Concise Prescribing Info
In combination w/ aromatase inhibitor as initial therapy for pre/peri- or postmenopausal women w/ hormone receptor (HR) +ve, human epidermal growth factor receptor 2 (HER2) -ve advanced or metastatic breast cancer. In combination w/ fulvestrant as initial or following disease progression therapy for postmenopausal women w/ HR +ve, HER2 -ve advanced or metastatic breast cancer.
Dosage/Direction for Use
Adult 600 mg once daily for 21 consecutive days followed by 7 days off-treatment to complete 28-day cycle. Severe renal impairment Initially 200 mg once daily. Moderate or severe hepatic impairment Initially 400 mg once daily.
May be taken with or without food: Swallow whole, do not chew/crush/split.
Hypersensitivity to ribociclib, peanut, soya.
Special Precautions
Discontinue use if severe cutaneous reactions appear. Avoid use in patients w/ or at significant risk of QT prolongation. Neutropenia. Monitor for pulmonary symptoms indicative of ILD/pneumonitis. Perform CBC & LFTs; assess ECG & monitor serum electrolytes eg, K, Ca, P & Mg prior to treatment. Avoid drugs prolonging QT interval &/or strong CYP3A inhibitors. Not recommended in concomitant use w/ tamoxifen. Breast cancer patients w/ severe renal impairment. Women of childbearing potential should use effective contraception during treatment & for at least 3 wk after last dose. May impair male fertility. Pregnancy & lactation. Ped. Elderly.
Adverse Reactions
UTI, infections; neutropenia, leukopenia, anaemia, lymphopenia; decreased appetite; headache, insomnia, dizziness; dyspnoea, cough; back pain, arthralgia; nausea, diarrhea, vomiting, constipation, stomatitis, abdominal pain; alopecia, rash, pruritus; fatigue, pyrexia, peripheral edema; pain in extremity; abnormal LFTs; decreased leukocyte, neutrophil, Hb, lymphocyte & platelet count, P & K, albumin, glucose serum; increased ALT, AST, creatinine, γ-glutamyl transferase.
Drug Interactions
Increased exposure w/ ritonavir; grapefruit or grapefruit juice. Decreased plasma exposure w/ rifampin. Increased midazolam exposure. Increased exposure of sensitive CYP3A4 substrates w/ narrow therapeutic index. Prolonged QT interval w/ antiarrhythmics eg, amiodarone, disopyramide, procainamide, quinidine, sotalol, drugs prolonging QT interval.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01EF02 - ribociclib ; Belongs to the class of cyclin-dependent kinase (CDK) inhibitors. Used in the treatment of cancer.
Kryxana FC tab 200 mg
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