Alpesib (Alpelisib) Tablets
Alpesib 150 mg (Alpelisib) is a kinase inhibitor specifically designed to target the phosphatidylinositol-3-kinase (PI3K) alpha enzyme.
Manufacturer: Everest Pharmaceuticals. Each pack contains 28 tablets. It works by inhibiting the PI3K pathway, which is often overactive in cancer cells due to mutations, specifically blocking tumor growth in patients with the PIK3CA mutation.
Precision Medicine:
Patients must be selected for treatment based on the presence of a PIK3CA mutation in tumor tissue or plasma specimens, confirmed by a validated test.
Indicated for use in combination with fulvestrant for the treatment of:
- ๐น Breast Cancer: Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative active breast cancer.
- ๐น Stage: Advanced or metastatic disease.
- ๐น Population: Postmenopausal women, and men, whose cancer has progressed on or after an endocrine-based regimen.
Packaging: 150 mg film-coated tablets.
โ ๏ธ ADMINISTRATION PROTOCOL:
- Standard Dose: 300 mg (two 150 mg tablets) taken orally once daily.
- Timing: Take at approximately the same time each day.
- Food Intake: Must be taken immediately following food to ensure proper absorption.
- Administration: Swallow tablets whole. Do not chew, crush, or split them.
- Missed Dose: If missed by more than 9 hours, skip the dose and resume the next day.
- Severe hypersensitivity to Alpelisib.
- History of severe cutaneous reactions (e.g., Stevens-Johnson syndrome).
- Pregnancy and breastfeeding (embryo-fetal toxicity).
Common and potentially serious adverse reactions include:
- ๐ฉธ Metabolic: Hyperglycemia (high blood sugar) is very common. Regular fasting glucose monitoring is essential.
- ๐ Gastrointestinal: Diarrhea, nausea, vomiting, stomatitis.
- ๐ Dermatologic: Rash (maculopapular), dry skin, alopecia.
- Patients should be monitored for signs of hypersensitivity and severe skin reactions.
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