Alpelisib dosage and administration depend on the disease being treated and the patient's age; specific use should be consulted with a physician. When taking Alpelisib, please strictly follow your doctor's instructions.
Recommended Dosage of Alpelisib
1. Breast Cancer
(1) Indication
In combination with fulvestrant for the treatment of postmenopausal women and men with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated (as detected by an FDA-approved test) advanced or metastatic breast cancer who have progressed on or after an endocrine-based regimen.
(2) Age Restriction
Safety and efficacy have not been established in patients under 18 years of age.
(3) Adult Usual Dose
300 mg once daily, taken with food, until disease progression or unacceptable toxicity.
(4) Fulvestrant Dose (when used in combination)
The recommended dose is 500 mg administered orally on Day 1, Day 15, Day 29, and then once monthly thereafter. Follow your doctor's instructions specifically.
2. PIK3CA-Related Overgrowth Spectrum (PROS)
(1) Indication
For the treatment of patients aged 2 years and older with PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy (accelerated approval).
(2) Adult Usual Dose
250 mg once daily until disease progression or unacceptable toxicity.
(3) Pediatric Usual Dose
Starting dose: 50 mg orally once daily.
Maintenance dose: For patients under 6 years of age, 50 mg once daily; for patients aged 6 years and older, after 24 weeks of treatment at 50 mg/day, increase to 125 mg once daily.
Maximum dose: 125 mg orally once daily.
(4) Duration of Treatment
Until disease progression or unacceptable toxicity.
(5) Age Restriction
Safety and efficacy have not been established in patients under 2 years of age.
Note: When pediatric patients reach 18 years of age, consider gradual dose escalation to 250 mg/day.
Important Administration Instructions for Alpelisib
1. Timing of Administration
Alpelisib should be taken at approximately the same time every day with food. Swallow tablets whole; do not chew, crush, or split. Do not take the tablet if it is broken, cracked, or otherwise damaged.
2. Missed Dose
If a dose of Alpelisib is missed, it may be taken with food within 9 hours after the usual dosing time. If more than 9 hours have passed, skip the missed dose for that day and take the next dose at the usual time the following day.
3. Vomiting
If vomiting occurs after taking a dose, do not take an additional dose that day; resume the next dose at the usual time the following day.
4. Difficulty Swallowing
For patients who have difficulty swallowing, Alpelisib may be administered as an oral suspension prepared with food:
(1) Place the Alpelisib tablet in a glass containing 2-4 ounces of water and let it stand for 5 minutes (use only water).
(2) Crush the tablet with a spoon and drink the suspension immediately. After administration, add 2-3 tablespoons of water to the same glass and drink all of it. If any particles remain, repeat this step.
(3) Discard the oral suspension if not consumed within 1 hour of preparation.
