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Palbocent 125 mg (Palbociclib)
Palbocent 125 mg is identified on this website as a pharmaceutical product containing palbociclib 125 mg, an oral cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor used in selected breast cancer treatment settings.
Product-specific information such as the manufacturer, marketing authorization holder, regulatory status, packaging and distribution relationship for Palbocent should be verified against the actual product packaging and applicable regulatory documentation before publication.
Palbociclib is the active ingredient in IBRANCE, the established reference product developed and marketed by Pfizer. IBRANCE received its initial U.S. approval in February 2015 and was the first CDK4/6 inhibitor approved by the FDA.
Incepta Pharmaceuticals Ltd. About the Manufacturer
Incepta Pharmaceuticals Ltd. is a leading pharmaceutical manufacturer in Bangladesh, established in 1999. The company develops and manufactures a wide range of pharmaceutical products for the domestic and international markets. Its major manufacturing facilities are located in Savar and Dhamrai, Bangladesh.
Incepta manufactures different dosage forms, including tablets, capsules, oral liquids, injections, eye drops, creams, ointments, gels, nasal sprays, prefilled syringes, lyophilized injections, and biological products. The company also focuses on technologically advanced dosage forms and pharmaceutical research and development.
Address: Incepta Pharmaceuticals Ltd. 40 Shahid Tajuddin Ahmed Sarani, Tejgaon I/A, Dhaka-1208, Bangladesh
| Topic | Information |
|---|---|
| Product name | Palbocent |
| Active ingredient | Palbociclib |
| Stated strength | 125 mg |
| Route | Oral, subject to product-specific documentation |
| Drug class | Cyclin-dependent kinase 4/6 inhibitor |
| Therapeutic category | Antineoplastic medicine |
| Reference product | IBRANCE |
| Reference-product developer/marketer | Pfizer |
| Specific Palbocent manufacturer | Incepta Pharmaceuticals Ltd. |
| Marketing authorization holder | Incepta Pharmaceuticals Ltd. |
| Regulatory status | Approved and regulated locally |
| Distributor/supplier | Incepta Pharmaceuticals Ltd. |
What is palbociclib?
Palbociclib is an oral targeted anticancer medicine that inhibits cyclin-dependent kinases 4 and 6 (CDK4/6). These enzymes play an important role in controlling progression through the cell cycle.
By inhibiting CDK4/6 activity, palbociclib can interfere with the progression of susceptible cancer cells through the cell cycle. This mechanism is particularly relevant to its use in hormone receptor-positive breast cancer.
What is palbociclib used for?
Palbociclib is used in selected treatment settings for hormone receptor-positive (HR-positive), HER2-negative advanced or metastatic breast cancer.
Depending on the applicable regulatory labeling, palbociclib may be used in combination with endocrine therapy, including an aromatase inhibitor or fulvestrant.
The appropriate treatment combination depends on the patient’s disease characteristics, previous treatment, menopausal status and other clinical considerations. Approved indications can differ between countries and may change as regulatory authorities update product information.
Palbocent 125 mg and IBRANCE
Palbocent should not automatically be described as IBRANCE.
Both products may contain the active ingredient palbociclib, but their product identity, manufacturer, formulation, excipients, packaging, authorization pathway and distribution arrangements may differ.
IBRANCE is the established reference product associated with palbociclib and Pfizer. The specific relationship between Palbocent and IBRANCE should only be stated when supported by appropriate product documentation.
How does palbociclib work?
Palbociclib selectively inhibits CDK4 and CDK6, proteins involved in regulating cell-cycle progression.
Blocking these enzymes can reduce phosphorylation of the retinoblastoma protein and interfere with progression from the G1 phase toward the S phase of the cell cycle.
In simple terms, palbociclib helps slow the division of susceptible cancer cells by interfering with molecular signals that control cell-cycle progression.
Palbocent 125 mg dosage
The 125 mg strength represents the stated amount of palbociclib in the dosage unit.
Under current U.S. IBRANCE labeling, the standard palbociclib regimen is 125 mg once daily for 21 consecutive days followed by 7 days without treatment, forming a 28-day treatment cycle.
Dose interruptions or reductions may be required because of adverse reactions, particularly abnormalities in blood-cell counts.
Patients should take palbociclib only according to the prescription and applicable official product information. The dose should not be changed independently.
Important Safety Information
Palbociclib can cause clinically significant adverse reactions. Neutropenia, or a reduction in neutrophil levels, is one of the major treatment-related risks and can increase susceptibility to infections.
Other reported adverse reactions can include:
Infections
Leukopenia
Anemia
Thrombocytopenia
Fatigue
Nausea
Diarrhea
Stomatitis
Decreased appetite
Alopecia
Rash
Laboratory abnormalities
Serious or clinically important pulmonary reactions, including interstitial lung disease/pneumonitis, have also been reported.
Palbociclib may cause embryo-fetal harm. Pregnancy considerations should therefore be discussed with an appropriately qualified healthcare professional.
Monitoring During Treatment
Palbociclib treatment commonly requires monitoring of blood counts because suppression of bone marrow function is an important safety consideration.
Depending on the individual treatment plan, healthcare professionals may monitor:
Complete blood counts
Neutrophil levels
Hemoglobin
Platelet counts
Liver function
Signs of infection
Other clinically relevant laboratory parameters
Dose interruption or modification may be necessary when clinically significant toxicity occurs.
Originator and Reference Product
Palbociclib was developed by Pfizer and is marketed under the reference brand IBRANCE.
IBRANCE became the first CDK4/6 inhibitor approved by the U.S. FDA in 2015.
The originator/reference product should be distinguished from a specific product such as Palbocent. The fact that two products contain the same active pharmaceutical ingredient does not, by itself, establish that they are identical products or that they are manufactured by the same company.
Incepta Pharmaceuticals Ltd. Verification Process
Scan the QR code printed on the product box. The QR code will take you to the official Incepta product verification page, where you can complete the verification process.
The QR code will direct you to the Incepta Pharmaceuticals Ltd. e-verification page, where you can complete the product verification process.
After completing the verification, check the result carefully to confirm whether the product is genuine.
If the verification indicates that the product is fake or unauthorized, do not use it. Report the suspected counterfeit product and take appropriate legal action against the supplier through the Directorate Incepta of Drug Administration (DGDA), World.
Always purchase medicines from licensed pharmacies or authorized suppliers and verify the product before use.
Medical Information Disclaimer
This website provides general educational information about Palbocent and palbociclib. It does not provide individualized medical advice, diagnosis or treatment recommendations.
Palbociclib is a prescription anticancer medicine and should be used under the supervision of an appropriately qualified healthcare professional.
Patients should consult the prescribing information applicable to their country and follow the instructions provided by their healthcare team. Do not start, stop, increase or reduce a prescribed medicine based solely on information published on this website.
References
U.S. Food and Drug Administration — IBRANCE (palbociclib) prescribing information.
DailyMed — IBRANCE (palbociclib) labeling.
Pfizer — IBRANCE and palbociclib product information.
Applicable national medicines regulatory authority.
Latest News
FAQs
Palbocent 125 mg is identified on this website as a product containing palbociclib, an oral targeted anticancer medicine belonging to the CDK4/6 inhibitor class.
CDK4/6 inhibition means blocking the activity of cyclin-dependent kinases 4 and 6, proteins that help regulate cell-cycle progression. Palbociclib works by inhibiting these proteins.
Palbociclib is used in selected breast cancer treatment settings together with endocrine therapies because CDK4/6 inhibition can complement hormonal treatment. The appropriate combination depends on the cancer subtype and treatment setting.
The standard labeled schedule includes 21 consecutive days of treatment followed by 7 days without palbociclib. This creates a 28-day treatment cycle. Patients should follow the schedule prescribed by their healthcare professional.
Blood counts are monitored because palbociclib can cause neutropenia and other blood-count abnormalities. Regular CBC testing helps healthcare professionals assess treatment safety and determine whether dose adjustment or treatment interruption is necessary.
Yes. Dose interruption or reduction may be necessary when clinically significant adverse reactions occur. Dose changes should only be made according to the applicable prescribing information and under medical supervision.
If a dose is missed or vomiting occurs after taking palbociclib, patients should follow the instructions for their specific formulation and contact their healthcare professional if clarification is needed. An extra dose should not be taken unless specifically instructed.
Yes. Palbociclib is used in combination with certain cancer medicines in approved treatment settings. These can include endocrine therapies and, in specific settings, other targeted or anti-HER2 treatments. The combination depends on the patient's diagnosis and applicable regulatory labeling.
Tell your healthcare professional about all prescription medicines, over-the-counter medicines, supplements and herbal products you use. Also discuss pregnancy, breastfeeding, liver or kidney problems, previous blood-count abnormalities and any history of significant lung problems.
There is no single treatment duration that applies to every patient. Palbociclib may be continued according to the treatment plan while it remains appropriate and tolerated, with decisions based on disease status, adverse reactions and the treating healthcare professional's assessment.