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
RECENT MAJOR CHANGES
Contraindications (4)
4/2018
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)
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)
KISQALI dose interruption, reduction, and/or discontinuation may be required based on individual safety and tolerability. (2.2)
FEMARA: 2.5 mg (one tablet) continuously for a 28-day cycle (2.1)
DOSAGE FORMS AND STRENGTHS
Tablets:
KISQALI: 200 mg (3)
FEMARA: 2.5 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to letrozole, or to any excipients of Femara. (4)
WARNINGS AND PRECAUTIONS
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)
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)
Neutropenia: Perform Complete Blood Count (CBC) before initiating therapy with KISQALI FEMARA CO-PACK. Monitor CBC every 2 weeks for the first 2 cycles, at the beginning of each subsequent 4 cycles, and as clinically indicated. (2.2, 5.3)
Embryo-Fetal Toxicity: Can cause fetal harm when administered to pregnant women. Advise women of child-bearing potential of the potential risk to a fetus and to use effective contraception during therapy. (5.4, 8.1, 8.3)
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥ 20%) are neutropenia, nausea, fatigue, diarrhea, leukopenia, alopecia, vomiting, constipation, headache and back pain. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
CYP3A4 Inhibitors: Avoid concomitant use of KISQALI FEMARA CO-PACK with strong CYP3A inhibitors. If strong inhibitors cannot be avoided, reduce KISQALI dose. (2.2, 7.1)
CYP3A4 Inducers: Avoid concomitant use of KISQALI FEMARA CO-PACK with strong CYP3A inducers. (7.2)
CYP3A Substrates: The dose of sensitive CYP3A substrates with narrow therapeutic indices may need to be reduced when given concurrently with KISQALI FEMARA CO-PACK. (7.3)
Drugs known to prolong QT interval: Avoid concomitant use of drugs known to prolong QT interval such as anti-arrhythmic medicines. (7.4)
USE IN SPECIFIC POPULATIONS
Lactation: Advise not to breastfeed. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 5/2018
