INDICATIONS AND USAGE（适应症）

The KISQALI® FEMARA® CO-PACK is indicated as initial endocrine-based therapy for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.

DOSAGE（服用剂量）

The KISQALI FEMARA CO-PACK is comprised of ribociclib tablets copackaged with letrozole tablets, to provide a 28-day treatment regimen.

The KISQALI FEMARA CO-PACK should be coadministered, with or without food, as follows:

KISQALI: The recommended starting dose for KISQALI is 600 mg (three 200 mg tablets) taken orally, once daily for 21 consecutive days followed by 7 days off KISQALI treatment resulting in a complete cycle of 28 days.

FEMARA: 2.5 mg (one tablet) taken once daily throughout the 28-day cycle.

Patients should take their doses of KISQALI FEMARA CO-PACK at approximately the same time each day, preferably in the morning.

Pre/perimenopausal women treated with KISQALI FEMARA CO-PACK should be treated with a luteinizing hormone-releasing hormone (LHRH) agonist according to current clinical practice standards.

If the patient vomits after taking the dose or misses a dose, no additional dose should be taken that day. The next prescribed dose should be taken at the usual time. Tablets should be swallowed 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.

For additional information on KISQALI® and FEMARA®, refer to the Full Prescribing Information for each product.

ADVERSE REACTIONS（不良反应）

Interstitial Lung Disease/Pneumonitis

Severe Cutaneous Adverse Reactions

QT Interval Prolongation

Hepatobiliary Toxicity

Neutropenia

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/aa5e4446-19cd-4235-a382-5b48bf6c3b2f/spl-doc?hl=Kisqali

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