Palbociclib, known commercially as Ibrance, is an orally administered prescription drug for advanced or metastatic hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. It is classified as a CDK4/6 inhibitor and is usually combined with endocrine therapies like letrozole or fulvestrant.

Mechanism of Action:

Palbociclib functions by focusing on certain enzymes known as cyclin-dependent kinases 4 and 6 (CDK4/6), which are essential for cell division. In HR+ breast cancers, these kinases frequently exhibit heightened activity, leading to the unchecked proliferation of cancer cells. Palbociclib slows or halts the growth of cancer cells by inhibiting CDK4/6, which improves the efficacy of other treatments and may extend patients’ progression-free survival.

Indications and Usage:

Palbociclib 125 mg is approved for treating:

Postmenopausal women with HR+/HER2- advanced or metastatic breast cancer, for whom an aromatase inhibitor (like letrozole) is used as the first-line endocrine-based treatment.

In patients with disease progression after endocrine therapy, HR+/HER2- advanced or metastatic breast cancer in men and women is treated with fulvestrant.

When Palbociclib is used alongside hormonal therapy, there are notable enhancements in progression-free survival compared to the use of hormonal therapy by itself.

Dosage and Administration:

Palbocicib 125 Mg (Ibrance) is usually prescribed at a dosage of 125 mg once daily for 21 days in a row, after which there is a 7-day break (no treatment), resulting in a total cycle length of 28 days. For the purpose of guaranteeing a steady concentration of the drug in the bloodstream, it is recommended to take the capsule with food at identical times every day.

Capsules must be ingested intact and should not be chewed, crushed, or opened. In the event that a dose is missed or vomiting occurs after administration, that dose should not be repeated; the patient should take the next dose that is scheduled instead.

Packaging and Storage:

Ibrance comes in bottle packs with 125 mg capsules, usually packaged in a 21-count bottle for a 21-day treatment cycle. It should be kept at room temperature, ranging from 20°C to 25°C (68°F to 77°F), and protected from moisture and light.

Adverse Effects:

As with any medication, Palbociclib can lead to side effects. The side effects that occur most frequently include:

Neutropenie (geringer Wert an weißen Blutkörperchen)

Müdigkeit

Übelkeit

Thinning hair or loss of hair

Durchfall

Erkrankungen

Mundschleimhautentzündung (Entzündung im Mundbereich)

Graver side effects may encompass:

Serious neutropenia with infection risk

lung embolism

Abnormal liver function

To detect and address potential adverse effects early on, routine blood tests are necessary to track white blood cell counts and liver function throughout treatment.

Drug Interactions:

Palbociclib may interact with other medications, especially those that affect liver enzymes (CYP3A inhibitors or inducers). Some examples include:

Strong CYP3A inhibitors (e.g., ketoconazole, clarithromycin) – may increase Palbociclib levels and side effects.

Strong CYP3A inducers (e.g., rifampin, St. John’s wort) – may decrease Palbociclib effectiveness.

Before commencing treatment, patients should notify their healthcare provider about all medications, supplements, and herbal products they are currently using.

Warnings and Precautions:

Pregnancy and Breastfeeding: Palbociclib can be harmful to an unborn child, so it should not be taken during pregnancy. Women who can become pregnant should use reliable contraceptive methods while undergoing treatment and for a minimum of 3 weeks post-treatment. It is advised not to breastfeed while on treatment and for at least three weeks following the final dose.

Fertility: Palbociclib might affect fertility in men and women alike.

Monitoring: To keep an eye out for neutropenia and other hematologic adverse events, regular complete blood counts (CBCs) should be carried out.

Clinical Benefits:

Clinical studies have shown that the combination of Palbociclib with hormonal therapies such as letrozole or fulvestrant can lead to a significant extension of progression-free survival in patients with HR+/HER2- advanced breast cancer. It has evolved into an essential element of treatment guidelines and is commonly utilized worldwide as a first-line or second-line therapy for suitable patients.

Conclusion:

Palbociclib 125 mg (Ibrance) is a significant development in the treatment of HR+/HER2- advanced breast cancer. It provides a more targeted method of disease management by focusing on CDK4/6 pathways, which often postpones the necessity for chemotherapy and enhances the quality of life for numerous patients. Nonetheless, like all cancer treatments, it necessitates careful medical oversight to assess its efficacy and handle any possible adverse effects.

Patients are advised to talk to their oncologist or healthcare provider for tailored medical guidance, an assessment of possible risks, and to find out if Palbociclib is suitable for their condition.

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1. What is the purpose of Palbociclib (Ibrance) 125 mg?
Palbociclib is primarily used to treat advanced or metastatic HR-positive, HER2-negative breast cancer. It is typically recommended alongside hormone treatments such as letrozole or fulvestrant.

2. What is the mechanism of action of Palbociclib?
Palbociclib inhibits CDK4/6. It functions by inhibiting proteins (CDK4 and CDK6) that drive the proliferation of cancer cells, thus decelerating or halting tumor advancement.

3. How is Palbociclib taken?
It is taken orally, once daily for 21 days, followed by a 7-day break (making a 28-day cycle). It is best to take it with food and at the same time each day, if possible.

4. Can men take Palbociclib?
Yes. Although it’s mostly prescribed to women with breast cancer, Palbociclib is also approved for use in men with HR+/HER2- metastatic breast cancer.

5. Is Palbociclib classified as chemotherapy?
Palbociclib, while not a conventional chemotherapy, is categorized as a targeted cancer therapy. It targets the growth of cancer cells specifically, without causing widespread damage to healthy cells as traditional chemotherapy does.