Applies to ribociclib: oral tablet.
Serious side effects of Ribociclib
Along with its needed effects, ribociclib may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking ribociclib:
More common
- Black, tarry stools
- bladder pain
- bleeding gums
- bloating or swelling of the face, arms, hands, lower legs, or feet
- bloody or cloudy urine
- chest tightness
- chills
- cough
- difficult, burning, or painful urination
- fever
- frequent urge to urinate
- lower back or side pain
- pale skin
- pinpoint red spots on the skin
- sore throat
- tingling of the hands or feet
- trouble breathing
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
Less common
- Chest pain
- confusion
- dark urine
- fainting
- general feeling of discomfort or illness
- irregular heartbeat
- loss of appetite
- mood or mental changes
- muscle cramps in the hands, arms, feet, legs, or face
- nausea
- numbness and tingling around the mouth, fingertips, or feet
- pain or tenderness in the upper stomach
- pale stools
- seizures
- stomach cramps
- thickening of bronchial secretions
- tremor
- vomiting
- yellow eyes or skin
Incidence not known
- Blistering, peeling, loosening of skin
- diarrhea
- joint or muscle pain
- rash or itching skin
- red irritated eyes
- red skin lesions, often with a purple center
- swollen glands
Other side effects of Ribociclib
Some side effects of ribociclib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Back pain
- constipation
- dry skin
- headache
- lack or loss of strength
- loss or thinning of the hair
- mouth or throat pain
- swelling or inflammation of the mouth
- trouble sleeping
Less common
- Belching
- dry eye
- heartburn
- increased tearing
- indigestion
- patchy loss of skin color
For Healthcare Professionals
Applies to ribociclib: oral tablet.
General
-The most common adverse reactions (reported at a frequency 20% or more) were neutropenia, nausea, fatigue, diarrhea, leukopenia, alopecia, vomiting, constipation, headache, and back pain.
-The most common laboratory abnormalities (reported at a frequency 20% or more) were decreased leukocyte count, decreased neutrophil count, decreased hemoglobin, decreased lymphocyte count, increased ALT, increased AST, decreased platelet count, and increased creatinine.[Ref]
Hematologic
Very common (10% or more): Decreased leukocyte count (93%), decreased neutrophil count (93%), neutropenia (75%), decreased hemoglobin (57%), decrease lymphocyte count (51%), leukopenia (33%), decreased platelet count (29%), anemia (18%), lymphopenia (11%)
Common (1% to 10%): Epistaxis[Ref]
Gastrointestinal
Very common (10% or more): Nausea (52%), diarrhea (35%), vomiting (29%), constipation (25%), stomatitis (12%), abdominal pain (11%)[Ref]
Hepatic
Very common (10% or more): Increased ALT (46%), increased AST (44%), abnormal liver function tests (18%), decreased appetite
Frequency not reported: Increased blood bilirubin[Ref]
Other
Very common (10% or more): Fatigue (37%), pyrexia (13%), peripheral edema (12%)
Uncommon (0.1% to 1%): On-treatment deaths, sudden death[Ref]
Dermatologic
Very common (10% or more): Alopecia (33%), rash (17%), pruritus (14%)[Ref]
Nervous system
Very common (10% or more): Headache (22%), insomnia (12%)
Common (1% to 10%): Syncope[Ref]
Metabolic
Very common (10% or more): Increased creatinine (20%), decreased appetite (19%), decreased phosphorous (13%), decreased potassium (11%)[Ref]
Musculoskeletal
Very common (10% or more): Back pain (20%)[Ref]
Respiratory
Very common (10% or more): Dyspnea (12%)
Common (1% to 10%): Interstitial lung disease, pneumonitis[Ref]
Genitourinary
Very common (10% or more): Urinary tract infection (11%)[Ref]
Cardiovascular
Frequency not reported: QT interval prolongation[Ref]
Ocular
Common (1% to 10%): Lacrimation increased, dry eye[Ref]
