125mg Palbociclib 21 Capsules Oral Chemotherapy Drugs For Breast Cancer

【Drug Name】
Generic name: palbociclib capsules

Product name: IBRANCE®/IBRANCE®

English name: Palbociclib Capsules

Chinese Pinyin: Paiboxili Jiaonang

【Indications】
This product is suitable for 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 aromatase inhibitors as the initial endocrine therapy for postmenopausal female patients. .

【Dosage】
Treatment with this product should be initiated and supervised by a physician experienced in the use of anticancer drugs.

Recommended dosage

The recommended dose of palbociclib is 125 mg once daily for 21 days followed by 7 days off (3/1 dosing regimen), resulting in a 28-day treatment cycle. Treatment should be continued unless the patient no longer has clinical benefit or develops unacceptable toxicity.

When used in combination with palbociclib, refer to the dosing regimen in the approved labeling for aromatase inhibitor administration.

Dosing method

oral. It should be taken with food, preferably with food to ensure consistent palbociclib exposure (see Pharmacokinetics). Palbociclib should not be taken with grapefruit or grapefruit juice (see Drug Interactions).

Palbociclib capsules should be swallowed whole (do not chew, crush, or open capsules before swallowing). Do not use capsules that are damaged, cracked, or otherwise incomplete.

Patients should be encouraged to take their medications at approximately the same time each day. If the patient vomits or misses a dose, he or she must not take another dose on the same day. The next dose should be taken as usual.

Dosage adjustment

It is recommended that the dose of palbociclib be adjusted based on individual safety and tolerability.

The occurrence of certain adverse reactions may require temporary interruption/delay of dosing and/or dose reduction, or permanent discontinuation for control. Please refer to the protocols provided in Tables 1, 2 and 3 for dose adjustments.

Special groups

Geriatric: No dose adjustment of palbociclib is required in patients ≥65 years of age.

Pediatric Population: The safety and efficacy of palbociclib have not been established in children and adolescent patients <18 years of age. No data available.

Hepatic Impairment: No dose adjustment of palbociclib is required in patients with mild or moderate hepatic impairment (Child-Pugh Classes A and B). The recommended dose for patients with severe hepatic impairment (Child Pugh Class C) is 75 mg once daily using a 3/1 dosing schedule.

Renal Impairment: No dose adjustment of palbociclib is required in patients with mild, moderate, or severe renal impairment (creatinine clearance [CrCl] ≥15 mL/min). Insufficient data are available in patients requiring hemodialysis to make any dose adjustment recommendations in this population.

Dose adjustments when coadministered with strong CYP3A inhibitors: Avoid concomitant use of strong CYP3A inhibitors and consider substituting with other concomitant medications that have no or only weak CYP3A inhibitory effects. If patients must co-administer a strong CYP3A inhibitor, reduce the palbociclib dose to 75 mg once daily. If a strong inhibitor is discontinued, increase the palbociclib dose to the dose prior to initiating the strong inhibitor of CYP3A (after 3 to 5 half-lives of the inhibitor).

【Adverse reactions】
The most common (≥20%) adverse reactions of any grade reported in patients receiving palbociclib were neutropenia, infection, leukopenia, fatigue, nausea, stomatitis, anemia, diarrhea, alopecia, and platelets Decreased disease.

The most common (≥2%) grade ≥3 adverse reactions with palbociclib were neutropenia, leukopenia, infection, anemia, increased aspartate aminotransferase (AST), fatigue, and alanine Acid aminotransferase (ALT) is increased.

【Storage】
Store at room temperature. Please keep opened medicines in their original packaging bottles.