• Inoperable carcinoma of the adrenal cortex.

Unlabeled Uses:

• Cushing’s syndrome due to pituitary disorders.

Contraindicated in:

• Hypersensitivity
• OB: Pregnancy (may cause fetal harm)
• Lactation: Lactation.

Use Cautiously in:

• Obesity (↑ risk of adverse reactions)
• Premenopausal women (↑ risk of ovarian macrocysts)
• Women of reproductive potential
• Pedi: Safety and effectiveness not established in children.

Exercise Extreme Caution in:

• Shock or severe trauma; discontinue temporarily and administer steroids.

CV: hypertension, hypotension.

Derm: maculopapular rash, flushing.

EENT: blurred vision, ↓ hearing, diplopia, lens opacities, optic neuritis, toxic retinopathy.

Endo: adrenal suppression, gynecomastia.

GI: anorexia, diarrhea, nausea, vomiting, ↑ salivation.

GU: albuminuria, hematuria, hemorrhagic cystitis, ovarian macrocysts.

Hemat: ↑bleeding time.

Metab: hypercholesterolemia, hypouricemia.

MS: arthralgia, myalgia.

Neuro: lethargy, somnolence, brain damage, dizziness, fatigue, functional impairment (high-dose, long-term therapy), headache, irritability, mental depression, tremors, vertigo, weakness.

Resp: dyspnea, wheezing.
Misc: fever.

Drug-Drug:

• May ↓ levels and effectiveness of CYP3A4 substrates; avoid concomitant use with narrow therapeutic index substrates; if concurrent use is unavoidable, ↑ dose of CYP3A4 substrate.
• May ↓ levels and effectiveness of warfarin.
• Additive CNS depression with other CNS depressants, including alcohol, antihistamines, antidepressants, opioid analgesics, or sedative/hypnotics.

• Tablets: 500 mg;

Adrenocortical Carcinoma

• PO (Adults): 2–6 g/day in 3–4 divided doses; may be ↑ as tolerated (range 2–16 g/day).

Cushing’s Syndrome

• PO (Adults): 3–6 g/day in 3–4 divided doses initially, ↓ to maintenance dose of 500 mg twice weekly to 2 g/day.

Lysodren

• Suppresses adrenal function.
• Has a direct cytotoxic effect on adrenal tumors.
• Structurally related to DDT (an insecticide).

• Regression of adrenal cortical tumors.

Therapeutic Classification: antineoplastics

Absorption: 30–40% absorbed following oral administration.

Distribution: Widely distributed to all body tissues; accumulates in fatty tissue.

Metabolism/Excretion: Slowly released from fatty tissue. Mostly metabolized by the liver; 10% excreted by the kidneys; 15% excreted in bile.

Half-life: 18–159 days.

(clinical effects†)

†Onset = inhibition of adrenocortical function; peak = tumor response.

• Instruct patient to take medication exactly as directed. Take missed doses as soon as remembered unless almost time for next dose. Notify health care professional of missed doses.
• Explain to patient that this drug suppresses the adrenal glands and therefore impairs the body’s ability to cope with stress. Concurrent corticosteroid and mineralocorticoid therapy may be ordered to ensure that adequate amounts of adrenal hormones are present. Health care professional should be notified if an infection, illness, or injury occurs because supplemental steroids may be necessary or mitotane may need to be discontinued in the event of severe trauma or shock.
• May cause drowsiness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
• Instruct patient to notify health care professional if vaginal bleeding, pelvic pain, depression, nausea, vomiting, anorexia, diarrhea, skin rash, or darkening of skin occurs or if muscle aches, fever, flushing, or muscle twitching becomes pronounced.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications. Avoid taking alcohol or other CNS depressants with this medication.
• May cause fetal harm. Advise females of reproductive potential to use an effective nonhormonal form of contraception during and following therapy for as long as instructed by health care professional. Advise patient to notify health care professional if pregnancy is planned or suspected and to avoid breastfeeding during therapy.
• Advise patient to carry identification describing medication regimen in the event of an emergency in which patient cannot relate medical history.
• Explain need for continued medical follow-up, including neurologic exam to assess effectiveness and possible side effects of medication.

MYE-toe-tane