PGX FDA

— Abacavir Amifampridine Amifampridine Phosphate Amphetamine Aripiprazole Aripiprazole Lauroxil Atomoxetine Azathioprine Belinostat Brexpiprazole Brivaracetam Capecitabine Carbamazepine Celecoxib Citalopram Clobazam Clopidogrel Clozapine Codeine Deutetrabenazine Dronabinol Eliglustat Erdafitinib Flibanserin Flurbiprofen Fluorouracil Fosphenytoin Gefitinib Iloperidone Irinotecan Lofexidine Meclizine Meloxicam Metoclopramide Mercaptopurine Mivacurium Oliceridine Pantoprazole Phenytoin Pimozide Piroxicam Pitolisant Propafenone Sacituzumab Govitecan-hziy Siponimod Succinylcholine Tacrolimus Tetrabenazine Thioguanine Thioridazine Tramadol Valbenazine Venlafaxine Vortioxetine Warfarin Allopurinol Carvedilol Cevimeline Efavirenz Isoniazid Lapatinib Nilotinib Oxcarbazepine Pazopanib Perphenazine Procainamide Simvastatin Sulfamethoxazole and Trimethoprim Sulfasalazine Tolterodine Voriconazole Amitriptyline Amoxapine Atorvastatin Avatrombopag Carisoprodol Clomipramine Darifenacin Desipramine Dexlansoprazole Diazepam Dolutegravir Donepezil Doxepin Elagolix Escitalopram Esomeprazole Fesoterodine Fluvoxamine Galantamine Hydralazine Ibuprofen Imipramine Metoprolol Mirabegron Nebivolol Nortriptyline Omeprazole Paroxetine Propranolol Protriptyline Rabeprazole Raltegravir Risperidone Rosuvastatin Tamoxifen Tamsulosin Trimipramine Viloxazine

— HLA-B NAT2 CYP2D6 TPMT and/or NUDT15 UGT1A1 CYP2C19 DPYD CYP2C9 BCHE CYP3A5 CYP4F2 VKORC1 HLA-A CYP2B6 Nonspecific (NAT) HLA-DRB1 HLA-DQA1 SLCO1B1

— *57:01 allele positive poor metabolizers intermediate or poor metabolizers *28/*28 (poor metabolizers) *15:02 allele positive poor metabolizers or *3 carriers ultrarapid metabolizers ultrarapid, normal, intermediate, or poor metabolizers *3/*3 (poor metabolizers) intermediate or poor metabolizer ultrarapid, intermediate, or poor metabolizers intermediate or normal metabolizers Ultrarapid metabolizers3 V433M variant carriers -1639G>A variant carriers *58:01 allele positive *31:01 allele positive *07:01 allele positive *02:01 allele positive 521 TC or 521 CC (intermediate or poor function transporters) 521 CC (poor function transporters) ultrarapid or poor metabolizers

— Results in higher adverse reaction risk (hypersensitivity reactions). Do not use abacavir in patients positive for HLA-B*57:01. Results in higher systemic concentrations and higher adverse reaction risk. Use lowest recommended starting dosage and monitor for adverse reactions. Refer to FDA labeling for specific dosing recommendations. Results in higher systemic concentrations. Use lowest recommended starting dosage (15 mg/day) and monitor for adverse reactions. May affect systemic concentrations and adverse reaction risk. Consider lower starting dosage or use alternative agent. Results in higher systemic concentrations and higher adverse reaction risk. Dosage adjustment is recommended. Refer to FDA labeling for specific dosing recommendations. Results in higher systemic concentrations. Dosage adjustment is recommended. Refer to FDA labeling for specific dosing recommendations. Results in higher systemic concentrations and higher adverse reaction risk. Adjust titration interval and increase dosage if tolerated. Refer to FDA labeling for specific dosing recommendations. Alters systemic active metabolite concentration and dosage requirements. Results in higher adverse reaction risk (myelosuppression). Consider alternative therapy in poor metabolizers. Dosage reduction is recommended in intermediate metabolizers for NUDT15 or TPMT. Intermediate metabolizers for both genes may require more substantial dosage reductions. Refer to FDA labeling for specific dosing recommendations. May result in higher systemic concentrations and higher adverse reaction risk. Reduce starting dose to 750 mg/m2 in poor metabolizers. Results in higher systemic concentrations and higher adverse reaction risk. Consider dosage reductions in poor metabolizers. Results in higher adverse reaction risk (severe, life-threatening, or fatal toxicities). No dosage has proven safe in poor metabolizers, and insufficient data are available to recommend a dosage in intermediate metabolizers. Withhold or discontinue in the presence of early-onset or unusually severe toxicity. Results in higher adverse reaction risk (severe skin reactions). Avoid use unless potential benefits outweigh risks and consider risks of alternative therapies. Patients positive for HLA-B*15:02 may be at increased risk of severe skin reactions with other drugs that are associated with a risk of Stevens Johnson Syndrome/Toxic Epidermal necrolysis (SJS/TEN). Genotyping is not a substitute for clinical vigilance. Results in higher systemic concentrations. Reduce starting dose to half of the lowest recommended dose in poor metabolizers. Consider alternative therapy in poor metabolizers with juvenile rheumatoid arthritis. Results in higher systemic concentrations and adverse reaction risk (QT prolongation). The maximum recommended dose is 20 mg. Results in higher systemic active metabolite concentrations. Poor metabolism results in higher adverse reaction risk. Dosage adjustment is recommended. Refer to FDA labeling for specific dosing recommendations. Results in lower systemic active metabolite concentrations, lower antiplatelet response, and may result in higher cardiovascular risk. Consider use of another platelet P2Y12 inhibitor. Results in higher systemic concentrations. Dosage reductions may be necessary. Results in higher systemic active metabolite concentrations and higher adverse reaction risk (life-threatening respiratory depression and death). Codeine is contraindicated in children under 12 years of age. Results in higher systemic concentrations and adverse reaction risk (QT prolongation). The maximum recommended dosage should not exceed 36 mg (maximum single dose of 18 mg). May result in higher systemic concentrations and higher adverse reaction risk. Monitor for adverse reactions. Alters systemic concentrations, effectiveness, and adverse reaction risk (QT prolongation). Indicated for normal, intermediate, and poor metabolizer patients. Ultrarapid metabolizers may not achieve adequate concentrations to achieve a therapeutic effect. The recommended dosages are based on CYP2D6 metabolizer status. Coadministration with strong CYP3A inhibitors is contraindicated in intermediate and poor CYP2D6 metabolizers. Refer to FDA labeling for specific dosing recommendations. May result in higher systemic concentrations and higher adverse reaction risk. Monitor patients for adverse reactions. Results in higher systemic concentrations. Use a reduced dosage in poor metabolizers. Results in higher adverse reaction risk (severe, life-threatening, or fatal toxicities). No dosage has proven safe in poor metabolizers and insufficient data are available to recommend a dosage in intermediate metabolizers. Withhold or discontinue in the presence of early-onset or unusually severe toxicity. May result in higher systemic concentrations and higher adverse reaction risk (central nervous system toxicity). Consider starting at the lower end of the dosage range and monitor serum concentrations. Refer to FDA labeling for specific dosing recommendations. Carriers of CYP2C9*3 alleles may be at increased risk of severe cutaneous adverse reactions. Consider avoiding fosphenytoin as an alternative to carbamazepine in patients who are CYP2C9*3 carriers. Genotyping is not a substitute for clinical vigilance and patient management. May result in higher adverse reaction risk (severe cutaneous reactions). Patients positive for HLA-B*15:02 may be at increased risk of Stevens Johnson Syndrome/Toxic Epidermal necrolysis (SJS/TEN). Consider avoiding fosphenytoin as an alternative to carbamazepine in patients who are positive for HLA-B*15:02. Genotyping is not a substitute for clinical vigilance and patient management. Results in higher systemic concentrations and higher adverse reaction risk. Monitor for adverse reactions. Results in higher systemic concentrations and higher adverse reaction risk (QT prolongation). Reduce dosage by 50%. Results in higher systemic active metabolite concentrations and higher adverse reaction risk (severe neutropenia). Consider reducing the starting dosage by one level and modify the dosage based on individual patient tolerance. Results in higher systemic concentrations and higher adverse reaction risk. Monitor for orthostatic hypotension and bradycardia. May affect systemic concentrations. Monitor for adverse reactions and clinical effect. Results in higher systemic concentrations. Consider dose reductions in poor metabolizers. Monitor patients for adverse reactions. Results in higher systemic concentrations and higher adverse reaction risk. The recommended dosage is lower. Refer to FDA labeling for specific dosing recommendations. Alters systemic active metabolite concentration and dosage requirements. Results in higher adverse reaction risk (myelosuppression). Initial dosages should be reduced in poor metabolizers; poor metabolizers generally tolerate 10% or less of the recommended dosage. Intermediate metabolizers may require dosage reductions based on tolerability. Intermediate metabolizers for both genes may require more substantial dosage reductions. Refer to FDA labeling for specific dosing recommendations. Results in higher systemic concentrations and higher adverse reaction risk (prolonged neuromuscular blockade). Avoid use in poor metabolizers. Results in higher systemic concentrations and higher adverse reaction risk (respiratory depression and sedation). May require less frequent dosing. Results in higher systemic concentrations. Consider dosage reduction in children who are poor metabolizers. No dosage adjustment is needed for adult patients who are poor metabolizers. May result in higher systemic concentrations and higher adverse reaction risk (central nervous system toxicity). Refer to FDA labeling for specific dosing recommendations. Carriers of CYP2C9*3 alleles may be at increased risk of severe cutaneous adverse reactions. Consider avoiding phenytoin as an alternative to carbamazepine in patients who are CYP2C9*3 carriers. Genotyping is not a substitute for clinical vigilance and patient management. May result in higher adverse reaction risk (severe cutaneous reactions). Patients positive for HLA-B*15:02 may be at increased risk of Stevens Johnson Syndrome/Toxic Epidermal necrolysis (SJS/TEN). Consider avoiding phenytoin as an alternative to carbamazepine in patients who are positive for HLA-B*15:02. Genotyping is not a substitute for clinical vigilance and patient management. Results in higher systemic concentrations. Dosages should not exceed 0.05 mg/kg in children or 4 mg/day in adults who are poor metabolizers and dosages should not be increased earlier than 14 days. Results in higher systemic concentrations. Consider reducing dosage in poor metabolizers. Results in higher systemic concentrations. Use lowest recommended starting dosage. Refer to FDA labeling for specific dosing recommendations. Results in higher systemic concentrations and higher adverse reaction risk (arrhythmia). Avoid use in poor metabolizers taking a CYP3A4 inhibitor. May result in higher systemic concentrations and adverse reaction risk (neutropenia). Monitor for adverse reactions and tolerance to treatment. Results in higher systemic concentrations. Adjust dosage based on genotype. Do not use in patients with CYP2C9 *3/*3 genotype. Refer to FDA labeling for specific dosing recommendations. Results in higher systemic concentrations and higher adverse reaction risk (prolonged neuromuscular blockade). Avoid use in poor metabolizers. May administer test dose to assess sensitivity and administer cautiously via slow infusion. Results in lower systemic concentrations, lower probability of achieving target concentrations and may result in higher rejection risk. Measure drug concentrations and adjust dosage based on trough whole blood tacrolimus concentrations. Results in higher systemic concentrations. The maximum recommended single dose is 25 mg and should not exceed 50 mg/day. Results in higher systemic concentrations and higher adverse reaction risk (QT prolongation). Predicted effect based on experience with CYP2D6 inhibitors. Contraindicated in poor metabolizers. Results in higher systemic and breast milk active metabolite concentrations, which may result in respiratory depression and death. Contraindicated in children under 12 and in adolescents following tonsillectomy/adenoidectomy. Breastfeeding is not recommended during treatment. Results in higher systemic active metabolite concentrations and higher adverse reaction risk (QT prolongation). Dosage reductions may be necessary. Alters systemic parent drug and metabolite concentrations. Consider dosage reductions. Results in higher systemic concentrations. The maximum recommended dose is 10 mg. Alters systemic concentrations and dosage requirements. Select initial dosage, taking into account clinical and genetic factors. Monitor and adjust dosages based on INR. May affect dosage requirements. Monitor and adjust doses based on INR. Alters dosage requirements. Select initial dosage, taking into account clinical and genetic factors. Monitor and adjust dosages based on INR. Results in higher adverse reaction risk (severe skin reactions). Results in higher adverse reaction risk (severe skin reactions). Consider risk and benefit of carbamazepine use in patients positive for HLA-A*31:01. Genotyping is not a substitute for clinical vigilance. Results in higher systemic concentrations and higher adverse reaction risk (dizziness). May result in higher adverse reaction risk. Use with caution. Results in lower systemic active metabolite concentrations and may result in reduced efficacy. Results in higher systemic concentrations and higher adverse reaction risk (QT prolongation). May result in higher systemic concentrations and adverse reaction risk. Results in higher adverse reaction risk (hepatotoxicity). Monitor liver function tests regardless of genotype. Results in higher adverse reaction risk (hyperbilirubinemia). Results in higher adverse reaction risk (severe skin reactions). Patients positive for HLA-B*15:02 may be at increased risk of severe skin reactions with other drugs that are associated with a risk of Stevens Johnson Syndrome/Toxic Epidermal necrolysis (SJS/TEN). Genotyping is not a substitute for clinical vigilance. May result in higher adverse reaction risk (liver enzyme elevations). Monitor liver function tests regardless of genotype. Results in higher systemic concentrations and higher adverse reaction risk. Alters systemic parent drug and metabolite concentrations. May result in higher adverse reaction risk. Results in higher systemic concentrations and higher adverse reaction risk (myopathy). The risk of adverse reaction (myopathy) is higher for patients on 80 mg than for those on lower doses. May result in higher adverse reaction risk. Results in higher systemic metabolite concentrations and higher adverse reaction risk. Results in higher systemic concentrations and may result in higher adverse reaction risk. May alter systemic concentrations. May result in higher systemic concentrations. Results in higher systemic concentrations. Results in higher systemic concentrations. Use with caution. May affect systemic concentrations. Alters systemic concentrations. Results in higher systemic active metabolite concentrations. Results in higher systemic concentrations. Titrate dosage based on tolerability. Alters systemic parent drug and metabolite concentrations. Results in lower systemic active metabolite concentrations. The impact of CYP2D6 intermediate or poor metabolism on efficacy is not well established. Results in higher systemic concentrations. Predicted effect based on experience with CYP2D6 inhibitors. Use with caution.

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