Generic Alpelisib Price
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Product Overview
Alpesib is designed for the treatment of postmenopausal women, and men, with Hormone Receptor (HR)-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-negative, and PIK3CA-mutated advanced or metastatic breast cancer. It is typically used in combination with Fulvestrant, an endocrine therapy, after the cancer has progressed during or following an endocrine-based regimen.
Key Specifications
Brand Name: Alpesib
Generic Name: Alpelisib
Strength: 150 mg
Dosage Form: Film-coated tablet
Manufacturer: Everest Pharmaceuticals Ltd.
Pack Size: Commonly available in 28-tablet packs.
Mechanism of Action
To understand how Alpesib works, one must look at the PI3K signaling pathway. In a healthy body, this pathway regulates cell growth and survival. However, in approximately 40% of HR+/HER2- breast cancers, a mutation in the PIK3CA gene causes this pathway to become overactive.
This overactivity allows cancer cells to grow uncontrollably and often makes them resistant to standard hormone therapies. Alpelisib specifically targets and inhibits the alpha-isoform of PI3K ($PI3K\alpha$). By blocking this enzyme, Alpesib:
Interrupts the growth signals sent to cancer cells.
Restores sensitivity to endocrine therapy.
Induces apoptosis (programmed cell death) in mutated cells.
Therapeutic Indications
Alpesib 150 mg is indicated for:
Advanced or Metastatic Breast Cancer: Specifically HR-positive and HER2-negative cases.
PIK3CA Mutation: Patients must be tested and confirmed to have a PIK3CA mutation using an FDA-approved diagnostic test before starting treatment.
Combination Therapy: It is used alongside Fulvestrant to maximize anti-tumor activity.
Additionally, Alpelisib is sometimes utilized in treating PIK3CA-Related Overgrowth Spectrum (PROS), a group of rare genetic conditions characterized by overgrowth of specific body parts.
Dosage and Administration
The administration of Alpesib requires strict adherence to medical guidance to ensure efficacy and manage potential metabolic changes.
Standard Adult Dose: The typical recommended dose is 300 mg once daily (taken as two 150 mg tablets).
Timing: It should be taken at approximately the same time each day.
Food Requirement: Alpesib must be taken with food. Food significantly enhances the absorption of the medication.
Method: Tablets should be swallowed whole. Do not crush, chew, or split them.
Missed Dose: If a dose is missed, it can be taken with food within 9 hours of the scheduled time. If more than 9 hours have passed, the dose should be skipped.
Safety and Precautions
Because Alpesib affects metabolic pathways, patients and healthcare providers must monitor for specific side effects:
1. Hyperglycemia (High Blood Sugar)
Since PI3K is involved in insulin signaling, Alpesib can cause significant increases in blood glucose. Patients should have their Fasting Plasma Glucose (FPG) and HbA1c levels tested before starting and regularly during treatment.
2. Severe Cutaneous Reactions
Patients should be monitored for rashes. In rare cases, severe reactions like Stevens-Johnson Syndrome (SJS) can occur. Treatment should be interrupted if a severe rash develops.
3. Diarrhea
Diarrhea is a common side effect. Patients are often advised to keep antidiarrheal medications (like loperamide) on hand and increase fluid intake.
4. Pneumonitis
Inflammation of the lungs has been reported. Any new or worsening respiratory symptoms (cough, shortness of breath) should be reported to a doctor immediately.
Contraindications and Drug Interactions
Hypersensitivity: Alpesib is contraindicated in patients with a history of severe hypersensitivity to Alpelisib.
Pregnancy and Lactation: This medication can cause fetal harm. Effective contraception is required during treatment and for one week after the last dose. Breastfeeding is not recommended during treatment.
Drug Interactions: Avoid co-administration with strong CYP3A4 inducers (which can lower the drug’s effectiveness) and be cautious with BCRP inhibitors, which can increase the risk of toxicity.
Why Choose Alpesib (Everest Pharma)?
Everest Pharmaceuticals Ltd. is a leading manufacturer in the oncology sector, known for producing high-quality, globally accessible versions of advanced life-saving medicines. Alpesib offers a cost-effective alternative to the innovator brand, ensuring that patients with PIK3CA-mutated breast cancer have access to precision medicine that can significantly improve progression-free survival.
Disclaimer: This description is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional before starting any new medication.
