![Background](https://usim.beprod.kisqali-hcp.com/sites/kisqali_hcp_com/files/styles/hero_full_width_width_2560/public/2023-10/kisqali-metastatic-breast-cancer-path-1200_0.jpg?itok=vsjbUDoR)
Ensure patients start right away with a few standard assessments
- Complete blood count (CBC)1
- Liver function tests (LFTs)1,*
- Electrolyte levels1,†
- Electrocardiogram (ECG)1,‡
Simple and straightforward ECG testing
- The 3 required ECGs are all completed within the first 30 days of treatment1
- Novartis Oncology Specialists may be able to provide a solution for fast, easy, and accurate ECG assessments for eligible offices
![Background](https://usim.beprod.kisqali-hcp.com/sites/kisqali_hcp_com/files/styles/hero_full_width_width_2560/public/2023-10/kisqali-metastatic-breast-cancer-divider-bar-1200-2.jpg?itok=u8bWOZXw)
*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
§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
Access and support options
Novartis is committed to helping patients who have been prescribed KISQALI receive all the support they need on their treatment journey. So, help ensure your patients start and stay on therapy with favorable access and strong financial support they can count on.
Commercial insurance
- $0 co-pay||
- Bridge Program (up to 5 free treatment cycles¶)
- One free treatment cycle voucher#
Government insurance
- One free treatment cycle voucher#
Patient Support Services
- Novartis Patient Navigator Program**
- Specialized support brought to you by Novartis Patient Support (NPS)
![Background](https://usim.beprod.kisqali-hcp.com/sites/kisqali_hcp_com/files/styles/hero_full_width_width_2560/public/2023-10/kisqali-metastatic-breast-cancer-divider-bar-1200-2_0.jpg?itok=E0jp3SjV)
¶Limitations apply. Eligible patients must have commercial insurance, a completed Service Request Form, and be experiencing a delay in obtaining coverage for KISQALI. Program is not available to patients whose medications are reimbursed in whole or in part by Medicare, Medicaid, TRICARE, or any other federal or state program. No purchase necessary. Participation is not a guarantee of insurance coverage. Once coverage is approved, patients will no longer be eligible. Novartis Pharmaceuticals Corporation reserves the right to rescind, revoke, or amend this program without notice.
#Your patients are eligible to receive a 1-treatment-cycle supply of KISQALI, FEMARA, the KISQALI FEMARA Co-Pack, and/or generic letrozole at no cost. No purchase required of KISQALI, FEMARA, the KISQALI FEMARA Co-Pack, and/or generic letrozole. This offer is available for patients with a valid prescription for KISQALI, FEMARA, the KISQALI FEMARA Co-Pack, and/or generic letrozole, including patients who have not been prescribed KISQALI or another Novartis product. Please see your sales representative for vouchers. You can also visit www.FreeTreatmentVoucher.com or call 1-800-282-7630.
**The Novartis Patient Navigator Program is available for select Novartis Oncology products. Patient Navigator services do not involve the practice of nursing or provide clinical advice and counseling.
††Unrestricted or single-step edit coverage from MMIT data as of July 2023.2
The only CDK4/6 inhibitor to maintain overall survival in patients requiring dose reductions across 3 phase III trials
For patients who had ≥1 dose reduction, overall survival was maintained with KISQALI across 3 phase III trials.3-7
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, median OS was 63.9 months with KISQALI + letrozole (95% CI: 52.4- 71.0) vs 51.4 months with letrozole (95% CI: 47.2-59.7); HR=0.765 (95% CI: 0.628- 0.932); P=0.004.1,8,9
MONALEESA-3 was a randomized, double-blind, placebo-controlled phase III study of KISQALI + fulvestrant (n=484) vs placebo + fulvestrant (n=242) for the treatment of postmenopausal patients with HR+/HER2- mBC who have received no or only 1 line of prior ET for advanced disease. OS was a secondary end point; PFS was the primary end point. At a median follow-up of 39 months, statistical significance was established for overall survival in the ITT population; median OS was not reached with KISQALI + fulvestrant (95% CI: 42.5-NR) vs 40.0 months with placebo + fulvestrant (95% CI: 37.0-NR); HR=0.724 (95% CI: 0.568-0.924); P=0.00455.1,10,11
MONALEESA-7 was a randomized, double-blind, placebo-controlled phase III study of KISQALI + ET (NSAI or tamoxifen) + goserelin vs placebo + ET (NSAI or tamoxifen) + goserelin (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 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, with similar results observed in the NSAI subgroup. At a median follow-up of 35 months, median OS was not reached with KISQALI + NSAI + goserelin (95% CI: NR-NR) vs 40.7 months with placebo + NSAI + goserelin (95% CI: 37.4-NR); HR=0.699 (95% CI: 0.501-0.976).1,12,13
Only KISQALI offers single-strength tablets for simple dose reductions
With simple dose reductions, eliminate the need for new mid-cycle prescriptions and additional costs1
KISQALI is given as 600 mg (3 x 200-mg tablets) orally once daily (3 weeks on, 1 week off) with either:
An AI once daily (continuously); in premenopausal patients and men, an LHRH agonist should be administered according to current clinical practice guidelines; or
Fulvestrant 500 mg intramuscularly on Days 1, 15, and 29, and once monthly thereafter for postmenopausal patients or men. In male patients, an LHRH agonist should be administered according to current clinical practice guidelines
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 can be taken with or without food.
Adverse reactions that resulted in permanent discontinuation of KISQALI in ≥2% of patients were alanine aminotransferase increased, aspartate aminotransferase increased, and vomiting. Adverse reactions that required dose reductions in ≥2% of patients included neutropenia, neutrophils decreased, and alanine aminotransferase increased.1
Lowering the dose of KISQALI can help address side effects and in clinical studies didn’t impact overall survival
![6.5 months longer on therapy](https://usim.beprod.kisqali-hcp.com/sites/kisqali_hcp_com/files/styles/single_featured_content_card_without_content_width_744/public/2023-10/kisqali-metastatic-breast-cancer-6.5-months.png?itok=QGQJ9CzS)
In MONALEESA-2, managing adverse reactions with dose reductions helped patients stay on therapy an average of 6.5 months longer than those without dose reductions.4
![Background](https://usim.beprod.kisqali-hcp.com/sites/kisqali_hcp_com/files/styles/hero_full_width_width_2560/public/2023-10/kisqali-metastatic-breast-cancer-divider-bar-1200-2_0.jpg?itok=E0jp3SjV)