| What is the most important information I should know about LYSODREN? |
| LYSODREN can cause serious side effects including: |
Adrenal Insufficiency and Adrenal Crisis.
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Adrenal Insufficiency. LYSODREN can cause your adrenal glands to stop making enough corticosteroid hormones (adrenal insufficiency) or make this problem worse in people with cancer of the adrenal glands (adrenocortical carcinoma). Your healthcare provider may temporarily stop, reduce your dose, or permanently stop treatment with LYSODREN if you develop adrenal insufficiency during treatment.
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Adrenal Crisis. LYSODREN can cause your adrenal glands to suddenly stop making enough corticosteroid hormones (adrenal crisis). You are at increased risk for developing adrenal crisis if you experience shock, severe injury, or infection during treatment with LYSODREN. Adrenal crisis may lead to death. Tell your healthcare provider right away if you get an injury, infection, or other illness during treatment with LYSODREN. Your healthcare provider will temporarily stop LYSODREN if shock, severe injury, or infections happen during treatment. Tell your healthcare provider if you have any planned surgery.
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| Your healthcare provider will check your levels of corticosteroid hormones during treatment and may give you corticosteroid medicine if you develop adrenal gland problems. Tell your healthcare provider right away if you develop any signs or symptoms of adrenal gland problems, including: |
- severe weakness
- confusion
- pain in the lower back and legs
- stomach (abdominal) pain
- nausea, vomiting, or diarrhea
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- feeling lightheaded or dizzy
- passing out
- feeling very tired
- decreased appetite
- weight loss
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- areas of darkened skin
- craving salt
- low blood sugar
- feeling irritable or depressed
- hair loss
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| See "What are the possible side effects of LYSODREN?" for more information about side effects. |
| What is LYSODREN? |
| LYSODREN is a prescription medicine used to treat people with cancer of the adrenal glands (adrenocortical carcinoma) that is functional (when the adrenal glands make more corticosteroid hormone than normal) or nonfunctional (when the adrenal glands make less corticosteroid hormone than normal) and the cancer cannot be removed by surgery. |
| Effectiveness in pediatric patients has not been established. |
Before taking LYSODREN, tell your healthcare provider about all of your medical conditions, including if you:
- have an injury, infection or illness
- plan to have surgery. Tell your healthcare providers you are taking LYSODREN. You may need to stop taking LYSODREN before any surgery and dental procedures.
- have cysts on your ovaries
- have liver or kidney problems
- have bleeding problems
- are pregnant or plan to become pregnant. LYSODREN can harm your unborn baby.
Females who can become pregnant:
- Your healthcare provider will do a pregnancy test before you start treatment with LYSODREN.
- Use birth control (contraception) that does not contain hormones (nonhormonal) such as condoms or diaphragms and spermicide during treatment with LYSODREN and for as long as your healthcare provider tells you to after you stop treatment. Birth control methods that contain hormones such as birth control pills, injections, or patches may not work as well during and after treatment with LYSODREN.
Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with LYSODREN.
- are breastfeeding or plan to breastfeed. LYSODREN can pass into your breast milk and may harm your baby. Do not breastfeed during treatment and after you stop taking LYSODREN until your healthcare provider tells you it is okay. Talk to your healthcare provider about the best way to feed your baby during and after treatment with LYSODREN.
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| Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking LYSODREN with certain other medicines may affect the way LYSODREN and the other medicines work and may increase your risk of side effects. |
| Especially tell your healthcare provider if you take: |
- spironolactone
- midazolam or other CYP3A substrates
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| Ask your healthcare provider about any other medicine that may not be listed above. |
| Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. |
How should I take LYSODREN?
- Take LYSODREN exactly as your healthcare provider tells you to take it.
- Do not change your dose unless your healthcare provider tells you to.
- Take your daily dose of LYSODREN in 3 or 4 divided doses each day.
- Swallow LYSODREN tablets whole. Do not crush, chew or split the tablets.
- Do not take any LYSODREN tablets that are broken or crushed.
- Take LYSODREN with food, preferably a high-fat meal or snack. Talk to your healthcare provider about examples of foods you should eat.
- Caregivers should wear disposable gloves when handling LYSODREN tablets. You should avoid contact with crushed or broken tablets. If skin contact with crushed or broken tablets happens, thoroughly wash the skin area right away with soap and water.
- If you miss a dose of LYSODREN, skip the missed dose and take the next dose at your regularly scheduled time. Do not take 2 doses at the same time to make up for a missed dose.
- If you vomit after taking LYSODREN, take the next dose at your regularly scheduled time.
- If you take too much LYSODREN, call your healthcare provider right away or go to the nearest emergency room.
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| What should I avoid while taking LYSODREN? |
| Do not drive or operate machinery until you know how LYSODREN affects you. LYSODREN may cause sleepiness, decreased energy, and dizziness, which may affect your ability to drive and operate machinery. |
| What are the possible side effects of LYSODREN? |
| LYSODREN can cause serious side effects including: |
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- slow thinking
- slow movement or decreased coordination
- confusion
- difficulty concentrating
- memory loss
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- trouble talking
- sleepiness
- dizziness
- feelings of pins and needles in your hands and feet
- feeling very tired
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| Your healthcare provider may test your blood to make sure your thyroid is producing enough thyroid hormone and to check the mitotane level if you develop any of these signs and symptoms during treatment. |
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Ovarian cysts in premenopausal women. LYSODREN can cause noncancerous large cysts (macrocysts) on the ovaries of women who have not gone through menopause (premenopausal). The cysts may cause pain or discomfort in your pelvic area and abnormal periods, or they may not cause any symptoms at all. If you are premenopausal, your healthcare provider will do an ultrasound of your ovaries before starting LYSODREN and as needed during treatment. Tell your healthcare provider right away if you develop vaginal bleeding or pelvic pain.
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Liver problems. LYSODREN can cause liver problems, including liver injury or liver failure. Tell your healthcare provider right away if you develop any signs and symptoms of liver problems during LYSODREN treatment, including:
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- yellowing of your skin or the white part of your eyes
- dark colored (tea colored) urine
- pain in your right upper stomach-area (abdomen)
- itching
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- loss of appetite
- nausea, vomiting or diarrhea
- bleeding or bruising
- tiredness
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Low blood cell counts. LYSODREN can cause decreased blood cell counts including decreases in white blood cells, platelets, and red blood cells. This may increase your risk of infection, bleeding, and anemia. Tell your healthcare provider right away if you develop any signs or symptoms of low blood cell counts, including:
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- fever
- trouble breathing
- unusual bruising or bleeding
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- dizziness or lightheadedness
- tiredness
- pale skin or lightness of skin color
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Prolonged bleeding time. LYSODREN can cause bleeding that lasts longer than usual. If you need to have surgery or dental procedures during treatment with LYSODREN, your healthcare provider will do blood tests to check for prolonged bleeding risks. Tell your healthcare provider right away if you develop signs or symptoms of prolonged bleeding during treatment with LYSODREN, including:
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- unusual bleeding or bleeding that will not stop
- bruising
- lightheadedness
- vomiting blood or your vomit looks like coffee grinds
- blood in your stool or black stool that looks like tar
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- pink or brown urine
- coughing up blood or blood clots
- menstrual bleeding that is heavier than normal
- nose bleeds that happen often
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Changes in hormone levels. LYSODREN may cause changes in certain hormone levels in your blood. If you are male, your breasts may swell or become larger during treatment.
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| Your healthcare provider will do blood tests before you start treatment with LYSODREN, during your treatment, and after you stop treatment with LYSODREN to check mitotane levels in your body and to check for side effects. |
| Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with LYSODREN if you develop certain side effects. |
| The most common side effects of LYSODREN include: |
- eating disorders (anorexia)
- upper stomach area (abdominal) discomfort
- nausea
- vomiting
- diarrhea
- depression
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- dizziness or lightheadedness
- rash
- high cholesterol
- increase of triglycerides (fat in blood)
- decreased thyroid hormones
- decreased testosterone (in males)
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| These are not all of the possible side effects of LYSODREN. |
| Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
| You may also report side effects to Direct Success Inc. at 1-844-597-6373. |
| How should I store LYSODREN? |
| Store LYSODREN at 77°F (25°C). |
| Keep LYSODREN and all medicines out of the reach of children. |
| General information about the safe and effective use of LYSODREN. |
| Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use LYSODREN for a condition for which it was not prescribed. Do not give LYSODREN to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about LYSODREN that is written for health professionals. |
| What are the ingredients in LYSODREN? |
| Active ingredient: mitotane |
| Inactive ingredients: microcrystalline cellulose, polyethylene glycol 3350, silicon dioxide, and starch. |
| Manufactured by: Latina Pharma S.p.A., Via Murillo, 7, 04013 Sermoneta (Latina), Italy; Manufactured for HRA Pharma Rare Diseases. |
| For more information, go to www.lysodren.com or call 1-844-597-6373. |
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