Mitotane  

Brand name: Lysodren®  

Generic name:Mitotane  

Therapeutic Class: antineoplastic agent 

Manufacturer / Distributor: HRA Pharma  

Availability: Mitotane is available by prescription only  

Indications: Mitotane is used to treat adrenal gland cancer (cancer of the adrenal glands). 

Mitotane may also be prescribed for other medical conditions besides cancer of the adrenal gland; contact your doctor or pharmacist for more information. 

Dosage form: Mitotane comes as a tablet to be taken by mouth 

Dosage: Mitotane is taken by mouth, usually 3 or 4 times daily with or without food, around the same times every day.  At the beginning of the therapy, the drug can be given in hospital starting with small doses until a stable dosage is established. Once the most effective and appropriate dosage is determined, you will take the drug at home as directed by your oncologist or pharmacist. It is important that you follow the instructions carefully.  

Your physician will determine the dosage based on your medical condition(s), other medications you are taking, your body surface area (BSA) and the response of your body to the treatment.  Depending on the reaction of your body to the drug, your doctor may reduce or increase the dosage. The fact you develop side effects it does not mean complications; Mitotane cause adverse reactions in most patients.   

Storage: store Mitotane at room temperature (15-25 ° C), away from heat, light and moisture. Always keep your medications out of the reach of children . Mitotane and all drugs should not be used beyond the expiration date printed on the container.      

Overdose: it is very important that you take Mitotane as indicated by your health care provider. Regardless of the circumstance, do not take Mitotane more often. Even when taken at normal dose , Mitotane can reduce the amount of steroid hormones (cortisol) synthesized by the adrenal cortex, which can lead to the development of life-threatening conditions. If you think you have taken an overdose, contact your doctor or the poison control center nearest you as soon as possible. 

Missing dose: Take Mitotane as indicated your doctor or pharmacist. In case you forget to take a dose, take the missed one as soon as you remember it. However, if it is almost time for your next dose, do not double the next dose to recover the missed one; it can be dangerous. Contact your doctor or wait to go back to your regular schedule.  

Contraindications: Mitotane is contraindicated in cases of allergy to it or any of its ingredients. Before beginning a treatment with Mitotane, tell your doctor if you are: 

·         breast-feeding

·         Pregnant or may become pregnant

·         Had or having surgery (including dental surgery). 

Mechanism of action (MOA):  Mitotane is an antineoplastic agent that works by reducing the amount of steroid hormones synthesized by the adrenal cortex, which slows or stops division or reproduction of cancer cells that need these hormones to survive.  

Interactions:  talk you to your doctor before taking aspirin, vitamins, nutritional supplements or St. John wort. Certain medications may interact with Mitotane. Tell your doctor or pharmacist if you are taking any of these medications:   

·         sedatives 

·         sleeping pills 

·         tranquilizers 

·         antidepressants  

·         spironolactone (Aldactone) 

·         anticoagulants such as warfarin (Coumadin) 

·         Medications for anxiety, mental illness, or seizures.  

Side effects: in certain patients, Mitotane can lead to the following side effects:       

• hair loss 
• nausea 
• vomiting 
• diarrhea 
• dizziness  
• depression 
• sleep problems  
• lack of energy 
• decreased appetite 
• unusual drowsiness 
• Rash or changes in skin color.  

If the side effects above persist for weeks, contact your oncologist. In addition, contact your doctor if you experience any of these symptoms:    

• vision changes 
• anxiety  
• depression 
• confusion 
• fast or irregular heartbeat 
• abdominal or side pain  
• high fever or shaking chills 
• excessive sweating, mainly at night 
• Purple, blue, or black discoloration of the skin.