HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LUCIMITO safely and effectively. See full prescribing information for LUCIMITO.

INDICATIONS AND USAGE

LUCIMITO is an adrenal cytotoxic agent indicated for the treatment of inoperable, functional or nonfunctional, adrenal cortical carcinoma.

DOSAGE AND ADMINISTRATION

· Initial dose: 2 g to 6 g orally daily, in three or four divided doses.  

· Increase dose incrementally to achieve a blood concentration of 14 to 20 mg/L, or as tolerated.

DOSAGE FORMS AND STRENGTHS

Tablets: 500 mg×100 tablets

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

· Central Nervous System (CNS) Toxicity: Plasma concentrations exceeding 20 mcg/mL are associated with a greater incidence of toxicity.

· Adrenal Insufficiency: Institute steroid replacement as clinically indicated. Measure free cortisol and corticotropin (ACTH) levels to achieve optimal steroid replacement.

· Embryo-Fetal Toxicity: Can cause fetal harm. Advise women of reproductive potential of the potential risk to a fetus and use of effective contraception.

· Ovarian Macrocysts in Premenopausal Women: Advise women to seek medical advice if they experience gynecological symptoms such as vaginal bleeding and/or pelvic pain.

ADVERSE REACTIONS

Common adverse reactions (≥15%) include: anorexia, nausea, vomiting and diarrhea; depression, dizziness or vertigo; and rash.

DRUG INTERACTIONS

Adjust dosage of concomitant coumarin-type anticoagulants as needed.

USE IN SPECIFIC POPULATIONS

· Lactation: Do not breastfeed.  

· Hepatic Impairment: Administer LUCIMITO with caution to patients with hepatic impairment.

Storage

Store at 20℃ to 25℃ (68℉ to 77℉), excursions permitted between 15℃ and 30℃ (59℉ and 86℉) [see USP Controlled Room Temperature]. Protect from moisture.