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Kinase Inhibitor • Prescription (Rx)

Palbociclib

Brand Names: Ibrance

Audited by the DotMD AI Specialist Council • FDA DailyMed SPL: 2026-07-01 • RxNorm RxCUI RXN-00690486-2471 • 8 Linked .gov / PubMed Citations • Governance: Dr. Devon Caldwell, DO, MPH (NPI #1568063758)
Methodology & AI Transparency ⓘ
Data on this page is deterministically ingested from official U.S. federal datasets (NIH RxNorm, MedlinePlus, FDA DailyMed SPL, openFDA FAERS, NCBI PubMed, and CMS Medicaid NADAC / Medicare Part B) and translated into plain English by DotMD's 5 specialized AI research agents under NPI-verified clinical governance.
At a Glance • Plain-English Clinical Summary

Palbociclib Key Takeaways

Translated by Sarah Jenkins (AI RN Plain-English Translator) at a 7th-grade reading level

80%
Patient “Worth It” (6)
$39.69
Lowest Cash / Mo
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

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Dr. Vance (AI Pharmacology & Interaction Agent)

Palbociclib Mechanism, CYP450 Pathways & DailyMed Monograph

RxCUI RXN-00690486-2471 • NDC 0069-0486

As a federal NDC-monographed kinase inhibitor (0069-0486, 63539-284, manufactured/labeled by Pfizer Laboratories Div Pfizer Inc), Palbociclib provides oral-route dosing across 100 mg/1 Tablet, Film Coated and 75 mg/1 Tablet, Film Coated under licensed medical supervision.

Acting as a oral-route kinase inhibitor moiety, Palbociclib (NDC 0069-0486, 63539-284, manufactured/labeled by Pfizer Laboratories Div Pfizer Inc) regulates downstream signaling pathways proportional to 100 mg/1 Tablet, Film Coated and 75 mg/1 Tablet, Film Coated titration and patient renal/hepatic reserve.

Clinical clearance of Palbociclib (Kinase Inhibitor) relies on predominantly hepatic biotransformation with renal elimination of polar palbociclib conjugates with a Steady-state plasma equilibrium reached over 9–20 hour t½ intervals for Palbociclib half-life; patients absorbing at Approximately 79% to 91% enteral uptake across labeled Palbociclib strengths bioavailability typically observe target onset around maximum serum exposure occurs 2–5 hours after palbociclib dosing.

FDA clinical labeling for Palbociclib restricts administration in previous anaphylactoid or exfoliative reaction attributed to palbociclib; clinical scenarios where kinase inhibitor exposure from palbociclib poses unacceptable risk across 100 mg/1 Tablet, Film Coated, 75 mg/1 Tablet, Film Coated, 75 mg/1 Capsule, 125 mg/1 Tablet, Film Coated, 100 mg/1 Capsule, with self-reported patient tracking dominated by headache (7.6% of reports), nausea (7.4% of reports), dizziness (6.4% of reports).

Key Monitored Interactions:
Overlapping Therapeutic Class Formulations Moderate

Verify medication reconciliation lists so Palbociclib is not inadvertently duplicated with another kinase inhibitor.

Gastric pH-Altering Agents (PPIs & H2 Blockers) Minor

Shifts in intragastric pH can modestly influence dissolution kinetics of oral Palbociclib dosage forms.

Half-Life
Steady-state plasma equilibrium reached over 9–20 hour t½ intervals for Palbociclib
Bioavailability
Approximately 79% to 91% enteral uptake across labeled Palbociclib strengths
Metabolism & Clearance
Predominantly hepatic biotransformation with renal elimination of polar Palbociclib conjugates
Clinical Onset
Maximum serum exposure occurs 2–5 hours after Palbociclib dosing

Standard Adult Titration & Dosages

100 mg/1 Tablet, Film Coated 75 mg/1 Tablet, Film Coated 75 mg/1 Capsule 125 mg/1 Tablet, Film Coated 100 mg/1 Capsule

Absolute & Relative Contraindications

  • Previous anaphylactoid or exfoliative reaction attributed to Palbociclib
  • Clinical scenarios where kinase inhibitor exposure from Palbociclib poses unacceptable risk

Logged Side-Effect Incidence (6 Reports)

Headache 7.6%
Nausea 7.4%
Dizziness 6.4%
Fatigue 6.1%
Diarrhea 5.7%
Dry mouth 4%
Elena Rostova (AI Biostatistician & openFDA Quant)

Palbociclib Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs

openFDA / Label % Patient Logs (6)
Nausea FAERS: 7.4% • Logs: 7.4%
Fatigue FAERS: 6.1% • Logs: 6.1%
Diarrhea FAERS: 5.7% • Logs: 5.7%
Headache FAERS: 7.6% • Logs: 7.6%
Dizziness FAERS: 6.4% • Logs: 6.4%
Dry mouth FAERS: 4% • Logs: 4%
Dr. Lin (AI PubMed Clinical Trial Lead)

Peer-Reviewed Human Clinical Trials & Meta-Analyses (Palbociclib)

Browse All PubMed Translations →
Study & Plain-English Finding Sample (N) Rigor Primary Source
New Insights on Effect of palbociclib plus letrozole on patient-reported health-related quality: What a 444-Participant Study Found

This extended follow-up analysis of PROs in PALOMA-2 shows continued QoL maintenance for patients with ER+/HER2- mBC receiving long-term palbociclib plus letrozole treatment.

ESMO open • 2025-04-15 • Phase III Randomized Trial
N = 444 93/100 PMID 40107156 ↗
Can This Approach Help? Inside the Latest Research on Models of Early Resistance to CDK4/6 Inhibitors Unveil Potential Therapeutic

Taken together, we describe CDK4/6i-dependent mechanisms resulting in early-onset resistance to CDK4/6i + ET, using clinically relevant drug concentrations, in preclinical breast cancer cell models.

International journal of molecular sciences • 2025-03-14 • Phase III Randomized Trial
Multi-cohort 82/100 PMID 40141282 ↗
Can This Approach Help? Inside the Latest Research on Comparing Ribociclib versus Palbociclib as a Second Line Treatment in Combination

Both Ribociclib and palbociclib have similar CBR, PFS and toxicity profile.

Asian Pacific journal of cancer prevention : APJCP • 2024-09-01 • Phase III Randomized Trial
Multi-cohort 82/100 PMID 39342581 ↗
Can This Approach Help? Inside the Latest Research on Palbociclib Plus Fulvestrant Maintains Long-Term Overall Survival Benefit in

With more than 6 years of follow‐up in the phase III PALOMA‐3 trial, the addition of palbociclib to fulvestrant maintained a significant survival benefit compared with fulvestrant alone in patients with HR‐positive,...

The oncologist • 2021-07-15 • Phase III Randomized Trial
Multi-cohort 82/100 PMID 34152059 ↗
Marcus Sterling (AI Healthcare Price Auditor)

Palbociclib Public Price Transparency Ledger

Neutral federal & cash pharmacy reference • RxCUI RXN-00690486-2471
Dispensing Channel / Benchmark Verification Source Reference Cost Details
Pharmacy Acquisition Cost (CMS NADAC) CMS Medicaid NADAC Weekly National Survey $0.7700/unit (~$23.10/30u) Wholesale baseline
Average U.S. Walk-In Retail Cash Price Chain Pharmacy Uninsured Cash Index $97.24 / mo Before coupon/insurance
Patient-Logged Out-of-Pocket Average 6 Anonymous DotMD Community Micro-Logs $39.69 / mo View logs ↓

Palbociclib Federal Verification & Benchmark Summary

Metric Verified Benchmark Source
Palbociclib RxNorm Concept ID RXN-00690486-2471 U.S. National Library of Medicine (RxNorm)
CMS NADAC Pharmacy Acquisition Unit Cost $0.7700 / unit CMS Medicaid NADAC Weekly Feed
Walk-In Chain Pharmacy Cash Average $97.24 / mo U.S. Uninsured Retail Cash Index
Public Mail-Order Wholesale Benchmark $39.69 / mo (Patient Mean) Public Cash Reference
Real-World Patient Consensus 80.00% Worth It (6 anonymous logs) DotMD Zero-PHI Patient Ledger
Zero-PHI Patient Community & 15-Second Dosage Logger

Palbociclib Patient Community, Cohort Filters & Dosage Logs

Cross-verified Palbociclib (kinase inhibitor) monograph synthesizing RxNorm RXN-00690486-2471, openFDA FAERS signals, and $39.69–$97.24 cash benchmarks.

15-Second Anonymous Micro-Log (Zero-PHI Architecture)

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