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Table 5 Examples of drugs with genetic information in thier labels

From: Animal models and conserved processes

Drug Sponsor Indication Gene or genotype Effect of genotype Clinical directive on label
Abacavir (Ziagen) GlaxoSmithKline HIV-1 HLA-B*5701 Hypersensitivity Black-box warning. "Prior to initiating therapy with abacavir, screening for the HLA-B*5701 allele is recommended." "Your doctor can determine with a blood test if you have this gene variation."
Azathioprine (Imuran) Prometheus Renal allograft transplantation, rheumatoid TPT*2TPT*3A and TPMT*3C Severe myeloxicity "TPT genotyping or phenotyping can help identify patients who are at an increased risk for developing Imuran toxicity." "Phenotyping and genotyping methods are commercially available."
Carbamazepine (Tegretol) Novartis Epilepsy, trigeminal neuralgia HLA-B*1502 Stevens-Johnson syndrome or toxic epidermal necrolysis Black-box warning: "Patients with ancestry in genetically at-risk populations should be screened for the presence of HLA-B*1502 prior to initiating treatment with Tegretol. Patients testing positive for the allele should not be treated with Tegretol." "For genetically at-risk patients, high-resolution HLA-B*1502 typing is recommended."
Cetuximab (Erbitux) Imclone Metastatic colorectal cancer KRAS mutations Efficacy "Retrospective subset analyses of metastatic or advanced colerectal cancer trials have not shown a treatment benefit for Erbitux in patients whose tumors had KRAS mutations in codon 12 or 13. Use of Erbitux is not recommended for the treatment of colorectal cancer with mutations."
Clopidogrel (Plavix) Bristol-Myer Squibb Anticoagulation CYP2C19*2*3 Efficacy "Tests are available to identify a patient’s CYP2C19 genotype; these tests can be used as an aid in determining therapeutic strategy. Consider alternative treatment or treatment strategies in patienrs identified as CYP2C19 poor metabolizer."
Irinotecan (Camptosar) Pfizer Metastatic colorectal cancer UGT1A1*28 Diarrhea neutropenia "A reduction in the starting dose by at least one level of Camptosar should be consider for patients knows to be homozygous for the UGT1A1*28 allele. "A laboratory test is available to determine the UGT1A1 status of patients."
Pantumumab (Vectibix) Amgen Metastatic colorectal cancer KRAS mutations Efficacy "Retrospective subset analyses of metastatic colorectal cancer trials have not shown a treatment benefit for Vectibix in patients whose tumors had KRAS mutations in codon 12 or 13. Use of Vectibix is not recommended for the treatment of colorectal cancer with these mutations."
Transtuzumab (Herceptin) Genetech HER2-positive breastcancer HER2 expression Efficacy "Detection of HER2 protein overexpression is necessary for selection of patients appropriate for Herceptin therapy because these are the only patients studied and for whom benefit has shown." "Several FDA-approved commercial assays are available to aid in the selection of breast cancer and metastatic cancer patients for Herptin therapy."
Wafarin (Coumadin) Bristol-Myer Squibb Venous thrombosis CYP2C9*2*3 and VKORC1 variants Bleeding complications Includes the following table: Range of Expected Therapeutic Warfarin Doses Based on CYP2CP and VKORC1 Genotypes.
  1. *All drug labels were accessed through Drugs @FDA at www.accessdata.fda.gov/scripts/cder/drugsatfda. HIV-1 denotes human immunodeficiency virus type 1, TPMT thiopurine methyltransferase, UGT1A1 UDP glucuronosyltransferanse 1 family polypeptide A1, and VKORC1 vitamins K epoxide reductase complex subunit 1