LYSODREN- mitotane tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

E.R. Squibb & Sons, L.L.C.

INN (International Name):

mitotane

Composition:

mitotane 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

LYSODREN is indicated for the treatment of patients with inoperable, functional or nonfunctional, adrenal cortical carcinoma. None. 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. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Mitotane is excreted in human milk; however, the effect of LYSODREN on the breastfed infant, or effect on milk production is unknown. Because of the potential for serious adverse reactions in the breastfed infant, advise nursing women that breastfeeding is not recommended during treatment with LYSODREN and after discontinuation of treatment

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. 100 tablets per bottle: NDC 0015-3080-60 Store bottles at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F-86°F). Mitotane is a cytotoxic drug. Follow applicable special handling and disposal procedures [see References (15)] .

Authorization status:

New Drug Application

Summary of Product characteristics

LYSODREN- MITOTANE TABLET
E.R. SQUIBB & SONS, L.L.C.
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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 OR SEVERE TRAUMA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
IN PATIENTS TAKING LYSODREN, ADRENAL CRISIS OCCURS IN THE SETTING OF
SHOCK OR SEVERE TRAUMA AND
RESPONSE TO SHOCK IS IMPAIRED. ADMINISTER HYDROCORTISONE, MONITOR FOR
ESCALATING SIGNS OF SHOCK AND
DISCONTINUE LYSODREN UNTIL RECOVERY. (2.2, 5.1)
INDICATIONS AND USAGE
LYSODREN is an adrenal cytotoxic agent indicated for the treatment of
inoperable, functional or nonfunctional, adrenal
cortical carcinoma. (1)
DOSAGE AND ADMINISTRATION
•Initial dose: 2 g to 6 g orally daily, in three or four divided
doses. (2.1)
•Increase dose incrementally to achieve a blood concentration of 14
to 20 mg/L, or as tolerated. (2.1)
DOSAGE FORMS AND STRENGTHS
Tablets: 500 mg, scored (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Central Nervous System (CNS) Toxicity: Plasma concentrations exceeding
20 mcg/mL are associated with a greater
incidence of toxicity. (5.2)
Adrenal Insufficiency: Institute steroid replacement as clinically
indicated. Measure free cortisol and corticotropin
(ACTH) levels to achieve optimal steroid replacement. (5.3)
Embryo-Fetal Toxicity: Can cause fetal harm. Advise women of
reproductive potential of the potential risk to a fetus
and use of effective contraception. (5.4, 8.1, 8.3)
Ovarian Macrocysts in Premenopausal Women: Advise women to seek
medical advice if they experience gynecological
symptoms such as vaginal bleeding and/or pelvic pain. (5.5)
ADVERSE REACTIONS
Common adverse reactions (≥15%) include: anorexia, nausea, vomiting
and diarrhea; depression, dizziness or vertigo; and
rash. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BRISTOL-MYERS SQUIB