Mitotane is indicated for patients with unresectable functional or non-functional adrenocortical carcinoma. The usual oral daily dose is 2 to 6 grams, divided into 3 to 4 doses per day. Specific dosage and administration should follow the physician's instructions.
U.S. Boxed Warning for Mitotane
Adrenal crisis in the setting of shock or severe trauma: Patients taking this drug may experience adrenal crisis in the event of shock or severe trauma, and their ability to respond to shock may be impaired. In such cases, administer hydrocortisone, monitor for worsening of shock symptoms, and withhold treatment until recovery.
Recommended Dosage of Mitotane
1. Target Population
Mitotane is indicated for adult patients with unresectable functional or non-functional adrenocortical carcinoma.
2. Initial Dosage
2 to 6 grams orally per day, divided into 3 to 4 doses.
3. Dose Titration
Gradually increase the dose to achieve a plasma concentration of 14 mg/L to 20 mg/L, or adjust based on patient tolerability.
4. Administration Precautions
Mitotane is a cytotoxic drug. Follow special handling and disposal procedures applicable to hazardous drugs.
Mitotane Use in Special Populations
1. Patients with Renal Impairment
No dose adjustment data available.
2. Patients with Hepatic Impairment
Use with caution; drug accumulation may occur.
3. Pediatric Use
Safety and efficacy in patients under 18 years of age have not been established.
4. Dialysis
No data available regarding dialysis.
Dose Adjustments in Special Situations for Mitotane
1. Adrenal Crisis in the Setting of Shock or Severe Trauma
Withhold treatment until recovery.
2. Central Nervous System Toxicity
Withhold treatment until symptoms resolve. After symptoms have resolved for 7 to 10 days, restart treatment at a lower dose (e.g., reduce by 500 to 1000 mg).
