Mytanne MITOTANE 500MG 100 tablets Approval No. 09 L 0707/16 Expiry Date 19-9-2026

Mitotane is a drug used to treat adrenocortical carcinoma (ACC) and some other types of adrenal and endocrine gland-related diseases. Mitotane has a strong adrenocortical suppressive effect and is often used to treat patients with adrenocortical carcinoma that cannot be removed surgically or that is likely to recur after surgery.

Here is a summary of Mitotane 's instructions:

1. Name of drug

• Generic Name : Mitotane
• Product name : Mytanne (brand name)

2. Drug classification

• Drug category : Anti-tumor drugs, steroid synthesis inhibitors
• Mechanism of action : Mitotane inhibits the synthesis of steroids, especially cortisol, and the growth of adrenocortical cancer cells by directly damaging adrenal cortical cells.

3. Indications

Mitotane is mainly used for:

• Treatment of adrenocortical carcinoma (ACC) , especially locally advanced or metastatic cases.
• As postoperative adjuvant therapy to reduce the risk of recurrence of adrenocortical carcinoma.
• It may have an adjunctive role in certain endocrine disorders (such as Cushing's syndrome), especially when the disease is refractory to other treatments.

4. Usage and Dosage

• Dosage form : Oral tablet

• Recommended dose : The initial dose is usually 2-4 times a day, 500 mg each time, and the dose is gradually adjusted until the effective therapeutic dose is reached. The common maintenance dose is 2-3 times a day, 500-1000 mg each time. The specific dose needs to be adjusted according to the patient's tolerance and efficacy.

  • Initial phase : Usually starts with a lower dose and increases gradually, aiming to reach a dose of 3–6 g per day.
  • Maintenance therapy : The dose is usually adjusted on an individual basis for the patient.

5. Contraindications

• Patients with hypersensitivity to Mitotane or any of its ingredients.
• Pregnant or breastfeeding women (Mitotane may be teratogenic to the fetus or infant and can be secreted in breast milk).

6. Notes

• Monitoring of liver and kidney function : Mitotane can be toxic to the liver and kidneys, so liver and kidney function should be checked regularly during treatment.
• Steroid replacement therapy : Mitotane inhibits steroid synthesis and may lead to steroid deficiency, especially cortisol deficiency. Therefore, during treatment, patients may need steroid supplementation, especially during stressful periods (such as surgery, infection, etc.).
• Central nervous system (CNS) monitoring : Mitotane may cause neurological side effects such as dizziness, drowsiness, and impaired consciousness. Special attention should be paid to these symptoms during treatment.
• Long-term use : Long-term use may cause side effects such as gastrointestinal discomfort, fatigue, and skin discoloration. The treatment effects and side effects need to be evaluated regularly.

7. Adverse Reactions

Mitotane may cause a variety of side effects, common ones include:

• Gastrointestinal system : nausea, vomiting, loss of appetite, diarrhea, indigestion.
• Nervous system : drowsiness, dizziness, insomnia, somnolence, neurotic symptoms.
• Endocrine system : Steroid deficiency (such as cortisol deficiency) requires steroid supplementation.
• Liver function impairment : increased ALT, AST, hepatitis, liver failure.
• Skin reactions : Skin discoloration (skin may appear yellow or bluish), increased sweating.
• Others : weight loss, fatigue, bone marrow suppression, etc.

8. Drug Interactions

Mitotane may interact with other medications:

• When used concomitantly with **anticoagulants (e.g., warfarin),** the dose of the anticoagulant may need to be adjusted.
• When used in combination with **steroids (such as chlorthixene, chlorthixene), **the dosage of steroids should be adjusted to prevent cortisol deficiency.
• Antiepileptic drugs (eg, phenobarbital, carbamazepine) may affect the blood concentration of Mitotane.

9. Storage conditions

• Store in a cool, dry place away from direct sunlight and high temperatures. Store at room temperature (15-30°C).

10. Overtreatment

• In case of overdose, seek medical attention immediately. Symptomatic treatment should be given based on clinical manifestations, including maintenance of vital signs and treatment of any possible toxic reactions.

Summarize

Mitotane (Mytanne) is a drug used to treat adrenocortical carcinoma (ACC) and certain endocrine diseases. Due to its potential side effects, especially its effects on the liver, kidneys, and steroid levels, it requires regular monitoring and dosage adjustments. During treatment, patients may need to supplement with steroids to prevent steroid deficiency. This drug should be used under the guidance of a doctor to ensure safe and effective treatment of related diseases.