insurance coverage [450:<200 mg once daily not recommended; discontinue drug if 200-mg daily dosage is not tolerated. 1 Hematologic Toxicity Oral If grade 4 neutropenia (ANC> <500/mm 3 ) occurs, temporarily interrupt ribociclib therapy. 1 When neutropenia improves to grade 2 or less, resume therapy at reduced dosage. 1 If grade 3 febrile neutropenia (ANC 500 to> <1000/mm 3 with fever 38.5ºC or fever> 38ºC lasting >1 hour and/or infection) occurs, temporarily interrupt ribociclib therapy. 1 When neutropenia improves to grade 2 or less, resume therapy at reduced dosage. 1 For first occurrence of grade 3 neutropenia (ANC 500 to <1000/mm 3 ), temporarily interrupt ribociclib therapy; upon recovery to grade 2 or less, resume therapy at same dosage. 1 For subsequent occurrences of grade 3 neutropenia, temporarily interrupt ribociclib therapy; upon return to grade 2 or less, resume therapy at reduced dosage. 1 If grade 1 or 2 neutropenia (ANC 1000/mm 3 to less than the lower limit of normal [LLN]), no dosage modification required. 1 Hepatic Toxicity Oral If grade 4 serum ALT and/or AST elevations (> 20 times the ULN) with total bilirubin concentrations 2 times the ULN occur, discontinue ribociclib therapy. 1 For first occurrence of grade 3 serum ALT and/or AST elevations (>5 times the ULN, but 20 times the ULN) with total bilirubin concentrations 2 times the ULN, temporarily interrupt ribociclib therapy; upon recovery to baseline or better grade, resume therapy at reduced dosage. 1 If grade 3 hepatotoxicity recurs at reduced dosage, discontinue ribociclib therapy. 1 For first occurrence of grade 2 serum ALT and/or AST elevations (>3 times the ULN, but 5 times the ULN) with total bilirubin concentrations 2 times the ULN in patients with preexisting ALT and/or AST concentrations 3 times the ULN , temporarily interrupt ribociclib therapy; upon recovery to baseline or better grade, resume therapy at same dosage. 1 For subsequent occurrences, temporarily interrupt ribociclib therapy; upon recovery to baseline or better grade, resume therapy at reduced dosage. 1 If grade 2 serum ALT and/or AST elevations with total bilirubin concentrations 2 times the ULN persist in patients with preexisting ALT and/or AST concentrations >3 times the ULN, but 5 times the ULN , continue ribociclib therapy without interruption. 1 If grade 1 serum ALT and/or AST elevations (i.e., exceeding the ULN, but 3 times the ULN) with total bilirubin concentrations 2 times the ULN occur, no dosage modification required. 1 If serum ALT and/or AST elevations >3 times the ULN with concomitant total bilirubin concentrations >2 times the ULN (irrespective of baseline hepatic function) occur in the absence of cholestasis, discontinue ribociclib therapy. 1 Cardiovascular Toxicity Oral If QT c interval >480 msec occurs, temporarily interrupt ribociclib therapy; resume therapy at same dosage when QT c interval improves to <481 msec. 1 If QT c -interval prolongation (i.e., 481 msec) recurs, temporarily interrupt ribociclib therapy; resume therapy at reduced dosage when QT c interval improves to> <481 msec. 1 If QT c interval> 500 msec occurs on 2 separate ECGs during a single visit, temporarily interrupt ribociclib therapy; resume therapy at reduced dosage when QT c interval improves to <481 msec. 1 When QT c -interval prolongation (> 500 msec or increase of >60 msec from baseline) occurs concurrently with torsades de pointes, polymorphic ventricular tachycardia, unexplained syncope, or signs and/or symptoms of serious arrhythmia, permanently discontinue ribociclib therapy. 1 Other Toxicity Oral If grade 4 adverse reactions occur, discontinue ribociclib therapy. 1 If grade 3 adverse reactions occur, temporarily interrupt ribociclib therapy; resume therapy at same dosage when toxicity improves to grade 1 or less. 1 For subsequent occurrences of grade 3 adverse reactions, temporarily interrupt ribociclib therapy; resume therapy at reduced dosage when toxicity improves to grade 1 or less. 1 If grade 1 or 2 adverse reactions occur, no dosage modification required; initiate appropriate medical therapy and additional monitoring as clinically indicated. 1 Concomitant Use with Drugs and Foods Affecting Hepatic Microsomal Enzymes Oral If used concomitantly with a potent CYP3A inhibitor, reduce ribociclib dosage to 400 mg once daily. 1 (See Drugs and Foods Affecting Hepatic Microsomal Enzymes under Interactions.) Prescribing Limits Adults Breast Cancer Oral Dosages <200 mg once daily not recommended. 1 Special Populations Hepatic Impairment Moderate or severe preexisting hepatic impairment (Child-Pugh class B or C): 400 mg once daily. 1 (See Hepatic Impairment under Cautions.) Mild preexisting hepatic impairment (Child-Pugh class A): No dosage adjustment required. 1 Preexisting grade 3 or greater ALT and/or AST elevations: No specific dosage recommendations at this time. 1 Renal Impairment No specific dosage recommendations at this time. 1 (See Renal Impairment under Cautions.) Geriatric Patients No specific dosage recommendations at this time. 1 (See Geriatric Use under Cautions.) Cautions for Ribociclib Succinate Contraindications Manufacturer states none known. 1 Warnings/Precautions Prolongation of QT Interval QT c -interval prolongation, including one fatal case, reported. 1 2 Prolongation appears to occur in a plasma concentration-dependent manner. 1 Usually occurs within first 4 weeks of therapy and recovers upon dosage interruption. 1 Torsades de pointes not observed in principal efficacy study. 1 Avoid use in patients with congenital long QT syndrome, uncontrolled or clinically important cardiac disease (e.g., MI, CHF, unstable angina, bradyarrhythmias), electrolyte abnormalities, or other risk factors for developing prolongation of QT interval. 1 Avoid concomitant use with potent CYP3A inhibitors or with drugs known to prolong the QT interval. 1 (See Specific Drugs and Foods under Interactions.) Monitor ECGs at baseline, around day 14 of cycle 1, prior to initiation of cycle 2, and then as clinically indicated. 1 More frequent ECG monitoring recommended in patients who develop QT c -interval prolongation during therapy. 1 Monitor serum electrolytes (i.e., potassium, calcium, phosphorus, magnesium) at baseline, prior to initiation of cycles 1 6, and then as clinically indicated. 1 QT c intervals must be> <450 msec and electrolyte abnormalities must be corrected prior to initiation of therapy. 1 If QT c -interval prolongation occurs, temporary interruption, dosage reduction, or discontinuance of ribociclib may be necessary. 1 (See Dosage Modification for Toxicity under Dosage and Administration.) Hepatic Toxicity Drug-induced hepatotoxicity reported. 1 Median time to onset of grade 3 or greater elevations in ALT/AST concentrations: 57 days; resolution to grade 2 or less occurred in approximately 24 days. 1 Monitor liver function tests at baseline, every 2 weeks for cycles 1 and 2, prior to initiation of cycles 3 6, and then as clinically indicated. 1 More frequent testing necessary in patients who develop AST/ALT elevations. 1 If hepatotoxicity occurs, temporary interruption, dosage reduction, or discontinuance of ribociclib may be necessary. 1 (See Dosage Modification for Toxicity under Dosage and Administration.) Neutropenia Grade 3 or 4 neutropenia occurs frequently. 1 Median time to onset of grade 2 or greater neutropenia: 16 days. 1 Median duration of grade 3 or greater neutropenia: 15 days. 1 Febrile neutropenia also reported. 1 Monitor CBC at baseline, every 2 weeks for cycles 1 and 2, prior to initiation of cycles 3 6, and then as clinically indicated. 1 If neutropenia occurs, temporary interruption, dosage reduction, or discontinuance of ribociclib may be necessary. 1 (See Dosage Modification for Toxicity under Dosage and Administration.) Fetal/Neonatal Morbidity and Mortality May cause fetal harm based on mechanism of action; embryofetal toxicity and teratogenicity demonstrated in animals. 1 Confirm pregnancy status prior to initiating ribociclib therapy. 1 Avoid pregnancy during therapy. 1 Use effective contraceptive methods in women of childbearing potential while receiving ribociclib and for 3 weeks after drug is discontinued. 1 Apprise patients of potential fetal hazard. 1 Impairment of Fertility Animal studies suggest ribociclib may impair male fertility. 1 Specific Populations Pregnancy May cause fetal harm. 1 (See Fetal/Neonatal Morbidity and Mortality under Cautions.) Confirm pregnancy status prior to initiating ribociclib therapy. 1 Lactation Distributed into milk in rats; not known whether distributed into human milk. 1 Discontinue nursing during therapy and for 3 weeks after drug discontinuance. 1 Pediatric Use Safety and efficacy not established in pediatric patients. 1 Dose-limiting toxicities were fatigue and thrombocytopenia in pediatric patients with relapsed or refractory neuroblastoma, malignant rhabdoid tumors, or other tumors with documented cyclin D-CDK4/6-inhibitor of CDK4 (INK4)-retinoblastoma (Rb) pathway (cyclin D-CDK4/6-INK4-Rb pathway) abnormalities. 16 Hematologic dose-limiting toxicities not observed in patients receiving ribociclib 350 mg/m once daily. 16 Dosage of 350 mg/m orally once daily for 21 days followed by a 7-day rest period recommended for phase 2 studies in pediatric patients. 16 Geriatric Use No overall differences in safety and efficacy relative to younger patients. 1 Hepatic Impairment Mild preexisting hepatic impairment (Child-Pugh class A): Systemic exposure not substantially altered. 1 3 Moderate to severe preexisting hepatic impairment (Child-Pugh class B or C): Increased mean systemic exposure less than twofold. 1 3 Dosage adjustment required. 1 (See Hepatic Impairment under Dosage and Administration.) Renal Impairment Mild to moderate renal impairment (estimated GFR 30 to> <90 mL/minute per 1.73 m 2 ): Systemic exposure not substantially altered. 1 Severe renal impairment (estimated GFR> <30 mL/minute per 1.73 m 2 ): Not studied. 1 Common Adverse Effects Combination therapy with letrozole: Neutropenia, 1 2 nausea, 1 2 infection (most commonly urinary tract and upper respiratory tract infections), 1 2 fatigue, 1 2 diarrhea, 1 2 alopecia, 1 2 leukopenia, 1 2 vomiting, 1 2 constipation, 1 2 headache, 1 2 hot flush, 2 back pain, 1 2 decreased appetite, 1 2 anemia, 1 2 elevated AST/ALT concentrations, 1 2 rash, 1 2 pruritus, 1 pyrexia, 1 dyspnea, 1 insomnia, 1 peripheral edema, 1 stomatitis, 1 abdominal pain, 1 lymphopenia, 1 decreased platelet count, 1 elevated S cr concentrations, 1 decreased serum phosphorus or potassium concentrations. 1 Interactions for Ribociclib Succinate Metabolized principally by CYP3A4. 1 In vitro, reversible inhibitor of CYP1A2, 2E1, and 3A4/5 at clinically relevant concentrations; inhibition of CYP3A4/5 is time dependent. 1 In vitro, does not inhibit CYP2A6, 2B6, 2C8, 2C9, 2C19, and 2D6; cause time-dependent inhibition of CYP1A2, 2C9, and 2D6; or induce CYP1A2, 2B6, 2C9, and 3A4 at clinically relevant concentrations. 1 In vitro, may inhibit breast cancer resistance protein (BCRP), organic cation transporter (OCT) 2, multidrug and toxic compound extrusion (MATE) 1, and bile salt export pump (BSEP); low potential for inhibition of P-glycoprotein (P-gp), MATE2K, OCT1, organic anion transport protein (OATP) 1B1, and OATP1B3 at clinically relevant concentrations. 1 Drugs and Foods Affecting Hepatic Microsomal Enzymes Potent CYP3A inhibitors: Possible pharmacokinetic interaction (increased plasma concentrations and AUC of ribociclib). 1 Avoid concomitant use; consider choosing alternative agent with less CYP3A inhibition potential. 1 If concomitant use cannot be avoided, reduce ribociclib dosage to 400 mg once daily. 1 If potent CYP3A inhibitor is discontinued, resume ribociclib (after 5 terminal half-lives of the CYP3A inhibitor) at dosage used prior to initiation of potent CYP3A inhibitor. 1 (See Specific Drugs and Foods under Interactions.) Potent CYP3A inducers: Possible pharmacokinetic interaction (decreased plasma concentrations and AUC of ribociclib). 1 Avoid concomitant use; consider choosing alternative agent with no or minimal CYP3A induction potential. 1 (See Specific Drugs and Foods under Interactions.) Drugs Metabolized by Hepatic Microsomal Enzymes Substrates of CYP3A: Possible pharmacokinetic interaction (increased plasma concentrations of CYP3A substrate). 1 If concomitant use of ribociclib and CYP3A substrates with a narrow therapeutic index cannot be avoided, consider dosage reduction of CYP3A substrate. 1 (See Specific Drugs and Foods under Interactions.) Drugs Affecting Gastric Acidity Pharmacokinetic interaction unlikely with drugs that increase gastric pH. 1 3 Drugs that Prolong QT Interval Potential pharmacologic interaction (additive effect on QT-interval prolongation). 1 (See Prolongation of QT Interval under Cautions.) Specific Drugs and Foods Drug Interaction Comments Anastrozole No effect on pharmacokinetics of anastrozole or ribociclib 1 Antiarrhythmic agents (e.g., amiodarone, disopyramide, procainamide, quinidine, sotalol) Possible additive effects on QT-interval prolongation 1 Avoid concomitant use 1 Antiemetic agents that prolong QT interval (e.g., type 3 serotonin [5-HT3] receptor antagonists such as IV ondansetron) Possible additive effects on QT-interval prolongation 1 Avoid concomitant use 1 Antifungals, azoles (e.g., itraconazole, ketoconazole, posaconazole, voriconazole) Possible increased peak concentrations and exposure of ribociclib 1 Avoid concomitant use 1 Select alternative agent with less CYP3A inhibition potential; if concomitant use unavoidable, reduce ribociclib dosage to 400 mg once daily 1 If potent CYP3A inhibitor discontinued, resume ribociclib (after 5 terminal half-lives of the CYP3A inhibitor) at dosage used prior to initiation of potent CYP3A inhibitor 1 Antipsychotic agents that prolong QT interval (e.g., haloperidol, pimozide) Possible additive effects on QT-interval prolongation 1 Avoid concomitant use 1 Antiretrovirals, HIV protease inhibitors (e.g., indinavir, nelfinavir, ritonavir, lopinavir/ritonavir, saquinavir) Possible increased peak concentrations and exposure of ribociclib 1 Ritonavir increased AUC and peak concentrations of ribociclib by 3.2- and 1.7-fold, respectively; AUC and peak concentrations of major metabolite, LEQ803, decreased by 98 and 96%, respectively 1 Avoid concomitant use 1 Select alternative agent with less CYP3A inhibition potential; if concomitant use unavoidable, reduce ribociclib dosage to 400 mg once daily 1 If potent CYP3A inhibitor discontinued, resume ribociclib (after 5 terminal half-lives of the CYP3A inhibitor) at dosage used prior to initiation of potent CYP3A inhibitor 1 Caffeine Peak concentrations of caffeine decreased by 10% and AUC increased by 20% 1 3 Carbamazepine Possible decreased peak concentrations and exposure of ribociclib 1 Avoid concomitant use 1 Select alternative agent with no or minimal CYP3A induction potential 1 Chloroquine Possible additive effects on QT-interval prolongation 1 Avoid concomitant use 1 Conivaptan Possible increased peak concentrations and exposure of ribociclib 1 Avoid concomitant use 1 Select alternative agent with less CYP3A inhibition potential; if concomitant use unavoidable, reduce ribociclib dosage to 400 mg once daily 1 If conivaptan discontinued, resume ribociclib (after 5 terminal half-lives of conivaptan) at dosage used prior to initiation of conivaptan 1 Ergot derivatives (e.g., dihydroergotamine, ergotamine) Possible increased concentrations of ergot derivative 1 Caution advised with CYP3A substrates with narrow therapeutic index; if concomitant use unavoidable, consider dosage reduction of ergot derivative 1 Exemestane No effect on pharmacokinetics of exemestane or ribociclib 1 Grapefruit or grapefruit juice Possible increased peak concentrations and exposure of ribociclib 1 Avoid concomitant use 1 Immunosuppressive agents (e.g., cyclosporine, everolimus, sirolimus, tacrolimus) Possible increased concentrations of immunosuppressive agents metabolized by CYP3A 1 Caution advised with CYP3A substrates with narrow therapeutic index; if concomitant use unavoidable, consider dosage reduction of CYP3A substrate 1 Letrozole No effect on pharmacokinetics of letrozole or ribociclib 1 Macrolides (e.g., clarithromycin, erythromycin) Possible increased peak concentrations and exposure of ribociclib 1 Clarithromycin: Possible additive effects on QT-interval prolongation 1 Macrolides that prolong QT interval: Avoid concomitant use 1 Potent CYP3A inhibitors: Avoid concomitant use; select alternative agent with less CYP3A inhibition potential 1 If concomitant use of potent CYP3A inhibitor unavoidable, reduce ribociclib dosage to 400 mg once daily; if potent CYP3A inhibitor is discontinued, resume ribociclib (after 5 terminal half-lives of the CYP3A inhibitor) at dosage used prior to initiation of potent CYP3A inhibitor 1 Methadone Possible additive effects on QT-interval prolongation 1 Avoid concomitant use 1 Midazolam Ribociclib 400 mg daily increased AUC and peak concentrations of midazolam by 3.8- and 2.1-fold, respectively 1 3 Pharmacokinetic models suggest ribociclib 600 mg daily may increase AUC and peak concentrations of midazolam by 5.2- and 2.4-fold, respectively 1 3 Moxifloxacin Possible additive effects on QT-interval prolongation 1 Avoid concomitant use 1 Nefazodone Possible increased peak concentrations and exposure of ribociclib 1 Avoid concomitant use 1 Select alternative agent with less CYP3A inhibition potential; if concomitant use unavoidable, reduce ribociclib dosage to 400 mg once daily 1 If nefazodone discontinued, resume ribociclib (after 5 terminal half-lives of nefazodone) at dosage used prior to initiation of nefazodone 1 Opiate agonists (e.g., alfentanil, fentanyl) Possible increased concentrations of opiate agonists metabolized by CYP3A 1 Caution advised with CYP3A substrates with narrow therapeutic index; if concomitant use unavoidable, consider dosage reduction of CYP3A substrate 1 Phenytoin Possible decreased peak concentrations and exposure of ribociclib 1 Avoid concomitant use 1 Select alternative agent with no or minimal CYP3A induction potential 1 Pimozide Possible increased concentrations of pimozide 1 Possible additive effects on QT-interval prolongation 1 Avoid concomitant use 1 Pomegranate or pomegranate juice Possible increased peak concentrations and exposure of ribociclib 1 Avoid concomitant use 1 Proton-pump inhibitors No substantial effect on absorption of ribociclib 1 3 Quinidine Possible increased concentrations of quinidine 1 Possible additive effects on QT-interval prolongation 1 Avoid concomitant use 1 Rifampin Rifampin decreased AUC and peak concentrations of ribociclib by 89 and 81%, respectively; peak concentrations of major metabolite, LEQ803, increased by 1.7-fold and AUC decreased by 27% 1 Avoid concomitant use 1 St. John s wort ( Hypericum perforatum ) Possible decreased peak concentrations and exposure of ribociclib 1 Avoid concomitant use 1 Ribociclib Succinate Pharmacokinetics Absorption Bioavailability Following oral administration, peak plasma concentrations attained in 1 4 hours. 1 15 17 AUC and peak plasma concentrations are more than dose proportional over dosage range of 50 1200 mg; mean accumulation ratio is 2.5. 1 15 17 Steady-state concentrations achieved in 8 days. 1 15 17 Food Administration with high-fat, high-calorie meal (approximately 800 1000 calories with approximately 50% of calories from fat) does not substantially affect rate or extent of absorption. 1 3 Special Populations Mean systemic exposure of ribociclib increased less than twofold in individuals with moderate or severe hepatic impairment (Child-Pugh class B or C). 1 3 Mild hepatic impairment (Child-Pugh class A) does not affect systemic exposure. 1 3 Mild or moderate renal impairment (estimated GFR 30 to> <90 mL/minute per 1.73 m ) does not substantially affect systemic exposure. 1 Pharmacokinetics not studied in severe renal impairment (estimated GFR> <30 mL/minute per 1.73 m ). 1 Age (23 84 years), gender, race, and body weight do not have clinically important effects on ribociclib exposure. 1 3 Distribution Extent Not known whether distributed into human milk. 1 Plasma Protein Binding Approximately 70%. 1 Elimination Metabolism Principally metabolized by CYP3A4. 1 Elimination Route Eliminated in feces (69%) and urine (23%). 1 Half-life Mean terminal plasma half-life: 29.7 54.7 hours. 1 Stability Storage Oral Tablets 20 25 C. 1 Store in original container. 1 Actions Selective inhibitor of cyclin-dependent kinases 4 (CDK4) and 6 (CDK6). 1 2 4 14 CDK4 and CDK6 involved in regulation of progression from the G1 into S phase of the cell cycle through regulation of phosphorylation of the tumor suppressor protein retinoblastoma. 5 6 7 8 9 10 11 12 13 Inhibits the G1 into S phase of the cell cycle and reduces cellular proliferation of breast cancer cells. 1 4 Ribociclib and an antiestrogen (e.g., letrozole) increased cell growth arrest in patient-derived estrogen receptor-positive breast tumor xenografts compared with either drug alone. 1 Ribociclib reduced tumor volume, which correlated with inhibition of retinoblastoma protein phosphorylation, in xenograft models of human cancer. 1 Advice to Patients Importance of advising patients to swallow ribociclib succinate tablets whole and not to break, chew, crush, or split the tablets. 1 If a dose is missed or vomited, importance of administering the next dose at the regularly scheduled time; do not administer an additional dose to make up for a missed dose. 1 Risk of QT-interval prolongation. 1 Importance of informing clinicians immediately if an abnormal heartbeat or feelings of dizziness or faintness occur. 1 Risk of hepatotoxicity. 1 Importance of advising patients to immediately report possible symptoms of hepatotoxicity (e.g., fatigue, anorexia, right upper quadrant pain, jaundice, dark urine, bleeding diathesis) to their clinician. 1 Risk of neutropenia. 1 Importance of informing clinician immediately if signs or symptoms of neutropenia or infection (e.g., fever, chills) occur. 1 Risk of fetal harm. 1 Necessity of advising women of childbearing potential to use an effective method of contraception during treatment and for 3 weeks after discontinuance of therapy. 1 Importance of women informing clinicians if they are or plan to become pregnant. 1 Apprise patient of potential fetal hazard if used during pregnancy. 1 Importance of advising women to discontinue nursing during therapy and for 3 weeks after discontinuance of the drug. 1 Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements (e.g., St. John s wort), as well as any concomitant illnesses (e.g., hepatic impairment, cardiovascular disease [including congenital long QT syndrome]). 1 Importance of informing patients of other important precautionary information. 1 (See Cautions.) Preparations Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Ribociclib Succinate Routes Dosage Forms Strengths Brand Names Manufacturer Oral Tablets, film-coated 200 mg (of ribociclib) Kisqali Novartis Ribociclib Succinate Combinations Routes Dosage Forms Strengths Brand Names Manufacturer Oral Kit Ribociclib succinate 200 mg (of ribociclib) (21, 42, or 63 film-coated tablets) Letrozole 2.5 mg (28 film-coated tablets) Kisqali Femara Co-Pack Novartis AHFS DI Essentials. Copyright 2017, Selected Revisions October 16, 2017. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. References 1. Novartis Pharmaceuticals. Kisqali (ribociclib succinate) tablets prescribing information. East Hanover, NJ; 2017 Mar. 2. Hortobagyi GN, Stemmer SM, Burris HA et al. Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer. N Engl J Med . 2016; 375:1738-1748. [PubMed 27717303] 3. Food and Drug Administration. Center for Drug Evaluation and Research. Application number 209092Orig1s000: Multi-discipline review. From FDA website. Accessed 2017 Aug 8. 4. Tripathy D, Bardia A, Sellers WR. Ribociclib (LEE011): Mechanism of Action and Clinical Impact of This Selective Cyclin-Dependent Kinase 4/6 Inhibitor in Various Solid Tumors. Clin Cancer Res . 2017; [PubMed 28351928] 5. Morikawa A, Henry NL. Palbociclib for the Treatment of Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer. Clin Cancer Res . 2015; 21:3591-6. [PubMed 26100274] 6. Rocca A, Farolfi A, Bravaccini S et al. Palbociclib (PD 0332991) : targeting the cell cycle machinery in breast cancer. Expert Opin Pharmacother . 2014; 15:407-20. [PubMed 24369047] 7. Murphy CG, Dickler MN. The Role of CDK4/6 Inhibition in Breast Cancer. Oncologist . 2015; 20:483-90. [PubMed 25876993] 8. Mangini NS, Wesolowski R, Ramaswamy B et al. Palbociclib: A Novel Cyclin-Dependent Kinase Inhibitor for Hormone Receptor-Positive Advanced Breast Cancer. Ann Pharmacother . 2015; 49:1252-60. [PubMed 26324355] 9. Vidula N, Rugo HS. Cyclin-Dependent Kinase 4/6 Inhibitors for the Treatment of Breast Cancer: A Review of Preclinical and Clinical Data. Clin Breast Cancer . 2016; 16:8-17. [PubMed 26303211] 10. Hosford SR, Miller TW. Clinical potential of novel therapeutic targets in breast cancer: CDK4/6, Src, JAK/STAT, PARP, HDAC, and PI3K/AKT/mTOR pathways. Pharmgenomics Pers Med . 2014; 7:203-15. [PubMed 25206307] 11. Finn RS, Dering J, Conklin D et al. PD 0332991, a selective cyclin D kinase 4/6 inhibitor, preferentially inhibits proliferation of luminal estrogen receptor-positive human breast cancer cell lines in vitro. Breast Cancer Res . 2009; 11:R77. [PubMed 19874578] 12. Sutherland RL, Musgrove EA. CDK inhibitors as potential breast cancer therapeutics: new evidence for enhanced efficacy in ER+ disease. Breast Cancer Res . 2009; 11:112. [PubMed 20067604] 13. DeMichele A, Clark AS, Tan KS et al. CDK 4/6 inhibitor palbociclib (PD0332991) in Rb+ advanced breast cancer: phase II activity, safety, and predictive biomarker assessment. Clin Cancer Res . 2015; 21:995-1001. [PubMed 25501126] 14. Novartis Pharmaceuticals. Kisqali Femara Co-Pack (ribociclib succinate copackaged with letrozole) tablets prescribing information. East Hanover, NJ; 2017 May. 15. Curigliano G, Gómez Pardo P, Meric-Bernstam F et al. Ribociclib plus letrozole in early breast cancer: A presurgical, window-of-opportunity study. Breast . 2016; 28:191-8. [PubMed 27336726] 16. Geoerger B, Bourdeaut F, DuBois SG et al. A Phase I Study of the CDK4/6 Inhibitor Ribociclib (LEE011) in Pediatric Patients with Malignant Rhabdoid Tumors, Neuroblastoma, and Other Solid Tumors. Clin Cancer Res . 2017; 23:2433-2441. [PubMed 28432176] 17. Infante JR, Cassier PA, Gerecitano JF et al. A Phase I Study of the Cyclin-Dependent Kinase 4/6 Inhibitor Ribociclib (LEE011) in Patients with Advanced Solid Tumors and Lymphomas. Clin Cancer Res . 2016; 22:5696-5705. [PubMed 27542767] Next Interactions Print this page Add to My Med List More about ribociclib Side Effects During Pregnancy Dosage Information Drug Interactions Support Group En Español 0 Reviews Add your own review/rating Drug class: CDK 4/6 inhibitors Consumer resources Ribociclib Ribociclib (Advanced Reading) Professional resources Other brands: Kisqali Related treatment guides Breast Cancer, Metastatic Breast Cancer> ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Drug Class CDK 4 / 6 inhibitors Related Drugs Breast Cancer, Metastatic anastrozole , tamoxifen , letrozole , Arimidex , Femara , Xeloda , Taxol , capecitabine , Ibrance , Herceptin , Faslodex , Taxotere , More... Breast Cancer methotrexate , anastrozole , tamoxifen , letrozole , Arimidex , Femara , exemestane , fluorouracil , Xeloda , Taxol , capecitabine , Aromasin , More... Ribociclib Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first!} } a hundred and fortieth
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