ADVERSE REACTIONS

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

• Dose reductions due to ARs: 32% with KISQALI + fulvestrant⁴

• Permanent discontinuations: 8% with KISQALI + fulvestrant⁴

• 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 lymphocytes, increase in creatinine, decrease in hemoglobin, increase in gamma-glutamyl transferase, increase in AST, nausea, increase in ALT, infections, decrease in platelets, diarrhea, vomiting, constipation, decrease in glucose serum, cough, rash, and pruritus⁴

• Fatal ARs occurred in 1.2% of patients who received KISQALI. Fatal ARs in ≥0.1% of patients receiving KISQALI included cardiac failure, ventricular arrhythmia, pneumonia, acute respiratory distress, pulmonary embolism, and hemorrhagic shock (0.2% each)⁴

• 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%).
†Includes the following fatal adverse reactions: pneumonia (n=1).
^‡Only includes grade 3 ARs.

1L, first line; 2L, second 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-3