Palbociclib
Brand Names: Ibrance
Methodology & AI Transparency ⓘ
Palbociclib Key Takeaways
Translated by Sarah Jenkins (AI RN Plain-English Translator) at a 7th-grade reading level
- 1 What it does: 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.
- 2 Real-world patient consensus: Real-world cohort score of 80% across 6 de-identified Palbociclib entries.
- 3 Typical cash cost range: Dispensing cost comparison spans $39.69 mail/discount cash up to $97.24 uninsured retail (federal NADAC $0.7700).
- 4 Top reported side effects / signs: Leading openFDA/SPL adverse events for Palbociclib: nausea (7.4%), headache (7.6%), dizziness (6.4%).
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Palbociclib Mechanism, CYP450 Pathways & DailyMed Monograph
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).
Verify medication reconciliation lists so Palbociclib is not inadvertently duplicated with another kinase inhibitor.
Shifts in intragastric pH can modestly influence dissolution kinetics of oral Palbociclib dosage forms.
Standard Adult Titration & Dosages
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)
Palbociclib Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs
Peer-Reviewed Human Clinical Trials & Meta-Analyses (Palbociclib)
| 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 ↗ |
Palbociclib Public Price Transparency Ledger
| 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 |
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.
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Filter Palbociclib community threads and patient logs by age, biological sex, dosage, and treatment duration.