Mitotane Dosage

Medically reviewed by Drugs.com. Last updated on Mar 5, 2025.

Usual Adult Dose for Adrenal Cortical Carcinoma

Initial dose: 2 to 6 g orally per day, in 3 to 4 divided doses

Comments:

• Increase the dose incrementally to achieve a blood concentration of 14 to 20 mg/L, or as tolerated.

Use: For the treatment of patients with inoperable, functional or nonfunctional, adrenal cortical carcinoma.

Renal Dose Adjustments

Renal dysfunction: Data not available

Liver Dose Adjustments

Liver dysfunction: Use with caution; drug may accumulate.

Dose Adjustments

Adrenal crisis in the setting of shock or severe trauma:

• Discontinue therapy until recovery.

Central nervous system toxicity:

• Discontinue therapy until symptoms resolve.
• Within 7 to 10 days after symptoms resolve, restart at a lower dose (e.g., decrease by 500 to 1000 mg).

Precautions

US BOXED WARNING:

• ADRENAL CRISIS IN THE SETTING OF SHOCK OR SEVERE TRAUMA: In patients taking this drug, 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 therapy until recovery.

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available.

Other Comments

Administration advice:

• This is a cytotoxic drug. Follow applicable special handling and disposal procedures for hazardous drugs.

Storage requirements:

• Store bottles at 25C (77F); excursions permitted between 15C and 30C (59F to 86F).

Monitoring:

• General: Plasma drug levels (during treatment to achieve therapeutic levels and avoid toxicity; after treatment discontinuation to determine when contraception use can be stopped)
• Endocrine: For signs/symptoms of adrenal insufficiency; free cortisol and corticotropin (ACTH) levels (if steroid replacement therapy is indicated)
• Nervous System: For signs/symptoms of CNS toxicity

Patient advice:

• Discuss any planned surgeries while on treatment with your health care provider.
• Seek immediate medical attention in the event of shock or severe trauma.
• Premenopausal women: Notify your health care provider if vaginal bleeding or pelvic pain occur.
• Do not breastfeed during treatment.
• Females of childbearing potential:
• Notify your health care provider of a known/suspected pregnancy.
• Understand the potential risk to the fetus while on therapy with this drug.
• Use effective contraception during treatment and after discontinuation for as long as instructed by health care provider.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer