Leaf Pharma

What is MITOSAFE ?
MITOSAFE (Mitotane) is an adrenal cytotoxic active substance – which suppresses production of adrenal cortex corticosteroid hormonesOnly FDA approved treatment for inoperable, functional or nonfunctional, adrenocortical carcinoma
  What is MITOSAFE ?   MITOSAFE is a prescription medication used to treat the symptoms of adrenal cortical carcinoma (cancer of the outer layer of the adrenal gland).MITOSAFE is used when the cancer cannot be removed by surgery.
In patients taking MITOSAFE, adrenal crisis (severe adrenal insufficiency) occurs in the setting of shock or severe trauma and response to shock is impaired. Administer hydrocortisone, monitor for increasing signs of shock and discontinue MITOSAFE until recovery.
Adrenal insufficiency is when the adrenal glands do not produce enough hormones. Check with your doctor if you have any of the following symptoms: fatigue, abdominal pain, nausea, vomiting, diarrhea and confusion.
MITOSAFE may cause some patients to become dizzy or lose their balance, drowsy, have a lack of energy, or less alert than normal.
How MITOSAFE works ?Mitotane or o,p′DDD (1,1-dichloro-diphenil-dichloroethane), is derived from the family of insecticides that includes DDT (dichloro-diphenyl-trichloroethane).A direct cytotoxic effect on adrenal cortical cells, mediated through mitochondrial alterations and inhibition of sterol-O-acyl transferaseIt inhibits adrenal steroidogenesis catalyzed by cholesterol desmolase,358 11- and 18-hydroxylase, and 3β-hydroxysteroid dehydrogenase.359 It also has marked direct cytotoxic effects on the zona fasciculata and the zona reticulosa, which led to its original use in high doses (5 to 20 g/day) as treatment for inoperable adrenocortical carcinoma.360,361In this condition, it now is used more commonly as adjunctive treatment to surgery, and it does appear to prolong recurrence-free survival with lower doses of between 1 and 5 g/day.362,363 At such doses, it may take a longer time to reach therapeutic levels, and monitoring of serum levels should be undertaken when possible due to the narrow therapeutic window and the risk for toxicity.What should I tell my doctor before taking MITOSAFE?   ·         Are pregnant or plan to become pregnant. MITOSAFE may cause harm to the unborn child.Are breastfeeding or plan to breastfeed. MITOSAFE may cause serious adverse reactions in the breastfed infant. Talk to your healthcare provider about the best way to feed your baby if you use MITOSAFE or when it safe to start breastfeeding after discontinuation of treatment.Tell your doctor if you have pelvic pain or vaginal bleeding since MITOSAFE may produce ovarian cysts in some women.Have a history of liver disease.It is suggested that target levels should be between 15 and 20 mg/L.364 Combined treatment of mitotane with standard chemotherapeutic agents such as cisplatin, etoposide, and doxorubicin has been used in a number of small studies in advanced adrenal carcinoma with variable benefit.Inhibition of corticosteroid synthesis by modifying the peripheral metabolism of cortisol and directly suppressing the production of corticosteroids from the adrenal cortexWhat are the most common side effects of MITOSAFE?
The most common side effects of MITOSAFE include:
Anorexia (weight loss)DiarrheaNausea (upset stomach)Dizziness or vertigo (loss of balance)VomitingRash