Lysodren mitotane 500 mg Tablet, 100-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Other antineoplastic agents class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- Lysodren is a targeted cancer drug used to treat adrenocortical carcinoma, which is a rare cancer of the adrenal gland. It is sometimes grouped with chemotherapy, but it works diff...
- What exactly is Lysodren treating — is it chemotherapy?
- Yes, it matters. Lysodren is a fat-loving drug, and eating — especially a high-fat meal — significantly helps your body absorb it. You should take it with food every time, and try...
- Why do I need to take it with food, and does it matter what I eat?
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII G2M7P15E5P
Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
4 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $15.72 | $1,572.22 / 100 tablets |
| Medicare drug plans payPart D · Q2 2026 | $39.43 | $3,943.27 / 100 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Lysodren 500 mg 68118-0080-60 | ESTEVE | 100 tablets | — | — | FDA listed | — |
| Lysodren 500 mgthis 76336-0080-60 | HRA | 100 tablets | — | — | FDA listed | — |
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⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
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🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 76336-0080-60 You're viewing this | 1 BOTTLE in 1 CARTON (76336-080-60) / 100 TABLET in 1 BOTTLE | 1978-10-15 | Active |
🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | ✓ Available |
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: ADRENAL CRISIS IN THE SETTING OF SHOCK, SEVERE TRAUMA OR INFECTION Patients treated with LYSODREN are at increased risk for developing adrenal crisis in the setting of shock, severe trauma or infection that may lead to death. If shock, severe trauma or infection occurs or develops, temporarily discontinue LYSODREN and administer exogenous steroids. Monitor patients closely for infections and instruct patients to contact their physician immediately if injury, infection, or any other concomitant illness occurs [see Dosage and Administration (2.3) and Warnings and Precautions (5.1)].
WARNING: ADRENAL CRISIS IN THE SETTING OF SHOCK, SEVERE TRAUMA OR INFECTION See full prescribing information for complete boxed warning. Patients treated with LYSODREN are at increased risk for developing adrenal crisis in the setting of shock, severe trauma or infection that may lead to death. If shock, severe trauma or infection occurs or develops, temporarily discontinue LYSODREN and administer exogenous steroids.
Monitor patients closely for infections and instruct patients to contact their physician immediately if injury, infection, or any other concomitant illness occurs ( 2.3 , 5.1 ).
🎯 Indications and Usage ▾
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 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION The recommended initial dose of LYSODREN is 2000 mg to 6000 mg orally, in three or four divided doses per day with food. ( 2.3 ) Titrate LYSODREN dose to achieve a plasma level of 14 to 20 mg/L. ( 2.3 ) LYSODREN is lipophilic and accumulates in adipose tissue. ( 2.3 )
2.1Recommended Evaluation and Testing Before Initiating LYSODREN Before initiating LYSODREN, evaluate pelvic ultrasound in premenopausal women, liver functions tests and complete blood count [see Warnings and Precautions (5.3 , 5.4 , 5.5) ].
2.2General Precautions LYSODREN is a hazardous drug. Advise caregivers to wear disposable gloves when handling LYSODREN tablets [see References (15) and Storage and Handling (16) ].
2.3Recommended Dosage and Administration Recommended Dosage The recommended initial dose of LYSODREN is 2000 mg to 6000 mg orally, in three or four divided doses per day. Monitor mitotane plasma levels and increase the dose based on patient tolerance and clinical response incrementally to achieve a mitotane plasma level of 14 to 20 mg/L, or as tolerated. Consider monitoring mitotane plasma levels every 2 weeks after starting treatment and after each dose adjustment.
The target plasma level is usually reached within a period of 3 to 5 months. Monitor mitotane plasma levels periodically (e.g., monthly). Severe neurotoxicity may occur with levels > 20 mg/L.
Dose Adjustments, Monitoring and Discontinuation In case of mitotane plasma levels above 20 mg/L without toxicities, consider reducing the dose by 50 to 75%. Monitor mitotane plasma levels regularly (e.g., every two months) after discontinuation of treatment. Due to the prolonged half-life, significant levels may persist for weeks after cessation of therapy.
LYSODREN is lipophilic and accumulates in adipose tissue. Despite maintaining a constant dose, mitotane levels may suddenly increase. Monitor mitotane plasma levels even when LYSODREN has been withheld as adipose tissue may continue to release mitotane [see Clinical Pharmacology (12.3) ] .
Due to adipose tissue accumulation of mitotane, close monitoring of mitotane plasma levels is recommended in overweight patients and patients with recent weight loss. Administration Swallow LYSODREN tablets whole; do not crush, chew or split. Take LYSODREN with food.
Timing of the dose relative to meals must be consistent. Administration with high fat food enhances absorption [See Clinical Pharmacology Section (12.3) ]. Do not take tablets showing signs of deterioration.
Caregivers should wear disposable gloves when handling the tablets. Avoid exposure to crushed and/or broken tablets. If contact with crushed/broken tablets occurs, wash the contaminated skin immediately and thoroughly.
If a patient misses a dose, instruct the patient to take the next dose as scheduled. If a patient vomits after taking a dose, instruct the patient to take the next dose as scheduled.
2.4Dosage Modifications for Adverse Reactions The recommended dosage reduction for adverse reactions is to decrease the usual daily dose by 500 – 1000 mg. Table 1 describes the dosage modifications for specific adverse reactions. Table 1: Recommended Dosage Modifications for LYSODREN for Adverse Reactions Adverse Reaction Severity Severity defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Dosage Modification Adrenal Crisis and Adrenal Insufficiency [see Warnings and Precautions (5.1) ] All Grades Withhold LYSODREN during shock, trauma, infection or adrenal insufficiency until recovery to Grade ≤1 or baseline. Resume LYSODREN at a reduced dose or permanently discontinue based on severity. Central Nervous System (CNS) Toxicity [see Warnings and Precautions (5.2) ] Grade 2 Measure mitotane plasma level and modify the dosage according to the following recommendations: Mitotane plasma level less than 14 mg/L: reduce the daily dose by 1000 mg.
Mitotane plasma level in the therapeutic window (14 to 20 mg/L): reduce…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Tablets: 500 mg, scored. ( 3 ) Tablets: 500 mg white, round, biconvex, scored tablets, bisected on one side and impressed with "BL" over "L1" on the other side.
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Adrenal Insufficiency and Adrenal Crisis: Temporarily withhold LYSODREN during shock, trauma, infection or adrenal insufficiency. Steroid replacement may be necessary. (5.1) Central Nervous System (CNS) Toxicity : Monitor behavioral and neurologic assessments and mitotane plasma levels at regular intervals.
Mitotane plasma levels exceeding 20 mg/L are associated with a greater incidence of toxicity. Advise patients not to drive or operate hazardous machinery if experiencing CNS adverse reactions. (5.2) Ovarian Macrocysts in Premenopausal Women : Monitor pelvic ultrasound at baseline and at regular intervals.
Withhold, reduce the dose, or permanently discontinue LYSODREN based on severity. (5.3) Hepatotoxicity : Monitor liver functions tests prior to starting LYSODREN, during dose titration and as clinically indicated. Withhold, reduce the dose or permanently discontinue based on severity.
(5.4) Hematologic Toxicity: Monitor complete blood counts prior to starting LYSODREN, during dose titration and as clinically indicated. Withhold, reduce the dose or permanently discontinue based on severity. (5.5) Prolonged Bleeding Time : Prolonged bleeding time has occurred in patients treated with mitotane and this should be taken into account when surgery is considered.
(5.6) Embryo-Fetal Toxicity : Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective, nonhormonal contraception. (5.8)
5.1Adrenal Insufficiency and Adrenal Crisis Adrenal Insufficiency LYSODREN can cause adrenal insufficiency or worsen existing adrenal insufficiency in patients with adrenocortical carcinoma. Monitor for both glucocorticoid and mineralocorticoid insufficiency and replace systemic corticosteroids accordingly. Due to increased steroid clearance and increase of steroid-binding protein, high-dose replacement therapy may be required and free cortisol and corticotropin (ACTH) should be monitored to adapt the systemic corticosteroids.
Withhold, reduce the dose, or permanently discontinue LYSODREN based on severity [see Dosage and Administration (2.4) ]. Adrenal Crisis in the Setting of Shock, Severe Trauma or Infection LYSODREN can cause adrenal suppression and adrenal crisis in the setting of shock, severe trauma or infection. Advise patients of the signs and symptoms of adrenal suppression and to contact their healthcare provider immediately if shock, trauma, infection, or adrenal suppression occurs.
Withhold LYSODREN before planned surgeries. Temporarily withhold LYSODREN during shock, trauma, infection or adrenal suppression [see Dosage and Administration (2.4) ]. Provide supportive care and administer systemic corticosteroids until recovery.
5.2Central Nervous System Toxicity LYSODREN can cause central nervous system toxicity, including sedation, lethargy, and vertigo [see Adverse Reactions (6.1) ]. Monitor behavioral and neurologic assessments and mitotane plasma levels at regular intervals. Mitotane plasma levels exceeding 20 mg/L are associated with a greater incidence of toxicity.
In cases of cognitive dysfunction, thyroid function should be evaluated as mitotane may induce hypothyroidism. LYSODREN can impair the ability to drive and operate machinery. Advise patients not to drive or operate hazardous machinery if they are experiencing CNS adverse reactions.
Withhold, reduce the dose, or permanently discontinue LYSODREN based on severity [see Dosage and Administration (2.4) ].
5.3Ovarian Macrocysts in Premenopausal Women LYSODREN can cause non-malignant, multiple and bilateral ovarian macrocysts in premenopausal women. Ovarian macrocysts can be symptomatic (e.g., pelvic pain or discomfort, or menstrual irregularities) or asymptomatic. Complications from these cysts, including adnexal torsion and hemorrhagic cyst rupture, have occurred.
Advise female patients to contact their healthcare provider immediately for gynecological symptoms such as vaginal bleeding and/or…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Adrenal Insufficiency and Adrenal Crisis [see Warnings and Precautions (5.1)] • Central Nervous System Toxicity [see Warnings and Precautions (5.2)] • Ovarian Macrocysts in Premenopausal Women [see Warnings and Precautions (5.3)] • Hepatotoxicity [see Warnings and Precautions (5.4)] • Hematologic Toxicity [see Warnings and Precautions (5.5)] • Prolonged Bleeding Time [see Warnings and Precautions (5.6)] • Hormone Binding Protein [see Warnings and Precautions (5.7)] • Embryo-Fetal Toxicity [see Warnings and Precautions (5.8)] Most common adverse reactions include: anorexia, epigastric discomfort, nausea, vomiting, diarrhea, dizziness, vertigo, rash, hypercholesterolemia, hypertriglyceridemia, hypothyroidism, and decreased blood free testosterone in males.
(6) To report SUSPECTED ADVERSE REACTIONS, contact Direct Success Inc.at 1-844-597-6373 or FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Reported adverse reactions include: Metabolism and nutrition disorders: Anorexia Gastrointestinal disorders: Epigastric discomfort, nausea, vomiting, diarrhea, mucosal inflammation, dyspepsia Nervous system disorders: Dizziness, vertigo, confusion, headache, ataxia, mental impairment, weakness, dysarthria, paresthesia, polyneuropathy, movement disorder, balance disorder, dysgeusia Skin and subcutaneous tissue disorders: Rash, pruritus, hypersensitivity reactions Blood and lymphatic system disorders: Leukopenia, anemia, thrombocytopenia, prolonged bleeding time, hematuria, hemorrhagic cystitis Endocrine: Growth retardation, hypothyroidism Eye disorders: Maculopathy, visual blurring, diplopia, lens opacity, retinopathy Hepatobiliary disorders: Hepatitis, elevation of liver enzymes, liver injury (hepatocellular/cholestatic/mixed) Reproductive system and breast disorders: Gynecomastia, hypogonadism (in males) Investigations: Hypercholesterolemia, hypertriglyceridemia, decreased plasma androstenedione, decreased plasma testosterone in females, increased sex hormone binding globulin in females and males, decreased blood free testosterone in males, hypouricemia Musculoskeletal disorders: Muscular weakness, generalized aching General disorders: Fever Renal and urinary disorders: Albuminuria/proteinuria Vascular disorders: Hypertension, orthostatic hypotension, flushing Infections: Opportunistic infection Respiratory, thoracic and mediastinal disorders: Dyspnoea
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Spironolactone: Avoid concomitant use with LYSODREN. ( 7.1 ) Certain CYP3A Substrates: Avoid concomitant use with LYSODREN. ( 7.2 ) Hormonal contraceptives: Avoid concomitant use with LYSODREN. ( 7.2 ) Warfarin: Avoid concomitant use with LYSODREN. ( 7.2 )
7.1Effects of Other Drugs on LYSODREN Spironolactone Spironolactone may block the action of mitotane. Avoid concomitant use of mitotane with spironolactone [see Clinical Pharmacology (12.3) ].
7.2Effects of LYSODREN on Other Drugs Certain CYP3A substrates Mitotane is a strong CYP3A inducer. Concomitant use of LYSODREN may decrease the levels of CYP3A substrates, which may reduce the activity of these substrates [see Clinical Pharmacology (12.3) ]. Avoid concomitant use of LYSODREN with other CYP3A substrates, where minimal level changes may lead to serious therapeutic failures.
If concomitant use cannot be avoided, modify the dosage of the CYP3A substrate in accordance with the approved product labeling. Hormonal Contraceptives Avoid concomitant use of LYSODREN with hormonal contraceptives [see Warnings and Precautions (5.8) , Use in Specific Populations (8.3) ]. Warfarin Mitotane may induce the metabolism of warfarin, which may reduce its level and its efficacy [see Clinical Pharmacology (12.3) ] .
Avoid concomitant use of LYSODREN with warfarin. If concomitant use cannot be avoided, monitor INR more frequently and adjust warfarin dose as recommended in accordance with the recommendations in the warfarin Prescribing Information.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS 8 USE IN SPECIFIC POPULATIONS Lactation :Advise not to breastfeed. (8.2) Hepatic Impairment :LYSODREN is not recommended for patients with severe hepatic impairment. In patients with mild to moderate hepatic impairment, monitor mitotane plasma levels frequently and modify the dosage as needed.
(8.6) Renal Impairment : LYSODREN is not recommended for patients with severe renal impairment. In patients with mild or moderate renal impairment, monitor mitotane plasma levels frequently and modify the dosage as needed. (8.7)
8.1Pregnancy Risk Summary LYSODREN can cause fetal harm. Limited postmarketing cases report preterm births and early pregnancy loss in women treated with LYSODREN during pregnancy. Animal reproduction studies have not been conducted with mitotane.
Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
8.2Lactation Risk Summary Mitotane is excreted in human milk; however, the effect of LYSODREN on the breastfed child, or on milk production is unknown. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with LYSODREN and after discontinuation of treatment for as long as mitotane plasma levels are detectable.
8.3Females and Males of Reproductive Potential Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to initiating LYSODREN [see Use in Specific Populations (8.1) ] . Contraception LYSODREN can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ] . Females Advise females of reproductive potential to use effective nonhormonal contraception during treatment with LYSODREN and after discontinuation of therapy for as long as mitotane plasma levels are detectable [see Clinical Pharmacology (12.3) ] .
LYSODREN can render hormonal contraceptives ineffective [see Drug Interaction (7.2) ] .
8.4Pediatric Use Effectiveness in pediatric patients has not been established. Based on published case reports, mitotane may negatively impact neuro-psychological development (e.g., motor and speech delay, memory impairment) in children and adolescents. In cases of cognitive dysfunction, thyroid function should be evaluated as mitotane may induce hypothyroidism.
Other effects of mitotane observed in pediatric patients that are cited in medical literature or in a pharmacovigilance database include growth delay and estrogenic-like effects such as uterine bleeding, breast development in females and gynecomastia in males.
8.5Geriatric Use Clinical studies of LYSODREN did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients. Other reported clinical experience has not identified differences in responses between the older and younger patients. In general, dose selection for an older patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
8.6Hepatic Impairment Mitotane is metabolized through the liver and mitotane plasma levels may increase if liver function is impaired. Because of the increased risk of adverse reactions in patients with mild or moderate hepatic impairment, monitor mitotane plasma levels more frequently and modify the dosage as needed [see Dosage and Administration (2.3) ]. LYSODREN is not recommended for use in patients with severe hepatic impairment [see Warnings and Precautions (5.4) ] .
8.7Renal Impairment Mitotane is eliminated through the kidney and mitotane plasma levels may increase if renal function is impaired. Because of the increased risk of adverse reactions in patients with mild and moderate renal impairment, monit…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary LYSODREN can cause fetal harm. Limited postmarketing cases report preterm births and early pregnancy loss in women treated with LYSODREN during pregnancy. Animal reproduction studies have not been conducted with mitotane.
Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
🧒 Pediatric Use ▾
8.4Pediatric Use Effectiveness in pediatric patients has not been established. Based on published case reports, mitotane may negatively impact neuro-psychological development (e.g., motor and speech delay, memory impairment) in children and adolescents. In cases of cognitive dysfunction, thyroid function should be evaluated as mitotane may induce hypothyroidism.
Other effects of mitotane observed in pediatric patients that are cited in medical literature or in a pharmacovigilance database include growth delay and estrogenic-like effects such as uterine bleeding, breast development in females and gynecomastia in males.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of LYSODREN did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients. Other reported clinical experience has not identified differences in responses between the older and younger patients. In general, dose selection for an older patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
🆘 Overdosage ▾
10 OVERDOSAGE LYSODREN overdosage (plasma levels are above 20 mg/L) can cause central nervous system toxicity, including sedation, lethargy, and vertigo, as well as muscular weakness and gait disturbance. Withhold LYSODREN as clinically indicated for signs or symptoms of toxicity. LYSODREN is lipophilic and has a prolonged half-life; therefore, it may take weeks for plasma levels to decrease.
LYSODREN is not likely to be dialyzable. Increase the frequency of mitotane plasma level monitoring, as clinically indicated.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism 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.
12.2Pharmacodynamics Mitotane exposure-response relationships and the time course of pharmacodynamic response have not been fully characterized.
12.3Pharmacokinetics Absorption Following oral administration of LYSODREN, 40% of the dose is absorbed. Effect of Food The effect of food on the absorption of mitotane (LYSODREN) is not known. High fat food: Data with various mitotane formulations suggest that administration with high fat food enhances absorption of mitotane.
Distribution Mitotane is found in most tissues of the body; however, fat is the primary site of distribution. Elimination Following discontinuation of mitotane, the plasma terminal half-life ranges from 18 to 159 days (median 53 days). Metabolism Mitotane is converted to a water-soluble metabolite.
Mitotane metabolism includes hepatic and extrahepatic metabolism. Mitotane is metabolized to 1,1-(o,p'-dichlorodiphenyl) acetic acid (o,p'-DDA), as the major circulating metabolite. Excretion No unchanged mitotane is found in urine or bile.
Approximately 10% of the administered dose is recovered in the urine as a water-soluble metabolite. A variable amount of metabolite (1%-17%) is excreted in the bile. Specific Populations Patients with Hepatic or Renal Impairment The pharmacokinetics of mitotane have not been studied in patients with hepatic impairment or patients with renal impairment.
Drug Interaction Studies Effects of Mitotane on Other Drugs Midazolam: Coadministration of a single dose of midazolam (CYP3A substrate) in patients who received LYSODREN resulted in decreased midazolam concentrations relative to patients who had not received LYSODREN. Spironolactone : The effect of concomitant spironolactone on the pharmacokinetics of mitotane has not been studied; however, patients exhibited significantly lower mitotane levels compared to those who did not receive concomitant spironolactone despite receiving higher mitotane doses.
🧬 Mechanism of Action ▾
12.1Mechanism 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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING LYSODREN tablets are supplied as 500 mg white, round, biconvex, scored tablets, bisected on one side and impressed with "BL" over "L1" on the other side. 100 tablets per bottle: NDC 76336-080-60 Store bottles at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F-86°F). Mitotane is a hazardous drug. Follow applicable special handling and disposal procedures [see References (15) ] .
📦 Storage and Handling ▾
Store bottles at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F-86°F). Mitotane is a hazardous drug. Follow applicable special handling and disposal procedures [see References (15) ] .
📋 Description ▾
11 DESCRIPTION LYSODREN (mitotane) is an oral adrenal cytotoxic agent. The chemical name is (±)-1,1-dichloro-2-( o -chlorophenyl)-2-( p -chlorophenyl) ethane (also known as o,p'-DDD). The chemical structure is: Mitotane is a white granular solid composed of clear colorless crystals.
It is tasteless and has a slight pleasant aromatic odor. It is soluble in ethanol and has a molecular weight of 320.05. Inactive ingredients in LYSODREN are: microcrystalline cellulose, polyethylene glycol 3350, silicon dioxide, and starch.
Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION 17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Adrenal Insufficiency and Adrenal Crisis • Advise patients of the risk of adrenal suppression that may require steroid treatment and interruption or discontinuation of LYSODREN [see Warnings and Precautions (5.1)]. • Advise patients to discontinue LYSODREN in the case of shock, severe trauma or infection and contact their healthcare provider immediately [see Warnings and Precautions (5.1)]. • Advise patients to inform their healthcare provider of any planned surgeries [see Warnings and Precautions (5.1)].
Central Nervous System Toxicity • Advise patients to contact their healthcare provider if they experience new or worsening symptoms of central nervous system (CNS) toxicity including sedation, lethargy and vertigo [see Warnings and Precautions (5.2)]. • Instruct patients not to drive or operate hazardous machinery if they are experiencing CNS adverse reactions [see Warnings and Precautions (5.2)]. Ovarian Macrocysts in Premenopausal Women • Advise premenopausal women that their healthcare provider will monitor them with routine imaging and to contact their healthcare provider if they experience gynecological symptoms such as vaginal bleeding and/or pelvic pain [see Warnings and Precautions (5.3)].
Hepatotoxicity • Advise patients that their healthcare provider will monitor them with laboratory tests to monitor liver function and to immediately contact their healthcare provider to report signs and symptoms of hepatotoxicity [see Warnings and Precautions (5.4)]. Hematologic Toxicity • Advise patients to immediately contact their healthcare provider for fever, other signs of infection, unusual bruising, bleeding, tiredness or pallor [see Warnings and Precautions (5.5)]. Prolonged Bleeding Time • Advise patients of the possibility of prolonged bleeding time while taking LYSODREN and of the need to withhold LYSODREN if surgery or dental procedures are needed [see Warnings and Precautions (5.6)]. • Advise patients to inform their healthcare provider of any planned surgeries or dental procedures [see Warnings and Precautions (5.6)]. • Advise patients to contact their healthcare provider for bruising or bleeding [see Warnings and Precautions (5.6)].
Embryo-Fetal Toxicity • Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.8) and Use in Specific Populations (8.1)]. Females of Reproductive Potential • Advise females of reproductive potential to use effective nonhormonal contraception during treatment with LYSODREN and after discontinuation of treatment for as long as mitotane plasma levels are detectable, since LYSODREN can render some hormonal contraceptives ineffective [see Drug Interactions (7.2), Use in Specific Populations (8.3)].
Lactation • Advise females not to breastfeed during treatment with LYSODREN [see Use in Specific Populations (8.2)]. Drug Interactions • Advise patients and their caregivers to inform their healthcare providers of all concomitant medications, herbal and dietary supplements [see Drug Interactions (7.1, 7.2)]. Address medical inquiries to: Direct Success Inc.
1710 Hwy 34 Farmingdale, NJ 07727 1-844-597-6373 Fax: 1-855-674-6767 Manufactured by: Latina Pharma S.p.A. Via Murillo, 7 04013 Sermoneta (Latina) Italy For: HRA Pharma Rare Diseases Advise the patient to read the FDA-approved patient labeling (Medication Guide). Adrenal Insufficiency and Adrenal Crisis Advise patients of the risk of adrenal suppression that may require steroid treatment and interruption or discontinuation of LYSODREN [see Warnings and Precautions (5.1) ].
Advise patients to discontinue LYSODREN in the case of shock, severe trauma or infection and contact their healthcare provider immediately [see Warnings and Precautions (5.1) ]. Advise patients to inform the…
💬 Medication Guide ▾
MEDICATION GUIDE LYSODREN® (LY-SO-DREN) (mitotane) tablets, for oral use What is the most important information I should know about LYSODREN? LYSODREN can cause serious side effects including: Adrenal Insufficiency and Adrenal Crisis. Adrenal Insufficiency.
LYSODREN can cause your adrenal glands to stop making enough corticosteroid hormones (adrenal insufficiency) or make this problem worse in people with cancer of the adrenal glands (adrenocortical carcinoma). Your healthcare provider may temporarily stop, reduce your dose, or permanently stop treatment with LYSODREN if you develop adrenal insufficiency during treatment. Adrenal Crisis.
LYSODREN can cause your adrenal glands to suddenly stop making enough corticosteroid hormones (adrenal crisis). You are at increased risk for developing adrenal crisis if you experience shock, severe injury, or infection during treatment with LYSODREN. Adrenal crisis may lead to death.
Tell your healthcare provider right away if you get an injury, infection, or other illness during treatment with LYSODREN. Your healthcare provider will temporarily stop LYSODREN if shock, severe injury, or infections happen during treatment. Tell your healthcare provider if you have any planned surgery.
Your healthcare provider will check your levels of corticosteroid hormones during treatment and may give you corticosteroid medicine if you develop adrenal gland problems. Tell your healthcare provider right away if you develop any signs or symptoms of adrenal gland problems, including: severe weakness confusion pain in the lower back and legs stomach (abdominal) pain nausea, vomiting, or diarrhea feeling lightheaded or dizzy passing out feeling very tired decreased appetite weight loss areas of darkened skin craving salt low blood sugar feeling irritable or depressed hair loss See "What are the possible side effects of LYSODREN?" for more information about side effects.
What is LYSODREN? LYSODREN is a prescription medicine used to treat people with cancer of the adrenal glands (adrenocortical carcinoma) that is functional (when the adrenal glands make more corticosteroid hormone than normal) or nonfunctional (when the adrenal glands make less corticosteroid hormone than normal) and the cancer cannot be removed by surgery. Effectiveness in pediatric patients has not been established.
Before taking LYSODREN, tell your healthcare provider about all of your medical conditions, including if you: have an injury, infection or illness plan to have surgery. Tell your healthcare providers you are taking LYSODREN. You may need to stop taking LYSODREN before any surgery and dental procedures. have cysts on your ovaries have liver or kidney problems have bleeding problems are pregnant or plan to become pregnant.
LYSODREN can harm your unborn baby. Females who can become pregnant: Your healthcare provider will do a pregnancy test before you start treatment with LYSODREN. Use effective birth control (contraception) that does not contain hormones (nonhormonal) such as condoms or diaphragms and spermicide during treatment with LYSODREN and for as long as your healthcare provider tells you to after you stop treatment.
Talk to your healthcare provider about nonhormonal birth control methods that may be right for you. Birth control methods that contain hormones such as birth control pills, injections, or patches may not work as well during and after treatment with LYSODREN. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with LYSODREN. are breastfeeding or plan to breastfeed.
LYSODREN can pass into your breast milk and may harm your baby. Do not breastfeed during treatment and after you stop taking LYSODREN until your healthcare provider tells you it is okay. Talk to your healthcare provider about the best way to feed your baby during and after treatment with LYSODREN.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-co…