Lysodren is primarily used to treat inoperable, metastatic, or recurrent adrenocortical carcinoma (ACC), a rare cancer of the adrenal gland. It helps slow tumor growth and reduce excess hormone production.
Mitotane
Generic Name/API:Mitotane
Packaging:Bottle of 100 tablets
Storage:Store bottle at 25°C, can exceed between 15°C and 30°C.
Dosage:For dosage information, please check the General Information section.
Strength:500 mg scored tablets.
Indication:Mitotane is indicated for the treatment of inoperable, metastatic, or recurrent adrenocortical carcinoma (ACC). It is used to reduce tumor burden and control excess adrenal hormone production associated with the disease.
Mitotane, marketed as Lysodren, is a unique and essential therapeutic agent specifically designed for the treatment of adrenocortical carcinoma (ACC), a rare and aggressive cancer of the adrenal cortex. Its primary USP lies in its selective cytotoxic action on adrenal cortical cells, making it the only FDA-approved drug for inoperable, metastatic, or recurrent ACC.
Unlike conventional chemotherapeutics, Mitotane not only targets tumor cells but also suppresses adrenal hormone production, offering dual benefits in managing both tumor growth and hormone-related symptoms such as those seen in Cushing’s syndrome. Its long half-life allows for sustained therapeutic effects, making it suitable for long-term disease control.
STRENGTH:
500 mg scored tablets.
DOSAGE:
The recommended dosage of mitotane is as follows:
- The initial dose of mitotane is 2000mg to 6000mg orally, in three or four divided doses per day.
- Examine the mitotane plasma levels and increase the dose based on the patient tolerance and clinical response to achieve a mitotane plasma level of 14 to 20 mg/L, or as tolerated.
- Dose adjustment: If mitotane plasma levels exceed 20 mg/L without signs of toxicity, consider reducing the dose by 50% to 75% as a precautionary measure.
- Dose modification for adverse reactions: For adverse reactions, it is recommended to reduce the usual daily dose of mitotane by 500 to 1000 mg.
ADVERSE REACTIONS:
The following are the adverse reaction which are observed due to mitotane:
-
- Adrenal insufficiency and adrenal crisis
- Central nervous system toxicity
- Ovarian macrocysts in premenopausal women
- Hepatotoxicity
- Hematological toxicity
- Prolonged bleeding time
- Hormone binding protein
- Embro-fetal toxicity
STORAGE: Mitotane tablets are stored at 25°C, can exceed between 15°C and 30°C.
- Adrenal insufficiency and adrenal crisis: Mitotane may worsen adrenal insufficiency, requiring monitoring and corticosteroid replacement. Withhold treatment during severe illness or before surgery, and inform patients of symptoms.
- Central nervous system toxicity: Mitotane may cause CNS toxicity above 20 mg/L. Monitor neurologic status and drug levels, check thyroid if cognition declines, and advise patients to avoid driving. Adjust or stop treatment as needed.
- Ovarian Macrocysts in Premenopausal women: Mitotane may cause benign bilateral ovarian macrocysts in premenopausal women, sometimes leading to complications. Patients should report pelvic symptoms promptly. Regular imaging is advised, and treatment may be adjusted based on severity.
- Hepatotoxicity: Mitotane can cause hepatotoxicity, including rare cases of liver failure. Monitor liver function before starting treatment, during dose adjustments, and as needed. Isolated GGT elevation may occur. Adjust or discontinue treatment based on the severity of liver toxicity.
- Hematological toxicity: Mitotane can cause blood disorders like leukopenia, anemia, and thrombocytopenia. Monitor blood counts, including neutrophils, before and during treatment. Adjust, pause, or stop therapy based on severity.
- Prolonged bleeding time: Mitotane may impair platelet function and prolong bleeding, undetectable by standard tests. Use ADP-induced aggregometry before surgery. Adjust or pause treatment if bleeding risk is identified.
- Hormone binding protein: Mitotane increases levels of hormone-binding proteins like SHBG and CBG, which can affect hormone test results and may cause gynecomastia.
- Embryo Fetal toxicity: Mitotane risks fetal harm, including preterm birth and loss. Pregnant women should be warned, and women of childbearing age must use non-hormonal contraception during treatment and until the drug clears.
FAQ
How is Lysodren taken?
Lysodren is taken orally, usually with food to improve absorption. The dose is individualized and gradually increased based on patient tolerance and blood drug levels.
Can lysodren affect hormone levels?
Yes. Lysodren can suppress adrenal hormone production and increase levels of hormone-binding proteins, which may alter hormone test results and cause symptoms like gynecomastia (breast enlargement in males.
Is it safe to use Lysodren during pregnancy?
No. Mitotane can harm a developing fetus. Women who are pregnant or planning to become pregnant should avoid this medication and use effective non-hormonal contraception during treatment and afterward, as long as the drug remains in the system.
What are the key criteria for selecting a supplier?
While selecting a supplier, we essentially ensure that the supplier holds a valid Good Distribution Practice (GDP) certification and possesses a valid operating license. These credentials confirm the supplier’s adherence to international standards for the proper distribution of medicinal products.
What is the cost of Mitotane 500mg Tablets in India?
The cost of Mitotane 500 mg tablets varies as it’s not approved in India and must be imported. Factors like international currency exchange rates (USD/EUR), import duties, and supplier availability influence the final price. For the latest pricing and details, please contact 247 QualityMeds.
How to buy mitotane 500mg tablets online in India?
To buy Lysodren (mitotane) 500mg tablets in India at a genuine price, contact 24/7 QualityMeds. We assist you in importing this medication legally and at the best possible price.
