Lysodren (Mitotane) is an adrenal cytotoxic agent used for the treatment of inoperable, functional or nonfunctional, adrenal cortical carcinoma.
Dosage: The recommended initial mitotane dose is 2 to 6 g orally, in three or four divided doses per day. Swallow the tablets with a glass of water during meals containing fat-rich food. Increase the doses incrementally in order to achieve a blood concentration of 14-20 mg/L, or as tolerated. Inform your healthcare team promptly if you have accidentally administered more dose than you should or if a child has accidentally swallowed some. If you miss a dose, just administer the next dose as scheduled. Never take a double dose in order to make up for the missed/forgotten one.
Side Effects: The most commonly reported mitotane side effects include:
Warnings and Precautions:
- Patients are advised to discontinue the mitotane 500mg in the case of shock or severe trauma and contact their healthcare professional immediately.
- Premenopausal women are advised to seek medical care in case they have gynecological symptoms such as vaginal bleeding/pelvic pain.
- Females of reproductive potential are advised about the potential risk to a fetus and to inform their doctor of a known/suspected pregnancy.
- Advise females who are nursing not to breastfeed while on mitotane 500mg therapy.
- Hepatic impairment can interfere with the metabolism of mitotane and the drug may accumulate. Administer lysodren 500 with caution to patients with hepatic impairment.
- CNS toxicity, including lethargy, sedation, and vertigo, occurs with mitotane therapy. Mitotane plasma concentrations exceeding 20 mcg/mL are related with a greater incidence of toxicity.
- The lysodren 500 therapy has a major influence on the ability to drive and use machines. Ask your healthcare professional for advice.