Mitotane, MITODX, Mitotane 500mg Manufacturer: Laos Daxiong Pharmaceutical

Introduction: Mitotane, also known as phenylthiourea and totimaramine (O,P'-DDD), is a drug for the treatment of adrenocortical tumors (ACC) and Cushing's syndrome. It is an organic compound that inhibits the synthesis of adrenal hormones. Mittan was first synthesized by German chemist Gerhard Schindler in 1942 and introduced into clinical use in 1959 for the treatment of adrenal tumors.

【 Drug name 】

Name: Mitotane Tablets

Product Name: MITODX

 

【 Specifications 】 500 mg

 

【 Indications 】

MITODX is indicated for the treatment of non-functioning adrenocortical carcinoma in patients with inoperable, functioning or diseased adrenal glands.

 

【 Recommended dosage 】

The recommended initial dose of MITODX is 2 g to 6 g orally, taken three to four times daily. Gradually increase the dose to achieve a blood concentration of 14 to 20 mg/L, or to tolerated levels.

MITODX is a cytotoxic drug and is subject to applicable special handling and disposal procedures.

If adrenal crisis occurs during shock or severe trauma:

Withhold MITODX until recovery from central nervous system (CNS) toxicity.

Withhold MITODX until symptoms resolve. Restart at a lower dose (e.g., 500-1000 mg less) 7 to 10 days after symptoms resolve.

 

【 side effect 】

Adrenal crisis in shock or severe trauma

Patients taking MITODX may experience adrenal crisis in the setting of shock or severe trauma, and

Impaired response to shock. Give hydrocortisone and monitor for escalating shock symptoms.

and disable MITODX until it is restored.

Central nervous system toxicity

Central nervous system toxicities, including sedation, somnolence, and dizziness, have occurred with MITODX treatment. Mitotane plasma concentrations exceeding 20 mcg/mL were associated with a higher incidence of toxicities.

Adrenal insufficiency

MITODX treatment can cause adrenal insufficiency. Administer steroid replacement as clinically indicated. Measure free cortisol and adrenocorticotropic hormone (ACTH) levels to achieve optimal steroid replacement.

Embryo-fetal toxicity

MITODX may cause fetal harm when taken by a pregnant woman. Patients exposed to mitotane during pregnancy may experience abnormal pregnancy outcomes, such as premature delivery and early miscarriage. Inform pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with MITODX and after cessation of treatment as long as mitotane plasma levels are detectable.

Large ovarian cysts in premenopausal women

Large ovarian cysts, usually bilateral and multiple, have been reported in premenopausal patients receiving MITODX. Complications of these cysts have been reported to include adnexal torsion and hemorrhagic cyst rupture. In some cases, improvement after discontinuation of the drug has been described. Advise female patients to seek medical attention if they experience gynecologic symptoms such as vaginal bleeding and/or pelvic pain.

Adverse Reactions

The following adverse reactions are discussed in more detail elsewhere in the labeling:

Adrenal crisis in shock or severe trauma                      Central nervous system toxicity

Adrenal insufficiency Ovarian cysts

The following adverse reactions have been reported in clinical trials or postmarketing reports that have been associated with the use of MITODX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Common adverse reactions to MITODX treatment include:

Anorexia , nausea, vomiting, and diarrhea (80%) Depression , dizziness, or vertigo (15%-40%)

Rash (15%) Neutropenia

Growth retardation, hypothyroidism , confusion, headache, ataxia, mental impairment, weakness, dysarthria

Macular degeneration , hepatitis, elevated liver enzymes

Gynecomastia, hypercholesterolemia , and hypertriglyceridemia were reduced , sex hormone-binding globulin in women and men increased, and free blood testosterone in men decreased.

Less common adverse reactions include blurred vision, diplopia, lens opacities, retinopathy, prolonged bleeding time, hematuria, hemorrhagic cystitis, proteinuria, hypertension, orthostatic hypotension, flushing, generalized pain, and fever.

 

【 store 】

Store bottle at 25°C (77°F); store between 15°C and 30°C (59°F-86°F).

Keep MITODX and all medicines out of the reach of children.