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KISQALI® (ribociclib) dosing and monitoring

Indications:1

 

  • KISQALI is indicated for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy

  • In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist

KISQALI is not recommended to be used in combination with tamoxifen.

KISQALI should be used together with an aromatase inhibitor (taken orally once daily continuously throughout the 28-day cycle) or with fulvestrant (administered intramuscularly on Days 1, 15 and 29, and once monthly thereafter).1 Please refer to the Summary of Product Characteristics (SmPC) of the co-administered aromatase inhibitor, fulvestrant or LHRH agonist for dosing, dose modification guidelines and other relevant safety information in the event of toxicity.

Abacus style icon representing adjustable dosing.

KISQALI offers adjustable dosing based on tolerability1

The recommended dose is 600 mg (three 200 mg film-coated tablets) of KISQALI once daily for 21 consecutive days followed by 7 days off treatment, resulting in a complete cycle of 28 days. In patients with advanced or metastatic breast cancer, the treatment should be continued as long as the patient is deriving clinical benefit from therapy or until unacceptable toxicity occurs.1

Please refer to the SmPC for further information.

Box wth the text 'Recommended dose 3 tablets'. 3 tablet icons.
Box with the text 'First reduction 2 tablets. 2 tablet icons.
Box with the text 'Second reduction 1 tablet. 1 tablet icon.
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Each film-coated tablet contains 200 mg of ribociclib1

Pill icon.

Dose modification of KISQALI is recommended based on individual tolerability and made in a stepwise order by reducing the number of tablets taken1

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If dose reduction below 200 mg/day is required, treatment should be permanently discontinued1

Tablets shown are not actual size.

Administering KISQALI1

  • KISQALI should be taken orally once daily with or without food

  • Patients should be encouraged to take their dose at approximately the same time each day, preferably in the morning

  • If a patient vomits after taking the dose or misses a dose, an additional dose should not be taken that day. The next prescribed dose should be taken at the usual time

  • Tablets should be swallowed whole and should not be chewed, crushed or split prior to swallowing

Abacus style icon representing adjustable dosing.

Post-hoc analysis of MONALEESA-2 showed that OS with KISQALI + ET* may not be compromised in patients that require dose modification2

 

  • At median follow-up of 79.7 months, median OS for patients with ≥1 dose reduction and no dose reduction was 66.0 months (95% CI: 57.6–75.7) versus 60.6 (42.5–79.2) months, respectively (HR=0.87 [95%  CI: 0.65–1.18])2

*KISQALI is not recommended for use with tamoxifen.1

ET is defined as AI.2

Click through the slider below to see dose modification and management in hepatobiliary toxicity, QTcF interval prolongation, ILD/pneumonitis and other toxicities.

Recommended monitoring schedule:1

Recommended monitoring table for KISQALI® (ribociclib).

Adapted from KISQALI® (ribociclib) Summary of Product Characteristics.1

†After initiating treatment, assess every 2 weeks for the first 2 cycles.1
‡After initiating treatment, assess on Day 14 of cycle 1.1

An established safety profile with KISQALI + ET1,3,4
 

ET is defined as AI or fulvestrant and LHRH.3,4

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AE, adverse event; CBC, complete blood count; CI, confidence interval; CYP3A4, cytochrome P450 3A4; ECG, electrocardiogram; ET, endocrine therapy; HER2−, human epidermal growth factor receptor-2 negative; HR, hazard ratio; HR+, hormone receptor-positive; LFT, liver function test; LHRH, luteinising hormone-releasing hormone; OS, overall survival; QTcF, corrected QT interval by Fredericia’s formula; SmPC, summary of product characteristics.

References

  1. KISQALI (ribociclib) Summary of Product Characteristics.

  2. Hart, L. et al. Poster 1017. ASCO Annual Meeting. 3–7 June 2022, Chicago USA and virtual.

  3. Borstnar S, et al. Radiol Oncol. 2022;65(2):238–247.

  4. Jackisch C, et al. Poster presentation P4-01-01. San Antonio Breast Cancer Symposium. 6–10 December 2022, San Antonio, USA.

UK | April 2025 | 442215

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis online through the pharmacovigilance intake (PVI) tool at www.novartis.com/report, or alternatively email [email protected] or call 01276 698370.