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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© Kisqali Patient Information is supplied by Cerner Multum, Inc. and Kisqali Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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