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:
Oral
1.5 - 4 g per m² of body surface area (BSA)
From 0.5 To 1.333 g per m² of body surface area (BSA) 3 time(s) per day every day
1.5 g per m² of body surface area (BSA)
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.
Mitotane should be taken with a glass of water during meals containing fat-rich food.