Ribociclib Tablets
Name: Ribociclib Tablets
Indications
KISQALI® is 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.
Side effects
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- QT Interval Prolongation [see WARNINGS AND PRECAUTIONS]
- Hepatobiliary Toxicity [see WARNINGS AND PRECAUTIONS]
- Neutropenia [see WARNINGS AND PRECAUTIONS]
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety data reported below are based on Study 1 (MONALEESA-2), a clinical study of 668 postmenopausal women receiving KISQALI plus letrozole or placebo plus letrozole. The median duration of exposure to KISQALI plus letrozole was 13 months with 58% of patients exposed for ≥ 12 months.
Dose reductions due to adverse reactions (ARs) occurred in 45% of patients receiving KISQALI plus letrozole and in 3% of patients receiving placebo plus letrozole. Permanent discontinuations due to ARs were reported in 7% of patients receiving KISQALI plus letrozole and 2% in patients receiving placebo plus letrozole. The most common ARs leading to treatment discontinuation of KISQALI in patients receiving KISQALI plus letrozole were ALT increased (4%), AST increased (3%), vomiting (2%). Antiemetics and antidiarrhea medications were used to manage symptoms as clinically indicated.
On-treatment deaths, regardless of causality, were reported in three cases (0.9%) of KISQALI plus letrozole treated patients vs. one case (0.3%) of placebo plus letrozole treated patients. Causes of death on KISQALI plus letrozole included one case each of the following: progressive disease, death (cause unknown), and sudden death (in the setting of Grade 3 hypokalemia and Grade 2 QT prolongation).
The most common ARs (reported at a frequency ≥ 20%) were neutropenia, nausea, fatigue, diarrhea, leukopenia, alopecia, vomiting, constipation, headache and back pain.
The most common Grade 3/4 ARs (reported at a frequency > 2%) were neutropenia, leukopenia, abnormal liver function tests, lymphopenia, and vomiting.
ARs and laboratory abnormalities occurring in patients in Study 1 are listed in Table 6 and Table 7, respectively.
Table 6: Adverse Reactions Occurring in ≥ 10% and ≥ 2% higher than Placebo Arm in Study 1 (All Grades)
| Adverse drug reactions | KISQALI + letrozole N=334 | Placebo + letrozole N=330 | ||||
| All Grades % | Grade 3 % | Grade 4 % | All Grade % | Grade 3 % | Grade 4 % | |
| Infections and Infestations | ||||||
| Urinary tract infection | 11 | 1 | 0 | 8 | 0 | 0 |
| Blood and lymphatic system disorders | ||||||
| Neutropenia | 75 | 50 | 10 | 5 | 1 | 0 |
| Leukopenia | 33 | 20 | 1 | 1 | <1 | 0 |
| Anemia | 18 | 1 | <1 | 5 | 1 | 0 |
| Lymphopenia | 11 | 6 | 1 | 2 | 1 | 0 |
| Metabolism and nutrition disorders | ||||||
| Decreased appetite | 19 | 2 | 0 | 15 | <1 | 0 |
| Nervous system disorders | ||||||
| Headache | 22 | <1 | 0 | 19 | <1 | 0 |
| Insomnia | 12 | <1 | 0 | 9 | 0 | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Dyspnea | 12 | 1 | 0 | 9 | 1 | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| Back pain | 20 | 2 | 0 | 18 | <1 | 0 |
| Gastrointestinal disorders | ||||||
| Nausea | 52 | 2 | 0 | 29 | 1 | 0 |
| Diarrhea | 35 | 1 | 0 | 22 | 1 | 0 |
| Vomiting | 29 | 4 | 0 | 16 | 1 | 0 |
| Constipation | 25 | 1 | 0 | 19 | 0 | 0 |
| Stomatitis | 12 | <1 | 0 | 7 | 0 | 0 |
| Abdominal pain | 11 | 1 | 0 | 8 | 0 | 0 |
| Skin and subcutaneous tissue disorders | ||||||
| Alopecia | 33 | 0 | 0 | 16 | 0 | 0 |
| Rash | 17 | 1 | 0 | 8 | 0 | 0 |
| Pruritus | 14 | 1 | 0 | 6 | 0 | 0 |
| General disorders and administration site conditions | ||||||
| Fatigue | 37 | 2 | <1 | 30 | 1 | 0 |
| Pyrexia | 13 | <1 | 0 | 6 | 0 | 0 |
| Edema peripheral | 12 | 0 | 0 | 10 | 0 | 0 |
| Investigations | ||||||
| Abnormal liver function tests1 | 18 | 8 | 2 | 6 | 2 | 0 |
| Grading according to CTCAE 4.03 (Common Terminology Criteria for Adverse Events) 1abnormal liver function tests: ALT increased, AST increased, blood bilirubin increased | ||||||
Table 7: Laboratory Abnormalities Occurring in ≥ 10% of Patients in Study 1
| Laboratory parameters | KISQALI + letrozole N=334 | Placebo + letrozole N=330 | ||||
| All Grades % | Grade 3 % | Grade 4 % | All Grade % | Grade 3 % | Grade 4 % | |
| HEMATOLOGY | ||||||
| Leukocyte count decreased | 93 | 31 | 3 | 29 | 1 | < 1 |
| Neutrophil count decreased | 93 | 49 | 11 | 24 | 1 | < 1 |
| Hemoglobin decreased | 57 | 2 | 0 | 26 | 1 | 0 |
| Lymphocyte count decreased | 51 | 12 | 2 | 22 | 3 | 1 |
| Platelet count decreased | 29 | 1 | < 1 | 6 | 0 | < 1 |
| CHEMISTRY | ||||||
| Alanine aminotransferase increased | 46 | 8 | 2 | 36 | 1 | 0 |
| Aspartate aminotransferase increased | 44 | 6 | 1 | 32 | 2 | 0 |
| Creatinine increased | 20 | 1 | 0 | 6 | 0 | 0 |
| Phosphorous decreased | 13 | 5 | 1 | 4 | 1 | 0 |
| Potassium decreased | 11 | 1 | 1 | 7 | 1 | 0 |
Read the entire FDA prescribing information for Kisqali (Ribociclib Tablets)
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