HIGHLIGHTS OF PRESCRIBING INFORMATION

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

INDICATIONS AND USAGE

LuciCapiva is a kinase inhibitor indicated, in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations as detected by an FDA-approved test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.

DOSAGE AND ADMINISTRATION

• Select patients for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer with LuciCapiva based on the presence of one or more of the following genetic alterations in tumor tissue: PIK3CA/AKT1/PTEN.

• Recommended Dosage: 400 mg orally twice daily, with or without food,  for 4 days followed by 3 days off.

DOSAGE FORMS AND STRENGTHS

Tablets: 160 mg×64 tablets、200 mg×64 tablets

CONTRAINDICATIONS

Severe hypersensitivity to LuciCapiva or any of its components.

WARNINGS AND PRECAUTIONS

• Hyperglycemia: Evaluate blood glucose levels prior to starting and at regular intervals during treatment. Withhold, reduce dose, or permanently discontinue LuciCapiva based on severity.

• Diarrhea: LuciCapiva caused diarrhea in most patients. Advise patients to increase oral fluids, start antidiarrheal treatment, and consult with a healthcare provider if diarrhea occurs while taking LuciCapiva. Withhold, reduce dose, or permanently discontinue LuciCapiva based on severity.

• Cutaneous Adverse Reactions: Monitor for signs and symptoms of cutaneous adverse reactions. Withhold, reduce dose, or permanently discontinue LuciCapiva based on severity.

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

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥20%), including laboratory abnormalities, were diarrhea, cutaneous adverse reactions, increased random glucose, decreased lymphocytes, decreased hemoglobin, increased fasting glucose, nausea, fatigue, decreased leukocytes, increased triglycerides, decreased neutrophils, increased creatinine, vomiting and stomatitis.

DRUG INTERACTIONS

• Strong CYP3A Inhibitors: Avoid concomitant use. If concomitant use cannot be avoided, reduce LuciCapiva dose.  

• Moderate CYP3A Inhibitors: Reduce LuciCapiva dose.

• Strong and Moderate CYP3A Inducers: Avoid concomitant use.

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed.

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.