Product Information
Palboxen (Palbociclib) 125mg is an oral cyclin-dependent kinase 4/6 (CDK4/6) inhibitor used, in combination with an aromatase inhibitor or fulvestrant, to treat hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer. It works by blocking CDK4 and CDK6, proteins that sit downstream of the signalling pathways driving cell proliferation, preventing hormone receptor-positive breast cancer cells from progressing from the G1 into the S phase of the cell cycle. Palboxen is not used alone; it is always combined with endocrine therapy as part of the approved treatment regimen. Manufactured by Everest Pharmaceuticals Ltd., Bangladesh and globally supplied by Mediaid Pharmacy with worldwide shipping.
Basic Product Information of Palboxen (Palbociclib) 125mg
| Brand Name | Palboxen (Palbociclib) |
| Generic Name | Palbociclib INN |
| Drug Class | Cyclin-Dependent Kinase 4/6 (CDK4/6) Inhibitor |
| Available Strength | 125mg |
| Formulation | Capsule (Must Be Taken With Food) |
| Pack Size | 21 Capsules per Pack (One 21-Day Active-Dosing Cycle) |
| Primary Indication | HR-Positive, HER2-Negative Advanced or Metastatic Breast Cancer, with an Aromatase Inhibitor or Fulvestrant |
| Regulatory Approvals | USFDA Approved (Combination Therapy for HR+/HER2- Advanced Breast Cancer). EMA Approved. |
| Originator Brand | Ibrance by Pfizer |
| Manufacturer | Everest Pharmaceuticals Ltd., Dhaka, Bangladesh |
| Global Supplier | Mediaid Pharmacy, Worldwide Shipping Available |
| Registration Status | Export Only – Manufactured for International Markets |
| Storage Conditions | Store between 20 and 25 degrees Celsius. Keep in a dry place away from light and moisture. Keep out of the reach of children. |
How Palboxen (Palbociclib) Works
Palboxen contains Palbociclib, a selective, reversible small-molecule inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6). Cyclin D1 and CDK4/6 sit downstream of multiple signalling pathways that drive cellular proliferation, and their activity is required for a cell to progress from the G1 phase into the S phase of the cell division cycle. In hormone receptor-positive breast cancer, oestrogen signalling promotes cyclin D1 expression, driving continued tumour cell division.
By inhibiting CDK4/6, Palboxen blocks this G1-to-S phase transition, halting the proliferation of oestrogen receptor-positive breast cancer cells. In pre-clinical models, the combination of Palbociclib with endocrine therapy (an aromatase inhibitor or fulvestrant) produced greater anti-tumour activity than either approach alone, which is why Palboxen is always given as part of a combination regimen rather than as a standalone treatment.
Palboxen is taken as an oral capsule with food, using a distinctive 21 days on treatment, followed by 7 days off schedule, repeated in 28-day cycles.
Indications for Palboxen (Palbociclib)
Palboxen (Palbociclib) is indicated for the following conditions:
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In Combination with an Aromatase Inhibitor As initial endocrine-based therapy for HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women (and in men, per standard oncology practice). |
In Combination with Fulvestrant For patients with HR-positive, HER2-negative advanced or metastatic breast cancer whose disease has progressed following prior endocrine therapy. |
Benefits of Palboxen (Palbociclib) 125mg
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First-in-Class CDK4/6 Inhibitor Palbociclib was the first CDK4/6 inhibitor approved for breast cancer, establishing a treatment class that fundamentally changed the management of HR-positive, HER2-negative advanced disease. |
Delays Progression to Chemotherapy By overcoming a common mechanism of endocrine therapy resistance, CDK4/6 inhibitors like Palboxen have helped delay the need for more toxic chemotherapy in many patients. |
Backed by the PALOMA Trials Palbociclib’s efficacy and safety profile are supported by the PALOMA clinical trial programme, one of the most extensively studied CDK4/6 inhibitor datasets in breast cancer. |
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Affordable Alternative to Ibrance Palboxen contains the same active ingredient as Ibrance by Pfizer, at a significantly lower cost, making CDK4/6 inhibitor therapy more financially accessible. |
Bioequivalence-Tested Manufacturing Palboxen undergoes bioequivalence testing to match the dissolution profile, peak plasma concentration, and overall drug exposure established for the innovator product. |
WHO-GMP and ISO Certified Produced by Everest Pharmaceuticals Ltd. under WHO-GMP and ISO-certified manufacturing standards, with every batch tested before global distribution. |
How to Take Palboxen (Palbociclib)
Route: Oral, taken WITH FOOD, preferably at the same time each day. Capsules should be swallowed whole and not opened, crushed, or chewed.
Standard dose: 125mg (one capsule) once daily for 21 consecutive days, followed by 7 days off treatment, comprising a complete 28-day cycle, continued until disease progression or unacceptable toxicity, exactly as directed by the prescribing oncologist.
With aromatase inhibitor: Administer the recommended dose of an aromatase inhibitor (such as letrozole) continuously alongside Palboxen; refer to the full prescribing information for the specific aromatase inhibitor used.
With fulvestrant: The recommended dose of fulvestrant when combined with Palboxen is 500mg, given on Days 1, 15, and 29, and then monthly thereafter; refer to the full prescribing information for fulvestrant.
Missed or vomited dose: If a dose is missed, or if vomiting occurs after taking a dose, do not take an additional dose that day; resume the normal schedule with the next planned dose.
Dose reduction for toxicity: For adverse reactions such as significant neutropenia, the dose is typically reduced first to 100mg once daily, and if needed, further reduced to 75mg once daily, on the same 21-days-on/7-days-off schedule. If a further reduction below 75mg once daily is required, treatment is generally discontinued.
Strong CYP3A4 inhibitors: Avoid concomitant use where possible. If unavoidable, reduce the Palboxen dose to 75mg once daily during co-administration.
Paediatric use: Palboxen is not indicated for use in children.
Monitoring and Dosage Adjustments
Regular monitoring is essential throughout Palboxen treatment. Your oncologist will check complete blood counts before starting treatment, at the beginning of each cycle, and on Day 15 of the first two cycles, given the risk of neutropenia. Monitoring also includes assessment for signs of infection, and prompt evaluation of any new or worsening respiratory symptoms suggestive of interstitial lung disease or pneumonitis. Monitoring in line with the aromatase inhibitor or fulvestrant component of your regimen will also apply. Report any fever, chills, unusual bruising or bleeding, persistent fatigue, breathlessness, or cough to your oncology team immediately.
Drug Interactions and Important Information
Palbociclib is primarily metabolised by CYP3A and the sulfotransferase enzyme SULT2A1, and is itself a time-dependent inhibitor of CYP3A. Avoid concomitant use of Palboxen with strong CYP3A4 inhibitors (such as ketoconazole, itraconazole, and clarithromycin) where possible; if unavoidable, a dose reduction to 75mg once daily is required. Avoid concomitant use with strong CYP3A4 inducers (such as rifampicin, carbamazepine, and phenytoin), as these reduce Palbociclib effectiveness. Avoid grapefruit and grapefruit juice during treatment.
Because Palboxen inhibits CYP3A, caution is advised with sensitive CYP3A substrate medications, which may need dose adjustment. Women of childbearing potential should use effective contraception during treatment and for at least 3 weeks after the final dose. Always inform your physician of all medications, supplements, and herbal products you are currently taking before starting Palboxen.
Side Effects and Precautions
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Common Side Effects Nausea and vomiting Fatigue and weakness Diarrhoea and decreased appetite Hair thinning (alopecia) Mouth sores (stomatitis) Rash and dry skin Numbness or tingling in the arms or legs |
Serious Warnings and Precautions Neutropenia, the most common serious adverse reaction, requiring regular blood count monitoring. Leukopenia, thrombocytopenia, and anaemia. Serious infections. Interstitial lung disease/pneumonitis, rare but can be fatal. Embryo-foetal toxicity. Not recommended during pregnancy or breastfeeding. |
Who Should Use Palboxen (Palbociclib)?
Palboxen is suitable for adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer, whether being started on first-line endocrine-based therapy in combination with an aromatase inhibitor, or being treated with fulvestrant after progression on prior endocrine therapy. It is prescribed by medical oncologists experienced in managing HR-positive breast cancer. A thorough medical assessment including confirmed HR-positive/HER2-negative status, baseline blood counts, and a review of respiratory symptoms is required before initiating treatment.
Manufacturer: Everest Pharmaceuticals Ltd.
Everest Pharmaceuticals Ltd. is a vertically integrated pharmaceutical company based in Dhaka, Bangladesh, and a recognised specialist in complex generic oncology formulations. Everest operates under strict WHO-GMP guidelines and maintains rigorous ISO certifications. To help ensure therapeutic equivalence to the innovator brand, Palboxen undergoes bioequivalence testing, checking the dissolution profile, peak plasma concentration, and overall drug exposure against the established safety and efficacy profile from the PALOMA clinical trial programme, with each batch examined in a certified laboratory before global distribution. Palboxen is one of Everest’s specialty oncology products, offering a bioequivalent alternative to Ibrance by Pfizer at a fraction of the cost.
Global Supplier: Mediaid Pharmacy with Worldwide Shipping
Mediaid Pharmacy is a trusted global supplier of specialty and oncology medications. We ensure Palboxen (Palbociclib) is accessible to patients and healthcare providers worldwide through reliable worldwide shipping. Whether you are located in South Asia, the Middle East, Africa, Europe, or beyond, Mediaid Pharmacy provides fast and reliable delivery with full order support. Contact us directly via WhatsApp, phone, or WeChat for pricing, availability, and delivery enquiries.
Why Choose Palboxen (Palbociclib) from Mediaid Pharmacy?
Palboxen represents a foundational advance in the treatment of HR-positive, HER2-negative advanced breast cancer, helping delay disease progression and the need for chemotherapy. As the generic equivalent of Ibrance by Pfizer, it delivers the same active ingredient, Palbociclib, with the same proven CDK4/6-inhibition mechanism at a dramatically more affordable price. Manufactured by Everest Pharmaceuticals Ltd. under WHO-GMP and ISO-certified standards and distributed globally by Mediaid Pharmacy, Palboxen gives patients worldwide access to essential combination breast cancer therapy without the financial burden of brand-name alternatives. For patients and physicians seeking a proven, affordable, and accessible Palbociclib option with worldwide delivery, Palboxen from Mediaid Pharmacy is the trusted choice.
Frequently Asked Questions About Palboxen (Palbociclib)
What is Palboxen (Palbociclib) used for?
Palboxen (Palbociclib), used together with an aromatase inhibitor or fulvestrant, is used to treat adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer. It works by blocking CDK4 and CDK6, proteins that hormone receptor-positive breast cancer cells rely on to keep dividing.
How should I take Palboxen (Palbociclib)?
Palboxen capsules are taken orally, once daily, WITH FOOD, for 21 consecutive days, followed by 7 days off treatment, repeated in 28-day cycles. It is always taken together with an aromatase inhibitor or fulvestrant, never alone. Always follow your oncologist’s exact instructions.
What strength is Palboxen available in?
Palboxen is available in a 125mg capsule, supplied in a pack of 21 capsules, matching the 21 active-dosing days in each 28-day treatment cycle.
Is Palboxen the same as Ibrance (Palbociclib by Pfizer)?
Yes. Palboxen is the generic equivalent of Ibrance. Both contain the same active ingredient, Palbociclib, and work through the same CDK4/6-inhibition mechanism. Palboxen is manufactured by Everest Pharmaceuticals Ltd. in Bangladesh and offers the same clinical mechanism as Ibrance at a significantly lower cost.
What are the side effects of Palboxen (Palbociclib)?
Common side effects include nausea, fatigue, diarrhoea, decreased appetite, hair thinning, and mouth sores. The most common serious risk is neutropenia (low white blood cell count), which is why regular blood tests are required throughout treatment. Always consult your oncologist for a complete assessment of your individual risks and benefits before starting treatment.
Can Palboxen be used with other medications?
Palboxen is specifically designed to be used with an aromatase inhibitor or fulvestrant. It should not be combined with strong CYP3A4 inhibitors without a physician-directed dose reduction, and strong CYP3A4 inducers should be avoided. Always inform your physician of all medications, supplements, and herbal products you are taking before starting Palboxen.
Is Palboxen (Palbociclib) safe during pregnancy or breastfeeding?
No. Palboxen is not recommended during pregnancy or breastfeeding, as it can cause foetal harm. Women of childbearing potential should use effective contraception during treatment and for at least 3 weeks after the final dose. Please consult your physician before starting treatment if you are pregnant, planning to become pregnant, or breastfeeding.
Can I order Palboxen (Palbociclib) online with worldwide shipping?
Yes. Mediaid Pharmacy supplies Palboxen (Palbociclib) 125mg globally with worldwide shipping. Contact us via WhatsApp, phone, or WeChat at +8801773428128 or email us at info@mediaidpharmacy.com to enquire about pricing, availability, and delivery to your country.
Order Palboxen (Palbociclib) 125mg with Worldwide Shipping
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