HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use KISQALI - ® FEMARA - ® CO-PACK safely and effectively. See full prescribing information for KISQALI - ® FEMARA - ® CO-PACK ...
These highlights do not include all the information needed to use KISQALI ® FEMARA ® CO-PACK safely and effectively. See full prescribing information for KISQALI ® FEMARA ® CO-PACK.
KISQALI ® FEMARA ® CO-PACK (ribociclib tablets; letrozole tablets), co-packaged for oral use
Initial U.S. Approval: 2017
INDICATIONS AND USAGE
KISQALI FEMARA CO-PACK, a co-packaged product containing ribociclib, a kinase inhibitor, and letrozole, an aromatase inhibitor, is indicated as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. (1)
DOSAGE AND ADMINISTRATION
KISQALI FEMARA CO-PACK tablets are taken in combination orally with or without food. (2)
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KISQALI recommended starting dose: 600 mg orally (three 200 mg tablets) taken once daily for 21 consecutive days followed by 7 days off KISQALI treatment. (2.1)
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KISQALI dose interruption, reduction, and/or discontinuation may be required based on individual safety and tolerability. (2.2)
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FEMARA: 2.5 mg (one tablet) continuously for a 28-day cycle (2.1)
DOSAGE FORMS AND STRENGTHS
Tablets:
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KISQALI: 200 mg (3)
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FEMARA: 2.5 mg (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
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QT interval prolongation: Monitor electrocardiograms (ECGs) and electrolytes prior to initiation of treatment with KISQALI. Repeat ECGs at approximately Day 14 of the first cycle and at the beginning of the second cycle, and as clinically indicated. Monitor electrolytes at the beginning of each cycle for 6 cycles, and as clinically indicated. (2.2, 5.1)
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Hepatobiliary toxicity: Increases in serum transaminase levels have been observed. Perform Liver Function Tests (LFTs) before initiating treatment with KISQALI FEMARA CO-PACK. Monitor LFTs every 2 weeks for the first 2 cycles, at the beginning of each subsequent 4 cycles, and as clinically indicated. (2.2, 5.2)
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