Type:28 Capsules
Generic Name:Palbociclib
Manufacturer:Genvio Pharma Ltd.
Price:৳72800.00
Indicated for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, advanced breast cancer, in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women, or with fulvestrant in women with disease progression endocrine therapy
Hard Capsule: Should be taken with food. Take at the same time each day. Swallow whole, do not chew/crush/open. Avoid grapefruit products.
Oral Hormone receptor positive, HER2-negative locally advanced carcinoma of breast, Hormone receptor positive, HER2-negative metastatic carcinoma of breast Adult: In combination with aromatase inhibitor, or in combination with fulvestrant in women who have received prior endocrine therapy: 125 mg once daily for 21 days, followed by 7 days off, repeat every 28 days until disease progression or unacceptable toxicity. Dosage Modifications Dose reduction, dosing interruption, or discontinuation may be required according to individual safety or tolerability (refer to detailed product guideline). Recommended dose reduction: 1st reduction: 100 mg once daily; 2nd reduction: 75 mg once daily; discontinue if dose reduction below 75 mg once daily is required. Hepatic impairment Mild or moderate (Child-Pugh A or B): No dose adjustment required Severe (Child-Pugh C): Reduce dose to 75 mg/day for Days 1-21 of each 28-day cycle
Renal impairment Mild, moderate, or severe (CrCl >15 mL/min): No dose adjustment required Hemodialysis: Not studied
Pregnancy and lactation.
Palbociclib is a reversible, selective inhibitor of cyclin-dependent kinase (CDK) 4 and 6. Cyclin D1, CDK 4 and 6 are downstream of multiple signalling pathways which lead to cellular proliferation. Inhibition of CDK4/6 reduces proliferation of breast cancer cell lines by blocking progression from G1 into S phase of the cell cycle.
Neutropenia observed in clinical trials; febrile neutropenia also reported; monitor CBC count prior to starting drug and at the beginning of each cycle, as well as on Day 14 of the first 2 cycles, and as clinically indicated; dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop grade 3 or 4 neutropenia
>10% Neutropenia, all grades (75%) Neutropenia, grade 3 (48%) Leukopenia, all grades (43%) Fatigue, all grades (41%) Anemia, all grades (35%) Upper respiratory tract infection, all grades (31%) Stomatitis, all grades (25%) Nausea, all grades (25%) Alopecia, grade 1 (22%) Diarrhea, all grades (21%) Leukopenia, grade 3 (19%) Thrombocytopenia, all grades (17%) Decreased appetite, all grades (16%) Vomiting, all grades (15%) Peripheral neuropathy, all grades (13%) Asthenia, all grades (13%) Epistaxis, all grades (11%) 1-10% Neutropenia, grade 4 (6%) Anemia, grade 3 (5%) Diarrhea, grade 3 (4%) Thrombocytopenia, grade 3 (2%) Nausea, grade 3 (2%) Fatigue, grades 3/4 (2%) Asthenia, grade 3 (2%) Upper respiratory treact infection, grade 3 (1%) Decreased appetite, grade 3 (1%)
Increased plasma concentration and systemic exposure with strong CYP3A inhibitors (e.g. clarithromycin, telithromycin, itraconazole, ketoconazole, posaconazole, voriconazole, indinavir, ritonavir, ritonavir-boosted lopinavir, nelfinavir, saquinavir, telaprevir, nefazodone, verapamil). Decreased plasma concentration with moderate CYP3A inducers (e.g. bosentan, efavirenz, etravirine, modafinil, nafcillin) or strong CYP3A inducers (e.g. carbamazepine, phenytoin, enzalutamide, rifampicin). May increase the plasma concentration of CYP3A substrates (e.g. ciclosporin, everolimus, sirolimus, tacrolimus, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine).
