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mitotane (Rx)Brand and Other Names:Lysodren

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 500mg
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Adrenal Carcinoma

Indicated for inoperable adrenal cortical carcinoma of both functional and nonfunctional types

Initial: 2-6 g/day PO divided q6-8hr, THEN

Increase incrementally to 9-10 g/day divided q6-8hr

Maximum tolerated dose varies from 2-16 g/day, usually 9-10 g/day

The highest doses used in clinical trials were 18-19 g/day

Cushing's Syndrome (Off-label)

Initial: 1.5 g PO divided q6-8hr; not to exceed 3 g PO q8hr

Maintenance: 500 mg 2 x/week to 2 g/day

Administration

All tumor tissue should be surgically removed before administration

Monitor

Growth of adrenal cortex metastatic lesion

Hepatic Impairment

May need to decrease dose in patients with liver disease

Dosage Forms & Strengths

tablet

  • 500mg
more...

Adrenocortical Carcinoma (Off-label)

1-2 g/day PO in divided dose; may increase gradually not to exceed 5-7 g/day

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Interactions

Interaction Checker

mitotane and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Nausea (39%)

            Vomiting (37%)

            Lethargy/somnolence (25%)

            Anorexia (24%)

            Vertigo (15%)

            Skin rash (15%)

            Diarrhea (13%)

            Weakness (12%)

            Frequency Not Defined

            Eye: Visual blurring, diplopia, lens opacity, toxic retinopathy

            Genitourinary: Hematuria, hemorrhagic cystitis, and albuminuria

            Cardiovascular: Hypertension, orthostatic hypotension, and flushing

            Generalized aching and hyperpyrexia

            Decreased protein bound iodine

            Postmarketing Reports

            Blood and lymphatic system disorders: Neutropenia

            Endocrine disorders: Growth retardation, hypothyroidism

            Psychiatric disorders: Confusional state

            Nervous system disorders: Neuropsychological disturbance, dysarthria, headache, ataxia, mental impairment

            Eye disorders: Maculopathy

            Hepatobiliary disorders: Hepatitis, elevation of liver enzymes

            Reproductive system and breast disorders: Gynecomastia

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            Warnings

            Black Box Warnings

            Administered under the supervision of an experienced cancer chemotherapy physician in a facility equipped to manage complications

            The drug suppresses adrenal function; stop therapy temporarily after shock or severe trauma and administer exogenous steroids since the drug depressed adrenal function may not immediately return

            Contraindications

            Hypersensitivity

            Cautions

            Discontinue immediately following shock or severe trauma; exogenous steroid should be administered in such circumstances

            Adrenal insufficiency may develop requiring adrenal steroid replacement

            Patients with liver disease in addition to metastatic lesion of adrenal cortex

            Long-term administration of high doses may lead to brain damage

            Mitotane plasma concentrations >20 mcg/mL associated with a greater incidence of high grade CNS toxicity

            Increases hormone binding proteins, measurement of free cortisol and corticotropin (ACTH) levels may be useful in achieving optimal steroid replacement

            Prolonged bleeding time reported; consider this possibility prior to any surgical intervention or if coadministered with anticoagulants

            Reduces tumor mass but no evidence of cure

            Advise women of reproductive potential of risks to fetus; use effective contraception

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            Pregnancy & Lactation

            Pregnancy Category: D

            Lactation: Detected in breast milk; because of the potential for serious adverse reactions in nursing infants from mitotane, advise women to discontinue nursing during therapy and after treatment discontinuation for as long as mitotane plasma levels are detectable

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Adrenalytic agent; inhibits select adrenal cortex functions by binding to mitochondreal proteins resulting in adrenal atrophy and tumor death; atrophy observed in the zona fasciculata and reticularis

            Absorption

            5-40%

            Distribution

            Widely distributed with primary concentration in adipose tissue

            Metabolism

            Partly converted to an uncharacterized water-soluble metabolite

            Elimination

            Half-life: 18-159 days

            Peak plasma time: 3-5 hr

            Excretion

            • 10% urine (PO); 25% urine (IV); excreted in urine as water-soluble metabolite
            • Small amounts in bile
            • Balance stored in tissues
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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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