STARTING KISQALI

AI, aromatase inhibitor; QTcF, QT interval corrected by Fridericia’s formula.
*KISQALI should only be initiated in patients with QTcF <450 ms.¹
†Monitor serum electrolytes prior to the initiation of treatment, at the beginning of each of the first 6 cycles, and as clinically indicated. Correct any electrolyte abnormalities before initiating treatment.^1
‡Monitor LFTs prior to the initiation of treatment, every 2 weeks for the first 2 cycles, at the beginning of each of the subsequent 4 cycles, and as clinically indicated. For LFTs, if grade ≥2 abnormalities are noted, more frequent monitoring is recommended.¹
Additional monitoring may be required as clinically indicated.

Incidence of QT prolongation observed with KISQALI was low

Among cases of QT prolongation¹:

• 0.3% had a >500 ms postbaseline QTcF value

• 2% had a >60 ms increase from baseline in QTcF interval

• There were no reported cases of torsades de pointes

DOSING & ADJUSTMENTS

For your patients with stage II/III HR+/HER2- eBC at high risk of recurrence, in combination with an AI,

Start with KISQALI 400 mg—the starting dose chosen to help reduce both the risk of recurrence and dose-dependent ARs

KISQALI single-strength tablets make dose reduction simple and convenient—with no need for new mid-cycle prescriptions or additional costs¹

• KISQALI is given as 400 mg (2 x 200-mg tablets) orally, once daily (3 weeks on, 1 week off) for 36 months with an AI¹

  • Review the full Prescribing Information for recommended dosing of selected AI

  • An LHRH agonist should be used concomitantly with AI in men and premenopausal women

  • Patients should continue treatment for 3 years or until disease recurrence or unacceptable toxicity

Dose adjustments for adverse reactions should be made by reducing the number of tablets taken. Dose modification of KISQALI is recommended based on individual safety and tolerability. If dose reduction below 200 mg/day is required, discontinue treatment.

Lowering the dose of KISQALI can help address side effects and, in the NATALEE trial, did not impact efficacy.^1,3

• iDFS was similar irrespective of the relative dose intensity (RDI) of KISQALI: Patients with low (0% to <82.27%), medium (82.27% to <97.44%), and high (≥97.44%) RDI had similar iDFS outcomes (low vs high HR=0.93 [95% CI: 0.69-1.25]; medium vs high HR=0.99 [95% CI: 0.74-1.32])³

• Results are based on a post hoc exploratory analysis. There was no prespecified statistical procedure controlling for type 1 error, and the results should be interpreted with caution

NATALEE was a randomized, multicenter, open-label, phase III study of KISQALI + letrozole or anastrozole (n=2549) vs letrozole or anastrozole (n=2552) for the adjuvant treatment of men and women with stage II/III HR+/HER2- eBC, including all those with node-positive or high-risk node-negative disease (eligible stages and nodal status include: anatomic stage group IIB-III, or anatomic stage group IIA that is either node positive, or node negative with histologic grade 3, or histologic grade 2 with Ki-67 ≥20% and/or high risk by gene signature testing). At a median follow-up of 33.3 months, with 509 iDFS (primary end point) events in the study (226 [8.9%] in the KISQALI arm and 283 [11.1%] in the NSAI-alone arm), iDFS at the 3-year landmark was 90.7% for KISQALI + NSAI vs 87.6% for NSAI alone (absolute difference 3.1%); there was a 25.1% relative reduction in the risk of an iDFS event; HR=0.749 (95% CI: 0.628-0.892).^1,4

AR, adverse reaction; eBC, early breast cancer; HER2-, human epidermal growth factor receptor 2-negative; HR, hazard ratio; HR+, hormone receptor-positive; iDFS, invasive disease-free survival; LHRH, luteinizing hormone-releasing hormone; NSAI, nonsteroidal aromatase inhibitor.

NOVARTIS PATIENT SUPPORT™

A dedicated team for your patients

Novartis Patient Support is a comprehensive program that is designed to help your eligible patients start, stay, and save on KISQALI.

We support your patient’s journey with:

• Dedicated assistance with access and reimbursement

• Personalized support for your patients on therapy

• Single points of contact for you and your patients

Get your patients started by downloading the Start Form.

Unrestricted or single-step edit coverage from MMIT data as of July 2025.⁵
Novartis does not guarantee payment or coverage for any product or service. Actual coverage and reimbursement decisions are made by individual payers following receipt of claims. Coverage is subject to change by the relevant payer.