Mitotane is used to treat inoperable, functioning or nonfunctioning adrenocortical carcinoma.

Mitotane instructions

Product name: LUCIMITO

Manufacturer: Lucius Pharmaceuticals

Chinese name: Mitotane

English name: Mitotane

Drug approval number: 02 L 1062/24

 

 

【Summary】

Mitotane can be considered a cytotoxic agent that inhibits the adrenal glands without destroying the cells; the biochemical mechanism of its action is still unclear. Available data suggest that the drug not only modulates steroid metabolism in peripheral tissues, but also directly inhibits the adrenal cortex. Mitotane alters the metabolism of corisol in humans outside the kidneys; although plasma concentrations of corticosteroids do not decrease, 17-hydroxy corticosteroid measurements are reduced. The drug apparently increases the formation of 6-B-hydroxyl cortisol.

 

【Indications】

For the treatment of inoperable, functional or non-functional adrenocortical carcinoma.

 

【Specification】

500 mg/tablet, 100 tablets/bottle.

 

【Storage】

Store at 20°C to 25°C (68°C to 77°F); short-distance transport is permitted at a temperature range of 15 to 30°C (59–86°F).

 

【Usage and Dosage】

1. Initial dose: 2 to 6 grams orally per day, divided into three or four doses.

2. Gradually increase the dose to achieve a blood concentration of 14 to 20 mg/L, or a tolerable concentration.

【Contraindications】

People who have allergic reactions to this medicine should not take it

【 Side effects and adverse reactions】

The most common side effects of mitotane include:

Depression of the central nervous system, dizziness, drowsiness, skin rash, loss of appetite, nausea, vomiting, diarrhea, etc.

Other side effects: headache, hypertension, orthostatic hypotension, depression, confusion, muscle tremors, hemorrhagic cystitis, etc.

 

【Drug Interactions】

1. Spironolactone can reduce the efficacy of this drug, so it is not recommended to use it at the same time.

2. Alcohol, first-generation antihistamines, sedatives, hypnotics, morphine-type analgesics, anti-epileptic drugs, etc. have central nervous system depressant effects. Their combined use may increase related side effects such as drowsiness and dizziness.

3. This drug can increase the liver's metabolism of certain drugs (such as some anti-epileptic drugs, barbiturates, Warfarin, etc.). Concomitant use may reduce the efficacy of the latter, so special monitoring is required.

4. Please consult your doctor before taking other medicines.

 

【Notes】

1. This drug is a chemotherapy drug. Please be careful when handling and discarding it.

2. Taking this medicine on a full stomach can increase absorption.

3. This drug can inhibit the central nervous system, causing drowsiness, dizziness, etc. Therefore, try to avoid activities that require a high degree of mental concentration, such as driving or operating machinery, while taking the drug.

4. If the patient develops infection, trauma or other diseases, he/she should seek medical attention immediately to avoid acute adrenal insufficiency.

5. For patients with mild to moderate liver or kidney damage, the dose may need to be adjusted down accordingly based on the blood concentration of the drug.

6. This medicine is not recommended for patients with severe liver or kidney damage.

 

Safety and efficacy

The efficacy of mitotane in advanced ACC was evaluated in a clinical trial. A total of 127 patients with advanced ACC were enrolled and treated with mitotane alone. Kaplan-Meier estimates were used for progression-free survival and overall survival (PFS, OS).

Results showed that 26 patients (20.5%) had an objective response, including 3 complete responses. Overall, the median PFS was 4.1 months (range, 1.0-73) and the median OS was 18.5 months (range, 1.3-220).