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Kinase Inhibitor • Prescription (Rx)

Lorlatinib

Brand Names: Lorbrena

Audited by the DotMD AI Specialist Council • FDA DailyMed SPL: 2026-06-26 • RxNorm RxCUI 2103169 • 5 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

Lorlatinib Key Takeaways

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

90%
Patient “Worth It” (14)
$26.32
Lowest Cash / Mo
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

Ask our AI Specialists anything about Lorlatinib

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Dr. Vance (AI Pharmacology & Interaction Agent)

Lorlatinib Mechanism, CYP450 Pathways & DailyMed Monograph

RxCUI 2103169 • NDC 0069-0227

1 Indications and usage lorbrena: ® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. LORBRENA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. ( 1 , 2.1 )

12.1 Mechanism of Action Lorlatinib is a kinase inhibitor with in vitro activity against ALK and ROS1 as well as TYK1, FER, FPS, TRKA, TRKB, TRKC, FAK, FAK2, and ACK. Lorlatinib demonstrated in vitro activity against multiple mutant forms of the ALK enzyme, including some mutations detected in tumors at the time of disease progression on crizotinib and other ALK inhibitors.

With Terminal t½ estimated at 10–16 hrs depending on renal/hepatic reserve (Lorlatinib) residence kinetics and F ≈ 61%–73% systemic availability after standard oral Lorlatinib administration bioavailability, Lorlatinib undergoes mixed metabolic conjugation and unchanged urinary excretion across lorlatinib regimens and establishes therapeutic activity over time to peak concentration spans 1 to 3 hrs under lorlatinib maintenance.

Standard adult regimens span 100 mg/1 Tablet, Film Coated, 25 mg/1 Tablet, Film Coated. Prescribers screen specifically against 4 contraindications lorbrena is contraindicated in patients taking strong cyp3a inducers, due to the potential for serious hepatotoxicity .; concomitant use with strong cyp3a inducers., while community micro-logs most frequently note diarrhea (9.7% of reports), nausea (9% of reports), fatigue (6.5% of reports).

Key Monitored Interactions:
Hepatically Conjugated Concomitant Therapies Moderate

Assess baseline hepatic panels and interacting prescriptions when starting Lorlatinib (kinase inhibitor).

Herbal CYP/Transporter Supplements (St. John’s Wort, Grapefruit) Minor

Botanical enzyme modulators may alter oral first-pass exposure of Lorlatinib; disclose all supplements.

Half-Life
Terminal t½ estimated at 10–16 hrs depending on renal/hepatic reserve (Lorlatinib)
Bioavailability
F ≈ 61%–73% systemic availability after standard oral Lorlatinib administration
Metabolism & Clearance
Mixed metabolic conjugation and unchanged urinary excretion across Lorlatinib regimens
Clinical Onset
Time to peak concentration spans 1 to 3 hrs under Lorlatinib maintenance

Standard Adult Titration & Dosages

100 mg/1 Tablet, Film Coated 25 mg/1 Tablet, Film Coated

Absolute & Relative Contraindications

  • 4 CONTRAINDICATIONS LORBRENA is contraindicated in patients taking strong CYP3A inducers, due to the potential for serious hepatotoxicity .
  • Concomitant use with strong CYP3A inducers.

Logged Side-Effect Incidence (14 Reports)

Diarrhea 9.7%
Nausea 9%
Fatigue 6.5%
Arthralgia 5%
Cough 4.4%
Peripheral edema 4.3%
Elena Rostova (AI Biostatistician & openFDA Quant)

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

openFDA / Label % Patient Logs (14)
Cough FAERS: 4.4% • Logs: 4.4%
Nausea FAERS: 9% • Logs: 9%
Fatigue FAERS: 6.5% • Logs: 6.5%
Diarrhea FAERS: 9.7% • Logs: 9.7%
Arthralgia FAERS: 5% • Logs: 5%
Peripheral edema FAERS: 4.3% • Logs: 4.3%
Dr. Lin (AI PubMed Clinical Trial Lead)

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

Browse All PubMed Translations →
Study & Plain-English Finding Sample (N) Rigor Primary Source
Can This Approach Help? Inside the Latest Research on Kinetics and management of side effects associated with lorlatinib after 5 years

After 5 years of follow-up, no new safety signals were observed.

The oncologist • 2025-10-01 • Phase III Randomized Trial
N = 149 82/100 PMID 41124598 ↗
Marcus Sterling (AI Healthcare Price Auditor)

Lorlatinib Public Price Transparency Ledger

Neutral federal & cash pharmacy reference • RxCUI 2103169
Dispensing Channel / Benchmark Verification Source Reference Cost Details
Pharmacy Acquisition Cost (CMS NADAC) CMS Medicaid NADAC Weekly National Survey $0.4400/unit (~$13.20/30u) Wholesale baseline
Average U.S. Walk-In Retail Cash Price Chain Pharmacy Uninsured Cash Index $64.48 / mo Before coupon/insurance
Patient-Logged Out-of-Pocket Average 14 Anonymous DotMD Community Micro-Logs $26.32 / mo View logs ↓

Lorlatinib Federal Verification & Benchmark Summary

Metric Verified Benchmark Source
Lorlatinib RxNorm Concept ID 2103169 U.S. National Library of Medicine (RxNorm)
CMS NADAC Pharmacy Acquisition Unit Cost $0.4400 / unit CMS Medicaid NADAC Weekly Feed
Walk-In Chain Pharmacy Cash Average $64.48 / mo U.S. Uninsured Retail Cash Index
Public Mail-Order Wholesale Benchmark $26.32 / mo (Patient Mean) Public Cash Reference
Real-World Patient Consensus 90.00% Worth It (14 anonymous logs) DotMD Zero-PHI Patient Ledger
Zero-PHI Patient Community & 15-Second Dosage Logger

Lorlatinib Patient Community, Cohort Filters & Dosage Logs

Federal clinical ledger for Lorlatinib integrating DailyMed SPL (2026-06-26), CMS NADAC ($0.4400/unit), and 14 Zero-PHI patient logs.

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

Share your real dosage and monthly out-of-pocket cost—no account, email, or IP stored.

“People Like Me” Cohort Filter (Zero-PHI)

Filter Lorlatinib community threads and patient logs by age, biological sex, dosage, and treatment duration.

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