Patient Medication Information: uses, side effects, how to take - Lysodren
Serious Warnings and Precautions box
What LYSODREN is used for:
LYSODREN is used to treat a type of cancer that affects the adrenal gland. This cancer is called adrenocortical carcinoma of functional or non-functional type. Patients who take LYSODREN have a cancer that cannot be removed by surgery.
How LYSODREN works:
Mitotane is the active ingredient in LYSODREN. The way it works is not exactly known. However, it seems to affect how steroids are broken down. As well, it seems to stop the activity of the adrenal cortex. This is where the cancer is located.
The ingredients in LYSODREN are:
Medicinal ingredients: mitotane
Non-medicinal ingredients: colloidal silicon dioxide, corn starch, microcrystalline cellulose, polyethylene glycol
LYSODREN comes in the following dosage form:
Tablet: 500 mg
Do not use LYSODREN if:
- you are allergic to mitotane or to any other ingredients in this medicine
you are breastfeeding
At high doses, LYSODREN can cause severe brain damage and problems with how the brain works. This is called neurologic toxicity. If you are taking high doses of LYSODREN, your healthcare professional will monitor your behaviour and how your brain is working.
- you take a medication containing spironolactone
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take LYSODREN. Talk about any health conditions or problems you may have, including if you:
- have recently experienced a shock, severe trauma or infection
- have a condition called Cushing’s syndrome. You may be at a higher risk of experiencing infections.
- have or have had liver problems
- have or have had kidney problems
- have or are at risk of having heart problems
- have a history of depression or are at risk of developing depression
- take medication that acts on your central nervous system
- take medication that makes your blood thinner, such as warfarin
- are overweight or obese
- have recently lost weight
- have recently had or plan to have a surgery
- have metastases. This means that your cancer has spread outside of the adrenal gland.
Other warnings you should know about:
Adrenal insufficiency can happen with LYSODREN treatment. This is when the adrenal glands don’t make enough of the hormone cortisol. If you experience adrenal insufficiency, you may need to take other medicines.
Cysts on the ovaries (called ovarian macrocysts) are possible in women treated with LYSODREN. If you are a woman and you have unusual vaginal bleeding or pain in the pelvis, contact your healthcare professional. Ovarian macrocysts may also produce no symptoms. If you are pre-menopausal, you may need ultrasound scans of your ovaries.
Female patients – Pregnancy and breastfeeding:
- If you are pregnant, able to get pregnant or think you are pregnant, there are specific risks you should discuss with your healthcare professional.
- Avoid becoming pregnant while you are taking LYSODREN. It may harm your unborn baby.
- If you are able to get pregnant, you must use effective birth control during your treatment. You must also use this birth control after stopping LYSODREN. Your healthcare professional will do blood tests to determine when you can stop using this birth control. It will depend on the results of these tests.
- Do not breastfeed while you are taking LYSODREN. Mitotane may pass into your breastmilk. Your healthcare professional will tell you when you can start breastfeeding. It will depend on blood test results.
Driving and operating machines: LYSODREN can affect your brain and nervous system. This may affect your ability to drive and use machines. If you feel tired or dizzy, do not drive or use machines. Ask your healthcare professional for advice.
Blood tests:
- Taking LYSODREN can affect your blood cells
Your healthcare professional will do blood tests during your treatment. These tests will be done regularly (e.g. monthly).
- If you are overweight or have recently lost weight, suffer from metabolic syndrome, abuse alcohol or eat a high fat diet these tests may be done every 2 weeks.
- If you are taking blood thinners like warfarin, you will have regular blood tests to see if there are changes in how clots form in your blood.
- Tell your healthcare professional that you are taking LYSODREN each time you have blood work. It can affect some blood tests.
Liver problems:
- Taking LYSODREN can cause liver damage or autoimmune hepatitis. Autoimmune hepatitis occurs when your body's immune system turns against the liver cells.
- Liver function tests will be completed periodically during your treatment. Especially during the first months of treatment or when your dose is increased.
Heart rhythm problems:
- Taking LYSODREN can cause heart rhythm problems called QT prolongation.
- You are at a higher risk if you have heart problems, have an electrolyte imbalance, are dehydrated or experience a lot of vomiting, diarrhea, or sweating, or if you take medication that can affect your heart rhythm or electrolyte balance.
- Your healthcare professional may monitor your heart rhythm with ECG tests periodically during your treatment.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with LYSODREN:
- steroid replacement therapy (such as cortisol, hydrocortisone, prednisolone or dexamethasone)
- medicine containing spironolactone
- medicines used as blood thinners like warfarin
- the anti-cancer drugs etoposide and sunitinib
- medicines that act on the central nervous system
- midazolam, used before surgery to make you drowsy and reduce anxiety
How to take LYSODREN:
- This medicine should not be handled by persons other than the patient and his/her caregivers, and especially not by pregnant women. Always wear gloves when handling the LYSODREN bottle and tablets. If you touch broken tablets, wash thoroughly with soap and water right away.
- Do not crush, break, split or cut the tablets.
- Swallow the tablets whole with a glass of water.
Take your LYSODREN with a meal that contains foods high in fat like milk, chocolate or oil.
Usual dose:
Your healthcare professional will tell you how much and how often to take LYSODREN. Do not take more than you are told.
Your healthcare professional may change your dose, stop your treatment for a period of time or recommend that you stop treatment completely. This may happen if you:
- experience serious side effects, or
- your disease gets worse.
Overdose:
Too much LYSODREN can cause severe brain damage that can cause dizziness or problems with memory, speech, attention or balance.
If you think you, or a person you are caring for, have taken too much LYSODREN, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed Dose:
If you miss a dose, skip it. Take your next dose as per your usual schedule. Do not take two doses at once to make for the missed dose.
Possible side effects from using LYSODREN:
These are not all the possible side effects you may have when taking LYSODREN. If you experience any side effects not listed here, tell your healthcare professional.
- Skin rashes, itching
- Blood in urine
- Blurred or double vision
- Body aches
- Delayed growth
- Depression
- Diarrhea
- Dizziness, vertigo, confusional state
- Fever
- Flushing
- Growth of breast in men
- High blood pressure
- Infections
- Inflammation (swelling, heat, pain) of mucosa, upper abdominal pain, indigestion, taste disorder
- Lethargy (lack of energy), fatigue, weakness, drowsiness
- Loss of appetite
- Mental impairment (such as memory loss, concentration difficulty)
- Nausea, vomiting
- Quick drop of blood pressure when you stand up, that can cause dizziness, lightheadedness or fainting
- Sex hormones disturbances in males and females
- Shortness of breath
- Tingling or numbness in arms, hands, legs or feet
LYSODREN can cause abnormal blood test results. Your healthcare professional will conduct blood tests during your treatment and will interpret the results.
Serious side effects and what to do about them
| Frequency/Side effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Frequency/Side effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Rare/unknown | |||
| Adrenal insufficiency (adrenal glands don’t make enough cortisol): fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain, nausea, vomiting | x | ||
| Albuminuria (proteins in urine): swelling of the ankles, hands, abdomen or the face | x | ||
| Allergic reaction: difficulty swallowing or breathing, wheezing, drop in blood pressure, feeling sick to your stomach and throwing up, hives or rash, swelling of the face, lips, tongue or throat | x | ||
| Hemorrhagic cystitis (bladder inflammation): pain, discomfort, or burning when urinating, blood in urine | x | ||
| Hepatitis (inflammation of the liver), liver damage: fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, light-colored stools, joint pain, jaundice | x | ||
| Hypogonadism in males (the body doesn’t make enough testosterone): enlarged breast, libido decreased, erectile dysfunction, fertility disorders | x | ||
| Hypothyroidism (underactive thyroid gland): fatigue, sensitivity to cold, constipation, dry skin, weight gain, swelling of the face, voice changed, muscle weakness | x | ||
| Lens opacity (clouding of the lens of the eye): loss of vision, blurry or double vision, halos around light, trouble with bright lights, faded colors | x | ||
| Leukopenia (low white blood cells): mouth or skin sores, sore throat, cough, trouble breathing, feeling light-headed, fever, chills, sweating, body aches | x | ||
| Anemia (a decrease of red blood cells): skin pallor and fatigue | x | ||
| Thrombocytopenia (a decrease in blood platelets): bruising and bleeding | x | ||
| Maculopathy (a disease of the centre part of the retina called the macula): loss of vision, image distortion, central spot in vision | x | ||
| Neurologic toxicity and brain damage: severe headache, difficulty speaking or slurred speech, loss of muscle coordination, loss of balance, movement and coordination disorders, mental impairment, confusion | x | ||
| Ovarian macrocysts (fluid-filled sacs on the ovaries): menstrual irregularity, bloating, lower abdominal / pelvic pain, lower back pain, vaginal bleeding | x | ||
| Toxic retinopathy: loss of vision, diminished color vision, trouble reading | x | ||
| Bleeding time prolonged in case of injury or surgery | x | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Store in the original packaging at room temperature (15-30°C).
Keep out of sight and reach of children.
Do not use after the expiry date which is stated on the carton and the bottle after EXP.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
If you want more information about LYSODREN:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: Drug Product Database: Access the database) or the manufacturer’s website (www.esteve.com).