Brand name: MITOSIS
Composition:
Each tablet contains:
Mitotane……………………….…….500mg
Indications: MITOSIS is indicated for the treatment of patients with inoperable, functional or nonfunctional, adrenal cortical carcinoma.
Dosage:
The recommended initial dose of MITOSIS is 2 g to 6 g orally, in three or four divided doses per day. Increase doses incrementally to achieve a blood concentration of 14 to 20 mg/L, or as tolerated. MITOSIS is a cytotoxic drug. Follow applicable special handling and disposal procedures.
Contraindications: None
Warnings:
• In patients taking MITOSIS, adrenal crisis occurs in the setting of shock or severe trauma and response to shock is impaired. Administer hydrocortisone, monitor for escalating signs of shock, and discontinue MITOSIS until recovery.
• CNS toxicity, including sedation, lethargy, and vertigo, occurs with MITOSIS treatment. Mitotane plasma concentrations exceeding 20 mcg/mL are associated with a greater incidence of toxicity.
• Treatment with MITOSIS can cause adrenal insufficiency. Institute steroid replacement as clinically indicated. Measure free cortisol and corticotropin (ACTH) levels to achieve optimal steroid replacement.
• MITOSIS can cause fetal harm when administered to a pregnant woman. Abnormal pregnancy outcomes, such as preterm births and early pregnancy loss, can occur in patients exposed to mitotane during pregnancy. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with MITOSIS and after discontinuation of treatment for as long as mitotane plasma levels are detectable.
• Ovarian macrocysts, often bilateral and multiple, have been reported in premenopausal patients receiving MITOSIS. Complications from these cysts, including adnexal torsion and hemorrhagic cyst rupture, have been reported. In some cases, improvement after mitotane discontinuation has been described. Advise female patients to seek medical care if they experience gynecological symptoms such as vaginal bleeding and/or pelvic pain.
Adverse Effects:
Common adverse reactions include: anorexia, nausea, vomiting and diarrhea; depression, dizziness or vertigo; and rash.
Dosage form: White, round, biconvex, scored tablets.
Expiry date: 24 months from the date of manufacture.
Packaging: 100 tablets per bottle.
Storage:
• Store bottles at 25°C; excursions permitted between 15°C and 30°C.
• Keep out of reach of children.
DISCLAIMER
The information on this website about our medications is intended for general educational purposes only and should not be considered a substitute for professional medical advice, diagnosis, or treatment. Never disregard professional medical advice or delay seeking care because of something you have read on this website.
For your safety:
Do not self-diagnose or treat any medical condition based solely on the information on this website. If you have any questions or concerns about a medication, please talk to your doctor or pharmacist.
