jueves, 21 de junio de 2012

Genomics > Table of Pharmacogenomic Biomarkers in Drug Labels

Genomics > Table of Pharmacogenomic Biomarkers in Drug Labels


Table of Pharmacogenomic Biomarkers in Drug Labels

Pharmacogenomics can play an important role in identifying responders and non-responders to medications, avoiding adverse events, and optimizing drug dose. Drug labels may contain information on genomic biomarkers and can describe:
    • Drug exposure and clinical response variability
    • Risk for adverse events
    • Genotype-specific dosing
    • Mechanisms of drug action
    • Polymorphic drug target and disposition genes
The table below lists FDA-approved drugs with pharmacogenomic information in their labels. Some, but not all, of the labels include specific actions to be taken based on genetic information. Relevant sections of the label with such information are noted in the last column of the table. Biomarkers may include gene variants, functional deficiencies, expression changes, chromosomal abnormalities, and others. Microbial variants that influence sensitivity to anti-infectives are not included in the table. Please note that the table columns can be sorted.
Pharmacogenomic information can appear in different sections of the label. For more information on the relevance of information in various parts of the drug label (e.g. Indications and Usage, Dosage and Administration, Boxed Warning, etc.), please go to the relevant labeling guidance. For information on the FDA's initiative to improve prescription drug labels, visit the FDA/CDER Learn website.

Pharmacogenomic Biomarkers in Drug Labels


DrugTherapeutic AreaBiomarkerLabel Sections
Abacavir Antivirals HLA-B*5701 Boxed Warning, Contraindications, Warnings and Precautions, Patient Counseling Information
Aripiprazole Psychiatry CYP2D6 Clinical Pharmacology, Dosage and Administration
Arsenic Trioxide Oncology PML/RARα Boxed Warning, Clinical Pharmacology, Indications and Usage, Warnings
Atomoxetine Psychiatry CYP2D6 Dosage and Administration, Warnings and Precautions, Drug Interactions, Clinical Pharmacology
Atorvastatin Metabolic and Endocrinology LDL receptor Indications and Usage, Dosage and Administration, Warnings and Precautions, Clinical Pharmacology, Clinical Studies
Azathioprine Rheumatology TPMT Dosage and Administration, Warnings and Precautions, Drug Interactions, Adverse Reactions, Clinical Pharmacology
Boceprevir Antivirals IL28B Clinical Pharmacology
Brentuximab Vedotin Oncology CD30 Indications and Usage, Description, Clinical Pharmacology
Busulfan Oncology Ph Chromosome Clinical Studies
Capecitabine Oncology DPD Contraindications, Precautions, Patient Information
Carbamazepine Neurology HLA-B*1502 Boxed Warning, Warnings and Precautions
Carisoprodol Musculoskeletal CYP2C19 Clinical Pharmacology, Special Populations
Carvedilol Cardiovascular CYP2D6 Drug Interactions, Clinical Pharmacology
Celecoxib Analgesics CYP2C9 Dosage and Administration, Drug Interactions, Use in Specific Populations, Clinical Pharmacology
Cetuximab (1) Oncology EGFR Indications and Usage, Warnings and Precautions, Description, Clinical Pharmacology, Clinical Studies
Cetuximab (2) Oncology KRAS Indications and Usage, Clinical Pharmacology, Clinical Studies
Cevimeline Dermatology and Dental CYP2D6 Drug Interactions
Chlordiazepoxide and Amitriptyline Psychiatry CYP2D6 Precautions
Chloroquine Antiinfectives G6PD Precautions
Cisplatin Oncology TPMT Clinical Pharmacology, Warnings, Precautions
Citalopram (1) Psychiatry CYP2C19 Drug Interactions, Warnings
Citalopram (2) Psychiatry CYP2D6 Drug Interactions
Clobazam Neurology CYP2C19 Clinical Pharmacology, Dosage and Administration, Use in Specific Populations
Clomiphene Reproductive and Urologic Rh genotype Precautions
Clomipramine Psychiatry CYP2D6 Drug Interactions
Clopidogrel Cardiovascular CYP2C19 Boxed Warning, Dosage and Administration, Warnings and Precautions, Drug Interactions, Clinical Pharmacology
Clozapine Psychiatry CYP2D6 Drug Interactions, Clinical Pharmacology
Codeine Analgesics CYP2D6 Warnings and Precautions, Use in Specific Populations, Clinical Pharmacology
Crizotinib Oncology ALK Indications and Usage, Warnings and Precautions, Adverse Reactions, Clinical Pharmacology, Clinical Studies
Dapsone Dermatology and Dental G6PD Indications and Usage, Precautions, Adverse Reactions, Patient Counseling Information
Dasatinib Oncology Ph Chromosome Indications and Usage, Clinical Studies, Patient Counseling Information
Denileukin Diftitox Oncology CD25 Indications and Usage, Warnings and Precautions, Clinical Studies
Desipramine Psychiatry CYP2D6 Drug Interactions
Desloratadine and Pseudoephedrine Allergy CYP2D6 Clinical Pharmacology
Dexlansoprazole (1) Gastroenterology CYP2C19 Clinical Pharmacology, Drug Interactions
Dexlansoprazole (2) Gastroenterology CYP1A2 Clinical Pharmacology
Dextromethorphan and Quinidine Neurology CYP2D6 Clinical Pharmacology, Warnings and Precautions
Diazepam Psychiatry CYP2C19 Drug Interactions, Clinical Pharmacology
Doxepin Psychiatry CYP2D6 Precautions
Drospirenone and Ethinyl Estradiol Reproductive CYP2C19 Precautions, Drug Interactions
Erlotinib Oncology EGFR Clinical Pharmacology
Esomeprazole Gastroenterology CYP2C19 Drug Interactions, Clinical Pharmacology
Exemestane Oncology ER &/ PgR receptor Indications and Usage, Dosage and Administration, Clinical Studies, Clinical Pharmacology
Fluorouracil Dermatology and Dental DPD Contraindications, Warnings
Fluoxetine Psychiatry CYP2D6 Warnings, Precautions, Clinical Pharmacology
Fluoxetine and Olanzapine Psychiatry CYP2D6 Drug Interactions, Clinical Pharmacology
Flurbiprofen Rheumatology CYP2C9 Clinical Pharmacology, Special Populations
Fluvoxamine Psychiatry CYP2D6 Drug Interactions
Fulvestrant Oncology ER receptor Indications and Usage, Patient Counseling Information
Galantamine Neurology CYP2D6 Special Populations
Gefitinib Oncology EGFR Clinical Pharmacology
Iloperidone Psychiatry CYP2D6 Clinical Pharmacology, Dosage and Administration, Drug Interactions, Specific Populations, Warnings and Precautions
Imatinib (1) Oncology C-Kit Indications and Usage, Dosage and Administration Clinical Pharmacology, Clinical Studies
Imatinib (2) Oncology Ph Chromosome Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies
Imatinib (3) Oncology PDGFR Indications and Usage, Dosage and Administration, Clincal Studies
Imatinib (4) Oncology FIP1L1-PDGFRα Indications and Usage, Dosage and Administration, Clinical Studies
Imipramine Psychiatry CYP2D6 Drug Interactions
Indacaterol Pulmonary UGT1A1 Clinical Pharmacology
Irinotecan Oncology UGT1A1 Dosage and Administration, Warnings, Clinical Pharmacology
Isosorbide and Hydralazine Cardiovascular NAT1; NAT2 Clinical Pharmacology
Ivacaftor Pulmonary CFTR (G551D) Indications and Usage, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Lapatinib Oncology Her2/neu Indications and Usage, Clinical Pharmacology, Patient Counseling Information
Lenalidomide Hematology Chromosome 5q Boxed Warning, Indications and Usage, Clinical Studies, Patient Counseling
Letrozole Oncology ER &/ PgR receptor Indications and Usage, Adverse Reactions, Clinical Studies, Clinical Pharmacology
Maraviroc Antivirals CCR5 Indications and Usage, Warnings and Precautions, Clinical Pharmacology, Clinical Studies, Patient Counseling Information
Mercaptopurine Oncology TPMT Dosage and Administration, Contraindications, Precautions, Adverse Reactions, Clinical Pharmacology
Metoprolol Cardiovascular CYP2D6 Precautions, Clinical Pharmacology
Modafinil Psychiatry CYP2D6 Drug Interactions
Nefazodone Psychiatry CYP2D6 Drug Interactions
Nilotinib (1) Oncology Ph Chromosome Indications and Usage, Patient Counseling Information
Nilotinib (2) Oncology UGT1A1 Warnings and Precautions, Clinical Pharmacology
Nortriptyline Psychiatry CYP2D6 Drug Interactions
Omeprazole Gastroenterology CYP2C19 Dosage and Administration, Warnings and Precautions, Drug Interactions
Panitumumab (1) Oncology EGFR Indications and Usage, Warnings and Precautions, Clinical Pharmacology, Clinical Studies
Panitumumab (2) Oncology KRAS Indications and Usage, Clinical Pharmacology, Clinical Studies
Pantoprazole Gastroenterology CYP2C19 Clinical Pharmacology, Drug Interactions, Special Populations
Paroxetine Psychiatry CYP2D6 Clinical Pharmacology, Drug Interactions
Peginterferon alfa-2b Antivirals IL28B Clinical Pharmacology
Perphenazine Psychiatry CYP2D6 Clinical Pharmacology, Drug Interactions
Pertuzumab Oncology Her2/neu Indications and Usage, Warnings and Precautions, Adverse Reactions, Clinical Studies, Clinical Pharmacology
Phenytoin Neurology HLA-B*1502 Warnings
Pimozide Psychiatry CYP2D6 Warnings, Precautions, Contraindications, Dosage and Administration
Prasugrel Cardiovascular CYP2C19 Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Pravastatin Cardiovascular ApoE2 Clinical Studies, Use in Specific Populations
Propafenone Cardiovascular CYP2D6 Clinical Pharmacology
Propranolol Cardiovascular CYP2D6 Precautions, Drug Interactions, Clinical Pharmacology
Protriptyline Psychiatry CYP2D6 Precautions
Quinidine Antiarrhythmics CYP2D6 Precautions
Rabeprazole Gastroenterology CYP2C19 Drug Interactions, Clinical Pharmacology
Rasburicase Oncology G6PD Boxed Warning, Contraindications
Rifampin, Isoniazid, and Pyrazinamide Antiinfectives NAT1; NAT2 Adverse Reactions, Clinical Pharmacology
Risperidone Psychiatry CYP2D6 Drug Interactions, Clinical Pharmacology
Sodium Phenylacetate and Sodium Benzoate Gastroenterology UCD (NAGS; CPS; ASS; OTC; ASL; ARG) Indications and Usage, Description, Clinical Pharmacology
Sodium Phenylbutyrate Gastroenterology UCD (NAGS; CPS; ASS; OTC; ASL; ARG) Indications and Usage, Dosage and Administration, Nutritional Management
Tamoxifen Oncology ER receptor Indications and Usage, Precautions, Medication Guide
Telaprevir Antivirals IL28B Clinical Pharmacology
Terbinafine Antifungals CYP2D6 Drug Interactions
Tetrabenazine Neurology CYP2D6 Dosage and Administration, Warnings, Clinical Pharmacology
Thioguanine Oncology TPMT Dosage and Administration, Precautions, Warnings
Thioridazine Psychiatry CYP2D6 Precautions, Warnings, Contraindications
Ticagrelor Cardiovascular CYP2C19 Clinical Studies
Tolterodine Reproductive and Urologic CYP2D6 Clinical Pharmacology, Drug Interactions, Warnings and Precautions
Tositumomab Oncology CD20 antigen Indications and Usage, Clinical Pharmacology
Tramadol and Acetaminophen Analgesics CYP2D6 Clinical Pharmacology
Trastuzumab Oncology Her2/neu Indications and Usage, Precautions, Clinical Pharmacology
Tretinoin Dermatology and Dental PML/RARα Boxed Warning, Dosage and Administration, Precautions
Trimipramine Psychiatry CYP2D6 Drug Interactions
Valproic Acid Psychiatry UCD (NAGS; CPS; ASS; OTC; ASL; ARG) Contraindications, Precautions, Adverse Reactions
Vemurafenib Oncology BRAF Indications and Usage, Warning and Precautions, Clinical Pharmacology, Clinical Studies, Patient Counseling Information
Venlafaxine Psychiatry CYP2D6 Drug Interactions
Voriconazole Antifungals CYP2C19 Clinical Pharmacology, Drug Interactions
Warfarin (1) Hematology CYP2C9 Dosage and Administration, Precautions, Clinical Pharmacology
Warfarin (2) Hematology VKORC1 Dosage and Administration, Precautions, Clinical Pharmacology

No hay comentarios:

Publicar un comentario