Drug Index

Mitotane

Mechanism :

Mitotane is an adrenolytic agent that suppresses (directly) the adrenal cortex and alters the peripheral metabolism of steroids.


Indication :

  • Treatment of inoperable (functional or non-functional) adrenocortical carcinoma
  • Off-label: Cushing syndrome

Contraindications :

Hypersensitivity to mitotane or any component of the formulation.


Dosing :

Adrenocortical carcinoma (stage III or IV) (off-label use):
Oral: Initial: 0.5 to 1 g/day divided 3 times a day, increase weekly to a target dose of 4 g/m²/day (divided 3 times a day) in combination with 8 cycles of the CED regimen (cisplatin, etoposide, and doxorubicin).

Adverse Effect :

Nausea, vomiting, lethargy, anorexia, vertigo, skin rash, diarrhea, weakness, Visual blurring, diplopia, lens opacity, toxic retinopathy, hematuria, hemorrhagic cystitis, albuminuria, hypertension, orthostatic hypotension, flushing, neutropenia, hypothyroidism, growth retardation.


Interaction :

Antihepaciviral Combination Products: CYP3A4 Inducers may decrease the serum concentration of Antihepaciviral Combination Products.

CYP3A4 Substrates: Mitotane may decrease the serum concentration of CYP3A4 Substrates.



Hepatic Dose :

Hepatic impairment may interfere with the metabolism of mitotane and drug accumulation
can occur. No dose adjustments are recommended. Avoid use in patients with severe hepatic impairment. In patients with mild to moderate hepatic impairment, use with caution and monitor liver functions. Adjust dose as per mitotane plasma levels.
06/05/2024 07:49:58 Mitotane
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