Prescribing information

 

Please note that the black triangle (▼) and associated additional monitoring activities required for Kisqali®, only applies to its marketing authorisation in Great Britain. It is NOT applicable to the marketing authorisation of Kisqali® in Northern Ireland.

 

FOR WOMEN WITH ADVANCED BREAST CANCER, TIME IS PRECIOUS

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.1

*KISQALI is not recommended to be used in combination with tamoxifen.1

 

With KISQALI + ET*, you can give your HR+/HER2− aBC patients more
time worth having1–10

 

More time with their loved ones

  • KISQALI + ET* is the only CDK4/6i to show statistically significant improvements in OS in three phase III trials1–4,10,11
 

The quality time they need

Improved or preserved quality of life vs fulvestrant/NSAI alone5,6

 

Time with manageable side effects

Manageable and consistent safety profile1–4,7–9

 

 

*KISQALI is not recommended to be used in combination with tamoxifen.1

PLEASE SELECT A PATIENT POPULATION AND SETTING TO FIND OUT HOW KISQALI CAN HELP WOMEN WITH HR+/HER2− aBC

 

Premenopausal women

KISQALI + non-steroidal aromatase inhibitor (NSAI) in first-line premenopausal patient population.

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Postmenopausal women

KISQALI + fulvestrant in postmenopausal patient population.

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Postmenopausal women

KISQALI + aromatase inhibitor (AI) in first-line postmenopausal patient population.

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SAFETY

Learn about KISQALI’s safety profile

 

KISQALI DOSING & MONITORING

Find out how to get started with KISQALI

 

RESOURCES

Access HCP and patient materials

 

aBC, advanced breast cancer; CDK4/6i, cyclin-dependent kinase 4 and 6 inhibitor; ET, endocrine therapy; HR+/HER2-, hormone receptor-positive/human epidermal growth factor receptor 2-negative; LHRH, luteinising hormone-releasing hormone; NSAI, non-steroidal aromatase inhibitor; OS, overall survival.

  1. KISQALI (ribociclib). Summary of Product Characteristics.
  2. Slamon DJ, et al. J Clin Oncol. 2018;36(24):2465–2472.
  3. Slamon DJ, et al. N Engl J Med. 2020;382(6):514–524.
  4. Im S-A, et al. N Engl J Med. 2019;381(4):307–316. 
  5. Harbeck N, et al. Ther Adv Med Oncol. 2020;12:1758835920943065.
  6. Fasching P, et al. Breast. 2020;54:148–154.
  7. Lu Y-S, et al. Clin Cancer Res. 2022;2(5):851–859.
  8. De Laurentiis M, et al. J Clin Oncol. 2020;38(15):1055–1055.
  9. De Laurentiis M, et al. J Clin Oncol. 2018;36(15):1056–1056.
  10. Hortobagyi GN, et al. N Engl J Med. 2022;386(10):942–950.
  11. Hortobagyi GN, et al. Ann Oncol. 2018;29(7):1541–1547. 
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UK I April 2022 I 126157-1
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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 via uk.patientsafety@novartis.com or online through the pharmacovigilance intake (PVI) tool at www.report.novartis.com
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at medinfo.uk@novartis.com