Pharmacogenomic Biomarkers & pharmacogenetic test to prevent adverse drug reaction

Table of Pharmacogenomic Biomarkers in Drug Labeling

Pharmacogenomics can play an important role in identifying responders and non-responders to medications, avoiding adverse events, and optimizing drug dose. Drug labeling 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

Contact Connie Dello Buono, representative at medxprime to avail of pharmacogenetic test to prevent adverse drug reaction 408-854-1883 motherhealth@gmail.com . We are connecting with doctors and medical sales rep to bring personalize medicine this 2015.

The table below lists FDA-approved drugs with pharmacogenomic information in their labeling. The labeling for some, but not all, of the products includes specific actions to be taken based on the biomarker information. Biomarkers in the table include are not limited to germline or somatic gene variants, functional deficiencies, expression changes, and chromosomal abnormalities.

This table does not include non-human genetic biomarkers (e.g., viral or bacterial) i.e., microbial variants that influence sensitivity to anti-invectives; biomarkers that are used solely for diagnostic purposes unless they are linked to drug activity or used to identify a specific subset in whom prescribing information differs (e.g., for genetic diseases). Therapeutic areas do not necessarily reflect the FDA review division.

Pharmacogenomic information can appear in different sections of the labeling. Relevant sections of the labeling with such information are noted in the last column of the table. For more information on the relevance of information in various parts of drug labeling (e.g. Indications and Usage, Dosage and Administration, Boxed Warning, etc.), please refer to the appropriate labeling guidance. For information on the FDA’s initiative to improve prescription drug labeling, visit the FDA/CDER Learn website.

Pharmacogenomic Biomarkers in Drug Labeling

Drug Therapeutic Area* Biomarker† Referenced Subgroup Labeling Sections
Abacavir Infectious Diseases HLA-B HLA-B*5701 allele carriers Boxed Warning, Contraindications, Warnings and Precautions, Patient Counseling Information
Ado-Trastuzumab Emtansine Oncology ERBB2 HER2 protein overexpression or gene amplification positive Indications and Usage, Warnings and Precautions, Adverse Reactions, Clinical Pharmacology, Clinical Studies
Afatinib Oncology EGFR EGFR exon 19 deletion or exon 21 substitution (L858R) mutation positive Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical Studies, Patient Counseling Information
Amitriptyline Psychiatry CYP2D6 CYP2D6 poor metabolizers Precautions
Anastrozole Oncology ESR1, PGR Hormone receptor positive Indications and Usage, Clinical Pharmacology, Clinical Studies
Aripiprazole Psychiatry CYP2D6 CYP2D6 poor metabolizers Clinical Pharmacology, Dosage and Administration
Arsenic Trioxide Oncology PML/RARA PML/RARα (t(15;17)) gene expression positive Boxed Warning, Clinical Pharmacology, Indications and Usage, Warnings
Atomoxetine Psychiatry CYP2D6 CYP2D6 poor metabolizers Dosage and Administration, Warnings and Precautions, Drug Interactions, Clinical Pharmacology
Atorvastatin Endocrinology LDLR Homozygous familial hypercholesterolemia Indications and Usage, Dosage and Administration, Warnings and Precautions, Clinical Pharmacology, Clinical Studies
Azathioprine Rheumatology TPMT TPMT intermediate or poor metabolizers Dosage and Administration, Warnings and Precautions, Drug Interactions, Adverse Reactions, Clinical Pharmacology
Boceprevir Infectious Diseases IFNL3 IL28B rs12979860 T allele carriers Clinical Pharmacology
Bosutinib Oncology BCR/ABL1 Philadelphia chromosome (t(9;22)) positive Indications and Usage, Adverse Reactions, Clinical Studies
Brentuximab Vedotin Oncology TNFRSF8 CD30 positive Indications and Usage, Description, Clinical Pharmacology
Busulfan Oncology Ph Chromosome Ph Chromosome negative Clinical Studies
Capecitabine Oncology DPYD DPD deficient Contraindications, Warnings and Precautions, Patient Information
Carbamazepine (1) Neurology HLA-B HLA-B*1502 allele carriers Boxed Warning, Warnings and Precautions
Carbamazepine (2) Neurology HLA-A HLA-A*3101 allele carriers Boxed Warning, Warnings and Precautions
Carglumic Acid Metabolic Disorders NAGS N-acetylglutamate synthase deficient Indications and Usage, Warnings and Precautions, Special Populations, Clinical Pharmacology, Clinical Studies
Carisoprodol Rheumatology CYP2C19 CYP2C19 poor metabolizers Clinical Pharmacology, Special Populations
Carvedilol Cardiology CYP2D6 CYP2D6 poor metabolizers Drug Interactions, Clinical Pharmacology
Celecoxib Rheumatology CYP2C9 CYP2C9 poor metabolizers Dosage and Administration, Drug Interactions, Use in Specific Populations, Clinical Pharmacology
Cetuximab (1) Oncology EGFR EGFR protein expression positive Indications and Usage, Warnings and Precautions, Description, Clinical Pharmacology, Clinical Studies
Cetuximab (2) Oncology KRAS KRAS codon 12 and 13 mutation negative Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical Pharmacology, Clinical Studies
Cevimeline Dental CYP2D6 CYP2D6 poor metabolizers Drug Interactions
Chloroquine Infectious Diseases G6PD G6PD deficient Precautions
Chlorpropamide Endocrinology G6PD G6PD deficient Precautions
Cisplatin Oncology TPMT TPMT intermediate or poor metabolizers Clinical Pharmacology, Warnings, Precautions
Citalopram (1) Psychiatry CYP2C19 CYP2C19 poor metabolizers Drug Interactions, Warnings
Citalopram (2) Psychiatry CYP2D6 CYP2D6 poor metabolizers Drug Interactions
Clobazam Neurology CYP2C19 CYP2C19 poor metabolizers Clinical Pharmacology, Dosage and Administration, Use in Specific Populations
Clomipramine Psychiatry CYP2D6 CYP2D6 poor metabolizers Drug Interactions
Clopidogrel Cardiology CYP2C19 CYP2C19 intermediate or poor metabolizers Boxed Warning, Dosage and Administration, Warnings and Precautions, Drug Interactions, Clinical Pharmacology
Clozapine Psychiatry CYP2D6 CYP2D6 poor metabolizers Drug Interactions, Clinical Pharmacology
Codeine Anesthesiology CYP2D6 CYP2D6 ultra-rapid metabolizers Boxed Warnings, Warnings and Precautions, Use in Specific Populations, Clinical Pharmacology , Patient Counseling Information
Crizotinib Oncology ALK ALK gene rearrangement positive Indications and Usage, Dosage and Administration, Drug Interactions, Warnings and Precautions, Adverse Reactions, Clinical Pharmacology, Clinical Studies
Dabrafenib (1) Oncology BRAF BRAF V600E mutation positive Indications and Usage, Dosage and Administration, Warnings and Precautions, Clinical Pharmacology, Clinical Studies, Patient Counseling Information
Dabrafenib (2) Oncology G6PD G6PD deficient Warnings and Precautions, Adverse Reactions, Patient Counseling Information
Dapsone (1) Dermatology G6PD G6PD deficient Indications and Usage, Precautions, Adverse Reactions, Patient Counseling Information
Dapsone (2) Infectious Diseases G6PD G6PD deficient Precautions, Adverse Reactions, Overdosage
Dasatinib Oncology BCR/ABL1 Philadelphia chromosome (t(9;22)) positive; T315I mutation-positive Indications and Usage, Clinical Studies, Patient Counseling Information
Denileukin Diftitox Oncology IL2RA CD25 antigen positive Indications and Usage, Warnings and Precautions, Clinical Studies
Desipramine Psychiatry CYP2D6 CYP2D6 poor metabolizers Drug Interactions
Dexlansoprazole (1) Gastroenterology CYP2C19 CYP2C19 poor metabolizers Clinical Pharmacology, Drug Interactions
Dexlansoprazole (2) Gastroenterology CYP1A2 CYP1A2 genotypes Clinical Pharmacology
Dextromethorphan and Quinidine Neurology CYP2D6 CYP2D6 poor metabolizers Clinical Pharmacology, Warnings and Precautions, Drug Interactions
Diazepam Psychiatry CYP2C19 CYP2C19 poor metabolizers Drug Interactions, Clinical Pharmacology
Doxepin Psychiatry CYP2D6 CYP2D6 poor metabolizers Precautions
Drospirenone and Ethinyl Estradiol Neurology CYP2C19 CYP2C19 poor metabolizers Clinical Pharmacology, Warnings and Precautions, Drug Interactions
Eltrombopag (1) Hematology F5 Factor V Leiden carriers Warnings and Precautions
Eltrombopag (2) Hematology SERPINC1 Antithrombin III deficient Warnings and Precautions
Erlotinib (1) Oncology EGFR EGFR protein expression positive Clinical Pharmacology
Erlotinib (2) Oncology EGFR EGFR exon 19 deletion or exon 21 substitution (L858R) positive Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies
Esomeprazole Gastroenterology CYP2C19 CYP2C19 poor metabolizers Drug Interactions, Clinical Pharmacology
Everolimus (1) Oncology ERBB2 HER2 protein overexpression negative Indications and Usage, Boxed Warning, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Everolimus (2) Oncology ESR1 Estrogen receptor positive Clinical Pharmacology, Clinical Studies
Exemestane Oncology ESR1 Estrogen receptor positive Indications and Usage, Dosage and Administration, Clinical Studies, Clinical Pharmacology
Fluorouracil (1) Dermatology DPYD DPD deficient Contraindications, Warnings, Patient Information
Fluorouracil (2) Oncology DPYD DPD deficient Warnings
Fluoxetine Psychiatry CYP2D6 CYP2D6 poor metabolizers Warnings, Precautions, Clinical Pharmacology
Flurbiprofen Rheumatology CYP2C9 CYP2C9 poor metabolizers Clinical Pharmacology, Special Populations
Fluvoxamine Psychiatry CYP2D6 CYP2D6 poor metabolizers Drug Interactions
Fulvestrant Oncology ESR1 Estrogen receptor positive Indications and Usage, Clinical Pharmacology, Clinical Studies, Patient Counseling Information
Galantamine Neurology CYP2D6 CYP2D6 poor metabolizers Special Populations
Glimepiride Endocrinology G6PD G6PD deficient Warning and Precautions
Glipizide Endocrinology G6PD G6PD deficient Precautions
Glyburide Endocrinology G6PD G6PD deficient Precautions
Ibritumomab Tiuxetan Oncology MS4A1 CD20 positive Indications and Usage, Clinical Pharmacology, Description
Iloperidone Psychiatry CYP2D6 CYP2D6 poor metabolizers Clinical Pharmacology, Dosage and Administration, Drug Interactions, Specific Populations, Warnings and Precautions
Imatinib (1) Oncology KIT c-KIT D816V mutation negative Indications and Usage, Dosage and Administration Clinical Pharmacology, Clinical Studies
Imatinib (2) Oncology BCR/ABL1 Philadelphia chromosome (t(9;22)) positive Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies
Imatinib (3) Oncology PDGFRB PDGFR gene rearrangement positive Indications and Usage, Dosage and Administration, Clincal Studies
Imatinib (4) Oncology FIP1L1/PDGFRA FIP1L1/PDGFRα fusion kinase (or CHIC2 deletion) positive Indications and Usage, Dosage and Administration, Clinical Studies
Imipramine Psychiatry CYP2D6 CYP2D6 poor metabolizers Drug Interactions
Indacaterol Pulmonary UGT1A1 UGT1A1*28 allele homozygotes Clinical Pharmacology
Irinotecan Oncology UGT1A1 UGT1A1*28 allele carriers Dosage and Administration, Warnings, Clinical Pharmacology
Isosorbide and Hydralazine Cardiology NAT1-2 Slow acetylators Clinical Pharmacology
Ivacaftor Pulmonary CFTR CFTR G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R mutation carriers Indications and Usage, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Lansoprazole Gastroenterology CYP2C19 CYP2C19 poor metabolizers Drug Interactions, Clinical Pharmacology
Lapatinib Oncology ERBB2 HER2 protein overexpression positive Indications and Usage, Clinical Pharmacology, Patient Counseling Information
Lenalidomide Hematology del (5q) Chromosome 5q deletion Boxed Warning, Indications and Usage, Clinical Studies, Patient Counseling
Letrozole Oncology ESR1, PGR Hormone receptor positive Indications and Usage, Adverse Reactions, Clinical Studies, Clinical Pharmacology
Lomitapide Endocrinology LDLR Homozygous familial hypercholesterolemia Indication and Usage, Adverse Reactions, Clinical Studies
Mafenide Infectious Diseases G6PD G6PD deficient Warnings, Adverse Reactions
Maraviroc Infectious Diseases CCR5 CCR5 positive Indications and Usage, Warnings and Precautions, Clinical Pharmacology, Clinical Studies, Patient Counseling Information
Mercaptopurine Oncology TPMT TPMT intermediate or poor metabolizers Dosage and Administration, Precautions, Adverse Reactions, Clinical Pharmacology
Methylene Blue Hematology G6PD G6PD deficient Precautions
Metoclopramide Gastroentrology CYB5R1-4 NADH cytochrome b5 reductase deficient Precautions
Metoprolol Cardiology CYP2D6 CYP2D6 poor metabolizers Precautions, Clinical Pharmacology
Mipomersen Endocrinology LDLR Homozygous familial hypercholesterolemia Indication and Usage, Clinical Studies, Use in Specific Populations
Modafinil Psychiatry CYP2D6 CYP2D6 poor metabolizers Drug Interactions
Mycophenolic Acid Transplantation HPRT1 HGPRT deficient Precautions
Nalidixic Acid Infectious Diseases G6PD G6PD deficient Precautions, Adverse Reactions
Nefazodone Psychiatry CYP2D6 CYP2D6 poor metabolizers Drug Interactions
Nilotinib (1) Oncology BCR/ABL1 Philadelphia chromosome (t(9 :22)) positive Indications and Usage, Patient Counseling Information
Nilotinib (2) Oncology UGT1A1 UGT1A1*28 allele homozygotes Warnings and Precautions, Clinical Pharmacology
Nitrofurantoin Infectious Diseases G6PD G6PD deficient Warnings, Adverse Reactions
Nortriptyline Psychiatry CYP2D6 CYP2D6 poor metabolizers Drug Interactions
Obinutuzumab Oncology MS4A1 CD20 positive Indication and Usage, Warnings and Precautions, Description, Clinical Pharmacology, Clinical Studies
Ofatumumab Oncology MS4A1 CD20 positive Indications and Usage, Clinical Pharmacology
Omacetaxine Oncology BCR/ABL1 BCR-ABL T315I Clinical Pharmacology
Omeprazole Gastroenterology CYP2C19 CYP2C19 poor metabolizers Dosage and Administration, Warnings and Precautions, Drug Interactions
Panitumumab (1) Oncology EGFR EGFR protein expression positive Indications and Usage, Warnings and Precautions, Clinical Pharmacology, Clinical Studies
Panitumumab (2) Oncology KRAS KRAS codon 12 and 13 mutation negative Indications and Usage, Clinical Pharmacology, Clinical Studies
Pantoprazole Gastroenterology CYP2C19 CYP2C19 poor metabolizers Clinical Pharmacology, Drug Interactions, Special Populations
Paroxetine Psychiatry CYP2D6 CYP2D6 poor metabolizers Clinical Pharmacology, Drug Interactions
Pazopanib Oncology UGT1A1 (TA)7/(TA)7 genotype (UGT1A1*28/*28) Clinical Pharmacology, Warnings and Precautions
PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid Gastroenterology G6PD G6PD deficient Warnings and Precautions
Peginterferon alfa-2b Infectious Diseases IFNL3 IL28B rs12979860 T allele carriers Clinical Pharmacology
Pegloticase Rheumatology G6PD G6PD deficient Contraindications, Patient Counseling Information
Perphenazine Psychiatry CYP2D6 CYP2D6 poor metabolizers Clinical Pharmacology, Drug Interactions
Pertuzumab Oncology ERBB2 HER2 protein overexpression positive Indications and Usage, Warnings and Precautions, Adverse Reactions, Clinical Studies, Clinical Pharmacology
Phenytoin Neurology HLA-B HLA-B*1502 allele carriers Warnings
Pimozide Psychiatry CYP2D6 CYP2D6 poor metabolizers Warnings, Precautions, Contraindications, Dosage and Administration
Ponatinib Oncology BCR –ABL T315I BCR –ABL T315I mutation Indications and Usage, Adverse Reactions, Clinical Pharmacology, Clinical Studies
Prasugrel Cardiology CYP2C19 CYP2C19 poor metabolizers Use in Specific Populations, Clinical Pharmacology, Clinical Studies
Pravastatin Endocrinology LDLR Homozygous familial hypercholesterolemia Clinical Studies, Use in Specific Populations
Primaquine Infectious Diseases G6PD G6PD deficient Warnings and Precautions, Adverse Reactions
Propafenone Cardiology CYP2D6 CYP2D6 poor metabolizers Clinical Pharmacology
Propranolol Cardiology CYP2D6 CYP2D6 poor metabolizers Precautions, Drug Interactions, Clinical Pharmacology
Protriptyline Psychiatry CYP2D6 CYP2D6 poor metabolizers Precautions
Quinidine Cardiology CYP2D6 CYP2D6 poor metabolizers Precautions
Quinine Sulfate Infectious Diseases G6PD G6PD deficient Contraindications, Patient Counseling Information
Rabeprazole Gastroenterology CYP2C19 CYP2C19 poor metabolizers Drug Interactions, Clinical Pharmacology
Rasburicase Oncology G6PD G6PD deficient Boxed Warning, Contraindications
Rifampin, Isoniazid, and Pyrazinamide Infectious Diseases NAT1-2 Slow inactivators Adverse Reactions, Clinical Pharmacology
Risperidone Psychiatry CYP2D6 CYP2D6 poor metabolizers Drug Interactions, Clinical Pharmacology
Rituximab Oncology MS4A1 CD20 positive Indication and Usage, Clinical Pharmacology, Description, Precautions
Rosuvastatin Endocrinology LDLR Homozygous familial hypercholesterolemia Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies
Simeprevir Infectious Diseases IFNL3 IL28B rs12979860 T allele carriers Clinical studies, Clinical Pharmacology
Sodium Nitrite Antidotal Therapy G6PD G6PD deficient Warnings and Precautions
Sofosbuvir Infectious Diseases IFNL3 IL28B rs12979860 T allele carriers Clinical Pharmacology, Clinical Studies
Succimer Hematology G6PD G6PD deficient Clinical Pharmacology
Sulfamethoxazole and Trimethoprim Infectious Diseases G6PD G6PD deficient Precautions
Tamoxifen (1) Oncology ESR1, PGR Hormone receptor positive Indications and Usage, Precautions, Medication Guide
Tamoxifen (2) Oncology F5 Factor V Leiden carriers Warnings
Tamoxifen (3) Oncology F2 Prothrombin mutation G20210A positive Warnings
Telaprevir Infectious Diseases IFNL3 IL28B rs12979860 T allele carriers Clinical Pharmacology
Terbinafine Infectious Diseases CYP2D6 CYP2D6 poor metabolizers Drug Interactions
Tetrabenazine Neurology CYP2D6 CYP2D6 poor metabolizers Dosage and Administration, Warnings, Clinical Pharmacology
Thioguanine Oncology TPMT TPMT poor metabolizers Dosage and Administration, Precautions, Warnings
Thioridazine Psychiatry CYP2D6 CYP2D6 poor metabolizers Precautions, Warnings, Contraindications
Ticagrelor Cardiology CYP2C19 CYP2C19 poor metabolizers Clinical Studies
Tolterodine Genitourinary CYP2D6 CYP2D6 poor metabolizers Warnings and Precautions, Drug Interactions, Use in Specific Populations, Clinical Pharmacology
Tositumomab Oncology MS4A1 CD20 antigen positive Indications and Usage, Clinical Pharmacology
Tramadol Analgesic CYP2D6 CYP2D6 poor metabolizers Clinical Pharmacology
Trametinib Oncology BRAF BRAF V600E/K mutation positive Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical Studies, Patient Counseling Information
Trastuzumab Oncology ERBB2 HER2 protein overexpression positive Indications and Usage, Warnings and Precautions, Clinical Pharmacology, Clinical Studies
Tretinoin Oncology PML/RARA PML/RARα (t(15;17)) gene expression positive Clinical Studies, Indications and Usage, Warnings
Trimipramine Psychiatry CYP2D6 CYP2D6 poor metabolizers Drug Interactions
Valproic Acid (1) Neurology POLG POLG mutation positive Boxed Warning, Contraindications, Warnings and Precautions
Valproic Acid (2) Neurology NAGS, CPS1, ASS1, OTC, ASL, ABL2 Urea cycle enzyme deficient Contraindications, Warnings and Precautions, Adverse Reactions, Medication Guide
Vemurafenib Oncology BRAF BRAF V600E mutation positive Indications and Usage, Warning and Precautions, Clinical Pharmacology, Clinical Studies, Patient Counseling Information
Venlafaxine Psychiatry CYP2D6 CYP2D6 poor metabolizers Drug Interactions
Voriconazole Infectious Diseases CYP2C19 CYP219 intermediate or poor metabolizers Clinical Pharmacology, Drug Interactions
Vortioxetine Neurology CYP2D6 CYP2D6 poor metabolizers Dosage and Administration, Drug interactions, Clinical Pharmacology
Warfarin (1) Cardiology or Hematology CYP2C9 CYP2C9 intermediate or poor metabolizers Dosage and Administration, Drug Interactions, Clinical Pharmacology
Warfarin (2) Cardiology or Hematology VKORC1 VKORC1 rs9923231 A allele carriers Dosage and Administration, Clinical Pharmacology
Warfarin (3) Cardiology or Hematology PROC Protein C deficient Warning and precautions
Connie Dello Buono

Prevent vascular disease, manage inflammation, get GYV health caps to boost ATP cells performance and speedy repair of your body, email connie to get the caps and join in spreading the benefits with extra income for you at motherhealth@gmail.com and text 408-854-1883

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