Kisqali is a medicine used to treat early breast cancer at high risk of coming back and breast cancer that is locally advanced (has spread nearby) or metastatic (has spread to other parts of the body). It can only be used when the cancer cells have receptors (targets) for certain sex hormones on their surface (HR-positive) and do not have large quantities of another receptor called HER2 (HER2-negative). Kisqali should always be used in combination with hormonal treatment that reduces the effect of oestrogen: an aromatase inhibitor (which reduces oestrogen levels) in early breast cancer, or either fulvestrant (which blocks oestrogen receptors) or an aromatase inhibitor in advanced breast cancer. If Kisqali is used in women before the menopause or around the time of menopause (pre-menopausal or peri-menopausal), or in men, it should also be given in combination with an LHRH inhibitor (a medicine that blocks the effects of luteinising hormone-releasing hormone). Kisqali contains the active substance ribociclib.
Therapeutic Indication
### Therapeutic indication Early breast cancer Kisqali in combination with an aromatase inhibitor is indicated for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer at high risk of recurrence (see section 5.1 for selection criteria). In pre- or perimenopausal women, or in men, the aromatase inhibitor should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. Advanced or metastatic breast cancer Kisqali is indicated for the treatment of women with HR-positive, 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 LHRH agonist.
Therapeutic Area (MeSH)
ATC Code
L01EF02
ATC Item
ribociclib
Pharmacotherapeutic Group
Antineoplastic agents
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| ribociclib succinate | N/A | 瑞波西利 |
EMA Name
Kisqali
Medicine Name
Kisqali
Aliases
N/A