HIGHLIGHTS OF PRESCRIBING INFORMATION 

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

INDICATIONS AND USAGE

LuciPalbo is a kinase inhibitor indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with: 

•  an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or in men; or 

•  fulvestrant in patients with disease progression following endocrine therapy. 

DOSAGE AND ADMINISTRATION 

LuciPalbo capsules are taken orally with food in combination with an aromatase inhibitor or fulvestrant. 

•  Recommended starting dose: 125 mg once daily taken with food for 21 days followed by 7 days off treatment.

•  Dosing interruption and/or dose reductions are recommended based on individual safety and tolerability. 

DOSAGE FORMS AND STRENGTHS 

Capsules: 100mg×21 Capsules.

CONTRAINDICATIONS 

None.

WARNINGS AND PRECAUTIONS 

•  Neutropenia: Monitor complete blood count prior to start of LuciPalbo therapy and at the beginning of each cycle, as well as on Day 15 of the first 2 cycles, and as clinically indicated. 

•  Embryo-Fetal Toxicity: LuciPalbo can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. 

ADVERSE REACTIONS 

Most common adverse reactions (incidence ≥10%) were neutropenia, infections, leukopenia, fatigue, nausea, stomatitis, anemia, alopecia, diarrhea, thrombocytopenia, rash, vomiting, decreased appetite, asthenia, and pyrexia. 

DRUG INTERACTIONS 

•  CYP3A Inhibitors: Avoid concurrent use of LuciPalbo with strong CYP3A inhibitors. If the strong inhibitor cannot be avoided, reduce the LuciPalbo dose.

•  CYP3A Inducers: Avoid concurrent use of LuciPalbo with strong CYP3A inducers. 

•  CYP3A Substrates: The dose of sensitive CYP3A4 substrates with narrow therapeutic indices may need to be reduced when given concurrently with LuciPalbo. 

USE IN SPECIFIC POPULATIONS 

•  Lactation: Advise not to breastfeed.

Storage 

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