Alpelisib is a targeted drug for breast lesions with specific gene mutations, which exerts anti-lesion effects by inhibiting the PI3Kα signaling pathway. Its indications and global marketing progress provide patients with new hope for treatment.
Indications of Alpelisib
Precision treatment of PIK3CA mutation breast lesions
Alpelisib combined with Fulvestrant is suitable for patients with advanced or metastatic breast lesions who are hormone receptor (HR) positive, HER2 negative and carry PIK3CA gene mutations. Such patients need to confirm the mutation status by FDA-approved testing methods after previous endocrine therapy failure. Clinical studies have shown that the combination therapy can extend progression-free survival to more than 11 months.
Global marketing and market status
The original drug of Novartis in Switzerland was approved for marketing by the US FDA in 2019. Patients can obtain the original drug through cross-border medical channels.
Clarifying indications and drug accessibility is the basis for formulating personalized treatment plans. The following content will explain in detail the correct use of Alpelisib.
Dosage and Administration of Alpelisib
Standardized medication is the key to ensuring efficacy. Alpelisib needs to be used in combination with Fulvestrant, and the specific dosage and method of administration must be strictly followed according to the doctor's instructions.
Standard dosage and administration requirements
The recommended dose is 300mg (two 150mg tablets) once a day, taken with meals to improve absorption. The tablets must be swallowed whole and avoid chewing or crushing. If the missed dose is within 9 hours, it can be taken immediately; if it exceeds 9 hours, skip the dose of the day and take the medicine as planned the next day. Fulvestrant used in combination needs to be injected at a dose of 500 mg per month.
Dosage adjustment strategy for adverse reactions
If ≥ grade 3 hyperglycemia, severe rash or persistent diarrhea occurs, the medication should be suspended and the doctor should be contacted to adjust the dose. The first dose can be reduced to 250 mg (one 150mg tablet + one 100mg tablet), and further reduced to 200 mg if toxic reactions occur again. Patients with impaired liver and kidney function do not need to adjust the dose, but need to closely monitor relevant indicators.
Reasonable adjustment of the medication regimen can reduce the risk of treatment. The following content will focus on the common and serious side effects of Alpelisib.
Side effects of Alpelisib
Alpelisib may cause multi-system adverse reactions, and early identification and intervention are important to ensure patient safety.
Hyperglycemia and metabolic abnormalities
About 60% of patients have elevated blood sugar, of which 10% are grade 3-4. Fasting blood sugar and glycosylated hemoglobin should be tested before treatment, and blood sugar levels should be monitored weekly during treatment. If fasting blood sugar continues to be ≥160mg/dL or symptoms of polydipsia and polyuria occur, insulin treatment should be started and medication should be suspended. Elderly patients and diabetic patients are at higher risk and need to increase the frequency of monitoring.
Skin reactions and gastrointestinal symptoms
The incidence of rash is 30%-50%, and in severe cases it can develop into Stevens-Johnson syndrome. For mild rash, steroid ointment can be used topically, and severe cases require permanent discontinuation of medication. The incidence of diarrhea exceeds 50%. It is recommended to prepare antidiarrheal drugs and increase water intake. If the bowel movement exceeds 6 times a day or is accompanied by dehydration, treatment should be suspended and intravenous rehydration should be given.
Patients need to return for regular visits to evaluate the treatment response and report abnormal symptoms in a timely manner. Avoid sun exposure during treatment and use high SPF skin care products. If other drugs need to be combined, the doctor should be informed in advance to avoid interactions. Through scientific management and doctor-patient collaboration, Alpelisib can bring significant survival benefits to patients with PIK3CA-mutated breast lesions.
