LuciTuca

HIGHLIGHTS OF PRESCRIBING INFORMATION

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

 

INDICATIONS AND USAGE

LuciTuca is a kinase inhibitor indicated:

• in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based 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 that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

 

DOSAGE AND ADMINISTRATION

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

• Recommended dosage: 300 mg taken orally twice daily with or without food. 

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

 

DOSAGE FORMS AND STRENGTHS

Tablets: 150 mg×60 tablets

 

CONTRAINDICATIONS

None.

 

WARNINGS AND PRECAUTIONS

• Diarrhea: Severe diarrhea, including dehydration, acute kidney injury, and death, has been reported. Administer antidiarrheal treatment as clinically indicated. Interrupt dose, then dose reduce, or permanently discontinue LuciTuca based on severity.

• Hepatotoxicity: Severe hepatotoxicity has been reported on LuciTuca. Monitor ALT, AST and bilirubin prior to starting LuciTuca, every 3 weeks during treatment and as clinically indicated. Interrupt dose, then dose reduce, or permanently discontinue LuciTuca based on severity.

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

Also, refer to the Full Prescribing Information of trastuzumab and capecitabine for pregnancy and contraception information.

 

ADVERSE REACTIONS

• The most common adverse reactions (≥20%) with LuciTuca in combination with trastuzumab and capecitabine in patients with metastatic breast cancer are diarrhea, palmar-plantar erythrodysesthesia, nausea, hepatotoxicity, vomiting, stomatitis, decreased appetite, anemia, and rash.

• The most common adverse reactions (≥20%) with LuciTuca in combination with trastuzumab in patients with unresectable or metastatic colorectal cancer are 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; reduce LuciTuca dose if concomitant use cannot be avoided.

• CYP3A Substrates: Avoid concomitant use with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities.

• P-gp Substrates: Consider reducing the dose of P-gp substrates, where minimal concentration changes may lead to serious or life-threatening toxicities.

 

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.