Tucatinib is indicated for the treatment of: 1. Metastatic breast cancer, 2. Unresectable or metastatic colorectal cancer

LuciTuca Tablets Simple Instructions

Please use under the guidance of a physician

Product Name: LuciTuca

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

Chinese name: Tucatinib tablets

English name: Tucatinib tablets

Drug approval number: 03 L 1072/24

 

【Indications】

• In combination with trastuzumab and capecitabine for the treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including those with brain metastases, who have been previously treated with one or more anti-HER2 regimens in the metastatic setting.

• In combination with trastuzumab for the treatment of adult patients with RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer whose disease has progressed after chemotherapy with a fluoropyrimidine, oxaliplatin, and irinotecan.

 

【Usage and Dosage】

• For patients with unresectable or metastatic colorectal cancer, confirm the presence of HER2 protein overexpression and RAS wild-type in tumor specimens prior to initiating TUKYSA.

• Recommended dose: 300 mg orally twice daily, can be taken with or without food.

• For patients with severe liver impairment, the recommended dose is 200 mg orally twice daily.

 

【Specification】

150mg/tablet, 60 tablets/box.

 

【 Contraindications 】

none.

 

【 Warnings and precautions 】

• Diarrhea: Severe diarrhea, including dehydration, acute kidney injury, and death, has been reported. Administer antidiarrheal therapy as clinically indicated. Based on severity, interrupt dose, then reduce dose, or permanently discontinue TUKYSA.

• Hepatotoxicity: Severe hepatotoxicity has been reported with TUKYSA. Monitor ALT, AST, and bilirubin prior to initiating TUKYSA, every 3 weeks during treatment, and as clinically indicated. Based on severity, interrupt dose, then reduce dose, or permanently discontinue TUKYSA.

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

In addition, please see the full prescribing information for trastuzumab and capecitabine for pregnancy and contraception information.

 

【Adverse Reactions】

• The most common adverse reactions (≥20%) for TUKYSA in combination with trastuzumab and capecitabine in patients with metastatic breast cancer were diarrhea, hand and foot erythema, nausea, hepatotoxicity, vomiting, stomatitis, decreased appetite, anemia, and rash.

• The most common adverse reactions (≥20%) for TUKYSA in combination with trastuzumab in patients with unresectable or metastatic colorectal cancer were diarrhea, fatigue, rash, nausea, abdominal pain, infusion-related reactions, and pyrexia.

 

【Drug Interactions】

• Strong CYP3A inducers or moderate CYP2C8 inducers: Avoid concomitant use.

• Strong CYP2C8 Inhibitors: Avoid concomitant use; if concomitant use cannot be avoided, reduce TUKYSA dose.

• CYP3A Substrates: Avoid concomitant use with CYP3A substrates as minimal changes in concentrations may result in severe or life-threatening toxicity.

• P-gp substrates: Consider reducing the dose of P-gp substrates, as minimal changes in concentration may result in severe or life-threatening toxicity.

 

【Use by specific groups】

Breast-feeding: Breast-feeding 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.