Adrenal cortical carcinoma (ACC)

Indication for Mitotane

Population group: Suitable for both men and women, only children (1 year - 12 years old) , adolescents (12 years - 18 years old)

Symptomatic treatment of advanced (unresectable, metastatic or relapsed) adrenal cortical carcinoma (ACC).

The effect of mitotane on non functional adrenal cortical carcinoma is not established.

For this indication, competent medicine agencies globally authorize below treatments:

1.5-4 g/m² in 2-3 divided doses daily

Route of admnistration


Defined daily dose

1.5 - 4 g per m² of body surface area (BSA)

Dosage regimen

From 0.5 To 1.333 g per m² of body surface area (BSA) 3 time(s) per day every day

Loading dose

1.5 g per m² of body surface area (BSA)

Detailed description

The experience in children is limited.

The paediatric posology of mitotane has not been well characterised but appears equivalent to that of adults after correction for body surface.

Treatment should be initiated at 1.5 to 3.5 g/m²/day in children and adolescents with the objective of reaching 4 g/m²/day. Mitotane plasma levels should be monitored as for adults, with particular attention when plasma levels reach 10 mg/L as a quick increase in plasma levels may be observed. Dose may be reduced after 2 or 3 months according to the mitotane plasma levels or in case of serious toxicity.

Dosage considerations

Mitotane should be taken with a glass of water during meals containing fat-rich food.

Active ingredient

Mitotane is an adrenal cytotoxic active substance, although it can apparently also cause adrenal inhibition without cellular destruction. Available data suggest that mitotane modifies the peripheral metabolism of steroids and that it also directly suppresses the adrenal cortex. The administration of mitotane alters the extra-adrenal metabolism of cortisol in humans, leading to a reduction in measurable 17-hydroxy corticosteroids, even though plasma levels of corticosteroids do not fall.

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