How can patients get started with KISQALI + AI or fulvestrant?
Standard assessments are required before starting treatment with KISQALI® (ribociclib), in combination with an aromatase inhibitor (AI) or fulvestrant, for patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (mBC). Ongoing guidance and resources are available for dosing, dose adjustments, and support to help you and your patients approach treatment with confidence.1
STARTING KISQALI
A few standard assessments help to ensure your patients start right away
- Complete blood count (CBC)1
- Electrocardiogram (ECG)1,*
- Electrolytes1,†
- Liver function tests (LFTs)1,‡
Straightforward ECG testing
- The 2 required ECGs are performed at baseline and on Day 14 of Cycle 1—within the first 2 weeks of treatment1
- If you are unable to perform ECGs in office, speak with your Novartis Oncology Specialist about a simple solution for fast, easy, and accurate ECG testing
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.
There was a low incidence of QT prolongation across trials
In a pooled analysis across 3 phase III trials of 1054 pre- and postmenopausal patients treated with KISQALI + an AI + fulvestrant1:
1.4% (15/1054) of patients taking KISQALI had a >500 ms postbaseline QTcF value§
6% (61/1054) of patients had a >60 ms increase from baseline in QTcF intervals§
§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
Based on the observed QT prolongation during treatment, KISQALI may require dose interruption, reduction, or discontinuation. In case of QTcF prolongation at any given time during treatment, more frequent ECG monitoring is recommended. In the subgroup of patients who received tamoxifen, an increased risk for QT prolongation was observed. KISQALI is not indicated for concomitant use with tamoxifen.
DOSING & ADJUSTMENTS
What is the KISQALI starting dose for patients with HR+/HER2- mBC?
600 mg is the starting dose with proven outcomes in mBC1
KISQALI single-strength tablets make dose reduction simple and convenient—with no need for new mid-cycle prescriptions or additional costs.1
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 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 toxicity
Please refer to the full Prescribing Information for fulvestrant
Please refer to the full Prescribing Information for the recommended dose of the chosen AI
KISQALI can be taken with or without food
Patients may store at room temperature at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F)
Store in the original blister package in order to protect from moisture
Starting dose modifications for hepatic and severe renal impairment1
The recommended starting dose is 400 mg once daily for patients with moderate or severe (Child-Pugh class B or C) hepatic impairment
The recommended starting dose is 200 mg once daily for patients with severe renal impairment
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.
HER2-, human epidermal growth factor receptor 2-negative; HR+, hormone receptor-positive; LHRH, luteinizing hormone-releasing hormone; mBC, metastatic breast cancer.
Efficacy data in patients requiring down-dosing
Explore efficacy data from patients who required dose reduction with KISQALI in the 3 phase III MONALEESA clinical trials
NOVARTIS PATIENT SUPPORT™
What is Novartis Patient Support?
Novartis Patient Support is a dedicated team for your patients—a comprehensive program, 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.
More than 9 out of 10 patients have preferred formulary coverage for KISQALI |
>98% unrestricted coverage in Commercial and Medicare, based on MMIT data, as of June 2026.2
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.