卢修斯制药 LuciTala 他拉唑帕利 Talazopanib 0.1mg

Trade Name: LuciTala

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

English Name: Talazoparib capsules Drug Approval Number: 12 L 1421/25

【Indications】

LuciTala is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for: Breast Cancer

• Monotherapy for adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer. Select patients for LuciTala based on an FDA-approved companion diagnostic.

Metastatic Castration-Resistant Prostate Cancer (mCRPC) with HRR Gene Mutation • In combination with enzalutamide for adult patients with metastatic castration-resistant prostate cancer (mCRPC) with HRR gene mutation.

【Dosage and Administration】

• LuciTala may be taken with or without food. Breast Cancer

• The recommended dose of LuciTala is 1 mg orally once daily until disease progression or unacceptable toxicity.

• Interruption or dose reduction may be considered for adverse reactions. Metastatic Castration-Resistant Prostate Cancer (mCRPC) with HRR Gene Mutation

• The recommended dose of LuciTala is 0.5 mg orally once daily in combination with enzalutamide until disease progression or unacceptable toxicity.

• Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or have had bilateral orchiectomy.

【Specification】 0.1 mg × 30 capsules

【Contraindications】 None

【Warnings and Precautions】

• Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): MDS/AML, including fatal cases, has been reported in patients treated with LuciTala. Monitor for hematologic toxicity. Discontinue LuciTala if MDS/AML is confirmed.

• Myelosuppression: LuciTala may affect hematopoietic function and cause anemia, neutropenia, and/or thrombocytopenia.

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

【Adverse Reactions】

Most common adverse reactions (≥20%), including laboratory abnormalities, for monotherapy:

• Decreased hemoglobin, neutropenia, lymphopenia, thrombocytopenia, fatigue, increased blood glucose, increased aspartate aminotransferase, increased alkaline phosphatase, increased alanine aminotransferase, decreased calcium, nausea, headache, vomiting, alopecia, diarrhea, and decreased appetite.

Most common adverse reactions (≥10%), including laboratory abnormalities, in combination with enzalutamide:

• Decreased hemoglobin, neutropenia, lymphopenia, fatigue, thrombocytopenia, decreased calcium, nausea, decreased appetite, decreased sodium, decreased phosphorus, fracture, decreased magnesium, dizziness, increased bilirubin, decreased potassium, and dysgeusia.

【Drug Interactions】

• P-gp inhibitors: Reduce the dose of LuciTala when coadministered with certain P-gp inhibitors. Monitor for increased adverse reactions.

• BCRP inhibitors: Monitor for potential increased adverse reactions.

【Use in Specific Populations】

• Lactation: Advise against breastfeeding.

• Renal Impairment: Reduce the dose and monitor for increased adverse reactions in patients with moderate or severe renal impairment.

【Storage】

Store at 20°C to 25°C (68°F to 77°F); short-term exposure between 15°C and 30°C (59°F to 86°F) is permitted. Protect from moisture.