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Ribociclib

Class
Targeted therapy
Subclass
Cyclin-dependent kinase inhibitors
Generic name
Ribociclib
Brand names
Kisqali®
Common formulations
Film-coated tablet
Dosage and administration
Adults patients
Breast cancer in females • Advanced or metastatic
•
600 mg PO daily for 21 consecutive days followed by 7 days off treatment resulting in a complete cycle of 28 days
Breast cancer in postmenopausal females with PIK3CA mutation without HER2 mutation • Advanced or metastatic, HR-positive
•
600 mg PO daily for 21 consecutive days followed by 7 days off treatment resulting in a complete cycle of 28 days
Indications for use
Labeled indications
Adults
•
Treatment of breast cancer in females (advanced or metastatic)
•
Treatment of breast cancer in postmenopausal females with PIK3CA mutation without HER2 mutation (advanced or metastatic, HR-positive)
Safety risks
Boxed warnings
Exacerbation of pneumonitis
•
Use extreme caution with a history of pre-existing chronic lung disease.
Contraindications
A known hypersensitivity to ribociclib
Pre-existing QT interval prolongation, congenital long QT syndrome, or uncontrolled electrolyte abnormalities
Warnings and precautions
Bradycardia
•
Use caution with pre-existing cardiac disease or those receiving concomitant medications that can slow the HR.
Neutropenia
•
Use caution with pre-existing low neutrophil count or those with a history of bone marrow suppression.
Prolonged QT interval
•
Use caution with risk factors for QT interval prolongation, such as cardiac disease, bradyarrhythmias, or concomitant use of medications known to prolong the QT interval.
Specific populations
Renal impairment
eGFR 30-50 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required. Monitor for QT prolongation and signs of toxicity.
eGFR < 30 mL/min/1.73 m²
•
Use with caution. Monitor for QT prolongation and signs of toxicity. Manufacturer advises to use with caution in severe renal impairment due to lack of studies and to monitor closely for toxicity.
Renal replacement therapy
Continuous renal replacement
•
Use with caution. Dose as in eGFR < 30 mL/min/1.73 m². Monitor for QT prolongation and signs of toxicity.
Intermittent hemodialysis
•
Use with caution. Dose as in eGFR < 30 mL/min/1.73 m². Monitor for QT prolongation and signs of toxicity.
Peritoneal dialysis
•
Use with caution. Dose as in eGFR < 30 mL/min/1.73 m². Monitor for QT prolongation and signs of toxicity.
Hepatic impairment
Child-Pugh A (mild)
•
Use acceptable. No dose adjustment required.
Child-Pugh B (moderate)
•
Reduce dose. Start at dose of 400 mg once daily.
Child-Pugh C (severe)
•
Reduce dose. Start at dose of 400 mg once daily.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: D
•
Avoid use. Evidence of fetal harm in humans. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
•
Advise women of reproductive potential to use effective contraception (methods that result in less than 1% pregnancy rates) during therapy and for at least 3 weeks after the last dose.
•
Obtain a pregnancy test for females of reproductive potential before therapy initiation.
•
This drug may impair fertility in males of reproductive potential based on data from animal studies.
Breastfeeding
Do not use during breastfeeding.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Very common > 10%
•
Alopecia, ↓ WBC count, ↓ blood lymphocyte count, ↓ blood neutrophil count, ↑ serum ALT, infections, peripheral edema, abdominal pain, arthralgia, back pain, constipation, cough, diarrhea, dizziness, dyspnea, fatigue, fever, generalized pruritus, headache, insomnia, loss of appetite, nausea, skin rash, vomiting, stomatitis, urinary tract infections
Common 1-10%
•
Anemia, febrile neutropenia, ↑ serum AST, ↑QT interval, syncope
Unknown frequency
•
DRESS syndrome, interstitial lung disease, pneumonitis, Stevens-Johnson syndrome, toxic epidermal necrolysis
Interactions
Drug(s)
Check Interactions
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