Lysodren (mitotane) is an oral medication that’s used to treat advanced cancer of the adrenal gland. It can be taken by itself or together with other anticancer medications. Lysodren (mitotane) is a convenient pill that’s taken by mouth, but usually needs to be taken multiple times a day. It can commonly cause side effects like nausea and vomiting. You’re required to get blood work done regularly during treatment to check the medication levels in your body.
Advanced cancer of the adrenal gland
Lysodren (mitotane) is an anticancer medication that targets adrenal gland tumors. The exact way it works isn’t known. Lysodren (mitotane) is thought to lower the activity of the outer part of the adrenal gland, which is responsible for making steroid and sex hormones that keep your body in balance. It might also affect the way steroid hormones are broken down in the body.
Source: DailyMed
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
Darkening of the skin
dizziness or lightheadedness
drowsiness
loss of appetite
mental depression
nausea or vomiting
skin rash
unusual tiredness or weakness
Less common
Blood in the urine
blurred vision
double vision
Incidence not known
chills
cloudy urine
cold sweats
confusion
dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
feeling of warmth
headache
pelvic cramping, discomfort, pain, or heaviness
nervousness
pounding in the ears
redness of the face, neck, arms, and occasionally, upper chest
slow or fast heartbeat
vaginal bleeding
vision changes
white area over the eye
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Feeling of constant movement of self or surroundings
indigestion
passing of gas
sensation of spinning
sleepiness
Less common
Aching muscles
flushing or redness of the skin
muscle twitching
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
A pill that’s taken by mouth
A recommended treatment option for advanced cancer of the adrenal gland
Usually need to take several times a day
Can lower your body’s ability to handle stressful events, such as injury or illness
Not safe during pregnancy
Swallow Lysodren (mitotane) tablets whole. Don’t split, dissolve, or crush the tablets. Otherwise, the medication might harm you.
Let your healthcare team know if you have an upcoming surgery or medical procedure. You might need stop taking Lysodren (mitotane) or take steroid medications to help prevent complications and help your body recover better from a procedure. Your healthcare team will discuss your options with you.
You’ll need to get blood tests done regularly during Lysodren (mitotane) treatment. This is so your provider can check the levels of the medication in your body and make sure they’re at a safe and effective level. When Lysodren (mitotane) levels are too high, it can lead to more side effects like drowsiness, weakness, and upset stomach. But, having levels too low can mean that the medication might not work as well to treat your cancer. Your provider might change your medication dose based on your lab results. Follow the lab schedule your provider gives you.
It's important to tell your provider and pharmacist about all the medications you’re taking, including supplements and birth control. Your provider might need to change the dose of your medications. This is because Lysodren (mitotane) can interact with many medications. Usually, it causes other medications to not work as well. Before starting any new medications, make sure your providers know that you're taking Lysodren (mitotane).
If you’re a woman who can have children, use birth control while taking Lysodren (mitotane). This medication can harm an unborn baby or raise the risk for miscarriage (pregnancy loss). Let your provider know right away if you become pregnant during treatment.
Ask your healthcare provider or pharmacist about the best way to handle and dispose of Lysodren (mitotane). Anticancer medications can be hazardous to people who handle or come into contact with them.
Lysodren (mitotane) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Taking Lysodren (mitotane) can cause your adrenal glands to not make enough cortisol. Cortisol is the main hormone that helps to manage stress in your body. Your provider will check your hormone levels through regular blood work. You might need to take steroid medication to help balance hormone levels in your body.
In serious cases, taking Lysodren (mitotane) can cause your body to go into shock when a stressful or traumatic event happens, such as surgery or illness. This is called adrenal crisis. Get medical attention right away if you experience lightheadedness, dizziness, weakness, sweating, stomach pain, nausea, vomiting, or loss of consciousness.
Risk factors: High levels of Lysodren (mitotane) in your blood
Lysodren (mitotane) can cause you to become very drowsy, weak, or dizzy. Having higher levels of Lysodren (mitotane) in your blood are generally linked to more of these side effects. Your provider will check your blood work to see how much Lysodren (mitotane) is in your body. They might adjust your medication dose to lower your risk of these side effects if your lab results show higher than acceptable medication levels in your blood.
Lysodren (mitotane) can harm an unborn baby or raise the risk for miscarriage (pregnancy loss). Because of these risks, if you’re a woman who can get pregnant, you should use birth control while taking Lysodren (mitotane). Continue using birth control after stopping treatment until your provider says you’re in the clear. This is because the medication can stay in the body for a while even after you’ve stopped taking it. Your provider will check your blood work to see whether Lysodren (mitotane) is still in your body after the last dose. Let your provider know right away if you become pregnant during or after treatment.
Some premenopausal people who’ve taken Lysodren (mitotane) have developed ovarian cysts during treatment. These cysts can appear on both sides of the ovaries. Let your provider know if you experience any unusual vaginal bleeding or pain in the pelvic area, as these can be symptoms of an ovarian cyst. Sometimes, these symptoms can improve after stopping Lysodren (mitotane).
The typical starting dose is 2 to 6 grams by mouth daily, divided into 3 or 4 doses throughout the day. You’ll need to get regular blood work done to measure Lysodren (mitotane) levels in your body. Your provider might adjust your dose based on your lab results.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
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Center for Disease Control and Prevention. (n.d.). What you need to know: Neutropenia and risk for infection.
Elshimy, G., et al. (2023). Adrenal crisis. StatPearls.
HRA Pharma Rare Diseases. (2024). Lysodren- mitotane tablet [package insert]. DailyMed.
National Cancer Institute. (n.d.). Adrenal cortex.
National Cancer Institute. (2022). Nausea and vomiting.
National Cancer Institute. (2023). Adrenocortical carcinoma treatment (PDQ®)–Patient version.
National Comprehensive Cancer Network. (2022). Adrenal tumors.
National Institute of Diabetes and Digestive and Kidney Diseases. (2018). Definition & facts of adrenal insufficiency & Addison's disease.
Shah, M. H., et al. (2021). Neuroendocrine and adrenal tumors, Version 2.2021, NCCN Clinical Practice Guidelines in Oncology. Journal of the National Comprehensive Cancer Network.
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