INDICATIONS AND USAGE（适应症）

PIQRAY is indicated 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, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.

DOSAGE（服用剂量）

The recommended dose of PIQRAY is 300 mg (two 150 mg film-coated tablets) taken orally, once daily, with food.

Continue treatment until disease progression or unacceptable toxicity occurs.

Patients should take their dose of PIQRAY at approximately the same time each day.

Swallow PIQRAY tablets whole (tablets should not be chewed, crushed or split prior to swallowing). No tablet should be ingested if it is broken, cracked, or otherwise not intact.

If a dose of PIQRAY is missed, it can be taken with food within 9 hours after the time it is usually taken. After more than 9 hours, skip the dose for that day. The next day, take PIQRAY at the usual time.

If the patient vomits after taking the dose, advise the patient not to take an additional dose on that day, and to resume the dosing schedule the next day at the usual time.

When given with PIQRAY, the recommended dose of fulvestrant is 500 mg administered on Days 1, 15, and 29, and once monthly thereafter. Refer to the Full Prescribing Information for fulvestrant.

ADVERSE REACTIONS（不良反应）

Severe Hypersensitivity

Severe Cutaneous Adverse Reactions

Hyperglycemia

Pneumonitis

Diarrhea

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/b20b4e18-7a4b-4500-a08f-06c6dab0ee5b/spl-doc?hl=Alpelisib

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