LuciCapiva Capivasertib tablets

[Product Name] Capivasertib Tablets

[China Approval Name] Capivasertib Tablets; Quankede

[English Name] Capivasertib Tablets

[Specification] 160 mg × 64 tablets/box; 200 mg × 64 tablets/box

[Manufacturer] Lucius Pharmaceutical (Laos) Co., Ltd.

[Laos National Drug Administration Registration No.] 08 L 1167/24 (160 mg); 08 L 1160/24 (200 mg)

[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 whose tumors have one or more *PIK3CA/AKT1/PTEN* alterations as detected by an FDA-approved test, and who have progressed on at least one endocrine-based regimen in the metastatic setting, or who have recurred within 12 months of completing adjuvant therapy.

[Dosage and Administration]

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

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

[Contraindications]

Severe hypersensitivity to LuciCapiva or to any of its components.

[Warnings and Precautions]

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

Diarrhea: LuciCapiva can cause diarrhea in most patients. Advise patients to increase oral fluids, initiate anti-diarrheal treatment, and consult a physician if diarrhea occurs while taking LuciCapiva. Based on severity, withhold, reduce the dose, or permanently discontinue LuciCapiva. Cutaneous Adverse Reactions: Monitor for signs and symptoms of cutaneous adverse reactions. Depending on the severity, suspend, reduce the 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, are diarrhea, cutaneous adverse reactions, increased random glucose, lymphopenia, decreased hemoglobin, increased fasting glucose, nausea, fatigue, leukopenia, increased triglycerides, neutropenia, increased creatinine, vomiting, and stomatitis.

[Drug Interactions]

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

Moderate CYP3A Inhibitors: Reduce the dose of LuciCapiva.

Strong and Moderate CYP3A Inducers: Avoid concomitant use.

[Use in Specific Populations]

Lactation: Advise against breastfeeding.

[Storage]

Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Protect from moisture.