[Product Name] Palbociclib Capsules

[Other Names] Palbociclib / IBRANCE

[English Name] Palbociclib Capsules

[Specification] 125 mg × 21 capsules/box

[Manufacturer] Natco Pharmaceuticals

[Indications]

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

[Dosage and Administration]

Recommended Dose: 125 mg orally 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 until the patient no longer derives clinical benefit from therapy or until unacceptable toxicity occurs.

Method of Administration: Oral use. The capsules should be taken with food; it is recommended to take the medication with a meal to ensure consistent exposure to palbociclib. Do not consume grapefruit or grapefruit juice while taking this medication. The 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 appears to be damaged.

[Adverse Reactions]

In clinical studies, the most common (≥20%) adverse reactions of any grade reported in patients receiving palbociclib were neutropenia, infections, leukopenia, fatigue, nausea, stomatitis, anemia, alopecia, and diarrhea. The most common (≥2%) Grade ≥3 adverse reactions were neutropenia, leukopenia, anemia, fatigue, and infections.

[Contraindications]

Contraindicated in patients with known hypersensitivity to the active ingredient or to any of the excipients.

Concomitant use of products containing St. John's wort is contraindicated. [Precautions]

Pre-/Perimenopausal Women: When receiving combination therapy with palbociclib and an aromatase inhibitor, ovarian ablation or suppression of ovarian function using a Luteinizing Hormone-Releasing Hormone (LHRH) agonist is required.

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.

[Use in Specific Populations]

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

Pediatric Patients: The safety and efficacy of palbociclib in children and adolescents aged ≤18 years have not been established.

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

[Storage]

Store at room temperature. After opening, keep the medication in its original container. Product Specifications

Product Name: Palbociclib Capsules 125mg (21 capsules/box) — Palnat

Common Name: Palbociclib Capsules

Active Ingredient: Palbociclib

Dosage Form: Capsules

Specification: 125mg × 21 capsules/box

Manufacturer: Natco Pharmaceuticals

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

Dosage and Administration: Recommended Dose: 125 mg taken orally 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 until the patient no longer derives clinical benefit from therapy or until unacceptable toxicity occurs.

Method of Administration: Oral use. The capsules should be taken with food—preferably with a meal—to ensure consistent exposure to Palbociclib. Do not take with grapefruit or grapefruit juice. The capsules must be swallowed whole; they should not be chewed, crushed, or opened prior to swallowing. Do not take any capsule that is broken, cracked, or otherwise appears to be compromised.