Alpelisib is an oral PI3K inhibitor indicated in combination with fulvestrant for the treatment of adult patients with HR-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer.
Medication Guide
1. Recommended Dosage
300 mg orally once daily.
2. Administration Instructions
Take with food: Administer Alpelisib with food.
Take at the same time: Take the medicine at approximately the same time each day to maintain stable blood levels.
Swallow whole: Swallow the tablets whole. Do not chew, crush, or split the tablets prior to swallowing. Crushing the tablets may alter drug exposure.
Duration of treatment: Continue treatment until disease progression or unacceptable toxicity occurs.
3. Dosage of Fulvestrant
When co-administered with Alpelisib, the recommended dose of fulvestrant is 500 mg administered intramuscularly on Days 1, 15, and 29, and once monthly thereafter. Please strictly follow your doctor's advice for specific administration.
Precautions and Missed Doses
1. Management of Missed Doses
If a dose is missed, it can be taken with food within 9 hours of the regularly scheduled time. If more than 9 hours have passed, skip the missed dose and take the next dose at the regularly scheduled time the following day. Do not take two doses at the same time to make up for a missed dose.
2. Management of Vomiting After Taking the Medication
Do not take an additional dose on that day. If vomiting occurs after administration, do not take a replacement dose; resume the regular dosing schedule at the usual time the next day.
Dose Reduction Rules
1. Starting Dose: 300 mg once daily.
2. First Dose Reduction: 250 mg once daily.
3. Second Dose Reduction: 200 mg once daily.
4. Bottom Line: If a dose reduction below 200 mg once daily is required, discontinue Alpelisib permanently. Do not reduce the dose any further.
The dosage and treatment course of Alpelisib must be determined by a physician. All the aforementioned rules for dose reduction, temporary interruption, or permanent discontinuation must be executed under medical supervision. Do not alter the dose or stop the medication on your own.
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