Mitotane Dosage
This dosage information may not include all the information needed to use Mitotane safely and effectively. See additional information for Mitotane.
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Adrenal Cortical Carcinoma
Initial dose: 2 to 6 g/day orally in 3 to 4 divided doses.
Maintenance dose: 9 to 10 g/day orally in 3 to 4 divided doses.
May increase up to 16 g/day if tolerated. Highest doses used have been 18 to 19 g/day.
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Data not available
Dose Adjustments
The recommended dose of mitotane may depend on whether other cytotoxic agents are coadministered. Reference to specific protocols is recommended. The target dose is the highest tolerable dose. Doses are usually increased until mild toxicity is noted. Once mild toxicity is noted, doses are reduced slightly and then continued as long as clinical benefits are documented (at least for 3 months).
Precautions
It is very important not to stop mitotane too soon. Be cognizant of the need to discontinue mitotane and for increased doses of exogenous corticosteroid replacement in case of trauma or shock. Mitotane should be administered with care to patients with liver disease other than metastatic lesions from the adrenal cortex, since the metabolism of mitotane may be interfered with and the drug may accumulate.
Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).
Dialysis
Data not available
Other Comments
Treatment may be continued to maintain this patient's clinical status or slow the growth of metastatic lesions. Lack of these clinical benefits after three months may be evidence of treatment failure, however 10% of patients who show a measurable response require more than three months of therapy with the maximum tolerable dose.
The effectiveness of mitotane can be measured by reduction in tumor mass; reduction in pain, weakness or anorexia; and reduction of symptoms and signs due to excessive steroid production.
Monitoring for signs and symptoms of adrenal insufficiency is recommended. By measuring plasma cortisol levels periodically, the effectiveness of treatment can be assessed as well as to ensure adequate residual adrenal function. Exogenous corticosteroids may concomitantly be administered. Higher than normal doses of exogenous corticosteroids may be required because of altered extra-adrenal metabolism.
