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Kisqali

Last reviewed on RxList: 6/11/2020
Kisqali Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Kisqali?

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.

What Are Side Effects of Kisqali?

Common side effects of Kisqali include:

Dosage for Kisqali

The recommended starting dose of Kisqali 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.

What Drugs, Substances, or Supplements Interact with Kisqali?

Kisqali may interact with ritonavir, boceprevir, clarithromycin, conivaptan, grapefruit juice, pomegranates or pomegranate juice, indinavir, azole andtifungals, lopinavir/ritonavir, nefazodone, nelfinavir, saquinavir, phenytoin, rifampin, carbamazepine, St John's wort, alfentanil, cyclosporine, dihydroergotamine, ergotamine, everolimus, fentanyl, pimozide, quinidine, sirolimus, tacrolimus, amiodarone, disopyramide, procainamide, quinidine, and sotalol. Tell your doctor all medications and supplements you use.

Kisqali During Pregnancy and Breastfeeding

Kisqali is not recommended for use during pregnancy; it may harm a fetus. It is unknown if Kisqali passes into breast milk. Because of the potential for serious adverse reactions in breastfeeding babies, breastfeeding is not recommended while taking Kisqali.

Additional Information

Our Kisqali (ribociclib) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

A lump in the breast is almost always cancer. See Answer
Kisqali Consumer Information

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Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Call your doctor at once if you have:

  • fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
  • low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough, trouble breathing;
  • signs of inflammation in the lungs--new or worsening cough, painful or difficult breathing, wheezing, feeling short of breath even while resting; or
  • liver problems--loss of appetite, upper stomach pain, tiredness, easy bruising or bleeding, dark urine, jaundice (yellowing of the skin or eyes).

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

  • low white blood cells, infections;
  • cough;
  • nausea, vomiting;
  • diarrhea, constipation;
  • feeling tired;
  • rash;
  • headache; or
  • hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Kisqali (Ribociclib Tablets)

SLIDESHOW

Breast Cancer Awareness: Symptoms, Diagnosis, and Treatment See Slideshow
Kisqali Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

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.

MONALEESA-2

KISQALI In Combination With Letrozole

Postmenopausal Women With HR-positive, HER2-negative Advanced Or Metastatic Breast Cancer For Initial Endocrine Based Therapy

The safety data reported below are based on 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. Among patients receiving KISQALI plus letrozole, 7% were reported to have permanently discontinued both KISQALI and letrozole and 7% were reported to have permanently discontinued KISQALI alone due to ARs. Among patients receiving placebo plus letrozole, 2% were reported to have permanently discontinued both and 0.9% were reported to have permanently discontinued placebo alone due to ARs. Adverse reactions 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% on the KISQALI arm and ≥ 2% higher than placebo) were neutropenia, nausea, fatigue, diarrhea, leukopenia, alopecia, vomiting, constipation, headache, and back pain.

The most common Grade 3/4 ARs (reported at a frequency ≥ 5%) were neutropenia, leukopenia, abnormal liver function tests, and lymphopenia.

In MONALEESA-2, syncope occurred in 9 patients (3%) in the KISQALI plus letrozole arm vs. 3 (1%) in placebo plus letrozole arm.

Adverse reactions and laboratory abnormalities occurring in patients in MONALEESA-2 are listed in Table 6 and Table 7, respectively.

Table 6: Adverse Reactions Occurring in ≥ 10% and ≥ 2% higher than Placebo Arm in MONALEESA-2 (All Grades)

Adverse drug reactions KISQALI + letrozole
N = 334
Placebo + letrozole
N = 330
All Grades
%
Grade 3
%
Grade 4
%
All Grades
%
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

Additional adverse reactions in MONALEESA-2 for patients receiving KISQALI plus letrozole included interstitial lung disease (0.3%), lung infiltration (0.3%), pneumonitis (0.3%), and pulmonary fibrosis (0.6%).

Table 7: Laboratory Abnormalities Occurring in ≥ 10% of Patients in MONALEESA-2

Laboratory parameters KISQALI + letrozole
N = 334
Placebo + letrozole
N = 330
All Grades
%
Grade 3
%
Grade 4
%
All Grades
%
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

MONALEESA-7

KISQALI In Combination With An Aromatase Inhibitor

Pre/Perimenopausal Patients With HR-positive, HER2-negative Advanced Or Metastatic Breast Cancer For Initial Endocrine Based Therapy

MONALEESA-7 was conducted in 672 pre/perimenopausal patients with HR-positive, HER2-negative advanced or metastatic breast cancer receiving either KISQALI plus a non-steroidal aromatase inhibitor (NSAI) or tamoxifen plus goserelin or placebo plus NSAI or tamoxifen plus goserelin. The median duration of exposure on the KISQALI arm was 15.2 months with 66% of patients exposed for ≥ 12 months. The safety data reported below are based on 495 pre/perimenopausal patients receiving KISQALI plus NSAI plus goserelin or placebo plus NSAI plus goserelin.

Dose reductions due to ARs occurred in 33% of patients receiving KISQALI plus NSAI plus goserelin, and in 4% of patients receiving placebo plus NSAI plus goserelin. Among patients receiving KISQALI plus NSAI, 3% were reported to have permanently discontinued both KISQALI and NSAI and 3% were reported to have permanently discontinued KISQALI alone due to ARs. Among patients receiving placebo plus NSAI, 2% were reported to have permanently discontinued both and 0.8% were reported to have permanently discontinued placebo alone due to ARs. Adverse reactions leading to treatment discontinuation on KISQALI in patients receiving KISQALI plus NSAI (as compared to the placebo arm) were ALT increased (2% vs. 0.8%), AST increased (2% vs. 0.8%), drug-induced liver injury (1% vs. 0.4%). One patient (0.4%) died while on treatment with KISQALI plus NSAI plus goserelin due to the underlying malignancy.

The most common ARs (reported at a frequency ≥ 20% on the KISQALI arm and ≥ 2% higher than placebo) were neutropenia, infections, leukopenia, arthralgia, nausea, and alopecia. The most common Grade 3/4 ARs (reported at a frequency ≥ 5%) were neutropenia, leukopenia, and abnormal liver function tests. See Table 8 below.

Adverse reactions and laboratory abnormalities occurring in patients in MONALEESA-7 are listed in Table 8 and Table 9, respectively.

Table 8: Adverse Reactions Occurring in ≥ 10% and ≥ 2% higher than Placebo Arm in MONALEESA-7 (NSAI) (All Grades)

Adverse drug reactions KISQALI + NSAI + goserelin
N = 248
Placebo + NSAI + goserelin
N = 247
All Grades
%
Grade 3
%
Grade 4
%
All Grades
%
Grade 3
%
Grade 4
%
Infections and Infestations
Infections1 35 2 0 24 <1 0
Blood and lymphatic system disorders
Neutropenia 78 55 10 7 2 <1
Leukopenia 29 13 <1 3 <1 0
Anemia 19 3 0 8 1 0
Respiratory, thoracic and mediastinal disorders
Cough 15 0 0 10 0 0
Musculoskeletal and connective tissue disorders
Arthralgia 33 <1 0 29 1 0
Gastrointestinal disorders
Nausea 31 0 0 20 0 0
Constipation 16 0 0 12 0 0
Stomatitis 10 0 0 8 <1 0
Skin and subcutaneous tissue disorders
Alopecia 21 0 0 13 0 0
Rash 17 <1 0 9 0 0
Pruritus 10 0 0 4 0 0
General disorders and administration site conditions
Pyrexia 17 <1 0 6 0 0
Pain in extremity 10 0 0 8 1 0
Investigations
Alanine aminotransferase increased 13 5 0 9 1 0
Aspartate aminotransferase increased 13 4 0 10 1 0
Grading according to CTCAE 4.03 (Common Terminology Criteria for Adverse Events)
1Infections: urinary tract infections; respiratory tract infections; gastroenteritis; sepsis (< 1%).

Additional adverse reactions in MONALEESA-7 for patients receiving KISQALI plus NSAI included asthenia (12%), thrombocytopenia (9%), dry skin (8%), oropharyngeal pain (7%), dyspepsia (5%), lacrimation increased (4%), dry eye (4%), vitiligo (3%), hypocalcemia, (2%), blood bilirubin increased (1%), syncope (0.4%), and pneumonitis (0.4%)

Table 9: Laboratory Abnormalities Occurring in ≥ 10% of Patients in MONALEESA-7

Laboratory parameters KISQALI + NSAI + goserelin
N = 248
Placebo + NSAI + goserelin
N = 247
All Grades
%
Grade 3
%
Grade 4
%
All Grades
%
Grade 3
%
Grade 4
%
HEMATOLOGY            
Leukocyte count decreased 93 34 2 30 <1 <1
Neutrophil count decreased 92 54 9 27 2 0
Hemoglobin decreased 84 2 0 51 <1 0
Lymphocyte count decreased 55 12 0 18 2 <1
Platelet count decreased 26 <1 0 9 0 <1
CHEMISTRY            
Alanine aminotransferase increased 33 6 0 31 1 <1
Aspartate aminotransferase increased 37 5 0 35 1 <1
Creatinine increased 21 2 <1 20 <1 <1
Phosphorous decreased 14 2 0 11 <1 <1
Potassium decreased 11 <1 <1 14 <1 <1
Gamma-glutamyl transferase increased 42 5 2 42 8 1
Glucose serum decreased 10 <1 0 10 <1 0

MONALEESA-3

KISQALI In Combination With Fulvestrant

Postmenopausal Patients With HR-positive, HER2-negative Advanced Or Metastatic Breast Cancer For Initial Endocrine Based Therapy Or After Disease Progression On Endocrine Therapy

The safety data reported below are based on MONALEESA-3, a clinical study of 724 postmenopausal women receiving KISQALI plus fulvestrant or placebo plus fulvestrant. The median duration of exposure to KISQALI plus fulvestrant was 15.8 months with 58% of patients exposed for ≥ 12 months.

Dose reductions due to ARs occurred in 32% of patients receiving KISQALI plus fulvestrant and in 3% of patients receiving placebo plus fulvestrant. Among patients receiving KISQALI plus fulvestrant, 8% were reported to have permanently discontinued both KISQALI and fulvestrant and 9% were reported to have discontinued KISQALI alone due to ARs. Among patients receiving placebo plus fulvestrant, 4% were reported to have permanently discontinued both and 2% were reported to have discontinued placebo alone due to ARs. Adverse reactions leading to treatment discontinuation of KISQALI in patients receiving KISQALI plus fulvestrant (as compared to the placebo arm) were ALT increased (5% vs. 0%), AST increased (3% vs. 0.6%), and vomiting (1% vs. 0%).

On-treatment deaths, regardless of causality, were reported in seven patients (1.4%) due to the underlying malignancy and six patients (1.2%) due to other causes while on treatment with KISQALI plus fulvestrant. Causes of death included one pulmonary embolism, one acute respiratory distress syndrome, one cardiac failure, one pneumonia, one hemorrhagic shock, and one ventricular arrhythmia. Seven patients (2.9%) died due to the underlying malignancy and 1 patient (0.4%) died due to pulmonary embolism while on placebo plus fulvestrant.

The most common ARs (reported at a frequency ≥ 20% on the KISQALI arm and ≥ 2% higher than placebo) were neutropenia, infections, leukopenia, cough, nausea, diarrhea, vomiting, constipation, pruritus, and rash. The most common Grade 3/4 ARs (reported at a frequency ≥ 5%) were neutropenia, leukopenia, infections, and abnormal liver function tests. See Table 10.

Adverse reactions and laboratory abnormalities occurring in patients in MONALEESA-3 are listed in Table 10 and Table 11, respectively.

Table 10: Adverse Reactions Occurring in ≥ 10% and ≥ 2% higher than Placebo Arm in MONALEESA-3 (All Grades)

Adverse drug reactions KISQALI + fulvestrant
N = 483
Placebo + fulvestrant
N = 241
All Grades
%
Grade 3
%
Grade 4
%
All Grades
%
Grade 3
%
Grade 4
%
Infections and Infestations
Infections1 42 5 0 30 2 0
Blood and lymphatic system disorders
Neutropenia 69 46 7 2 0 0
Leukopenia 27 12 <1 <1 0 0
Anemia 17 3 0 5 2 0
Metabolism and nutrition disorders
Decreased appetite 16 <1 0 13 0 0
Nervous system disorders
Dizziness 13 <1 0 8 0 0
Respiratory, thoracic and mediastinal disorders
Cough 22 0 0 15 0 0
Dyspnea 15 1 <1 12 2 0
Gastrointestinal disorders
Nausea 45 1 0 28 <1 0
Diarrhea 29 <1 0 20 <1 0
Vomiting 27 1 0 13 0 0
Constipation 25 <1 0 12 0 0
Abdominal pain 17 1 0 13 <1 0
Skin and subcutaneous tissue disorders
Alopecia 19 0 0 5 0 0
Pruritus 20 <1 0 7 0 0
Rash 23 <1 0 7 0 0
General disorders and administration site conditions
Edema peripheral 15 0 0 7 0 0
Pyrexia 11 <1 0 7 0 0
Investigations
Alanine aminotransferase increased 15 7 2 5 <1 0
Aspartate aminotransferase increased 13 5 1 5 <1 0
Grading according to CTCAE 4.03 (Common Terminology Criteria for Adverse Events)
1Infections: urinary tract infections; respiratory tract infections; gastroenteritis; sepsis (< 1%).

Additional adverse reactions in MONALEESA-3 for patients receiving KISQALI plus fulvestrant included asthenia (14%), dyspepsia (10%), thrombocytopenia (9%) dry skin (8%), dysgeusia (7%), dry mouth (5%), vertigo (5%), dry eye (5%), lacrimation increased (4%), erythema (4%), hypocalcemia (4%), blood bilirubin increased (1%), syncope (1%), interstitial lung disease (0.4%), pneumonitis (0.4%), hypersensitivity pneumonitis (0.2%), and acute respiratory distress syndrome (0.2%).

Table 11: Laboratory Abnormalities Occurring in ≥ 10% of Patients in MONALEESA-3

Laboratory parameters KISQALI + fulvestrant
N = 483
Placebo + fulvestrant
N = 241
All Grades
%
Grade 3
%
Grade 4
%
All Grades
%
Grade 3
%
Grade 4
%
HEMATOLOGY            
Leukocyte count decreased 95 25 <1 26 <1 0
Neutrophil count decreased 92 46 7 21 <1 0
Hemoglobin decreased 60 4 0 35 3 0
Lymphocyte count decreased 69 14 1 35 4 <1
Platelet count decreased 33 <1 1 11 0 0
CHEMISTRY            
Creatinine increased 65 <1 <1 33 <1 0
Gamma-glutamyl transferase increased 52 6 1 49 8 2
Aspartate aminotransferase increased 49 5 2 43 3 0
Alanine aminotransferase increased 44 8 3 37 2 0
Glucose serum decreased 23 0 0 18 0 0
Phosphorous decreased 18 5 0 8 <1 0
Albumin decreased 12 0 0 8 0 0

Postmarketing Experience

The following adverse events have been reported during post-approval use of KISQALI. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Respiratory disorders: Interstitial lung disease (ILD)/pneumonitis

Read the entire FDA prescribing information for Kisqali (Ribociclib Tablets)

Related Resources for Kisqali

© 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.

QUESTION

A lump in the breast is almost always cancer. See Answer

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