LYSODREN- mitotane tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

mitotane (UNII: 78E4J5IB5J) (mitotane - UNII:78E4J5IB5J)

Available from:

HRA Pharma Rare Diseases

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

LYSODREN is indicated for the treatment of patients with inoperable, functional or nonfunctional, adrenocortical carcinoma (ACC). None. Risk Summary LYSODREN can cause fetal harm. Limited postmarketing cases report preterm births and early pregnancy loss in women treated with LYSODREN during pregnancy. Animal reproduction studies have not been conducted with mitotane. Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Risk Summary Mitotane is excreted in human milk; however, the effect of LYSODREN on the breastfed child, or on milk production is unknown. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with LYSODREN and after discontinuation of treatment for as long as mitotane plasma levels are detectable. Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to initiating LYSODREN [see Use in Specific Populations (8.1)] . Contraception LYSODREN can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)] . Females Advise females of reproductive potential to use effective nonhormonal contraception during treatment with LYSODREN and after discontinuation of therapy for as long as mitotane plasma levels are detectable [see Clinical Pharmacology (12.3)] . LYSODREN can render hormonal contraceptives ineffective [see Drug Interaction (7.2)] . Effectiveness in pediatric patients has not been established. Based on published case reports, mitotane may negatively impact neuro-psychological development (e.g., motor and speech delay, memory impairment) in children and adolescents. In cases of cognitive dysfunction, thyroid function should be evaluated as mitotane may induce hypothyroidism. Other effects of mitotane observed in pediatric patients that are cited in medical literature or in a pharmacovigilance database include growth delay and estrogenic-like effects such as uterine bleeding, breast development in females and gynecomastia in males. Clinical studies of LYSODREN did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients. Other reported clinical experience has not identified differences in responses between the older and younger patients. In general, dose selection for an older patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Mitotane is metabolized through the liver and mitotane plasma levels may increase if liver function is impaired. Because of the increased risk of adverse reactions in patients with mild or moderate hepatic impairment, monitor mitotane plasma levels more frequently and modify the dosage as needed [see Dosage and Administration (2.3)]. LYSODREN is not recommended for use in patients with severe hepatic impairment [see Warnings and Precautions (5.4)] . Mitotane is eliminated through the kidney and mitotane plasma levels may increase if renal function is impaired. Because of the increased risk of adverse reactions in patients with mild and moderate renal impairment, monitor mitotane plasma levels more frequently and modify the dosage as needed [see Dosage and Administration (2.4)]. LYSODREN is not recommended for use in patients with severe renal impairment.

Product summary:

LYSODREN tablets are supplied as 500 mg white, round, biconvex, scored tablets, bisected on one side and impressed with "BL" over "L1" on the other side. Store bottles at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F-86°F). Mitotane is a hazardous drug. Follow applicable special handling and disposal procedures [see References (15)] .

Authorization status:

New Drug Application

Patient Information leaflet

HRA Pharma Rare Diseases
----------
MEDICATION GUIDE
LYSODREN® (LY-SO-DREN)
(MITOTANE)
TABLETS, FOR ORAL USE
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Issued: 01/2024
What is the most important information I should know about LYSODREN?
LYSODREN can cause serious side effects including:
Adrenal Insufficiency and Adrenal Crisis.
•
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.
•
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.
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
•
feeling lightheaded or dizzy
•
passing out
•
feeling very tired
•
decreased appetite
•
weight loss
•
areas of darkened skin
•
craving salt
•
low blood sugar
•
feeling irritable or
depressed
•
hair loss
See "What are the pos

Summary of Product characteristics

LYSODREN- MITOTANE TABLET
HRA PHARMA RARE DISEASES
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LYSODREN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LYSODREN.
LYSODREN (MITOTANE) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1970
WARNING: ADRENAL CRISIS IN THE SETTING OF SHOCK, SEVERE TRAUMA OR
INFECTION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
PATIENTS TREATED WITH LYSODREN ARE AT INCREASED RISK FOR DEVELOPING
ADRENAL CRISIS IN
THE SETTING OF SHOCK, SEVERE TRAUMA OR INFECTION THAT MAY LEAD TO
DEATH.
IF SHOCK, SEVERE TRAUMA OR INFECTION OCCURS OR DEVELOPS, TEMPORARILY
DISCONTINUE
LYSODREN AND ADMINISTER EXOGENOUS STEROIDS. MONITOR PATIENTS CLOSELY
FOR INFECTIONS
AND INSTRUCT PATIENTS TO CONTACT THEIR PHYSICIAN IMMEDIATELY IF
INJURY, INFECTION, OR ANY
OTHER CONCOMITANT ILLNESS OCCURS (2.3, 5.1).
RECENT MAJOR CHANGES
BOXED WARNING
01/2024
INDICATIONS AND USAGE (1)
01/2024
DOSAGE AND ADMINISTRATION (2)
01/2024
CONTRAINDICATIONS (4)
01/2024
WARNINGS AND PRECAUTIONS (5)
01/2024
INDICATIONS AND USAGE
LYSODREN is an adrenal cytotoxic agent indicated for the treatment of
patients with inoperable, functional
or nonfunctional, adrenocortical carcinoma (ACC). (1)
DOSAGE AND ADMINISTRATION
The recommended initial dose of LYSODREN is 2000 mg to 6000 mg orally,
in three or four divided
doses per day with food. (2.3)
Titrate LYSODREN dose to achieve a plasma level of 14 to 20 mg/L.
(2.3)
LYSODREN is lipophilic and accumulates in adipose tissue. (2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 500 mg, scored. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Adrenal Insufficiency and Adrenal Crisis: Temporarily withhold
LYSODREN during shock, trauma,
infection or adrenal insufficiency. Steroid replacement may be
necessary. (5.1)
Central Nervous System (CNS) Toxicity: Monitor behavioral and
neurologic assessments and mitotane
plasma levels at regular intervals. Mitotane plasma levels exceeding
20 mg/L are associated with a