Introduction Palbocent 125 mg (Palbociclib):

Palbocent 125 mg is used to treat patients with breast cancer (estrogen receptor-positive, human epidermal growth factor receptor 2-negative) that has developed to other organs. Palbocent 125 is administered along with hormonal anticancer treatments. Palbocent 125 should be taken with food, but try to take it at the same time each day for the best results. The doctor will determine the appropriate dose and frequency with which you should take Palbociclib 125. The dose will be determined by the condition for which you are being treated and may alter over time. Taking Palbocent 125  improperly or in excess can lead to serious negative effects. It may take several weeks or months for you to see or feel the effects otherwise do not stop taking Palbocent 125 unless your doctor tells you to. 

Indications and Uses:

Palbocent 125 is used to treat HR-positive, HER2-negative advanced or metastatic breast cancer along with:
  1. Aromatase inhibitors as initial endocrine therapy in postmenopausal women
  2. Fulvestrant for disease progression after endocrine therapy.

Therapeutic Class:

Protein kinase inhibitor.

Pharmacology:

Palbocent 125 (Palbociclib) inhibits Cyclin-dependent kinases (CDKs) 4 and 6. Cyclin D1 and CDK4/6 are downstream of signaling pathways that promote cellular growth. Palbocent 125 (Palbociclib) inhibited the progression of estrogen receptor (ER)-positive breast cancer cell lines from the G1 to the S phase of the cell cycle, reducing cellular growth. When breast cancer cell lines are treated with a combination of Palbocent 125 (Palbociclib)  and antiestrogens, retinoblastoma (RB) protein phosphorylation is reduced, resulting in lower E2F production and signaling. Treatment of ER-positive breast cancer cell lines with a combination of Palbocent 125 (Palbociclib)  and antiestrogens resulted in increased cell senescence relative to either medication alone, which lasted up to 6 days after Palbocent 125 removal and was even greater if antiestrogen treatment was prolonged. In vivo experiments with a patient-derived ER-positive breast cancer xenograft model showed that the combination of Palbocent 125 (Palbociclib)   and letrozole inhibited RB phosphorylation, cascade signaling, and tumor development more than either medication alone.

Dosages and Administrations:

Palbocent 125 (Palbociclib)  should be taken as a 125 mg capsule once day for 21 days, followed by 7 days off for a total of 28 days. Palbocent 125 (Palbociclib)  must be Taken with food. Must avoid grapefruit products.
When using Palbocent 125 (Palbociclib)  in combination with an aromatase inhibitor, administer the prescribed dose. Please see the full Prescribing Information for the aromatase inhibitor being used such as the recommended dose of fulvestrant is 500 mg on days 1, 15, 29, and once monthly thereafter. Please refer to the full prescribing information for fulvestrant. Pre/perimenopausal women on Palbocent 125 (Palbociclib)  + fulvestrant therapy should receive LHRH agonists in accordance with current clinical practice standards.

Palbocent is not recommended for usage in children.

Side-effects:

The most commonly reported adverse effects of palbocent (incidence ≥10%) is included neutropenia, infections, leukopenia, fatigue, nausea, stomatitis, anemia, alopecia, diarrhea, thrombocytopenia, rash, vomiting, and decreased appetite,asthenia with pyrexia.

Drug Interaction:

Strong CYP3A inhibitors (e.g., clarithromycin, telithromycin, itraconazole, ketoconazole, posaconazole, voriconazole, indinavir, ritonavir, ritonavir-boosted lopinavir, nelfinavir, saquinavir, telaprevir, nefazodone, verapamil) increase plasma concentration and systemic exposure of Palbocent 125. Moderate CYP3A inducers (e.g., bosentan, efavirenz, etravirine, modafinil, nafcillin) and high CYP3A inducers (e.g., carbamazepine, phenytoin, enzalutamide, rifampicin) result in decreased plasma concentrations of Palbocent 125.

Overdose Effects:
Palbocent has no recognized antidote. So treatment for Palbocent overdose should include general supportive measures.

Pregnancy & Lactation:
Animal studies suggest that Palbocent may harm a fetus when administered to a pregnant woman. Pregnant women should be informed about the potential harm to the fetus. The background risk of serious birth abnormalities and miscarriage in the given population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. Palbocent’s presence in human milk, effects on milk supply, and impact on breastfed infants are unknown Breastfeeding during Palbocent 125  treatment and for 3 weeks following the last dosage of Palbociclib 125 is not recommended due to the risk of major adverse effects in breastfed infants.

Storage Conditions:

Palbocent 150 mg should be kept between 25°C and 30°C at room temperature. When a medication is no longer needed or has expired, dispose of it safely. Protect Palbociclib 150 mg from sunlight and humidity. Keep Palbocent 150 mg and all medicines out of the reach of children.

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