Mitotane (Oral)

Used to inhibit the adrenal cortex, Mitotane can be prescribed to treat specific cancers which affect the adrenal glands, such as adrenocortical carcinoma.

Overview

As a cytostatic antineoplastic, Mitotane is predominantly used to treat a form of cancer known as adrenocortical carcinoma. Affecting the cortex of the adrenal gland, adrenocortical carcinoma, is a rare type of cancer and has often spread to other parts of the body by the time it has been diagnosed.

If the tumor is diagnosed as function, it affects the steroid production of the adrenal glands. As a result, patients can also suffer from various hormonal disorders, such as Conn syndrome or Cushing's syndrome. Muscle wasting, excess weight gain, thinning skin, acne, excess hair, cessation of menstruation, headaches and deepening of the voice can all indicate that the patient has develop a hormone problem and may be suffering from adrenocortical carcinoma.

As this type of cancer is fairly aggressive, treatment tends to be instigated quickly. Often, Mitotane is used as a form of chemotherapy to treat adrenocortical carcinoma. Mitotane acts as a steroidogenesis inhibitor, in that it inhibits the enzymes that are involved in steroid production. Once steroid production has ceased, the adrenal cortex has effectively been inhibited and the tumor is no longer able to grow or spread.

Mitotane also has a cytotoxic effect on the adrenal cortex, in some cases. If the medication instigates the death of cells in the adrenal cortex, this can have a permanent effect on patients. Once cell death has occurred, adrenal atrophy may take place. As a result, the adrenal cortex will produce hormones in much lower quantities than is usual or may cease hormone production completely. Whilst this can result in the patient developing other hormonal problems, the benefits of using Mitotane to treat adrenocortical carcinoma usually outweigh the risks of permanent adrenal atrophy occurring.

Conditions Treated

  • Cancers affecting the adrenal glands

Type Of Medicine

  • Cytotoxic antineoplastic
  • Steroidogenesis inhibitor

Side Effects

Whilst patients can experience side-effects when taking any sort of medication, chemotherapy drugs are associated with a number of adverse effects. Before beginning treatment with Mitotane, patients should seek advice from their physician regarding the management of any potential side-effects which may occur.

When patients are taking Mitotane, they may exhibit the following adverse effects:

  • Feeling of constant movement of surroundings or self
  • Aching muscles
  • Indigestion
  • Redness or flushing of the skin
  • Passing of gas
  • Sleepiness
  • Muscle twitching
  • Sensation of spinning
  • Unusual dullness, drowsiness, weakness, tiredness or feelings of sluggishness
  • Stomach discomfort, fullness or pain

Depending on how severe the above side-effects are, patients may not need to seek medical intervention. If they are fairly mild and diminish over time, for example, patients may not require medical attention. Of course, if the patient's side-effects are severe or troublesome, medical advice should be sought.

Patients should also seek immediate medical advice if they experience any of the following side-effects when using Mitotane:

  • Darkening of the skin
  • Blood in the urine
  • Diarrhea
  • Blurred vision
  • Lightheadedness or dizziness
  • Shortness of breath
  • Drowsiness
  • Chills
  • Loss of appetite
  • Cloudy urine
  • Mental depression
  • Double vision
  • Nausea or vomiting
  • Rash on the skin
  • Cold sweats
  • Unusual weakness or tiredness
  • Confusion
  • Lightheadedness, faintness or dizziness when getting up from a sitting or lying position
  • Vision changes
  • Feeling of warmth
  • White area over the eye
  • Fast or slow heartbeat
  • Redness of the neck, face, arms and, sometimes, upper chest
  • Fever
  • Pounding in the ears
  • Frequent urination
  • Painful urination
  • Headache
  • Stomach or lower abdominal cramping
  • Nervousness

If patients experience any adverse effects which are not listed above when they are taking Mitotane, they should also access medical advice.

Dosage

When adult patients are prescribed Mitotane, they are usually advised to take 2-6g per day. However, this amount of medication should be taken in three or four equally divided doses throughout the day, rather than as one dose once per day.

Although this is a standard dose of Mitotane, patients may have their dose modified or altered by their physician. Patients should follow their doctor's instructions when taking Mitotane and should not take more than the recommended dose.

When taking Mitotane tablets, patients should not chew, crush or break it. Instead, patients should swallow the tablet whole. If the tablet is broken or crushed, patients should wash their hands straight away, wash any clothing or fabric the medication may have landed on and wipe down any surfaces which may have come into contact with the medicine.

Patients should not stop taking Mitotane unless they are advised to do so by a medical professional. If patients suddenly stop taking Mitotane, they may experience an increase in side-effects.

In order to be effective, Mitotane should be taken regularly. However, if patients forget to take a dose of Mitotane, they should take it as soon as they remember to do so. If their next dose is almost due, patients should skip the missed dose and continue with their normal treatment schedule. Patients should not attempt to take a double or extra dose of Mitotane.

If patients are unsure how to take Mitotane or when to take their medication, they should contact their physician or pharmacist for advice.

Potential Drug Interactions

Although some medications can be taken alongside one another, others cannot be used at the same time. Due to this, patients may not be treated with Mitotane if they are already taking:

  • Atazanavir
  • Elbasvir
  • Daclatasvir
  • Grazoprevir
  • Dasabuvir
  • Isavuconazonium
  • Delamanid

In most cases, the use of Mitotane is not recommended if patients are taking any of the following medicines:

  • Apremilast
  • Imatinib
  • Aprepitant
  • Fosaprepitant
  • Aripiprazole
  • Ixazomib
  • Axitinib
  • Ibrutinib
  • Bosutinib
  • Ivabradine
  • Cabozantinib
  • Fentanyl
  • Ceritinib
  • Tofacitinib
  • Cobimetinib
  • Oxycodone
  • Dabrafenib
  • Olaparib
  • Eliglustat
  • Tacrolimus
  • Erlotinib
  • Panobinostat
  • Everolimus
  • Vorapaxar
  • Netupitant
  • Vemurafenib
  • Exemestane
  • Romidepsin
  • Idelalisib
  • Ulipristal
  • Ketoconazole
  • Vilazodone
  • Sofosbuvir
  • Linagliptin
  • Regorafenib
  • Manidipine
  • Temsirolimus
  • Naloxegol
  • Vandetanib
  • Osimertinib
  • Velpatasvir
  • Palbociclib
  • Vinflunine
  • Quetiapine
  • Venetoclax
  • Sunitinib

Furthermore, if patients take Mitotane in conjunction with any of the following, they may have an increased risk of experiencing side-effects:

  • Warfarin
  • Midazolam

Before patients start taking Mitotane, they should tell their physician if they are using any other medicines, supplements or vitamins. In addition to this, patients should seek medical advice before using any new medicines, vitamins or supplements once they have started taking Mitotane.

Warnings

If patients have any other medical problems, they should notify their doctor before they start treatment with Mitotane. There are some conditions which could affect the use of Mitotane and these may include:

Specific studies on the effects of Mitotane on pediatric patients have not been carried out. Due to this, children and infants are not usually treated with this medication.

Although elderly patients can be prescribed Mitotane, they may have age-related conditions which could affect the way Mitotane works. Due to this, geriatric patients may be given a lower dose of Mitotane.

Mitotane can limit the body's defenses against inflammation and/or infection. If the patient suffers an injury, develops an infection or feels unwell, they should access medical help straight away.

When taking Mitotane, patients may be advised to wear a medical identification bracelet or to carry a medical identification card. In the event of an emergency medical situation, this will notify healthcare practitioners that the patient is being treated with Mitotane and any subsequent treatment can be modified to take this into account.

In some patients, Mitotane can cause patients to develop adrenal insufficiency. If patients experience one or more of the following symptoms, they should notify their physician straight away:

  • Dizziness
  • Loss of appetite
  • Darkening of the skin
  • Unusual weakness or tiredness
  • Diarrhea
  • Vomiting
  • Fainting
  • Rash on the skin
  • Nausea
  • Mental depression

When patients are taking Mitotane, they may feel drowsy, dizzy or less alert than usual. If so, patients should not operate machinery, drive or perform potentially dangerous tasks when they are suffering from these side-effects.

Mitotane is not normally prescribed to patients who are pregnant as it can cause significant harm to an unborn fetus. Due to this, Mitotane should only be prescribed to pregnant patients if there are in a life-threatening situation and no safer alternative is available.

Whilst taking Mitotane, patients are generally advised to use a reliable form of birth control. Following treatment, patients should continue to use effective birth control for as long as the medication remains in their system.

If patients become pregnant when taking Mitotane, they should notify their physician immediately.

As Mitotane can be excreted via breast milk, patients are typically advised not to breastfeed whilst they are taking this medication. Following the patient's final dose of Mitotane, the medication is likely to be present in their body for some time. Due to this, patients should not breastfeed until tests have confirmed that Mitotane is no longer present in their system.

If patients have any known allergies, they should inform their doctor before they begin taking Mitotane. This includes allergies to other medicines, animals, foods, dyes and/or preservatives. In rare cases, patients may exhibit an allergic reaction when taking Mitotane. If so, they will require emergency medical treatment. The symptoms of an allergic reaction may include:

  • Hives
  • Rash on the skin
  • Hoarseness
  • Difficulty swallowing
  • Difficulty breathing
  • Itching
  • Swelling of the face, lips, throat, tongue, mouth or hands
  • Wheezing
  • Shortness of breath

Storage

As patients are usually advised to take Mitotane on a daily basis, they will need to keep a supply of medication at home. However, it is essential that patients store Mitotane in an appropriate location and that children and/or pets cannot gain access to it.

When storing Mitotane, patients should follow the manufacturer's instructions and the medication guidelines. In most cases, Mitotane can be kept at room temperature but should always be kept in a closed container. Mitotane is a powerful medication and patients should not handle the tablets unnecessarily.

In addition to this, Mitotane should be protected from heat, light and moisture. Due to this, patients should not store their medication in locations which are exposed to extreme temperatures, such as the kitchen or bathroom.

If patients are advised to stop taking Mitotane or if the medication reaches its expiration date, patients should dispose of it carefully. Mitotane should not be thrown out with regular household waste as it may cause harm to other people. Patients should contact their physician's office or pharmacist and make use of a specialist medicine disposal service.

Summary

Although cancers of the adrenal glands are relatively rare, they can be aggressive when they do occur. Often, these types of cancers have become metastatic when the patient is diagnosed so fast-acting treatment is required to prevent cancer cells from spreading further.

As an oral chemotherapy drug, Mitotane can be used to facilitate the destruction existing cancer cells and prevent the spread of the cancer. Whilst surgery may be used to remove the patient's tumor, Mitotane may be prescribed following surgery or as an alternative if surgery is not a viable option for the patient.

Whilst Mitotane can be effective in treating cancers of the adrenal glands, it can have both short and long-term side-effects. In some cases, the medication has a cytotoxic effect on the adrenal cortex and may permanently prevent the adrenal glands from producing hormones. As a result, the patient could develop a hormone disorder and/or associated symptoms as a result of treatment with Mitotane.

Despite these risks, treatment with Mitotane is often preferable to not treating the patient's condition at all. Whilst long-term side-effects can often be managed with additional medication, cancers of the adrenal glands can worsen quickly if left untreated. Due to this, Mitotane is often used to treat patients who have been diagnosed with cancer, such as adrenocortical carcinoma, and treatment with this medication can successfully prolong the patient's life.