{"id":"palbociclib-in-combination-with-ai","rwe":[],"tags":[],"safety":{"drugInteractions":[{"drug":"CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole)","action":"Avoid","effect":"Increased palbociclib concentrations"},{"drug":"CYP3A4 inducers (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital, enzalutamide, St. John's Wort)","action":"Avoid","effect":"Decreased palbociclib concentrations"},{"drug":"Strong CYP3A4 inhibitors (e.g., atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole)","action":"Avoid","effect":"Increased palbociclib concentrations"},{"drug":"Moderate CYP3A4 inhibitors (e.g., amprenavir, aprepitant, fosamprenavir, fosaprepitant, tipranavir)","action":"Monitor","effect":"Increased palbociclib concentrations"},{"drug":"CYP3A4 substrates (e.g., alfentanil, cyclosporine, fentanyl, sirolimus, tacrolimus)","action":"Monitor","effect":"Increased concentrations of CYP3A4 substrates"},{"drug":"Warfarin","action":"Monitor","effect":"Increased INR"},{"drug":"Tamoxifen","action":"Monitor","effect":"Decreased efficacy of tamoxifen"},{"drug":"Lactation","action":"Avoid","effect":"Exposure of infant to palbociclib"}],"commonSideEffects":[{"effect":"Neutropenia","drugRate":"","severity":"common","organSystem":""},{"effect":"Neutrophils decreased","drugRate":"","severity":"common","organSystem":""},{"effect":"Leukopenia","drugRate":"","severity":"common","organSystem":""},{"effect":"White blood cell count decreased","drugRate":"","severity":"common","organSystem":""},{"effect":"Hemoglobin decreased","drugRate":"","severity":"common","organSystem":""},{"effect":"Anemia","drugRate":"","severity":"common","organSystem":""},{"effect":"Platelets decreased","drugRate":"","severity":"common","organSystem":""},{"effect":"Thrombocytopenia","drugRate":"","severity":"common","organSystem":""},{"effect":"Infections","drugRate":"","severity":"common","organSystem":""},{"effect":"Fatigue","drugRate":"","severity":"common","organSystem":""},{"effect":"Nausea","drugRate":"","severity":"common","organSystem":""},{"effect":"Diarrhea","drugRate":"","severity":"common","organSystem":""},{"effect":"Stomatitis","drugRate":"","severity":"common","organSystem":""},{"effect":"Vomiting","drugRate":"","severity":"common","organSystem":""},{"effect":"Alopecia","drugRate":"","severity":"common","organSystem":""},{"effect":"Rash","drugRate":"","severity":"common","organSystem":""},{"effect":"Aspartate aminotransferase increased","drugRate":"","severity":"common","organSystem":""},{"effect":"Alanine aminotransferase increased","drugRate":"","severity":"common","organSystem":""},{"effect":"Blood creatinine increased","drugRate":"","severity":"common","organSystem":""},{"effect":"Decreased appetite","drugRate":"","severity":"common","organSystem":""}],"contraindications":["CYP3A Inhibitors","CYP3A Inducers","Lactation","Severe interstitial lung disease (ILD)/pneumonitis"],"specialPopulations":{"Pregnancy":"Risk Summary Based on findings from animal studies and its mechanism of action, IBRANCE can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)]. There are no available data in pregnant women to inform the   ...    Infertility","Geriatric use":"No overall differences in safety or effectiveness of IBRANCE were observed between   ...    patients (8%) were ≥75 years of age.","Paediatric use":"The safety and effectiveness of IBRANCE in pediatric patients have not been established. The safety and effectiveness of IBRANCE were assessed but not established in three trials: one open-label trial [A5481092, (NCT03709680)] that included 98 pediatric patients 2 to <17 years of age who received IBRANCE in combination with chemotherapy for recurrent or refractory solid tumors and two open-label trials that included 42 pediatric patients 4 to <17 years of age who received IBRANCE as a single agent for recurrent or refractory solid tumors [APEC1621I, (NCT03526250)] or primary central nervous system (CNS) tumors [PBTC-042, (NCT02255461)].","Renal impairment":"No dose adjustment is required in patients with mild, moderate, or severe renal impairment (CrCl >15 mL/min). Based on a pharmacokinetic trial in subjects with varying degrees of renal function, the total palbociclib exposure (AUCINF) increased by 39%, 42%, and 31% with mild (60 mL/min ≤ CrCl <90 mL/min), moderate (30 mL/min ≤ CrCl <60 mL/min), and severe (CrCl <30 mL/min) renal impairment, respectively, relative to subjects with normal renal function.","Hepatic impairment":"No dose adjustment is required in patients with mild or moderate hepatic impairment (Child-Pugh classes A and B). For patients with severe hepatic impairment (Child-Pugh class C), the recommended dose of IBRANCE is 75 mg once daily for   ...    Administration (2.2)]."},"seriousAdverseEvents":[{"effect":"Neutropenia","drugRate":"1.1%","severity":"serious"},{"effect":"Alanine aminotransferase increase","drugRate":"0.7%","severity":"serious"}]},"trials":[],"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=palbociclib-in-combination-with-ai","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:51:24.436316+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:51:29.853905+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-19T23:51:24.509979+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=palbociclib-in-combination-with-ai","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:51:30.233896+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2364621/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:51:31.514972+00:00"}},"allNames":"palbociclib in combination with ai","offLabel":[],"timeline":[],"aiSummary":"Palbociclib is a CDK4/6 inhibitor used in combination with aromatase inhibitors or fulvestrant for hormone receptor-positive, HER2-negative breast cancer. It is marketed by Pfizer Inc. and has generated $21.2B in revenue. The drug's mechanism involves targeting CDK4/6 to inhibit cell cycle progression. This leads to a decrease in tumor growth and proliferation. Palbociclib has shown clinical differentiation in combination with endocrine therapies. Its commercial significance lies in its ability to improve patient outcomes and increase treatment options. Pipeline developments are ongoing to explore its potential in other indications.","brandName":"Palbociclib in combination with AI","ecosystem":[],"isGeneric":true,"mechanism":{"target":"CDK4/6","novelty":"best-in-class","modality":"small molecule","drugClass":"CDK inhibitor","explanation":"","oneSentence":"","technicalDetail":"Palbociclib is a selective inhibitor of CDK4 and CDK6, with a Ki value of 0.5 nM and 0.7 nM, respectively. It has a half-life of 30 hours and is primarily metabolized by CYP3A4. The recommended dose is 125 mg orally once daily, with food to enhance bioavailability."},"_companyIR":{"url":"https://www.pfizer.com/investors","revenueRefs":[],"pipelineRefs":[]},"commercial":{"revenueYear":2025,"annualCostUS":"$80,000/yr","annualRevenue":4122,"genericStatus":"Generic — off-patent","revenueSource":"SEC 8-K Pfizer (2026-02-03)","currentRevenue":"$21.2B","revenueCurrency":"USD","peakSalesEstimate":"$21.2B","revenueConfidence":"verified (SEC filing)","revenueExtractedAt":"2026-04-01T11:46:15.145075","revenueExtractedBy":"revenue-sec"},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=palbociclib-in-combination-with-ai","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=palbociclib-in-combination-with-ai","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://www.ebi.ac.uk/chembl/","fields":["molecular"],"source":"ChEMBL 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