Mitotane

Mitotane is a rare disease drug used to treat adrenal cortex cancer, which was launched in 1964 and approved by the FDA in 1970.

Mitotane produced by Lucius, Reg No is 02 L 1062/24, Inspection Number is 0193-24.

Mitotane is usually used as a first-line medication for adrenal cortical cancer, and is also used for the treatment of other types of adrenal tumors and certain endocrine disorders. However, due to its mechanism of action and side effects, the use of Mitotane requires strict medical supervision and management.

1.Main components

Mitotane

2. Adapt to the population

Adult patients with adrenal cortical carcinoma.

3.Medication for special populations

3.1Pregnant

Mitotane can cause fetal harm. Limited postmarketing cases report preterm births  and early pregnancy loss in women treated with Mitotane during pregnancy. Animal reproduction studies have not been conducted with mitotane. Advise pregnant women of the potential risk to a fetus.

3.2Lactation

Mitotane is excreted in human milk; however, the effect of Mitotane on the breastfed child, or on milk production is unknown. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with Mitotane and after discontinuation of treatment for as long as mitotane plasma levels are detectable. 

3.3Females and Males of Reproductive Potential

Advise females of reproductive potential to use effective nonhormonal contraception during treatment with Mitotane and after discontinuation of therapy for as long as mitotane plasma levels are detectable. Mitotane can render hormonal contraceptives ineffective

3.4 Pediatric Use

Effectiveness in pediatric patients has not been established.

3.5 Geriatric Use

Clinical studies of Mitotane 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.

3.6Hepatic 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 . Mitotane is not recommended for use in patients with severe hepatic impairment.

3.7 Renal 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. Mitotane is not recommended for use in patients with severe renal impairment.

4.Drug overdose

Mitotane 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 Mitotane as clinically indicated for signs or symptoms of toxicity. 

Mitotane is lipophilic and has a prolonged half-life; therefore, it may take weeks for plasma levels to decrease.Mitotane is not likely to be dialyzable. Increase the frequency of mitotane plasma level monitoring, as clinically indicated.

5. Drug storage

Store bottles at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F-86°F).

6.Pharmacokinetics

Following discontinuation of mitotane, the plasma terminal half-life ranges from 18 to 159 days (median 53 days).

from FDA,2024.01