Palbociclib 125 mg is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer

LuciPalbo Capsules Simple Instructions

Please use under the guidance of a physician

Product Name: LuciPalbo

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

Chinese name: Pibociclib Capsules

English name: Palbociclib capsules

Drug approval number: 08 L 1162/24 (125mg)

 

【Indications】

LuciPalbo is a kinase inhibitor indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with:

• aromatase inhibitors as initial breast cancer treatment in postmenopausal women or men; or

•Fulvestrant is used for patients with breast cancer whose disease has progressed after endocrine therapy.

 

【Usage and Dosage】

LuciPalbo capsules are taken orally with an aromatase inhibitor or fulvestrant.

•Recommended starting dose: 125 mg orally once daily with food for 21 days, followed by a 7-day rest period.

•Dose interruptions and/or reductions may be recommended based on individual safety and tolerability.

 

【Specification】

125mg×21 tablets

 

【 Contraindications 】

none

 

【 Warnings and precautions 】

• Neutropenia: Monitor complete blood counts prior to initiating LuciPalbo treatment, at the start of each cycle, and on Day 15 of the first 2 cycles as clinically indicated.

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

【Adverse Reactions】

The most common adverse reactions (incidence ≥10%) were neutropenia, infection, leukopenia, fatigue, nausea, stomatitis, anemia, alopecia, diarrhea, thrombocytopenia, rash, vomiting, decreased appetite, asthenia, and pyrexia.

【Drug Interactions】

•CYP3A Inhibitors: Avoid concomitant use of LuciPalbo and strong CYP3A inhibitors. If strong inhibitors cannot be avoided, reduce the LuciPalbo dose.

•CYP3A Inducers: Avoid concomitant use of LuciPalbo with strong CYP3A inducers.

•CYP3A Substrates: Dose reduction of sensitive CYP3A4 substrates with a narrow therapeutic index may be necessary when co-administered with LuciPalbo.

 

【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.