What is Kisqali (ribociclib) for?
Kisqali (ribociclib) is a kinase inhibitor indicated in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer[1,2].
How does Kisqali (ribociclib) work?
Ribociclib is an inhibitor of cyclin-dependent kinase (CDK) 4 and 6.
Before a cell can divide, it has to go through four phases: a growth phase (G1-phase), a synthesis phase (S-phase), another growth phase (G2-phase), and a last phase is where the cell divides (M-phase). Cancer cells divide exceedingly fast, passing through these 4 phases rapidly. Ribociclib blocks the progression from the first G1-phase, into the second S-phase. It does this by inhibiting the cyclin-dependent kinases 4 and 6 (CDK4 and CDK6) – two proteins that are involved in entering the S-phase1.
Where has Kisqali (ribociclib) been approved?
Kisqali (ribociclib) was approved in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with HR-positive HER2-negative advanced or metastatic breast cancer by:
FDA (USA) on March 13, 2017
EMA (EU) on August 22, 2017
TGA (Australia) on October 23, 2017[ ]
Health Canada on April 27, 2018
How is Kisqali (ribociclib) taken?
The standard dosage is:
600 mg orally (three 200 mg tablets) taken once daily with or without food for 21 consecutive days, followed by 7 days off treatment (one complete cycle consists of 28 days).
Dose interruption, reduction, and/or discontinuation may be required based on individual safety and tolerability.
Complete information about Kisqali (ribociclib) dosage and administration can be found in the references section.
Consult your treating doctor for personalised dosing.
Are there any known adverse reactions or side effects of Kisqali (ribociclib)
Most common adverse reactions (incidence ≥ 20%) are[1,4]:
- low levels of white blood cells
- back pain.
1. Summary of Product Characteristics [FDA]: Kisqali (ribociclib) [PDF]
Novartis Pharmaceuticals Corporation, March 2017
2. Summary of Product Characteristics [EMA]: Kisqali (ribociclib) [PDF]
Novartis Europharm Ltd, Aug 2017
3. Approved Drugs: Ribociclib (Kisqali)
FDA, March 2017
4. Human Medicines: Kisqali (ribociclib)
EMA, cited Oct 2017
5. Summary of Product Characteristics [TGA]: Kisqali (ribociclib) [PDF]
Novartis, Oct 2017
6. Summary of Product Characteristics [Health Canada]: Kisqali (ribociclib) [PDF]
Novartis, Apr 2018