SIMPLIFIED TREATMENT INITIATION

^*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  
†Monitor serum electrolytes prior to the initiation of treatment, at the beginning of the first 6 cycles, and as clinically indicated. Correct any electrolyte abnormalities before initiating treatment.^1
‡KISQALI should only be initiated in patients with QTcF <450 ms.¹
Additional monitoring may be required as clinically indicated.

^§There were no reported cases of torsades de pointes. KISQALI has been shown to prolong the QT interval in a concentration-dependent manner. In MONALEESA-2, there was 1 (0.3%) sudden death in a patient with grade 3 hypokalemia and grade 2 QT prolongation.¹

DOSING & ADJUSTMENTS

For your patients with HR+/HER2- mBC,

Start with KISQALI 600 mg—the starting dose with proven outcomes

KISQALI single-strength tablets make dose reduction simple and convenient¹

• KISQALI is given as 600 mg (3 x 200-mg tablets) orally, once daily (3 weeks on, 1 week off) with either¹:

  • An AI once daily (continuously); in men and premenopausal women, an LHRH agonist should also be administered according to current clinical practice guidelines; or

  • Fulvestrant 500 mg intramuscularly on Days 1, 15, and 29, and once monthly thereafter; in men and premenopausal women, an LHRH agonist should also be administered according to current clinical practice guidelines 

• Patients should continue treatment until disease progression or unacceptable toxicity¹

Dose adjustments for adverse reactions should be made in a stepwise order 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. 

KISQALI maintained overall survival in patients requiring dose reductions across 3 phase III trials

Results are based on a post hoc analysis; efficacy in the placebo comparator arms was not assessed and should be interpreted with caution.

MONALEESA-2 was a randomized, double-blind, placebo-controlled, phase III study of KISQALI + letrozole (n=334) vs placebo + letrozole (n=334) in postmenopausal patients with HR+/HER2- mBC who received no prior therapy for advanced disease. OS was a secondary end point; PFS was the primary end point. At a median follow-up of 80 months, mOS was 63.9 months with KISQALI + letrozole (95% CI: 52.4-71.0) vs 51.4 months with placebo + letrozole (95% CI: 47.2-59.7); HR=0.765 (95% CI: 0.628-0.932); P=0.004.^1,7,8

MONALEESA-3 was a randomized, double-blind, placebo-controlled, phase III study of KISQALI + fulvestrant (n=484) vs placebo + fulvestrant (n=242) in postmenopausal patients with HR+/HER2- mBC who received no or only 1 line of prior ET for advanced disease. OS was a secondary end point; PFS was the primary end point. In an exploratory analysis of a 1L subgroup of patients receiving KISQALI + fulvestrant (n=237) or placebo + fulvestrant (n=128), at a median follow-up of 71 months mOS was 67.6 months with KISQALI + fulvestrant (95% CI: 59.6-NR) vs 51.8 months with placebo + fulvestrant (95% CI: 40.4-61.2); HR=0.673 (95% CI: 0.504-0.899). At a median follow-up of 39 months, statistical significance was established for overall survival in the ITT population; HR=0.724 (95% CI: 0.568-0.924); P=0.00455. Results from the 71-month analysis were not prespecified and were observational in nature; as such, there was no prespecified statistical procedure controlling for type 1 error.^1,9-11

MONALEESA-7 was a randomized, double-blind, placebo-controlled, phase III study of KISQALI + ET (NSAI or tamoxifen) + goserelin (n=335) vs placebo + ET (NSAI or tamoxifen) + goserelin (n=337) (ITT) in premenopausal patients with HR+/HER2- mBC who received no prior ET for advanced disease. KISQALI is not indicated for concomitant use with tamoxifen. Efficacy results are from a prespecified subgroup analysis of 495 patients who received KISQALI (n=248) or placebo (n=247) with an NSAI + goserelin and were not powered to show statistical significance. OS was a secondary end point; PFS was the primary end point. At a median follow-up of 54 months (exploratory analysis), mOS was 58.7 months with KISQALI + NSAI + goserelin (95% CI: 48.5-NR) vs 47.7 months with placebo + NSAI + goserelin (95% CI: 41.2-55.4); HR=0.798 (95% CI: 0.615-1.035). At a median follow-up of 35 months, statistical significance was established for overall survival in the ITT population; HR=0.71 (95% CI: 0.54-0.95); P=0.00973. Results from the 54-month analysis were not prespecified and were observational in nature; as such, there was no prespecified statistical procedure controlling for type 1 error.^1,12-15

NOVARTIS PATIENT SUPPORT

A dedicated team for you and your patients

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

Your practice and patients will have access to a Novartis Patient Support team committed to providing the support you need, including:

• Dedicated assistance with access and reimbursement

• Assistance with relevant savings options for your eligible patients

• Personalized support for your patients on therapy

• Single points of contact for you and your patients