HIGHLIGHTS OF PRESCRIBING INFORMATION<\/p>\n
These highlights do not include all the information needed to use LuciTala safely and effectively. See full prescribing information for LuciTala.<\/p>\n
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INDICATIONS AND USAGE<\/strong><\/p>\n LuciTala is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for:<\/p>\n Breast Cancer<\/p>\n \u2022\u00a0As a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for LuciTala.<\/p>\n HRR Gene-mutated mCRPC.<\/p>\n \u2022\u00a0In combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC).<\/p>\n <\/p>\n DOSAGE AND ADMINISTRATION<\/strong><\/p>\n \u2022 Take LuciTala with or without food.<\/p>\n Breast Cancer<\/p>\n \u2022\u00a0The recommended dosage of LuciTala is 1 mg taken orally once daily until disease progression or unacceptable toxicity.<\/p>\n \u2022\u00a0For adverse reactions, consider dosing interruption or dose reduction.<\/p>\n HRR Gene-Mutated mCRPC<\/p>\n \u2022\u00a0The recommended dosage of LuciTala is 0.5 mg taken orally once daily in combination with enzalutamide until disease progression or unacceptable toxicity.<\/p>\n \u2022\u00a0Patients should also receive a gonadotropic-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.<\/p>\n <\/p>\n DOSAGE FORMS AND STRENGTHS<\/strong><\/p>\n Capsules:\u00a00.1mg\u00d730\u00a0capsules<\/p>\n <\/p>\n CONTRAINDICATIONS<\/strong><\/p>\n None<\/p>\n <\/p>\n WARNINGS AND PRECAUTIONS<\/strong><\/p>\n \u2022\u00a0Myelodysplastic Syndrome\/Acute Myeloid Leukemia (MDS\/AML): MDS\/AML occurred in patients exposed to LuciTala, and some cases were fatal. Monitor patients for hematological toxicity and discontinue if MDS\/AML is confirmed.<\/p>\n \u2022\u00a0Myelosuppression: LuciTala may affect hematopoiesis and can cause anemia, neutropenia, and\/or thrombocytopenia.<\/p>\n \u2022\u00a0Embryo-Fetal Toxicity: LuciTala can cause fetal harm. Advise of the potential risk to the fetus and to use effective contraception.<\/p>\n <\/p>\n ADVERSE REACTIONS<\/strong><\/p>\n Most common adverse reactions (\u226520%) as a single agent, including\u00a0laboratory abnormalities, are:<\/p>\n \u2022\u00a0Hemoglobin decreased, neutrophils decreased, lymphocytes decreased, platelets decreased, fatigue, glucose increased, aspartate aminotransferase increased, alkaline phosphatase increased, alanine aminotransferase increased, calcium decreased, nausea, headache, vomiting, alopecia, diarrhea, and decreased appetite.<\/p>\n <\/p>\n Most common adverse reactions (\u226510%) in combination with enzalutamide,\u00a0including laboratory abnormalities, are:<\/p>\n \u2022\u00a0Hemoglobin decreased, neutrophils decreased, lymphocytes decreased, fatigue, platelets decreased, calcium decreased, nausea, decreased appetite, sodium decreased, phosphate decreased, fractures, magnesium decreased, dizziness, bilirubin increased, potassium decreased, and dysgeusia.<\/p>\n <\/p>\n DRUG INTERACTIONS<\/strong><\/p>\n \u2022 P-gp Inhibitors: Reduce the dose when coadministered with certain P-gp inhibitors. Monitor for increased adverse reactions.<\/p>\n \u2022\u00a0BCRP Inhibitors: Monitor for potential increased adverse reactions.<\/p>\n <\/p>\n USE IN SPECIFIC POPULATIONS<\/strong><\/p>\n \u2022\u00a0Lactation: Advise women not to breastfeed.<\/p>\n \u2022Renal Impairment: Reduce the dose and monitor for increased adverse reactions for patients with moderate or severe renal impairment.<\/p>\n <\/p>\n Storage<\/strong><\/p>\n Store at 20\u00b0C to 25\u00b0C (68\u00b0F to 77\u00b0F), excursions permitted between 15\u00b0C and 30\u00b0C (59\u00b0F and 86\u00b0F) [see USP Controlled Room Temperature]. Protect from moisture.<\/p>\n","protected":false},"excerpt":{"rendered":"