Cykin 125 - Capsule Palbociclib - 125mg 28 Capsule(s) / Box Genvio Pharma Ltd. Introduction: Cykin 125 is used to treat patients with certain types of breast cancer (estrogen receptor-positive, human epidermal growth factor receptor 2-negative) which have spread to other organs. It is given together with hormonal anticancer therapies. Cykin 125 should be taken with food, but try to have it at the same time every day to get the most benefits. Your doctor will decide what dose is necessary and how often you need to take it. This will depend on what you are being treated for and may change from time to time. You should take it exactly as your doctor has... Uses of Cykin 125: Breast cancer Side effects of Cykin 125: FatigueHair lossRashVomitingDiarrheaNauseaDecreased blood cells (red cells, white cells, and platelets)InfectionDecreased appetiteFever How to use Cykin 125: Take this medicine in the dose and duration as advised by your doctor. Do not chew, crush or break it. Cykin 125 is to be taken with food. How Cykin 125 works: Cykin 125 is an anti-cancer medication. Cyclin dependent kinase 4 and 6 (chemical messengers) are downstream of signaling pathways which lead to the proliferation of cells. This medicine works by inhibiting cyclin dependent kinase 4 and 6, thus arrests the cancer cell cycle (cell growing process). It also targets the estrogen (hormone) receptor-positive breast cancer cells by disrupting the cell cycle. Indication: 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 Administration: Hard Capsule: Should be taken with food. Take at the same time each day. Swallow whole, do not chew/crush/open. Avoid grapefruit products. Adult Dose: 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... Renal Dose: Renal impairment Mild, moderate, or severe (CrCl >15 mL/min): No dose adjustment required Hemodialysis: Not studied Contraindication: Pregnancy and lactation. Mode of Action: 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. Precaution: 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 Side Effect: >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,... Interaction: 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).