Palbocent 125 mg Capsule (Box)

Presentation

Introduction

Palbocent 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. Palbocent 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 advised. Taking it in the wrong way or taking too much can cause very serious side effects. It may take several weeks or months for you to see or feel the benefits but do not stop taking it unless your doctor tells you to. Some common side effects of this medicine include fatigue, hair loss, rash, vomiting, and diarrhea. This medicine may reduce the number of blood cells (decrease red blood and white blood cells) in your blood, thereby, increasing the susceptibility to infections. It is better to inform your doctor if you notice symptoms of infection like fever, chills, and weakness, bleeding or bruising and nose bleed. It might also cause dizziness if it happens avoid driving or attention-seeking activities. Before taking it, tell your doctor if you have heart disease, liver, or kidney problems or are taking any medicines to treat infections. Many other medicines can affect, or be affected by, this medicine so let your healthcare team know all medications you are using. This medicine is not recommended during pregnancy or while breastfeeding. The use of effective contraception by both males and females during treatment is important to avoid pregnancy.

Uses of Palbocent 125

• Breast cancer

Side effects of Palbocent 125

Common

• Fatigue
• Hair loss
• Rash
• Vomiting
• Diarrhea
• Nausea
• Decreased blood cells (red cells, white cells, and platelets)
• Infection
• Decreased appetite
• Fever

How to use Palbocent 125

Take this medicine in the dose and duration as advised by your doctor. Do not chew, crush or break it. Palbocent 125 is to be taken with food.

How Palbocent 125 works

Palbocent 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.

Quick Tips

• Take it with food, preferably at the same time every day.
• If you forget to take the medicine or vomit, skip the missed dose and follow a regular schedule. Do not take a double dose to make up missed dose
• Use effective contraception method to prevent pregnancy while taking this medicine.
• It may cause dizziness. Avoid driving or any activity requiring mental focus until you know how it affects you.
• You may be asked for regular blood tests while taking this medication. Inform your doctor if you notice symptoms of infection like fever, chills, and weakness.
• Inform your doctor if you are pregnant, planning pregnancy or breastfeeding.
• Do not stop taking the medication without talking to your doctor first.

Brief Description

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 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 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, grade 3 (2%) Upper respiratory treact infection, grade 3 (1%) Decreased appetite, grade 3 (1%)

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).