KISQALI + Letrozole in 1L Postmenopausal | mBC | KISQALI® (ribociclib)

MONALEESA-2 safety profile

KISQALI + letrozole in 1L postmenopausal patients

ADVERSE REACTIONS

Majority of adverse reactions were manageable and reversible^1-3

Dose reductions due to ARs: 45% with KISQALI + letrozole⁴
Permanent discontinuations: 7% with KISQALI + letrozole⁴
Patients may require dose interruption, reduction, or discontinuation for ARs. Monitoring should include pulmonary symptoms, ECGs, serum electrolytes, LFTs, and CBCs. See Warnings and Precautions for risk of ILD/pneumonitis, SCARs, QT prolongation, hepatotoxicity, neutropenia, and embryo-fetal toxicity⁴
The most common ARs (≥20% on the KISQALI arm and ≥2% higher than placebo), including laboratory abnormalities, were decrease in neutrophils, decrease in leukocytes, decrease in hemoglobin, nausea, decrease in lymphocytes, increase in ALT, increase in AST, fatigue, diarrhea, alopecia, vomiting, decrease in platelets, constipation, headache, and back pain⁴
Fatal ARs occurred in 1.8% of patients who received KISQALI. Fatal ARs in ≥0.1% of patients receiving KISQALI included acute respiratory failure (0.6%), acute myocardial infarction, sudden death (with grade 3 hypokalemia and grade 2 QT prolongation), unknown cause, and pneumonia (0.3% each)⁴
ARs in patients with visceral metastases receiving KISQALI were consistent with ARs in those without visceral metastases⁵

A table showing adverse reactions (≥10% and ≥2% higher than placebo) in Monaleesa-2. Table shows adverse reactions with Kisqali + letrozole vs placebo + letrozole, and includes values for all grades and, separately, grade 3 or 4. Please see full Prescribing Information for complete safety data.

Grading according to CTCAE version 4.03.
*Only includes grade 3 ARs.

1L, first line; ALT, alanine aminotransferase; AR, adverse reaction; AST, aspartate aminotransferase; CBC, complete blood count; CTCAE, Common Terminology Criteria for Adverse Events; ECG, electrocardiogram; ILD, interstitial lung disease; LFT, liver function test; SCAR, severe cutaneous adverse reaction.

LAB ABNORMALITIES

Lab abnormalities in MONALEESA-2

Table showing select laboratory abnormalities (≥10%) in Monaleesa-2. Table compares Kisqali + letrozole to placebo + letrozole with two columns each, one for percentage of all grades and one for percentage of grade 3 or 4. Please see full Prescribing Information for complete safety data.

Scheduled blood tests and 2 upfront ECGs help to ensure your patients start KISQALI with confidence

Review the assessments schedule and the incidence of QT prolongation across clinical trials

SCHEDULED ASSESSMENTS

The majority of adverse reactions with KISQALI were manageable and reversible

Review dose adjustment guidance

DOSE ADJUSTMENTS

KISQALI Treatment Guide

A comprehensive guide to treatment with KISQALI + AI that includes dedicated sections to support you in treating your patients with early (stage II or III at high risk of recurrence) or metastatic HR+/HER2- breast cancer.

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KISQALI LFT Brochure

A clinical brochure that discusses the data on potential liver-related events with KISQALI in HR+/HER2- eBC and mBC, including monitoring and management.

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AI, aromatase inhibitor; eBC, early breast cancer; HER2-, human epidermal growth factor receptor 2-negative; HR+, hormone receptor-positive; mBC, metastatic breast cancer.

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