Brand Name
Lysodren
Generic Name
Mitotane
View Brand Information FDA approval date: October 15, 1978
Form: Tablet
What is Lysodren (Mitotane)?
LYSODREN is indicated for the treatment of patients with inoperable, functional or nonfunctional, adrenal cortical carcinoma. LYSODREN is an adrenal cytotoxic agent indicated for the treatment of inoperable, functional or nonfunctional, adrenal cortical carcinoma.
Approved To Treat
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A Phase I Dose-escalation Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
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Brand Information
Lysodren (mitotane)
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)].
1INDICATIONS AND USAGE
LYSODREN is indicated for the treatment of patients with inoperable, functional or nonfunctional, adrenocortical carcinoma (ACC).
2CONTRAINDICATIONS
None.
3ADVERSE 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)]
3.1Clinical 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
4USE IN SPECIFIC POPULATIONS
8 USE IN SPECIFIC POPULATIONS
4.1Pediatric 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.
4.2Geriatric 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.
4.3Hepatic 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
4.4Renal 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, monitor mitotane plasma levels more frequently and modify the dosage as needed
5OVERDOSAGE
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.
6DESCRIPTION
LYSODREN (mitotane) is an oral adrenal cytotoxic agent. The chemical name is (±)-1,1-dichloro-2-(
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.
7REFERENCES
1. OSHA Hazardous Drugs
8HOW 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
9PATIENT 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).
10PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton
NDC 76336-080-60
LYSODREN
EACH TABLET CONTAINS
100 Tablets
HRA Pharma
