lysodren Dosage

Generic name: mitotane 500mg
Dosage form: tablet
Drug class: Miscellaneous antineoplastics

Medically reviewed by Drugs.com. Last updated on Feb 23, 2024.

Recommended Evaluation and Testing Before Initiating LYSODREN

Before initiating LYSODREN, evaluate pelvic ultrasound in premenopausal women, liver functions tests and complete blood count [see Warnings and Precautions (5.3, 5.4, 5.5)].

General Precautions

LYSODREN is a hazardous drug. Advise caregivers to wear disposable gloves when handling LYSODREN tablets [see References (15) and Storage and Handling (16)].

Recommended Dosage and Administration

Recommended Dosage

The recommended initial dose of LYSODREN is 2000 mg to 6000 mg orally, in three or four divided doses per day.
Monitor mitotane plasma levels and increase the dose based on patient tolerance and clinical response incrementally to achieve a mitotane plasma level of 14 to 20 mg/L, or as tolerated. Consider monitoring mitotane 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.
Monitor mitotane plasma levels periodically (e.g., monthly). Severe neurotoxicity may occur with levels > 20 mg/L.

Dose Adjustments, Monitoring and Discontinuation

In case of mitotane plasma levels above 20 mg/L without toxicities, consider reducing the dose by 50 to 75%.
Monitor mitotane plasma levels regularly (e.g., every two months) after discontinuation of treatment. Due to the prolonged half-life, significant levels may persist for weeks after cessation of therapy.
LYSODREN is lipophilic and accumulates in adipose tissue. Despite maintaining a constant dose, mitotane levels may suddenly increase. Monitor mitotane plasma levels even when LYSODREN has been withheld as adipose tissue may continue to release mitotane [see Clinical Pharmacology (12.3)]. Due to adipose tissue accumulation of mitotane, close monitoring of mitotane plasma levels is recommended in overweight patients and patients with recent weight loss.

Administration

Swallow LYSODREN tablets whole; do not crush, chew or split.
Take LYSODREN with food. Timing of the dose relative to meals must be consistent. Administration with high fat food enhances absorption [See Clinical Pharmacology Section (12.3)].
Do not take tablets showing signs of deterioration.
Caregivers should wear disposable gloves when handling the tablets. Avoid exposure to crushed and/or broken tablets. If contact with crushed/broken tablets occurs, wash the contaminated skin immediately and thoroughly.
If a patient misses a dose, instruct the patient to take the next dose as scheduled.
If a patient vomits after taking a dose, instruct the patient to take the next dose as scheduled.

Dosage Modifications for Adverse Reactions

The recommended dosage reduction for adverse reactions is to decrease the usual daily dose by 500 – 1000 mg.

Table 1 describes the dosage modifications for specific adverse reactions.

Table 1: Recommended Dosage Modifications for LYSODREN for Adverse Reactions
Adverse Reaction	Severity*	Dosage Modification
* Severity defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Adrenal Crisis and Adrenal Insufficiency [see Warnings and Precautions (5.1)]	All Grades	Withhold LYSODREN during shock, trauma, infection or adrenal insufficiency until recovery to Grade ≤1 or baseline. Resume LYSODREN at a reduced dose or permanently discontinue based on severity.
Central Nervous System (CNS) Toxicity [see Warnings and Precautions (5.2)]	Grade 2	Measure mitotane plasma level and modify the dosage according to the following recommendations: - Mitotane plasma level less than 14 mg/L: reduce the daily dose by 1000 mg. - Mitotane plasma level in the therapeutic window (14 to 20 mg/L): reduce the daily dose by 1500 mg. - Mitotane plasma level above 20 mg/L: withhold LYSODREN until recovery to grade ≤1 or baseline. Seven to ten (7-10) days after symptoms resolve, resume LYSODREN at reduced dose.
	Grade 3 or 4	Measure mitotane plasma level and modify the dosage according to the following recommendations: - Withhold LYSODREN until recovery to grade ≤ 1 or baseline. Seven to ten (7-10) days after symptoms resolve, resume LYSODREN at a reduced dose or permanently discontinue based on severity.
Gastrointestinal (GI) toxicity	Grade 3 or 4	Measure mitotane plasma level and modify the dosage according to the following recommendations: - Mitotane plasma level less than 14 mg/L: reduce the daily dose by 1000 mg. - Mitotane plasma level in the therapeutic window (14 to 20 mg/L): reduce the daily dose by 1500 mg. - Mitotane plasma level above 20 mg/L: withhold LYSODREN until recovery to grade ≤1 or baseline. - After symptoms resolve, resume LYSODREN at a reduced dose or permanently discontinue based on severity.
Hepatotoxicity [see Warnings and Precautions (5.4)]	Grade 3 or 4	Measure mitotane plasma level and modify the dosage according to the following recommendations: - Withhold LYSODREN until recovery to Grade ≤1 or baseline. - Resume at a reduced dose or permanently discontinue based on severity.
Hematologic Toxicity [see Warnings and Precautions (5.5)]	Grade 2	Measure mitotane plasma level and modify the dosage according to the following recommendations: - Withhold LYSODREN until recovery to Grade ≤1 or baseline. - Resume at the same dose.
Hematologic Toxicity [see Warnings and Precautions (5.5)]	Grade 3 or 4	Measure mitotane plasma level and modify the dosage according to the following recommendations: - Withhold LYSODREN until recovery to Grade ≤1 or baseline. - Resume at a reduced dose or permanently discontinue based on severity.
Other Adverse Reactions [see Adverse Reactions (6.1)]	Grade 2	Measure mitotane plasma level and modify the dosage according to the following recommendations: - Withhold LYSODREN until recovery to Grade ≤1 or baseline. - Resume at the same dose.
Other Adverse Reactions [see Adverse Reactions (6.1)]	Grade 3 or 4	Measure mitotane plasma level and modify the dosage according to the following recommendations: - Withhold LYSODREN until recovery to Grade ≤1 or baseline. - Resume at a reduced dose or permanently discontinue based on severity.