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INDICATION AND IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING ON ADRENAL CRISIS IN THE SETTING OF SHOCK OR SEVERE TRAUMA

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What is LYSODREN®?

LYSODREN is a prescription medication used to treat the symptoms of adrenal cortical carcinoma (cancer of the outer layer of the adrenal gland).

LYSODREN is used when the cancer cannot be removed by surgery.

In patients taking LYSODREN, adrenal crisis (severe adrenal insufficiency) occurs in the setting of shock or severe trauma and response to shock is impaired. Administer hydrocortisone, monitor for increasing signs of shock and discontinue LYSODREN until recovery.

IMPORTANT SAFETY INFORMATION INCLUDING WARNINGS

What is the most important information I should know about LYSODREN®?

In patients taking LYSODREN, adrenal crisis (severe adrenal insufficiency) occurs in the setting of shock or severe trauma and response to shock is impaired. Administer hydrocortisone, monitor for increasing signs of shock and discontinue LYSODREN until recovery.

Adrenal insufficiency is when the adrenal glands do not produce enough hormones. Check with your doctor if you have any of the following symptoms: fatigue, abdominal pain, nausea, vomiting, diarrhea and confusion.

LYSODREN may cause some patients to become dizzy or lose their balance, drowsy, have a lack of energy, or less alert than normal.

What should I tell my doctor before taking LYSODREN®?

Are pregnant or plan to become pregnant. LYSODREN may cause harm to the unborn child.

Are breastfeeding or plan to breastfeed. LYSODREN may cause serious adverse reactions in the breastfed infant. Talk to your healthcare provider about the best way to feed your baby if you use LYSODREN or when it safe to start breastfeeding after discontinuation of treatment.

Tell your doctor if you have pelvic pain or vaginal bleeding since LYSODREN may produce ovarian cysts in some women.

Have a history of liver disease.

What are the most common side effects of LYSODREN®?

The most common side effects of LYSODREN include:

Anorexia (weight loss)
Diarrhea
Nausea (upset stomach)
Dizziness or vertigo (loss of balance)
Vomiting
Rash

These are not all of the possible side effects of LYSODREN. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS, contact Direct Success Pharmacy, Inc. at 1-844-LYSODREN (1-844-597-6373) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Full Prescribing Information, including boxed warning, for LYSODREN® (mitotane), tablets.

HRA Pharma Rare Diseases, 200 avenue de Paris, 92320, Chatillon, FRANCE
Tel: +33 (0) 1 40 33 94 14 / Fax: +33 (0) 1 40 33 30 87
© 2021 HRA Pharma Rare Diseases | Lysodren is a registered trademark of HRA Pharma Rare Diseases
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Last updated: June 2023; LYS – US – 0016

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