WARNING

Mitotane is a medication primarily used to treat adrenal cortical carcinoma, a rare form of cancer that affects the adrenal glands. While it can be effective in managing this condition, it also comes with certain risks and potential side effects. Here is a brief overview of the risks associated with taking Mitotane:

• Adverse Gastrointestinal Effects: Mitotane commonly causes gastrointestinal side effects such as nausea, vomiting, diarrhea, and loss of appetite. These symptoms can be bothersome and may require supportive care or dose adjustments.
• Hepatotoxicity: Mitotane can lead to liver toxicity, which may manifest as elevated liver enzymes in blood tests. Patients taking Mitotane require regular monitoring of liver function.
• Adrenal Insufficiency: Mitotane can suppress the function of the adrenal glands, leading to adrenal insufficiency. Patients may experience fatigue, weakness, and low blood pressure. Replacement therapy with corticosteroids may be necessary.
• Neurological Effects: Some individuals may experience neurological symptoms such as dizziness, confusion, or mood changes while taking Mitotane.
• Skin Reactions: Skin rashes and hypersensitivity reactions have been reported in rare cases.
• Endocrine Effects: Mitotane can disrupt hormone production in the body, potentially causing hormonal imbalances that require monitoring and management.
• Teratogenicity: Mitotane can harm a developing fetus if taken during pregnancy, so it is contraindicated in pregnant women.
• Interactions: Mitotane can interact with other medications, including those that affect liver enzymes, leading to altered drug levels in the body.
• Long-Term Effects: The long-term effects of Mitotane use are not well-documented due to its rarity and specific use. Therefore, patients may need ongoing monitoring for potential late effects.
• Rare Allergic Reactions: Although uncommon, some individuals may experience severe allergic reactions to Mitotane, which can be life-threatening.

It’s essential for individuals prescribed Mitotane to be closely monitored by their healthcare providers, adhere to their prescribed treatment plan, and report any concerning symptoms or side effects promptly. The benefits of using Mitotane should be carefully weighed against the potential risks, and the decision to use this medication should be made in consultation with a medical oncologist or specialist.

Why is this medication prescribed?

Mitotane is prescribed primarily to treat a rare form of cancer called adrenal cortical carcinoma (ACC), which originates in the adrenal cortex, the outer layer of the adrenal glands. ACC is a highly aggressive cancer, and Mitotane is used to manage it. Mitotane is the primary medical treatment for ACC. It works by destroying the adrenal cortex cells, which are responsible for producing hormones such as cortisol. ACC often overproduces cortisol and other hormones, leading to various health problems. Mitotane aims to control tumor growth and hormone production in ACC.

The use of Mitotane should be carefully managed by a medical oncologist or specialist, and the treatment plan may involve other therapies such as surgery or radiation therapy, depending on the stage and severity of the cancer.

How should this medicine be used?

Here are general guidelines for using Mitotane:

• Dosage: The dosage of Mitotane varies depending on the individual patient and their response to treatment. It is typically started at a low dose and gradually increased to the therapeutic dose. The goal is to reach a level of Mitotane in the blood that is effective against the cancer while minimizing side effects.
• Administration: Mitotane is usually taken orally in the form of tablets or capsules. It should be taken with meals to enhance absorption and minimize gastrointestinal side effects.
• Monitoring: Close monitoring is essential during Mitotane treatment. This includes regular blood tests to check the levels of Mitotane in the blood, liver function, and hormone levels. Adrenal function should also be assessed, and corticosteroid replacement therapy may be needed to manage adrenal insufficiency.
• Duration of Treatment: The duration of Mitotane treatment can vary widely, depending on the individual’s response to therapy and the stage of ACC. Some patients may require long-term treatment, while others may have their treatment course adjusted based on their progress.
• Adverse Effects: Patients should be aware of the potential side effects of Mitotane, which may include gastrointestinal symptoms, liver toxicity, adrenal insufficiency, neurological effects, and others. Any new or worsening symptoms should be reported to a healthcare provider.
• Pregnancy Precautions: Mitotane is contraindicated during pregnancy because it can harm the developing fetus. Adequate contraception should be used during treatment, and women of childbearing age should be informed about the risks.

It’s crucial for patients prescribed Mitotane to work closely with their healthcare team, adhere to their prescribed treatment plan, and follow their healthcare provider’s instructions for dosage and monitoring to optimize the effectiveness of the treatment and minimize potential risks.

Other uses for this medicine

While Mitotane is primarily used to treat adrenocortical carcinoma, it may have some off-label uses, which are uses that are not approved by regulatory authorities but are prescribed by healthcare providers based on their clinical judgment. Some potential off-label uses include:

• Treatment of Cushing’s syndrome: Mitotane can be used to reduce excess cortisol production in cases of Cushing’s syndrome.
• Treatment of neuroendocrine tumors: In some cases, Mitotane may be considered as part of the treatment regimen for certain types of neuroendocrine tumors.

What special precautions should I follow?

Regarding special precautions for Mitotane:

• Pregnancy and Contraception: Mitotane is contraindicated during pregnancy due to its teratogenic (harmful to the fetus) effects. Women of childbearing age should use effective contraception during Mitotane treatment, and pregnancy should be avoided. A healthcare provider can provide guidance on appropriate contraceptive methods.
• Liver Function: Since Mitotane can affect liver function, regular monitoring of liver enzymes is essential during treatment. If liver abnormalities are detected, the dosage may need to be adjusted or treatment discontinued.
• Adrenal Function: Mitotane can suppress adrenal gland function, leading to adrenal insufficiency. Patients should be monitored for signs and symptoms of adrenal insufficiency, such as fatigue, weakness, and low blood pressure. Corticosteroid replacement therapy may be required.
• Interactions: Mitotane can interact with other medications, including those that affect liver enzymes. It may alter the effectiveness of other drugs, so it’s crucial to inform your healthcare provider about all the medications you are taking.
• Neurological Effects: Mitotane may cause dizziness and neurological symptoms in some individuals. Patients should exercise caution when performing tasks that require mental alertness, such as driving, especially during the initial phase of treatment.
• Regular Monitoring: Close and regular monitoring by a medical oncologist or specialist is essential throughout the Mitotane treatment course. This includes monitoring Mitotane blood levels, liver function, hormone levels, and adrenal function.
• Adherence to Treatment Plan: It’s vital to follow the prescribed dosage and administration instructions precisely as directed by your healthcare provider.
• Patient Education: Patients should be well-informed about the potential side effects and risks associated with Mitotane, and any new or concerning symptoms should be promptly reported to their healthcare team.

Always consult with your healthcare provider for specific guidance and precautions related to your individual health condition and Mitotane treatment plan.

What special dietary instructions should I follow?

There are no specific dietary restrictions that are universally recommended for people taking Mitotane. However, you should maintain a balanced and healthy diet. It’s crucial to follow any dietary advice provided by your healthcare provider, especially if you have specific dietary concerns or if you are experiencing gastrointestinal side effects, such as nausea or diarrhea.

What should I do if I forget a dose?

If you forget to take a dose of Mitotane:

• Take it as Soon as You Remember: If you miss a dose and remember it within a few hours, take the missed dose as soon as you realize it.
• Skip If It’s Close to the Next Dose: If it’s close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to make up for the missed one.
• Notify Your Healthcare Provider: It’s a good practice to inform your healthcare provider or oncologist if you miss a dose, as they can provide guidance on how to proceed.

What side effects can this medication cause?

Mitotane can cause a range of side effects, and their severity can vary from person to person. It’s important to note that not everyone will experience these side effects, and some individuals may experience side effects that are not listed here. Common side effects of Mitotane may include:

• Gastrointestinal Effects: These are among the most common side effects and may include nausea, vomiting, diarrhea, and loss of appetite.
• Liver Toxicity: Mitotane can affect liver function, leading to elevated liver enzymes in blood tests. Regular monitoring of liver function is necessary during treatment.
• Adrenal Insufficiency: Mitotane can suppress the function of the adrenal glands, which may result in adrenal insufficiency. Symptoms may include fatigue, weakness, and low blood pressure. Replacement therapy with corticosteroids may be needed.
• Neurological Effects: Some individuals may experience dizziness, confusion, or mood changes while taking Mitotane.
• Skin Reactions: Skin rashes and hypersensitivity reactions have been reported in rare cases.
• Endocrine Effects: Mitotane can disrupt hormone production in the body, potentially causing hormonal imbalances that require monitoring and management.
• Weight Loss: Unintended weight loss is a possible side effect of Mitotane.
• Cardiovascular Effects: Mitotane may lead to changes in blood pressure and heart rate.
• Neuromuscular Effects: Muscle weakness and muscle pain can occur as side effects.
• Metabolic Changes: Alterations in glucose metabolism can occur, leading to changes in blood sugar levels.
• Bone Effects: Long-term use of Mitotane may be associated with bone loss and an increased risk of fractures.
• Hematological Effects: Changes in blood cell counts, including anemia and leukopenia (low white blood cell count), have been reported in some cases.
• Allergic Reactions: Although uncommon, some individuals may experience severe allergic reactions to Mitotane, which can be life-threatening.

It’s essential for individuals prescribed Mitotane to be closely monitored by their healthcare providers, adhere to their prescribed treatment plan, and report any concerning symptoms or side effects promptly. The benefits of using Mitotane should be carefully weighed against the potential risks, and the decision to use this medication should be made in consultation with a medical oncologist or specialist. Your healthcare provider can provide guidance on managing and mitigating these side effects as needed.

What should I know about storage and disposal of this medication?

Storage and disposal of Mitotane:

• Storage: Mitotane should be stored at room temperature, away from moisture, heat, and direct sunlight. Keep it in its original packaging, and store it out of the reach of children and pets. Do not freeze the medication.
• Disposal: Properly dispose of any unused or expired Mitotane tablets according to your local regulations or guidelines for hazardous waste disposal. Do not dispose of medications in wastewater (e.g., down the sink or toilet) unless specifically instructed to do so.

In case of emergency/overdose

If you suspect an overdose or experience severe adverse effects while taking Mitotane, seek immediate medical attention or contact your nearest poison control center. Overdose symptoms may include severe nausea, vomiting, confusion, dizziness, and other serious side effects.

What other information should I know

• Regular Monitoring: Throughout your Mitotane treatment, your healthcare provider will conduct regular blood tests and medical check-ups to monitor your progress, assess the medication’s effectiveness, and manage any potential side effects.
• Follow Healthcare Provider’s Instructions: Adhere to your healthcare provider’s instructions regarding dosing, administration, and any specific precautions related to your treatment.
• Contraception: If you are of childbearing age and sexually active, ensure you use effective contraception methods while taking Mitotane, as it can harm a developing fetus. Discuss contraception options with your healthcare provider.
• Inform All Healthcare Providers: Make sure to inform all healthcare providers (doctors, dentists, surgeons, etc.) that you are taking Mitotane, as it may interact with other medications or affect anesthesia during surgical procedures.
• Adrenal Insufficiency: Be aware of the signs and symptoms of adrenal insufficiency, such as extreme fatigue, weakness, and low blood pressure. If you experience these symptoms, contact your healthcare provider promptly.
• Avoid Alcohol: It’s generally advisable to avoid alcohol while taking Mitotane, as it may increase the risk of liver toxicity.
• Patient Education: Educate yourself about the potential side effects of Mitotane, and keep an open line of communication with your healthcare provider. Report any unusual or severe side effects promptly.
• Medication Interactions: Inform your healthcare provider about all medications, supplements, or herbal products you are taking, as Mitotane can interact with other drugs.
• Travel Precautions: If you plan to travel while on Mitotane, carry an ample supply of medication with you and keep a record of your treatment details. In case of an emergency, this information will be helpful.

Always consult with your healthcare provider for personalized guidance and to address any specific concerns or questions you may have about Mitotane treatment. Your healthcare team can provide you with the most up-to-date information and tailored advice based on your individual health needs.