Instructions for use. Impact on Medications. Compilation of Genetic Results. Individual Gene Review

Transcription

1 Date of Birth: [object Object] Test Date: 03/22/2016 Report Date: 03/22/2016 A Instructions for use PAGE 2 B Impact on Medications PAGE 3-4 C Compilation of Genetic Results PAGE 5-6 D Individual Gene Review PAGE 7-14 Copyrighted and Patent Pending 2016, Elevated Capital Group, LLC (d/b/a MyGenesRx). All rights reserved. 1

2 Key Words to Understand Gene - the molecular unit of heredity. Each gene codes for a protein. Proteins are complex "action" molecules that impact our physiology. Variant - alternative versions of a particular gene. Genotype - the variants you inherited for a particular gene from Mom and Dad. - function or behavior of the genotype. Physician - the person with whom you must share this information. The report contains three major sections Your Drug Guide Page Summary of Genes Tested Your Individual Gene Review Normal - A drug in GREEN FONT indicates that no genetic issues of clinical relevance were found for this drug among the genes tested. Impaired - A drug in YELLOW FONT indicates that genetic issues of clinical relevance were found for this drug. Extra caution should be observed when considering this drug for this patient. All three sections are color-coded to easily show whether you have a genetic predisposition that may affect your response to drugs or indicate the potential for adverse effects. Elevated Risk - A drug in RED FONT indicates that serious genetic issues of clinical relevance were found for this drug and extreme caution or avoidance of this drug should be observed when considering this drug for this patient. 1. Impact on Medications Your Impact on Medications (pages 3 and 4) integrates how the 12 genes tested can impact the most commonly prescribed drugs. The medications are grouped according to treatment category for easy reference by a qualified health care professional. 2. Compilation of Genetic Results Your Compilation of Genetic Results (pages 5 and 6) shares your genotype for each individually tested gene, its phenotype and an explanation of your result. Your genotype is presented as two numbers or letters (e.g. *1 / *4) which represent the two variations of the gene, one you inherited from your father and one inherited from your mother. The combination of these gene variants determines your phenotype for this gene (i.e. the impact of the genotype on how your body functions). The results are a detailed explanation of the impact of that phenotype. 3. Individual Gene Review Your Individual Gene Review reports on each tested gene (pages 7-14) and describes how your unique genotype and phenotype may impact medications. This section also illustrates the most commonly prescribed medications each gene effects. Copyrighted and Patent Pending 2016, Elevated Capital Group, LLC (d/b/a MyGenesRx). All rights reserved. 2

3 Impact on Medications These lists of drugs are color-coded to reflect whether a genetic predisposition indicates that there may be issues with regard to drug response or adverse effects. Normal - A drug in green font indicates that no genetic issues of clinical relevance were found for this drug among the genes tested. Impaired - A drug in yellow font indicates that genetic issues of clinical relevance were found for this drug. Extra caution should be observed when considering this drug for this patient. Elevated Risk - A drug in red font Indicates that serious genetic issues of clinical relevance were found for this drug and extreme caution or avoidance of this drug should be observed when considering this drug for this patient. Pain Management alfentanil (Alfenta) carisoprodol++ (Soma) celecoxib (Celebrex) codeine++ cyclobenzaprine (Flexaril) fentanyl (Actiq Duragesic Sublimaze) hydrocodone++ ibuprofen (Advil Motrin) lidocaine (xylocaine various brands) meperidine (Demerol) naproxen (Aleve) oxycodone++ (Oxycontin) ropivacaine (Naropin) tapentadol (Nucynta) tizanidine (Zanaflex) tramadol++ (Ultram) zolmitriptan (Zomig) Pain Management Neuropsychiatric methadone Neuropsychiatric - Anticonvulsant carbamazepine (Various brands) phenytoin (Dilantin) zonisamide (Zonegran) Neuropsychiatric - Anxiolytic alprazolam (Xanax) buspirone (BuSpar) diazepam (Valium) midazolam (Versed) phenobarbital triazolam (Halcion) zolpidem (Ambien) Neuropsychiatric - Precognitive Drug tacrine (Cognex) Antipsychotic aripiprazole (Abilify) asenapine (Saphris) chlorpromazine (Thorazine) clozapine (Clozaril) haloperidol (Haldol) Iloperidine (Fanapt) lurasidone (Latuda) olanzapine (Zyprexa) perphenazine (Trilafon) promazine (Sparine) quetiapine (Seroquel) risperidone (Risperdal) thioridazine (Mellaril) ziprasidone (Geodon) Neuropsychiatric - ADHD Drug / Stimulant amphetamine/dextroamphetamine salt combo (Adderall) atomoxetine (Strattera) Neuropsychiatric - Antidepressant amitriptyline (Elavil) bupropion citalopram (Celexa) clomipramine (Anafranil) desipramine (Norpramin) desvenlafaxine (Pristiq) doxepin (Sinequan Silenor Prudoxin Zonalon) escitalopram (Lexapro) fluoxetine (Prozac) imipramine (Tofranil) mirtazapine (Remeron) nefazodone (Serzone) nortriptyline (Aventyl Pamelor) paroxetine (Paxil) sertraline (Zoloft) trazodone (Oleptro) venlafaxine (Effexor) vilazodone (Viibryd) Copyrighted and Patent Pending 2016, Elevated Capital Group, LLC (d/b/a MyGenesRx). All rights reserved. 3

4 Neuropsychiatric - Pain Management duloxetine (Cymbalta) tiagabine (Gabitril) Antidiabetic glimepiride (Amaryl) glipizide (Glucotrol) glyburide (Diabeta) tolbutamide (Orinase) Steroids estradiol progesterone testosterone Gastrointestinal esomeprazole (Nexium) lansoprazole (Prevacid) omeprazole (Prilosec) pantoprazole (Protonix) rabeprazole (Aciphex) Anti-Infectives clarithromycin (Biaxin) efavirenza (Sustiva) erythromycin (E-Mycin) indinavir (Crixivan) nelfinavir (Viracept) ritonavir (Norvir) saquinavir (Invirase) telithromycin (Ketek) Cardiovascular - Antiarrhythmic amiodarone (Cordarone) dofetilide (Tikosyn) flecainide (Tambocor) propafenone (Rythmol) quinidine (Various brands) Cardiovascular - Antihypertensive amlodipine (Norvasc) carvedilol (Coreg) diltiazem (Cardizem) felodipine (Plendil) lercanidipine (Zanidip) losartan++ (Cozaar) metoprolol (Lopressor Toprol) nebivolol (Bystolic) nifedipine (Adalat Procardia) nisoldipine (Sular) nitrendipine propanolol (Inderal) timolol (Blocadren) Oncology cyclophosphamide (Cytoxan) docetaxel (Taxotere) ifosfamide tamoxifen++ (Nolvadex) vincristine (Vincasar Oncovin) Cardiovascular - Cholesterol Lowering atorvastatin (Lipitor Caduet) fluvastatin (Lescol) lovastatin (Mevacor) pravastatin (Pravachol) rosuvastatin (Crestor) simvastatin (Zocor) Cardiovascular - Anticoagulant clopidogrel++ (Plavix) rivaroxaban (Xarelto) ticargelor (Brilinta) warfarin (Coumadin) Cardiovascular - Antianginal ranolazine (Ranexa) Immunological cyclosporine (Gengraf) hydrocortisone tacrolimus (Prograf) zafirlukast (Accolate) Other caffeine sildinafil (Viagra) theophylline Copyrighted and Patent Pending 2016, Elevated Capital Group, LLC (d/b/a MyGenesRx). All rights reserved. 4

5 Your Compilation of Genetic Results The following is a summary of your drug sensitivity report. More detail on each gene can be found on the pages referenced. Genes affecting drug metabolism CYP2D6 *1/*2 CYP2C19 *17/*17 CYP3A4 *1/*1 CYP3A5 *3/*3 CYP2C9 *1/*1 CYP1A2 *1B/*1F Extensive (Normal) Ultra-Rapid Extensive (Normal) Poor Extensive (Normal) Ultra-Rapid This genotype predicts normal metabolic activity for the enzyme controlled by this gene. See page 7 Extremely rapid metabolic enzyme activity expected for the enzyme controlled by this gene. It may be difficult to achieve effective drug concentrations. ++ Caution should be observed with pro-drugs, e.g., clopidogrel. Excessive active metabolite formation may occur and a high risk for adverse drug reactions exists (e.g., for clopidogrel this can lead to increased risk for serious bleeding) See page 8 This genotype predicts normal metabolic activity for the enzyme controlled by this gene. See page 9 and 10 This genotype predicts markedly reduced or no metabolic activity for the enzyme controlled by this gene. High risk for drug accumulation and adverse drug reactions. See page 9 and 10 This genotype predicts normal metabolic activity for the enzyme controlled by this gene. See page 11 Extremely rapid metabolism expected for the enzyme controlled by this gene, especially in smokers. It may be difficult to achieve effective drug concentrations. See page 12 Copyrighted and Patent Pending 2016, Elevated Capital Group, LLC (d/b/a MyGenesRx). All rights reserved. 5

6 Your Compilation of Genetic Results The following is a summary of your drug sensitivity report. More detail on each gene can be found on the pages referenced. Genes affecting response or function MTHFR A/A - C/T OPRM1 A/G Factor II G/G Factor V G/G SLCO1B1 *1/*1B VKORC1 G/G - C/C Impaired Function Intermediate Opioid Responder Normal Function Normal Function Normal Function Low Warfarin Sensitivity This genotype predicts impaired function of the enzyme methylenetetrahydrofolate reductase (MTHFR). This enzyme plays a crucial role in converting dietary folate into methylfolate, the active form of this critical B vitamin. Impaired MTHFR function is associated with methylfolate deficiency which can lead to impaired neurotransmitter synthesis and other biochemical abnormalities. Dietary supplementation with L- methylfolate supplements may be benificial to your health. See Page 14 Impaired opiate receptor function expected. Morphine and other active opiates (e.g., oxymorphone, fentanyl) may not produce a usual analgesic response. Increased doses may be required. See page 13 The patient is wildtype for Factor II Prothrombin. Patients with this genotype (G/G) are associated with a normal risk of developing an abnormal blood clot. See page 13 The patient is wildtype for Factor V Prothrombin. Patients with this genotype (G/G) are associated with a normal risk of developing an abnormal blood clot. See page 13 No increased risk of statin-induced myopathy expected at low to moderate doses. See page 13 Higher warfarin doses may be required to produce the desired anticoagulant effect. Excessive anticoagulant activity is associated with an increased risk of serious bleeding. See page 13 Copyrighted and Patent Pending 2016, Elevated Capital Group, LLC (d/b/a MyGenesRx). All rights reserved. 6

7 Your Individual Gene Review Your Individual Gene Review reports on each tested gene and describes how your unique genotype and phenotype may impact medications. This section also illustrates the most commonly prescribed medications each gene effects. CYP2D6 Extensive (Normal) This genotype predicts normal metabolic activity for the enzyme controlled by this gene. COMMON MEDICINES METABOLIZED BY CYP2D6 amitriptyline (Elavil) amphetamine (Adderall) aripiprazole (Abilify) asenapine (Saphris) atomoxetine (Strattera) bupropion (Wellbutrin) chlorpromazine (Thorazine) citalopram (Celexa) * clomipramine (Anafranil) desipramine (Norpramin) desvenlafaxine (Pristiq)* doxepin (Sinequan, Silenor, Prudoxin, Zonalon) duloxetine (Cymbalta) escitalopram (Lexapro) fluoxetine (Prozac) Neuropsychiatric haloperidol (Haldol) iloperidone (Fanapt) imipramine (Tofranil) mirtazapine (Remeron) * nortriptyline (Aventyl,Pamelor) olanzapine (Zyprexa) * paroxetine (Paxil) perphenazine (Trilafon) quetiapine (Seroquel) * risperidone (Risperdal) sertraline (Zoloft) * tacrine (Cognex) thioridazine (Mellaril) trazadone (Oleptro) * venlafaxine (Effexor) Pain celecoxib (Celebrex) * codeine++ cyclobenzaprine (Flexeril) * hydrocodone++ ibuprofen * methadone * oxycodone++ (Oxycontin) tiagabine (Gabitril) * tramadol++ (Ultram) Anti-Infectives indinavir (Crixivan) * ritonavir (Norvir) * carvedilol (Coreg) flecainide (Tambocor) lercandipine (Zandip) metoprolol (Lopressor, Toprol) nebivolol (Bystolic) Cardiovascular propafenone (Rythmol) propanolol (Inderal) quinidine (various brands) timolol (Blocadren) tamoxifen ++ Oncology ++ Pro-drug; may not be effective in Poor s due to inability to metabolize and produce active metabolite * The enzyme encoded by this gene is a minor metabolic pathway for this drug (of minor clinical importance) Copyrighted and Patent Pending 2016, Elevated Capital Group, LLC (d/b/a MyGenesRx). All rights reserved. 7

8 Your Individual Gene Review, Continued CYP2C19 Ultra-Rapid Extremely rapid metabolic enzyme activity expected for the enzyme controlled by this gene. It may be difficult to achieve effective drug concentrations. ++ Caution should be observed with pro-drugs, e.g., clopidogrel. Excessive active metabolite formation may occur and a high risk for adverse drug reactions exists (e.g., for clopidogrel this can lead to increased risk for serious bleeding). COMMON MEDICINES METABOLIZED BY CYP2C19 citalopram (Celexa) clomipramine (Analafril) * diazepam (Valium) doxepin (Sinequan, Silenor, Prudoxin, Zonalon) escitalopram (Lexapro) imipramine (Tofranil) efavirenz (Sustiva) * nelfinavir (Viracept) Neuropsychiatric paroxetine (Paxil) * perphenazine (Trilafon) * phenobarbital phenytoin (Dilantin) sertraline (Zoloft) venlafaxine (Effexor) * vilazodone (Viibryd) * Antivirals, Hormones, and Anti-Diabetics progesterone * tolbutamide (Orinase) * Pain carisoprodol ++ (Soma) ibuprofen * meperidine (Demerol) methadone tapentadol (Nucynta) GERD esomeprazole (Nexium) lansoprazole (Prevacid) omeprazole (Prilosec) pantoprazole (Protonix) rabeprazole (Aciphex) clopidogrel ++ Anticoagulant Anti-Infectives indinavir (Crixivan) * ritonavir (Norvir) * ++ Pro-drug; may not be effective in Poor s due to inability to metabolize and produce active metabolite * The enzyme encoded by this gene is a minor metabolic pathway for this drug (of minor clinical importance) Copyrighted and Patent Pending 2016, Elevated Capital Group, LLC (d/b/a MyGenesRx). All rights reserved. 8

9 Your Individual Gene Review, Continued CYP3A4 CYP3A5 Extensive (Normal) Poor The expected metabolic activities for the enzymes controlled by these genes are shown at left. CYP3A4 and CYP3A5 are so similar that they generally affect the same drugs. If you are normal for one of these genes, then you can expect to metabolize these drugs normally. If you are impaired for both of these genes, then there is increased potential for drug accumulation and adverse drug reactions. COMMON MEDICINES METABOLIZED BY CYP3A4 and CYP3A5 alfentanil (Alfenta) codeine * cyclobenzaprine (Flexeril) fentanyl (Actiq, Duragesic, Sublimaze) hydrocodone * ibuprofen * alprazolam (Xanax) amphetamine (Adderall) * aripiprazole (Abilify) atomoxetine (Strattera) * buspirone (Buspar) carbamazepine (Tegretol, Various brands) chlorpromazine (Thorazine) * citalopram (Celexa) * clomipramine (Anafranil) * clozapine (Clozaril) * desvenlafaxine (Pristiq) diazepam (Valium) escitalopram (Lexapro) * fluoxetine (Prozac) * haloperidol (Haldol) iloperidone (Fanapt) lurasidone (Latuda) Pain lidocaine (xylocaine, various) * meperidine (Demerol) methadone oxycodone (Oxycontin) ropivacaine (Naropin) * tizanidine (Zanaflex) * tramadol (Ultram) * Neuropsychiatric midazolam (Versed) mirtazapine (Remeron) nefazodone (Serzone) paroxetine (Paxil) * perphenazine (Trilafon) phenytoin (Dilantin) * promazine (Sparine) quetiapine (Seroquel) sertraline (Zoloft) * thioridazine (Mellaril) tiagabine (Gabitril) trazodone (Oleptro) triazolam (Halcion) venlafaxine (Effexor) * vilazodone (Viibryd) ziprasidone (Geodon) zolpidem (Ambien) zonisamide (Zonegran) Cardiovascular amiodarone (Cordarone) amlodipine (Norvasc) atorvastatin (Lipitor, Caduet) carvedilol (Coreg) * clopidogrel (Plavix) * diltiazem (Cardizem) dofetalide (Tikosyn) felodipine (Plendil) fluvastatin (Lescol) * lercanidipine (Zanidip) losartan (Cozaar) lovastatin (Mevacor) nifedipine (Adalat, Procardia) nisoldipine (Sular) nitrendipine propafenone (Rythmol) quinidine (Various brands) ranolazine (Ranexa) rivaroxaban (Xarelto) simvastatin (Zocor) ticagreglor (Brilinta) Oncology docetaxel (Taxotere) tamoxifen (Nolvades) * vincristine (Vincasar, Oncovin) clarithromycin (Biaxin) efavirenz (Sustiva) erythromycin (E-Mycin) indinavir (Crixivan) Anti-Infective nelnavir (Viracept) ritonavir (Norvir) saquinavir (Invirase) telithromycin (Ketek) Hormonal / Endocrine estradiol hydrocortisone progesterone testosterone Copyrighted and Patent Pending 2016, Elevated Capital Group, LLC (d/b/a MyGenesRx). All rights reserved. 9

10 esomeprazole (Nexium) lansoprazole (Prevacid) omeprazole (Prilosec) * Gastrointestinal pantoprazole (Protonix) * rabeprazole (Aciphex) Antidiabetic glipizide (Glucotrol) * glyburide (Diabeta) cyclosporine (Gengraf) Immunosuppressant tacrolimus (Prograf) Impotence sildenafil (Viagra) cyclophosphamide (Cytoxan) * ifosfamide zafirlukast (Accolate) * Immunomodulation ++ Pro-drug; may not be effective in Poor s due to inability to metabolize and produce active metabolite * The enzyme encoded by this gene is a minor metabolic pathway for this drug (of minor clinical importance) Copyrighted and Patent Pending 2016, Elevated Capital Group, LLC (d/b/a MyGenesRx). All rights reserved. 10

11 Your Individual Gene Review, Continued CYP2C9 Extensive (Normal) This genotype predicts normal metabolic activity for the enzyme controlled by this gene. COMMON MEDICINES METABOLIZED BY CYP2C9 carvedilol (Coreg) * clopidogrel (Plavix) * fluvastatin (Lescol) glimepiride (Amaryl) glipizide (Glucotrol) carisoprodol celecoxib (Celebrex) ibuprofen (Advil, Motrin) Cardiovascular glyburide (Diabeta) losartan (Cozaar) rosuvastatin (Crestor) tolbutamide (Orinase) warfarin (Coumadin) Pain methadone * naproxen (Aleve) tapentadol (Nucynta) Steroids progesterone Anti-Infectives efavirenz (Sustiva) * Oncology tamoxifen (Nolvadex) * fluoxetine (Prozac) * phenobarbital phenytoin (Dilantin) Neuropsychiatric Other sildenafil (Viagra) * zarlukast (Accolate) Immunomodulation ++ Pro-drug; may not be effective in Poor s due to inability to metabolize and produce active metabolite * The enzyme encoded by this gene is a minor metabolic pathway for this drug (of minor clinical importance) Copyrighted and Patent Pending 2016, Elevated Capital Group, LLC (d/b/a MyGenesRx). All rights reserved. 11

12 Your Individual Gene Review, Continued CYP1A2 Ultra-Rapid Extremely rapid metabolism expected for the enzyme controlled by this gene, especially in smokers. It may be difficult to achieve effective drug concentrations. COMMON MEDICINES METABOLIZED BY CYP1A2 amphetamine (Adderall) * asenapine (Saphris) clomipramine (Anafranil) * clozapine (Clozaril) duloxetine (Cymbalta) mirtazapine (Remeron olanzapine (Zyprexa) Neuropsychiatric paroxetine (Paxil) * perphenazine (Trilafon) * promazine (Sparine) tacrine (Cognex) tiagabine (Gabitril) * thioridazine (Mellaril) ziprasidone (Geodon) * Other caffeine carvedilol (Coreg) * clopidogrel (Plavix) * estradiol propranolol (Inderal) ritonavir (Norvir) * theophylline cyclobenzaprine (Flexeril) naproxen (Aleve) tizanidine (Zanaflex) zolmitriptan (Zomig) Pain and Local Anesthetics lidocaine (xylocaine, various brands) ropivacaine (Naropin) ++ Pro-drug; may not be effective in Poor s due to inability to metabolize and produce active metabolite * The enzyme encoded by this gene is a minor metabolic pathway for this drug (of minor clinical importance) Copyrighted and Patent Pending 2016, Elevated Capital Group, LLC (d/b/a MyGenesRx). All rights reserved. 12

13 Your Individual Gene Review, Continued VKORC1 G/G - C/C SLCO1B1 *1/*1B Factor II G/G Factor V G/G OPRM1 A/G MTHFR A/A - C/T Low Warfarin Sensitivity Normal Function Normal Function Normal Function Intermediate Opioid Responder Impaired Function Higher warfarin doses may be required to produce the desired anticoagulant effect. Excessive anticoagulant activity is associated with an increased risk of serious bleeding. No increased risk of statin-induced myopathy expected at low to moderate doses. The patient is wildtype for Factor II Prothrombin. Patients with this genotype (G/G) are associated with a normal risk of developing an abnormal blood clot. The patient is wildtype for Factor V Prothrombin. Patients with this genotype (G/G) are associated with a normal risk of developing an abnormal blood clot. Impaired opiate receptor function expected. Morphine and other active opiates (e.g., oxymorphone, fentanyl) may not produce a usual analgesic response. Increased doses may be required. This genotype predicts impaired function of the enzyme methylenetetrahydrofolate reductase (MTHFR). This enzyme plays a crucial role in converting dietary folate into methylfolate, the active form of this critical B vitamin. Impaired MTHFR function is associated with methylfolate deficiency which can lead to impaired neurotransmitter synthesis and other biochemical abnormalities. Dietary supplementation with L- methylfolate supplements may be benificial to your health. Copyrighted and Patent Pending 2016, Elevated Capital Group, LLC (d/b/a MyGenesRx). All rights reserved. 13

14 Notice: The interpretation of these results is meant to assist the ordering clinician with managing a patient's drug regimen and is not intended to be used as a treatment recommendation. Only qualified healthcare professionals should provide advice to patients regarding the use of prescribed or OTC medications. Patient treatment and diagnosis is the sole responsibility of the ordering clinician. It is strongly recommended that these results be communicated to the patient in a setting that includes appropriate counseling. The individual response to medications is multifactorial. This test should not be used as the sole means of treatment decision making and should be regarded by the ordering physician as adjunctive to the overall patient management strategy. Besides genetic variants, further variables, for example, age, disease, comorbidity, concomitant medication, organ function and patient compliance may have an impact on pharmacotherapy and need to be addressed when medication is prescribed. Drug-drug and drug-gene interactions that lead to enzymatic inhibition and induction may lead to altered metabolism. Results should always be interpreted in context with the clinical picture and all co-administered medication. Results should be taken into the whole clinical picture and should not supersede the provider's clinical judgment. Therefore, UTC Laboratories, LLC and employees of UTC Laboratories, LLC shall have no liability to any person or entity with regard to claims, loss, or damage caused, or alleged to be caused, directly or indirectly, by the use of information contained herein. This test was developed and its performance characteristics determined by UTC Laboratories, LLC. It has not been cleared or approved by the US Food and Drug Administration. FDA does not require this test to go through premarket FDA review. This test is used for clinical purposes. It should not be regarded as investigational or for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical laboratory testing. References UTC Laboratories, LLC may utilize one or more of the following references in connection with the preparation of this report: PharmGKB, located at Dosing Guidelines of the Clinical Pharmacogenetics Implementation Consortium (CPIC), located at FDA labeling information, located at Epocrates, located at Lexicomp, located at Langman L and Dasgupta A. Pharmacogenomics in Clinical Therapeutics. Hoboken:Wiley-Blackwell, Copyrighted and Patent Pending 2016, Elevated Capital Group, LLC (d/b/a MyGenesRx). All rights reserved. 14