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KISQALI patient portrayal.

MONALEESA-2 safety profile

KISQALI + letrozole in 1L postmenopausal patients

Majority of adverse reactions were manageable and reversible1-3

  • 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.

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
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KISQALI Treatment Guide

A comprehensive guide to treatment with KISQALI, with dedicated sections to support you in treating your patients with HR+/HER2- early or metastatic breast cancer.
Download

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; mBC=metastatic breast cancer; SCAR=severe cutaneous adverse reaction.
 
References: 1. Tripathy D, Im S-A, Colleoni M, et al. Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial. Lancet Oncol. 2018;19(7):904-915. doi:10.1016/S1470-2045(18)30292-4 2. Slamon DJ, Neven P, Chia S, et al. Phase III randomized study of ribociclib and fulvestrant in hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer: MONALEESA-3. J Clin Oncol. 2018;36(24):2465-2472. doi:10.1200/JCO.2018.78.9909 3. Data on file. CLEE011A2301. Novartis Pharmaceuticals Corp; 2016. 4. Kisqali. Prescribing information. Novartis Pharmaceuticals Corp. 5. Yardley DA, Yap YS, Azim HA, et al. Pooled exploratory analysis of survival in patients with HR+/HER2− advanced breast cancer and visceral metastases treated with ribociclib + endocrine therapy in the MONALEESA trials. Poster presented at: ESMO Congress 2022; September 9-13, 2022; Paris, France. Poster 205P.