Adult Dosing

Adrenocortical carcinoma

• Start: 2-6 g/day PO divided tid-qid
• Increase 9-10 g/day; usual range 2-16 g/day
• Max: 18 g/day
• Note: Start elderly patients at low end of dosing range

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

• Mitotane is indicated for the treatment of inoperable adrenal cortical carcinoma of both functional and nonfunctional types

• Patients who have demonstrated a previous hypersensitivity to the drug

• Mitotane should be administered only under supervision of a physician experienced in cancer chemotherapy
• It may cause adrenal Suppression; hold therapy immediately after shock or severe trauma and administer exogenous steroids since adrenal steroid secretion may be depressed

Renal Dose Adjustment

• Renal impairment: Dose adjustment not defined

Hepatic Dose Adjustment

• Hepatic impairment: Caution advised

• Consider adrenal steroid replacement in patients treated with mitotane due to possibility of adrenal insufficiency
• Long-term continuous administration may lead to brain damage and impairment of cognitive function. Perform behavioral and neurological assessments at regular intervals when continuous treatment exceeds 2 years
• In order to minimize the possibility of infarction and hemorrhage in the tumor, all possible tumor tissues should be surgically removed from large metastatic masses before starting therapy with mitotane
• Administer with care to patients with liver disease other than metastatic lesions from the adrenal cortex due to possibility of drug accumulation
• Caution patients about driving, operating machinery, and engaging in other hazardous tasks requiring mental and physical alertness

Pregnancy Category:C

Breastfeeding: Safety unknown. Because of the potential for possible serious adverse reactions in nursing infants a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

• GI: Anorexia, nausea, vomiting and diarrhea
• CNS: Lethargy, somnolence, dizziness or vertigo
• EENT: Visual blurring, diplopia, lens opacity, toxic retinopathy
• GU: Hematuria, hemorrhagic cystitis and albuminuria
• CVS: Hypertension, flushing and orthostatic hypotension
• DERM: Skin toxcity
• MISC: Hyperpyrexia, generalized aching, lowered protein bound iodine

• Adrenalytic agent; suppresses adrenal function; has a direct cytotoxic effect on adrenal tumors, modifies steroid metabolism
• Mostly metabolized by liver; CYP450: unknown
• Excreted in urine (10%) and bile (1-17%)
• Half-life: 18-159 days

US Trade Name(s)

• Lysodren

US Availability

Lysodren

• TABS: 500 mg

Canadian Trade Name(s)

• Lysodren

Canadian Availability

Lysodren

• TABS: 500 mg

UK Trade Name(s)

• Lysodren

UK Availability

Lysodren

• TABS: 500 mg

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

Hematology/Oncology

Antineoplastics

Pricing data from www.DrugStore.com in U.S.A.

• Lysodren 500 MG TABS [Bottle] (B-M SQUIBB ONCOLOGY/IMMUNOLOGY)
  30 mg = $151.99
  90 mg = $445.96

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Lysodren 500 MG Oral Tablet

Ingredient(s): Mitotane

Imprint: BL;L1

Color(s): White

Shape: Round

Size (mm): 13.00

Score: 2

Inactive Ingredient(s): avicel / polyethylene glycol 3350 / silicon dioxide / starch

Drug Label Author:
Bristol-Myers Squibb

DEA Schedule:
Non-Scheduled