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   Indications of Alpelisib
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Jul 07, 2025

Alpelisib is an innovative targeted therapy drug that brings new hope for treatment of patients with specific types of breast cancer with its unique mechanism of action. This article aims to explore in depth the indications, applicable populations, and key considerations during the use of Alpelisib, in order to provide comprehensive and concise information guidance for clinicians and patients.

Indications of Alpelisib

The indications of Alpelisib mainly focus on specific subtypes of breast cancer, opening up new avenues for the treatment of advanced or metastatic breast cancer.

Specific breast cancer subtypes

Alpelisib, in combination with Fulvestrant, is particularly suitable for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated advanced or metastatic breast cancer in postmenopausal women and men. The establishment of this indication is based on rigorous clinical trial data, which shows the significant efficacy of this combination therapy in specific patient groups.

Choice of treatment options

For this indication, the addition of Alpelisib provides a new treatment option for patients who have failed or progressed endocrine therapy. Through the synergistic effect with Fulvestrant, it targets the specific target of PIK3CA mutation, effectively inhibits the growth and proliferation of tumor cells, and brings survival benefits to patients.

The indications of Alpelisib are clear and targeted, providing a precise treatment plan for patients with specific types of breast cancer.

Applicable population of Alpelisib

It is important to clarify the applicable population of Alpelisib to clarify the effectiveness of the drug.

Patient characteristics definition

Alpelisib is mainly suitable for postmenopausal female and male patients, and their tumors must meet the conditions of HR positive, HER2 negative and PIK3CA mutation. This strict screening standard aims to make sure that the drug can accurately act on the target patient group and achieve the best therapeutic effect.

Consideration of special populations

For special groups such as pregnant women, breastfeeding women, people with reproductive potential, children and the elderly, special caution should be taken when using Alpelisib. Pregnant women and breastfeeding women should avoid using it to avoid potential harm to the fetus or infant; people with reproductive potential should take effective contraceptive measures during treatment; children and the elderly should use it under the guidance of a doctor according to specific circumstances.

Therefore, when determining the applicable population of Alpelisib, it is necessary to comprehensively consider multiple factors such as the patient's age, gender, physiological state and tumor characteristics to clarify the safety and effectiveness of the treatment.

Precautions for the use of Alpelisib

During the use of Alpelisib, it is necessary to pay attention to multiple aspects to ensure the smooth progress of treatment and the safety of patients.

Dosage and method of medication

The recommended dose of Alpelisib is 300mg per day, taken with food, and should be taken at the same time every day. If a dose is missed, it must be taken within the prescribed time, otherwise the dose of the day should be skipped. At the same time, patients should avoid chewing, crushing or splitting tablets to clarify the integrity and effectiveness of the drug.

Adverse reaction monitoring

Various adverse reactions may occur during the treatment of Alpelisib, such as increased blood sugar, diarrhea, rash, etc. Patients need to monitor relevant indicators regularly, and if adverse reactions occur, they should inform the doctor in time to adjust the dose or take other necessary measures. In particular, the management of hyperglycemia requires special attention to prevent serious complications.

There is a risk of interaction between Alpelisib and certain drugs, such as strong CYP3A inducers and BCRP inhibitors. Therefore, before using Alpelisib, patients should inform their doctors in detail of all the drugs they are currently taking to avoid potential drug interactions.

Note: For internal discussion among medical personnel only. For specific medication, please consult the attending physician. Drug information may change over time. For the latest information, we recommend adding a medical consultant or consulting for free online.
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