palbociclib Palbocent Palbociclib 125mg

[Drug Name]

Generic Name: Palbociclib Capsules

Brand Name: Palbociclib Capsules

Full Pinyin Code: PaBoXiNiJiaoNang

[Active Ingredient] Palbociclib.

[Description] This product is in the form of capsules.

[Indications/Therapeutic Uses] Palbociclib is a kinase inhibitor indicated for use in combination with letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease. This indication is approved under accelerated approval based on progression-free survival (PFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

[Specification/Model] 125 mg × 21 capsules

[Dosage and Administration] Palbociclib capsules are taken orally in combination with letrozole and food. (1) Recommended starting dose: 125 mg once daily, taken with food for 21 consecutive days, followed by 7 days off treatment. (2) Dose interruption and/or dose reduction are recommended based on individual safety and tolerability.

[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.

[Contraindications] Not yet established.

[Precautions] (1) Hematologic: Neutropenia may occur. Monitor complete blood counts prior to the start of IBRANCE therapy, at the beginning of each cycle, on Day 14 of the first two cycles, and as clinically indicated. (2) Infections: Monitor for signs and symptoms, and withhold administration as appropriate. (3) Embryo-fetal toxicity: May cause fetal harm. Advise patients of the potential risk to the fetus and to use effective contraception. Please read the package insert carefully and use as directed by a physician.

[Pediatric Use] Not yet established. [Use in Elderly Patients] Not established.

[Use in Pregnant and Lactating Women] Not established.

[Drug Interactions] Not established.

[Overdosage] Not established.

[Pharmacology and Toxicology] Not established.

[Pharmacokinetics] Not established.

[Shelf Life] 36 months

Product Specifications

Product Name: Palbociclib Capsules (Palbocent) — 125 mg, 21 capsules/box (CDK4/6 Inhibitor)

Common Name: Palbociclib Capsules

Composition: Palbociclib

Dosage Form: Capsules

Specification: 125 mg / 21 capsules

Manufacturer: Incepta Pharmaceuticals Ltd.

Indications: Palbociclib is a kinase inhibitor indicated for use in combination with letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease. This indication is approved under accelerated approval based on progression-free survival (PFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Dosage and Administration: Recommended starting dose: 125 mg taken orally once daily with food for 21 consecutive days, followed by 7 days off treatment. Dosage interruption and/or reduction is recommended based on individual safety and tolerability.