卡帕塞替尼160mg 卡帕塞替尼与氟维司群联合适用于治疗激素受体 (HR) 阳性、人类表皮生长因子受体 2 (HER2) 阴性、局部晚期或转移性乳腺癌的成年患者，这些患者有一种或多种 PIK3CA/AKT1/PTEN 改变，在转移性乳腺癌中接受至少一种内分泌治疗方案后出现进展，或在完成辅助治疗时或完成辅助治疗后 12 个月内出现复发。

LuciCapiva simple instructions

Please use under the guidance of a physician

Product Name: LuciCapiva

Manufacturer: Lucius Pharmaceuticals (Laos) Co., Ltd.

Chinese name: Capasitinib tablets

English name: Capivasertib tablets

Drug approval number: 08 L 1167/24 (160mg)

08 L 1160/24 (200mg)

【Indications】

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 detected by an FDA-approved test, who have progressed after at least one endocrine therapy regimen in metastatic breast cancer or who have relapsed on or within 12 months of completing adjuvant therapy.

 

【Usage and Dosage】

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

• Recommended dose: 400 mg orally twice daily, with or without food, for 4 consecutive days, followed by a 3-day rest period.

 

【Specification】

160mg×64 tablets/box, 200mg×64 tablets/box

 

【 Contraindications 】

Severe allergy to LuciCapiva or any of its ingredients.

 

【 Warnings and precautions 】

• Hyperglycemia: Assess blood glucose levels prior to initiating and periodically during treatment. Based on severity, withhold, reduce dose, or permanently discontinue LuciCapiva.

• Diarrhea: LuciCapiva can cause diarrhea in most patients. Advise patients to increase oral fluid intake, initiate antidiarrheal therapy, and consult a physician if diarrhea develops while taking LuciCapiva. Depending on severity, withhold, reduce dose, or permanently discontinue LuciCapiva.

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

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

【Adverse Reactions】

The most common adverse reactions (incidence ≥20%), including laboratory abnormalities, were diarrhea, skin adverse reactions, random glucose increase, lymphocytopenia, hemoglobin decrease, fasting glucose increase, nausea, fatigue, leukopenia, triglyceride increase, neutropenia, creatinine increase, vomiting, and stomatitis.

 

【Drug Interactions】

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

• Moderate CYP3A inhibitors: Reduce LuciCapiva dose.

• Strong and moderate CYP3A inducers: Avoid concomitant use.

 

【Use by specific groups】

Lactation: Breastfeeding is not recommended.

 

【Storage】

Storage temperature is 20℃ to 25℃ (68℉ to 77℉), short-distance transportation is allowed between 15℃ to 30℃ (59℉ to 86℉). Protect from moisture.