Cited by 206HER2/EGFR in Cancer ResearchPharmacogenetics and Drug MetabolismLung Cancer Treatments and Mutations

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Clinical Pharmacokinetics and Pharmacodynamics of Afatinib

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Wind, Sven, Schnell, David, Ebner, Thomas, Freiwald, Matthias, Stopfer, Peter·2017·Clinical Pharmacokinetics

DOI 10.1007/s40262-016-0440-1PMC PMC5315738

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Abstract

Afatinib is an oral, irreversible ErbB family blocker that covalently binds to the kinase domains of epidermal growth factor receptor (EGFR), human EGFRs (HER) 2, and HER4, resulting in irreversible inhibition of tyrosine kinase autophosphorylation. Studies in healthy volunteers and patients with advanced solid tumours have shown that once-daily afatinib has time-independent pharmacokinetic characteristics. Maximum plasma concentrations of afatinib are reached approximately 2-5 h after oral administration and thereafter decline, at least bi-exponentially. Food reduces total exposure to afatinib. Over the clinical dose range of 20-50 mg, afatinib exposure increases slightly more than dose proportional. Afatinib metabolism is minimal, with unchanged drug predominantly excreted in the faeces and approximately 5 % in urine. Apart from the parent drug afatinib, the major circulation species in human plasma are the covalently bound adducts to plasma protein. The effective elimination half-life is approximately 37 h, consistent with an accumulation of drug exposure by 2.5- to 3.4-fold based on area under the plasma concentration-time curve (AUC) after multiple dosing. The pharmacokinetic profile of afatinib is consistent across a range of patient populations. Age, ethnicity, smoking status and hepatic function had no influence on afatinib pharmacokinetics, while females and patients with low body weight had increased exposure to afatinib. Renal function is correlated with afatinib exposure, but, as for sex and body weight, the effect size for patients with severe renal impairment (approximately 50 % increase in AUC) is only mildly relative to the extent of unexplained interpatient variability in afatinib exposure. Afatinib has a low potential as a victim or perpetrator of drug-drug interactions, especially with cytochrome P450-modulating agents. However, concomitant treatment with potent inhibitors or inducers of the P-glycoprotein transporter can affect the pharmacokinetics of afatinib. At a dose of 50 mg, afatinib does not have proarrhythmic potential.

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Influential
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BackgroundResult
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Background
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BackgroundInfluential
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Background
An observational study of the epidermal growth factor receptor-tyrosine kinase inhibitor resistance mechanism in epidermal growth factor receptor gene mutation-positive non-small cell lung cancer
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Optimizing afatinib dosage: enhancing treatment outcomes and minimizing toxicities in advanced EGFR-mutated non-small cell lung cancer patients in Vietnam
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Dual topoisomerase IIα/EGFR-TK inhibitors: Synthesis, biological evaluation, and in silico studies of new thiadiazolo[3,2-a]pyrimidinone derivatives as potential anticancer agents
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Novel Syngeneic Cell Lines for Studying High-Risk BRAFV600E-Driven Colorectal Cancer In Vivo
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DMPK Considerations for the Development of Covalent Drugs: Insights from an IQ Assessment
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Pharmacokinetics of Afatinib after Intravenous and Oral Administrations in Rats Using Validated UPLC MS/MS Assay
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Identification of FDA-Approved Drugs as Modulators of Multidrug Resistance Protein 2 (MRP2/ABCC2) Expression Levels in MRP2-Overexpressing Cells: Preliminary Data
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Afatinib amplifies cAMP-induced fluid secretion in a mouse mini-gut model via TMEM16A-mediated fluid secretion and secretory cell differentiation
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Influential
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“Ако бъдат приемани едновременно с лекарства, субстрати на P-gp и BCRP, може да се наблюдава повишаване на плазмените нива на тези лекарства и поява на нежелани ефекти (35-41).”
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“However, the ability of afatinib to cross the blood-brain barrier (BBB) to reach the effective concentration in the central nervous system has not been demonstrated (16).”
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The role of second-generation EGFR inhibitors in lung cancer therapy in the realities of modern clinical practice
Измайлов, А. А., Насретдинов, А. Ф., Султанбаев, А. В., Sakaeva, D., Меньшиков, К. В., Султанбаева, Н. И., & Мусин, Ш. И. (2021) · P A Herzen Journal of Oncology · doi:10.17116/onkolog20211004175 · Cited by 1
A randomized, open-label, two-cycle, two-crossover phase I clinical trial comparing the bioequivalence and safety of afatinib and Giotrif® in healthy Chinese subjects
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“According to the guideline of bioequivalence, the maximum dose is recommended, so the specification used in our trial is 40 mg (Wind et al. 2017; approved Drug Products 2022).”
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Comparison of the Incidence Rate of Radiation Pneumonitis Observed in Patients with Advanced Lung Adenocarcinoma Treated with Simultaneous Thoracic Radiotherapy and 1G/2G/3G EGFR-TKIsPreprint
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Effect of Afatinib for Lung Cancer on Papillary Thyroid Carcinoma
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Supplementary Figure S3 from Tarloxotinib Is a Hypoxia-Activated Pan-HER Kinase Inhibitor Active Against a Broad Range of HER-Family Oncogenes
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Data from Preclinical Comparison of the Blood–brain barrier Permeability of Osimertinib with Other EGFR TKIs
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Data from Tarloxotinib Is a Hypoxia-Activated Pan-HER Kinase Inhibitor Active Against a Broad Range of HER-Family Oncogenes
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Data from Preclinical Comparison of the Blood–brain barrier Permeability of Osimertinib with Other EGFR TKIs
Colclough, N., Chen, K., Johnström, P., Strittmatter, N., Yan, Y., Wrigley, G. L., Schou, M., Goodwin, R. J. A., Varnäs, K., Adua, S. J., et al. (2023) · doi:10.1158/1078-0432.c.6528456.v1
Data from Tarloxotinib Is a Hypoxia-Activated Pan-HER Kinase Inhibitor Active Against a Broad Range of HER-Family Oncogenes
Estrada‐Bernal, A., Le, A. T., Doak, A. E., Tirunagaru, V. G., Silva, S., Bull, M. R., Smaill, J. B., Patterson, A. V., Kim, C., Liu, S. V., et al. (2023) · doi:10.1158/1078-0432.c.6529985.v1
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BackgroundInfluential
Therapeutic Drug Monitoring of Protein Kinase Inhibitors in the Treatment of Non-small Cell Lung Cancer
Staša, J., Gregorová, J., Slanař, O., & Šíma, M. (2023) · Prague Medical Report · doi:10.14712/23362936.2023.16
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“This tablet needs to be stored at ambient temperature [9].”
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IKZF2-ERBB4 gene fusion leads to ERBB4 overexpression in Anal Squamous Cell Carcinoma but with no benefit for ERBB4 inhibitionPreprint
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Authors: Wind, S., Schnell, D., Ebner, T., Freiwald, M., & Stopfer, P.
Affiliations: Boehringer Ingelheim (Germany) (DE)
Corresponding author: Wind, Sven
ORCID: Wind, Sven
Ebner, Thomas
Stopfer, Peter
Venue: Clinical Pharmacokinetics
Publisher: Springer Science and Business Media LLC
Published: 2016-07-28
Volume: 56
Issue: 3
Pages: 235-250
ISSN: 0312-5963 (ISSN-L)
1179-1926
DOI: 10.1007/s40262-016-0440-1
PMC: PMC5315738
OpenAlex: W2484071785
Cited by: 206
References: 53
Citations by year: 2026: 14 · 2025: 23 · 2024: 21 · 2023: 28 · 2022: 35 · 2021: 18 · 2020: 24 · 2019: 15 · 2018: 17 · 2017: 9 · 2016: 1
FWCI: 1.41
Type: journal article
Language: en
Open access: hybrid
doi.org
Licence: cc-by-nc
creativecommons.org/licenses/by-nc/4.0 (unspecified)
Locations: Clinical Pharmacokinetics (publishedVersion, cc-by-nc)
PubMed Central (publishedVersion, cc-by-nc)
PubMed (publishedVersion)
Funders: Boehringer Ingelheim
Topics: Health Sciences › Medicine › Oncology › HER2/EGFR in Cancer Research
Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmacogenetics and Drug Metabolism
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
Keywords: afatinib, EGFR, HER2, ErbB4, pharmacokinetics, pharmacodynamics, food effect, dose proportionality, renal dysfunction, P-glycoprotein, drug-drug interactions, covalent protein adducts, drug-induced arrhythmia, interindividual variability, advanced solid tumors
MeSH terms: Afatinib, Animals, Drug Interactions, Humans, Kidney, Liver, Neoplasms, Protein Binding, Quinazolines, Radiation-Sensitizing Agents, ATP Binding Cassette Transporter, Subfamily B, Member 1, Protein Kinase Inhibitors, ErbB Receptors

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