MITOTANE

Other

Brand names: Lysodren

Oral

Mechanism of Action

12.1 Mechanism of Action Mitotane is an adrenal cytotoxic agent with an unknown mechanism of action. Mitotane modifies the peripheral metabolism of steroids and directly suppresses the adrenal cortex. A reduction in 17-hydroxycorticosteroids in the absence of decreased corticosteroid levels and increased formation of 6-β-hydroxycortisol have been reported.

Indications

1 INDICATIONS AND USAGE LYSODREN is indicated for the treatment of patients with inoperable

functional or nonfunctional

adrenocortical carcinoma (ACC). LYSODREN is an adrenal cytotoxic agent indicated for the treatment of patients with inoperable

functional or nonfunctional

adrenocortical carcinoma (ACC). ( 1 )

Contraindications

• 4 CONTRAINDICATIONS None. None. ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Adrenal Insufficiency and Adrenal Crisis: Temporarily withhold LYSODREN during shock, trauma, infection or adrenal insufficiency
Advise females of reproductive potential of the potential risk to a fetus and to use effective, nonhormonal contraception
Routine in vitro bleeding time is not suitable to detect this platelet defect and to assess bleeding risk
Perform ADP-inducted platelet aggregometry testing prior to surgery or dental procedures to determine mitotane-induced bleeding risk

Known Side Effects

8 documented side effects by frequency

Nausea

>10%

Fatigue

>10%

Diarrhea

1-10%

Vomiting

1-10%

Drug Not Working

1-10%

Weakness

1-10%

Dizziness

1-10%

Decreased Appetite

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral