ADVERSE REACTIONS

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

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

Grading according to CTCAE version 4.03.
*Infections included urinary and respiratory tract infections, gastroenteritis, and sepsis (<1%).
†Only includes grade 3 ARs.

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; ILD, interstitial lung disease; LFT, liver function test; NSAI, nonsteroidal aromatase inhibitor; SCAR, severe cutaneous adverse reaction.

LAB ABNORMALITIES

Lab abnormalities in MONALEESA-7