Description
Palbocent 125: Each capsule contains Palbociclib INN 125 mg.
Product Features:
| Product Name | : Palbocent |
| Generic Name | : Palbociclib |
| Manufacturer | : Incepta Pharma Ltd |
| Indication | : Breast cancer |
| Formulation | : Capsule |
| Strength | : 125 mg |
| Quantity | : 21 Capsules |
| Storage | : Room temperature |
| Registrations | : Export Only |
Palbocent (Palbociclib) is an inhibitor of cyclin-dependent kinases (CDK) 4 and 6. Cyclin D1 and CDK4/6 are downstream of signaling pathways which lead to cellular proliferation. It reduced cellular proliferation of estrogen receptor (ER)-positive breast cancer cell lines by blocking progression of the cell from G1 into S phase of the cell cycle. Treatment of breast cancer cell lines with the combination of Palbociclib and antiestrogens leads to decreased retinoblastoma (Rb) protein phosphorylation resulting in reduced E2F expression and signaling, and increased growth arrest compared to treatment with each drug alone.
In vitro, treatment of ER-positive breast cancer cell lines with the combination of palbociclib and antiestrogens resulted in a significant increase in cell senescence. This effect was more pronounced than using the drug alone. Extended senescence persisted for up to 6 days after removal of Palbocent. The effect was further amplified when antiestrogen therapy was continued. In vivo studies using patient-derived ER-positive breast cancer xenograft models have shown significant results. The combination of Palbocent and letrozole leads to an increased inhibition of Rb phosphorylation. It also enhanced the suppression of downstream signaling. This combination therapy was more effective in inhibiting tumor growth than each drug used alone.
In a separate in vitro study, human bone marrow mononuclear cells were treated with palbociclib. Whether treated with or without anti-estrogens, these cells did not become senescent. In addition, they recurred after the withdrawal of palbociclib.
Dosage & Administration
The recommended dose of Palbocent is a 125 mg capsule taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. Need to taken with food. Administer the recommended dose of an aromatase inhibitor when given. Please refer to the Full Prescribing Information for the aromatase inhibitor being use. When given with Palbocent, the recommended dose of fulvestrant is 500 mg administer on Days 1,15, 29, and once monthly thereafter. Please refer to the Full Prescribing Information of fulvestrant. Pre/perimenopausal women treated with the combination of Palbociclib plus fulvestrant therapy treated with luteinizing hormone-releasing hormone (LHRH) agonists according to current clinical practice standards.
Side Effects
The most common adverse reactions (incidence ≥10%) were neutropenia, infections, leukopenia, fatigue, nausea, stomatitis, anemia, alopecia, diarrhea, thrombocytopenia, rash, vomiting, decreased appetite, asthenia, and pyrexia.
Precautions
Neutropenia: Complete blood count should monitored before the start of Palbociclib therapy and at the beginning of each cycle, as well as on Day 15 of the first 2 cycles, and as clinically indicated.
Embryo-Fetal Toxicity: This can cause fetal harm. Patients should advised about the potential risk to the fetus and to use effective contraception.
Use in specific population
Pregnancy
Based on findings from animal studies and its mechanism of action. Palbocent 125 can cause fetal harm when administered to a pregnant woman. There are no available data in pregnant women to inform the drug-associated risk. In animal reproduction studies, the administration of Palbocent to pregnant rats and rabbits during organogenesis resulted in embryo-fetal toxicity at maternal exposures that were ≥4 times the human clinical exposure based on AUC.
Pregnant women should be advised about the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated 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.
Lactation
There is no information regarding the presence in human milk, its effects on milk production, or the breastfed infant. Because of the potential for serious adverse reactions in breastfed infants from Palbociclib, advise a lactating woman not to breastfeed during treatment with Palbociclib and for 3 weeks after the last dose.
Pediatric Use: The safety and effectiveness in pediatric patients have not been established.
Geriatric Use: No overall differences in safety or effectiveness were observed between these patients and younger patients.
Hepatic Impairment: Mild hepatic impairment had no effect on the exposure of Palbociclib. The pharmacokinetics of Palbociclib has not been studied in patients with moderate or severe hepatic impairment.
Renal Impairment:
Mild and moderate renal impairment had no effect on the exposure of Palbociclib. The pharmacokinetics of Palbociclib has not been studied in patients with severe renal impairment.
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Melanie Geller –
I have been undergoing treatment for HER2-positive breast cancer, and Palbociclib 125 Mg has been a game-changer for me. This medicine specifically targets HER2 receptors, inhibiting the growth of cancer cells. The treatment has significantly reduced the size of my tumor, and my oncologist has been impressed with the results. The side effects, such as mild nausea and fatigue, have been manageable with supportive care. Palbociclib 125 Mg has given me hope and improved my quality of life during this challenging time.
Nora Makolli –
I have been ordering Palbocent (Palbociclib) 125 MG – 21 Capsules for a year now and I am very grateful for finding your contact and for your services. I am also very grateful for the price, since using this medicine on monthly basis it allows me to afford the price and also keeps my sickness under control. This literally saved my life, cause if it was not for your services, I do not know if I would have been able to afford other prices and control my sickness. Thank you very much for everything.