Composition
Tab 200 mg: Ribociclib Succinate 200 mg
Indications & Dosage
Aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy or following disease progression on endocrine therapy: Adult: 600 mg (three 200 mg tablets) taken orally, once daily with or without food, for 21 consecutive days followed by 7 days off treatment resulting in a complete cycle of 28 days. Children: Not recommended.
Precautions
Hepatic or renal impairment, risk of interstitial lung disease (ILD) and/or pneumonitis; monitor patients for pulmonary symptoms, patients with respiratory symptoms suspected to be due to ILD or pneumonitis, interrupt treatment immediately and evaluate the patient. Risk of prolong the QT interval; treatment may require dose interruption, reduction or discontinuation. Monitor serum electrolytes (including potassium, calcium, phosphorous and magnesium) prior to the initiation of treatment and during treatment. Assess ECG prior to initiation of treatment. Risk of Neutropenia; perform CBC before initiating therapy. Monitor CBC every 2 weeks for the first 2 cycles, at the beginning of each subsequent 4 cycles, based on the severity of the neutropenia, it may require dose interruption, reduction or discontinuation.
Interactions
Drug that prolong QT interval, CYP3A4 inhibitors, inducers and substrates, caffeine, substrates of P-gp, BCRP, OATP1B1/1B3, OCT1, OCT2, MATE1 and BSEP(digoxin, metformin)
Pregnancy
Contraindicated in pregnancy.
Lactation
Contraindicated. Discontinue breast-feeding
Side Effects
Headache, abdominal pain, anemia, alopecia, insomnia, dyspnea, back pain, nausea, diarrhea, QT interval prolongation, vomiting, constipation, stomatitis, decreased appetite, rash, pruritus, fatigue, pyrexia, abnormal liver function tests, urinary tract infection. Rare: Neutropenia, leukopenia, lymphopenia, edema peripheral, interstitial lung disease (ILD), pneumonitis, hepatobiliary toxicity