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KISQALI patient portrayal.

MONALEESA-7 safety profile

KISQALI + AI in 1L premenopausal patients

Majority of adverse reactions were manageable and reversible1-3

These safety data are based on 495 patients who received KISQALI + NSAI + goserelin or placebo + NSAI + goserelin in MONALEESA-7:

  • Dose reductions due to ARs: 33% with KISQALI + NSAI + goserelin4

  • Permanent discontinuations: 3% with KISQALI + NSAI + goserelin4

  • 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 leukocytes, decrease in neutrophils, decrease in hemoglobin, decrease in lymphocytes, increase in gamma-glutamyl transferase, increase in AST, infections, arthralgia, increase in ALT, nausea, decrease in platelets, and alopecia4

  • 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-7. Table shows adverse reactions with KISQALI + NSAI + goserelin vs placebo + NSAI + goserelin, 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.
*Infections included urinary and respiratory tract infections, gastroenteritis, and sepsis (<1%). 
†Only includes grade 3 ARs.

Table showing select laboratory abnormalities (≥10%) in MONALEESA-7. Table compares KISQALI + NSAI + goserelin to placebo +NSAI + goserelin 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; AI=aromatase inhibitor; ALT=alanine aminotransferase; AR=adverse reaction; AST=aspartate aminotransferase; CBC=complete blood count; CTCAE=Common Terminology Criteria for Adverse Events; ECG=electrocardiogram; GGT=gamma-glutamyl transferase; ILD=interstitial lung disease; LFT=liver function test; mBC=metastatic breast cancer; NSAI=nonsteroidal aromatase inhibitor; 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.