LuciPalbo Palbociclib Capsules

Generic Name: Palbociclib Capsules

Brand Names: Aiboxin / IBRANCE / LuciPalbo

English Name: Palbociclib Capsules

Pinyin: Paiboxili Jiaonang

Specifications: 100 mg × 21 capsules/box; 125 mg × 21 capsules/box

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

Drug Approval Number: 08 L 1163/24 (100 mg); 08 L 1162/24 (125 mg)

Composition:

Active Ingredient: Palbociclib. Chemical Name: 6-acetyl-8-cyclopentyl-5-methyl-2-((5-(1-piperazinyl)-2-pyridinyl)amino)pyrido[2,3-d]pyrimidin-7(8H)-one. Molecular Formula: C₂₄H₂₉N₇O₂. Molecular Weight: 447.54.

Excipients: Microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate.

Description:

This product is a capsule; the contents consist of an off-white to yellow powder.

Indications:

This product is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. It should be used in combination with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women; it may also be used in combination with fulvestrant in patients with breast cancer whose disease has progressed following endocrine therapy.

Dosage and Administration:

Recommended Dose: 125 mg once daily for 21 consecutive days, followed by 7 days off treatment (a 3/1 dosing schedule), constituting a 28-day treatment cycle. Treatment should be continued unless the patient no longer derives clinical benefit from the therapy or experiences unacceptable toxicity. Administration: Oral use. Should be taken with food; preferably taken with a meal to ensure consistent palbociclib exposure. Must not be taken with grapefruit or grapefruit juice. Capsules should be swallowed whole; they must not be chewed, crushed, or opened prior to swallowing. Do not take any capsule that is broken, cracked, or otherwise compromised. Patients should be encouraged to take the medication at approximately the same time each day. If a patient vomits or misses a dose, they should not take an additional dose on that day but should resume their regular dosing schedule for the next planned dose.

Dose Adjustment: Adjust the dose based on individual safety and tolerability. In the event of hematologic or non-hematologic toxicity, dose adjustments—such as temporary interruption, dose reduction, or permanent discontinuation—may be made based on CTCAE grading.

Use in Specific Populations:

Geriatric Patients: No dose adjustment is required for patients aged ≥65 years.

Pediatric Patients: The safety and efficacy of palbociclib in children and adolescents (<18 years of age) have not been established.

Hepatic Impairment: No dose adjustment is required for patients with mild or moderate hepatic impairment (Child-Pugh Class A and B). For patients with severe hepatic impairment (Child-Pugh Class C), the recommended dose is 75 mg once daily, administered on a 3/1 schedule.

Renal Impairment: No dose adjustment is required for patients with mild, moderate, or severe renal impairment (creatinine clearance [CrCl] ≥15 mL/min). Data are insufficient to provide dose adjustment recommendations for patients requiring hemodialysis.

Adverse Reactions:

The most common adverse reactions (incidence ≥10%) are neutropenia, leukopenia, fatigue, anemia, upper respiratory tract infection, nausea, stomatitis, alopecia, diarrhea, thrombocytopenia, decreased appetite, vomiting, asthenia, peripheral neuropathy, and epistaxis.

Precautions:

Hematologic Toxicity: Neutropenia was the most frequently reported adverse reaction in clinical studies. Complete blood counts should be monitored prior to the start of therapy, at the beginning of each cycle, on Day 15 of the first two cycles, and as clinically indicated. Interstitial Lung Disease (ILD) / Pneumonitis: Severe, life-threatening, or fatal ILD and/or pneumonitis may occur. Monitor patients for pulmonary symptoms; for patients presenting with new or worsening respiratory symptoms where pneumonitis is suspected, immediately interrupt palbociclib and evaluate the patient. Palbociclib should be permanently discontinued in patients with severe ILD or pneumonitis.

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

Drug Interactions:

CYP3A Inhibitors: Avoid the concomitant use of palbociclib with strong CYP3A inhibitors. If concomitant use cannot be avoided, reduce the dose of palbociclib to 75 mg once daily.

CYP3A Inducers: Avoid the concomitant use of palbociclib with strong CYP3A inducers.

CYP3A Substrates: When co-administered with palbociclib, a dose reduction may be required for sensitive CYP3A4 substrates with a narrow therapeutic index.

Contraindications:

None known.

Storage:

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