Big Bear MITODX Mitotane 500mg

Product Information

• Product name: MITODX Mitotane 500mg
• Manufacturer / brand: Laos BigBear Pharma
• Active ingredient: Mitotane
• Current strength: 500mg
• SKU: BB-ITEM-54
• Site category: adrenocortical carcinoma, other cancer

Product Summary

MITODX Mitotane 500mg is an AISTIKA-listed product supplied by Laos BigBear Pharma. This page summarizes the product identity, strength, SKU, site category, and public medical reference information. Product name, manufacturer, packaging, and strength follow this AISTIKA product page.

Active Ingredient and Reference Data

Mitotane is the active ingredient used for this product page. Public prescribing information for Mitotane was used for the medical reference sections. Medical details are provided for reference and must be interpreted by a qualified healthcare professional.

Mechanism 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.

Reference Indications

Mitotane is indicated for the treatment of patients with inoperable, functional or nonfunctional, adrenocortical carcinoma (ACC). Mitotane is an adrenal cytotoxic agent indicated for the treatment of patients with inoperable, functional or nonfunctional, adrenocortical carcinoma (ACC).

Reference Dosage and Administration

Recommended dosage reduction for adverse reactions is to decrease the usual daily dose by 500 – 1000 mg. Swallow Mitotane tablets whole; do not crush, chew or split.

With this 500mg product, that corresponds to 2 x 500mg tablets when that reference dose is clinically appropriate.

This reference dosage is not an individualized prescription. Dose changes, treatment interruptions, or discontinuation must be directed by a physician.

Important Safety Information

WARNING: ADRENAL CRISIS IN THE SETTING OF SHOCK, SEVERE TRAUMA OR INFECTION Patients treated with Mitotane 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 Mitotane 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 . WARNING: ADRENAL CRISIS IN THE SETTING OF SHOCK, SEVERE TRAUMA OR INFECTION See for complete boxed warning. Patients treated with Mitotane are at increased risk for developing adrenal crisis in the setting of shock, severe trauma or infection that may lead to death.

Common Adverse Reactions and Monitoring

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.

Drug Interactions and Special Populations

Spironolactone: Avoid concomitant use with Mitotane. Certain CYP3A Substrates: Avoid concomitant use with Mitotane. Hormonal contraceptives: Avoid concomitant use with Mitotane. Warfarin: Avoid concomitant use with Mitotane. Avoid concomitant use of mitotane with spironolactone . Concomitant use of Mitotane may decrease the levels of CYP3A substrates, which may reduce the activity of these substrates . Avoid concomitant use of Mitotane 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 Mitotane with hormonal contraceptives .

Storage and Purchase Notes

Store according to the package or pharmacist instructions and keep out of reach of children. Before ordering, confirm product name, strength, quantity, price, shipping details, and payment method. After receipt, check packaging, batch number, expiration date, and storage conditions.

Sources

Sources: Lysodren public prescribing information; openFDA/DailyMed public label data. These sources are used for public medical reference. Product information follows this AISTIKA product page.

DisclaimerThis page is for product information and public-label reference only. It does not provide diagnosis, prescription, or individualized medical advice. Consult a physician for treatment decisions.