Generic Name and Formulations:
Ribociclib 200mg; tabs.
Novartis Pharmaceuticals Corp
Indications for KISQALI:
In combination with an aromatase inhibitor, as initial endocrine-based therapy, 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. In combination with fulvestrant, as initial endocrine-based therapy or following disease progression on endocrine therapy, for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer.
Swallow whole. Take preferably in the AM. 600mg once daily for 21 consecutive days followed by 7 days off treatment for a complete 28-day cycle. In combination with an aromatase inhibitor: refer to the drug's full labeling for the recommended dose. In combination with fulvestrant: give fulvestrant 500mg on Days 1, 15, 29, then once monthly thereafter. Pre/perimenopausal women on combination therapy: also treat with LHRH agonist. Concomitant strong CYP3A inhibitors: avoid; if unavoidable, reduce to 400mg once daily. Moderate and severe hepatic impairment: initially 400mg once daily. Severe renal impairment: initially 200mg once daily. Dose modifications for toxicity: see full labeling.
Risk of QT interval prolongation. Assess ECG prior to initiation; start therapy only if QTcF <450 msec. Repeat ECG at Day 14 of Cycle 1, beginning of Cycle 2, and as clinically indicated; monitor more frequently if any QTcF prolongation occurs. Monitor serum electrolytes prior to initiation, at the beginning of the first 6 cycles, and as clinically indicated; correct any abnormality before starting. Avoid in patients with long QT syndrome, uncontrolled or significant cardiac disease including recent MI, CHF, unstable angina and bradyarrhythmias, electrolyte abnormalities. Perform LFTs prior to initiation; monitor every 2 weeks for first 2 cycles, at the beginning of each subsequent 4 cycles, and as clinically indicated; monitor more frequently if Grade ≥2 abnormalities noted. Perform CBC prior to initiation; monitor every 2 weeks for first 2 cycles, at the beginning of each subsequent 4 cycles, and as clinically indicated. Hepatic impairment. Severe renal impairment. Embryo-fetal toxicity. Pregnancy: avoid; exclude status prior to initiation. Females of reproductive potential should use effective contraception during and for ≥3 weeks after last dose. Nursing mothers: not recommended (during and for ≥3 weeks after last dose).
Avoid concomitant strong CYP3A inhibitors (eg, boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, voriconazole, grapefruit, grapefruit juice); consider alternatives or reduce dose (see Adult). Avoid concomitant strong CYP3A inducers (eg, phenytoin, rifampin, carbamazepine, St. John’s wort); consider alternatives. Caution with concomitant CYP3A substrates with a narrow therapeutic index (eg, alfentanil, cyclosporine, ergots, everolimus, fentanyl, midazolam, pimozide, quinidine, sirolimus, tacrolimus); may need to reduce these doses. Avoid concomitant tamoxifen or drugs known to prolong QT interval (eg, amiodarone, bepridil, chloroquine, clarithromycin, disopyramide, halofantrine, haloperidol, methadone, moxifloxacin, ondansetron, pimozide, procainamide, quinidine, sotalol).
Neutropenia, nausea, infections, fatigue, diarrhea, leukopenia, vomiting, alopecia, headache, constipation, rash, cough; QT prolongation, hepatobiliary toxicity.
Blister packs—21 (1 x 21 tabs), 42 (3 x 14 tabs), 63 (3 x 21 tabs)
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