Comprehensive Drug Information for Smith, John

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PATIENT INFORMATION Name: Smith, John DOB: April 22, 1973 Age: 42 Sex: Male SAMPLE Date Collected: March 21, 2016 Date Received: March 21, 2016 Case ID: CARDI16-000001 Source: Buccal Swabs

1 PATIENT INFORMATION Name: Smith, John DOB: April 22, 1973 Age: 42 Sex: Male SAMPLE Date Collected: March 21, 2016 Date Received: March 21, 2016 Case ID: CARDI Source: Buccal Swabs Comprehensive Drug Information for Smith, John ICD-10: I10 Essential (primary) hypertension; I25.10 Athscl heart disease of native coronary artery w/o ang pctrs Admera Health, LLC REFERRING PHYSICIAN Name: Jane Doe, MD Institution: Local Hospital Atorvastatin (Lipitor ) Metoprolol (Lopressor ) by 50% Lovastatin (Mevacor ) Simvastatin (Zocor ) Atorvastatin (Lipitor ) Lovastatin (Mevacor ) to lowest necessary dose daily Ivabradine (Corlentor ) Simvastatin (Zocor ) Metoprolol (Lopressor ) Ticagrelor (Brilinta ) Warfarin (Coumadin ) NORMAL DOSE Warfarin daily dose 5-7mg Amlodipine (Norvasc ) Atenolol (Tenormin ) Diltiazem (Cardizem ) Carvedilol (Coreg ) Felodipine (Plendil ) Clopidogrel (Plavix ) Lercanidipine (Zanidip ) Phenprocoumon (Marcoumar ) Nifedipine (Adalat ) Nisoldipine (Sular ) Only selected drugs are listed here due to limited space. Please refer to Patient Specific Genotype Results table for comprehensive illustration of drugs in each action category. PGxCardio Report for Smith, John Laboratory Director: Dr. James Dermody CLIS ID: CLIA ID: 31D Page 1 of 11

2 Patient Specific Genotype Results and Comprehensive Drug Information for Smith, John ICD-10: I10 Essential (primary) hypertension;i25.10 Athscl heart disease of native coronary artery w/o ang pctrs Action Drug Impacted Clinical Interpretation Gene Genotype Phenotype Antianginal Drugs: Ivabradine (Corlentor ) CYP3A4 *1B/*1B Poor Antiplatelets: Ticagrelor (Brilinta ) CYP3A4 *1B/*1B Poor Metoprolol (Lopressor ) Atorvastatin (Lipitor ), Lovastatin (Mevacor ), Simvastatin (Zocor ) Rivaroxaban (Xarelto ) Calcium Channel Blockers: Amlodipine (Norvasc ), Diltiazem (Cardizem ), Felodipine (Plendil ), Lercanidipine (Zanidip ), Nifedipine (Adalat ), Nisoldipine (Sular ), Nitrendipine (Nitrepin ), Verapamil (Calan ) Antianginal Drugs: Ranolazine (Ranexa ) (e.g., bisoprolol, carvedilol) OR by 50% due to heart failure caused by the decreased drug cardioselectivity (e.g., pitavastatin, pravastatin, rosuvastatin) OR to lowest necessary dose daily due to Increased risk for myopathy and rhabdomyolysis due to increased bleeding risk due to significant increase in drug exposure and therefore clinical monitoring and dose adjustment may thus be required CYP2D6 *10/*41 Intermediate CYP3A4 *1B/*1B Poor CYP3A4 *1B/*1B Poor CYP3A4 *1B/*1B Poor CYP2D6 *10/*41 Intermediate PGxCardio Report for Smith, John Laboratory Director: Dr. James Dermody CLIS ID: CLIA ID: 31D Page 2 of 11

3 Action Drug Impacted Clinical Interpretation Gene Genotype Phenotype Phenprocoumon (Marcoumar ) CYP4F2 *1/*1 Normal Warfarin (Coumadin ) NORMAL DOSE Warfarin daily dose 5-7mg CYP2C9 *1/*1 Normal Warfarin (Coumadin ) NORMAL DOSE Warfarin daily dose 5-7mg VKORC1 WT/-1639G>A rs A Allele Carrier Antiplatelets: Clopidogrel (Plavix ) CYP2C19 *1/*17 Ultrarapid Atenolol (Tenormin ) LDLR WT/c.*773A>G rs G Allele Carrier Carvedilol (Coreg ) CYP2D6 *10/*41 Intermediate Pitavastatin (Livalo ), Pravastatin (Pravachol ), Rosuvastatin (Crestor ) SLCO1B1 *1/*1 Normal Activity PGxCardio Report for Smith, John Laboratory Director: Dr. James Dermody CLIS ID: CLIA ID: 31D Page 3 of 11

Current Medication Information for Smith, John Action Drug Impacted Clinical Interpretation Gene Genotype Phenotype

, bisoprolol, carvedilol) OR CYP2D6 *10/*41 Intermediate Calcium Channel Blockers: Norvasc Crestor by 50% due to heart

monitoring and dose adjustment may thus be required CYP3A4 *1B/*1B Poor SLCO1B1 *1/*1 Normal Activity Analgesic: Aspir 81

4 Current Medication Information for Smith, John Action Drug Impacted Clinical Interpretation Gene Genotype Phenotype Metoprolol (e.g., bisoprolol, carvedilol) OR CYP2D6 *10/*41 Intermediate Calcium Channel Blockers: Norvasc Crestor by 50% due to heart failure caused by the decreased drug cardioselectivity due to significant increase in drug exposure and therefore clinical monitoring and dose adjustment may thus be required CYP3A4 *1B/*1B Poor SLCO1B1 *1/*1 Normal Activity Analgesic: Aspir 81 CLINICAL EVIDENCE NOT SUFFICIENT CYP2D6 *10/*41 Intermediate Vitamins: Niacin CLINICAL INTERPRETATION NOT AVAILABLE NA NA NA PGxCardio Report for Smith, John Laboratory Director: Dr. James Dermody CLIS ID: CLIA ID: 31D Page 4 of 11

Drug-Drug Interactions for Smith, John Severity Drugs Warning Documentation Clinical Management Rosuvastatin -- Niacin Metoprolol -- Aspir 81 MAJOR Concurrent use of ROSUVASTATIN and NIACIN may

MODERATE Concurrent use of BETA- ADRENERGIC BLOCKERS and NONSTEROIDAL ANTIINFLAMMATORY AGENTS may result in decreased antihypertensive effect.

5 Drug-Drug Interactions for Smith, John Severity Drugs Warning Documentation Clinical Management Rosuvastatin -- Niacin Metoprolol -- Aspir 81 MAJOR Concurrent use of ROSUVASTATIN and NIACIN may result in an increased risk of myopathy or rhabdomyolysis. MODERATE Concurrent use of BETA- ADRENERGIC BLOCKERS and NONSTEROIDAL ANTIINFLAMMATORY AGENTS may result in decreased antihypertensive effect. Good Good Weigh the benefit of further alteration in lipid levels relative to the increased risk of this combination of agents. If concurrent therapy is required, monitor the patient for signs and symptoms of myopathy or rhabdomyolysis (muscle pain, tenderness, or weakness). Periodic CK determinations may be advisable in patients who are just starting or are increasing their dose of rosuvastatin, and in patients with complicated medical histories. Discontinue use if CK levels show a marked increase, or if myopathy or rhabdomyolysis is diagnosed or suspected. Use caution if an NSAID and a beta-adrenergic blocker are coadministered (Prod Info VIMOVO(TM) delayed release oral tablets, 2010). If concurrent therapy is required, monitor the patient's blood pressure carefully and assess the need for a dosage adjustment of the beta-blocker. PGxCardio Report for Smith, John Laboratory Director: Dr. James Dermody CLIS ID: CLIA ID: 31D Page 5 of 11

6 Portable Patient PGxCardio Genotype Results and Drug Information by Specialty for Smith, John Therapeutic Action Drug Impacted Clinical Interpretation Gene Genotype Phenotype Antianginal Drugs: Ivabradine (Corlentor ) CYP3A4 *1B/*1B Poor Antiarrhythmic Drugs: Amiodarone (Cordarone ), Dronedarone (Multaq ) Antiarrhythmic Drugs: Propafenone (Rythmol ) Antiplatelets: Ticagrelor (Brilinta ) CYP3A4 *1B/*1B Poor CYP2D6 *10/*41 Intermediate (e.g., sotalol, disopyramide, quinidine, amiodarone) CYP3A4 *1B/*1B Poor Metoprolol (Lopressor ) (e.g., bisoprolol, carvedilol) CYP2D6 *10/*41 Intermediate OR by 50% due to heart failure caused by the decreased drug cardioselectivity Atorvastatin (Lipitor ), Lovastatin (Mevacor ), Simvastatin (Zocor ) (e.g., pitavastatin, pravastatin, rosuvastatin) OR CYP3A4 *1B/*1B Poor to lowest necessary dose daily due to Increased risk for myopathy and rhabdomyolysis Antiarrhythmic Drugs: Flecainide (Tambocor ) by 25% CYP2D6 *10/*41 Intermediate Phosphodiesterase Inhibitors: Cilostazol (Pletal ) by 50% CYP3A4 *1B/*1B Poor Rivaroxaban (Xarelto ) due to increased bleeding risk CYP3A4 *1B/*1B Poor PGxCardio Report for Smith, John Laboratory Director: Dr. James Dermody CLIS ID: CLIA ID: 31D Page 6 of 11

7 Therapeutic Action Drug Impacted Clinical Interpretation Gene Genotype Phenotype Calcium Channel CYP3A4 *1B/*1B Poor Blockers: due to significant increase in Amlodipine (Norvasc ), Diltiazem (Cardizem ), Felodipine (Plendil ), drug exposure and therefore clinical monitoring and dose adjustment may thus be Lercanidipine (Zanidip ), required Nifedipine (Adalat ), Nisoldipine (Sular ), Nitrendipine (Nitrepin ), Verapamil (Calan ) Atorvastatin (Lipitor ), Lovastatin (Mevacor ), Simvastatin (Zocor ) due to impaired efficacy CYP3A5 *1A/*1A High Expresser Antianginal Drugs: CYP2D6 *10/*41 Intermediate Ranolazine (Ranexa ) Phenprocoumon (Marcoumar ) CYP4F2 *1/*1 Normal Warfarin (Coumadin ) NORMAL DOSE Warfarin daily dose 5-7mg CYP2C9 *1/*1 Normal Warfarin (Coumadin ) NORMAL DOSE Warfarin daily dose 5-7mg VKORC1 WT/-1639G>A rs A Allele Carrier Antiplatelets: Clopidogrel (Plavix ) CYP2C19 *1/*17 Ultrarapid Atenolol (Tenormin ) LDLR WT/c.*773A> G rs G Allele Carrier Carvedilol (Coreg ) CYP2D6 *10/*41 Intermediate Pitavastatin (Livalo ), Pravastatin (Pravachol ), Rosuvastatin (Crestor ) Simvastatin (Zocor ) SLCO1B1 *1/*1 Normal Activity SLCO1B1 *1/*1 Normal Activity PGxCardio Report for Smith, John Laboratory Director: Dr. James Dermody CLIS ID: CLIA ID: 31D Page 7 of 11

8 Patient PGxCardio Genotype and Phenotype Results for Smith, John Gene Genotype Phenotype CYP2C19 *1/*17 Ultrarapid CYP2C9 *1/*1 Normal CYP2D6 *10/*41 Intermediate CYP3A4 *1B/*1B Poor CYP3A5 *1A/*1A High Expresser CYP4F2 *1/*1 Normal LDLR WT/c.*773A>G rs G Allele Carrier SLCO1B1 *1/*1 Normal Activity VKORC1 WT/-1639G>A rs A Allele Carrier PGxCardio Report for Smith, John Laboratory Director: Dr. James Dermody CLIS ID: CLIA ID: 31D Page 8 of 11

9 PGxCardio Panel Genes and Variants: This test only detects those genes and variants listed below. A normal (wild type) genotype signifies the absence of the targeted alleles and does not indicate the absence of other mutations not covered by the assay. The possibility cannot be ruled out that the indicated genotypes may be present but below the limits of detection for this assay. The panel includes 9 genes and 68 variants based on the recommendations of the Clinical Pharmacogenetics Implementation Consortium (CPIC) and Dutch Pharmacogenetics Working Group (DPWG) and the FDA s work group guidance. Gene Allele Type Alleles CYP2C19 CYP2C9 CYP2D6 CYP3A4 CYP3A5 CYP4F2 LDLR Increased Activity Inactive Inactive Inactive Deletion Amplification Inactive *1 *17 *9, *10 *2, *3, *4, *5, *6, *7, *8, *12 *1 *2, *3, *4, *5, *8, *9, *11, *12, *13, *14, *16 *6, *15 *1, *2, *35, *9, *10, *17, *29, *36, *41 *3, *4, *6, *7, *8, *11, *12, *14, *15, *19, *20, *40 *5 *1XN, *2XN, *4XN, *10XN, *17XN, *41XN *1A *1B, *2, *3, *12, *17 *1A *1D, *2, *7, *8, *9 *3A, *3B, *6 *1 *3 rs688 SLCO1B1 *5 VKORC1 Increased Warfarin Sensitivity -1639G>A PGxCardio Report for Smith, John Laboratory Director: Dr. James Dermody CLIS ID: CLIA ID: 31D Page 9 of 11

10 Assay Methodology and Limitations for PGxCardio Panel: Pharmacogenomics testing to assess how a patient may respond to prescribed drugs was performed by massively parallel Next Generation Sequencing (NGS). PGxCardio was developed, and assessed for accuracy and precision by Admera Health, South Plainfield NJ. The sensitivity and specificity of this test is 100% and 100% respectively. PGxCardio has not been cleared or approved by the U.S. Food and Drug Administration (FDA) but the FDA has determined that such clearance or approval is not necessary. The PGxCardio test is used for clinical purposes. It should not be regarded as investigational or for research. Drug interaction information is based upon data available in scientific literature and prescribing information for the most commonly prescribed drugs. This laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical laboratory testing. The DNA testing is not a substitute for clinical monitoring. Warnings & Precautions for PGxCardio Recommended Drugs: Atenolol (Tenormin ): Carvedilol (Coreg ): Clopidogrel (Plavix ): Pitavastatin (Livalo ): Pravastatin (Pravachol ): Ranolazine (Ranexa ): Rosuvastatin (Crestor ): Warfarin (Coumadin ): General Pharmacogenomics References: 1. Drug labels with pharmacogenomics information: 2. Pharmacogenomics drug dosing guidelines: 3. FDA Orange Book Search Engine: PGxCardio Report for Smith, John Laboratory Director: Dr. James Dermody CLIS ID: CLIA ID: 31D Page 10 of 11

11 Disclaimer of Liability: The information contained in this report is provided as a service and does not constitute medical advice. At the time of report generation this information is believed to be current and is based upon published research; however, research data evolves and amendments to the prescribing information of the drugs listed will change over time. While this report is believed to be accurate and complete as of the date issued, THE DATA IS PROVIDED "AS IS", WITHOUT WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. As medical advice must be tailored to the specific circumstances of each case, the treating health care professional has ultimate responsibility for all treatment decisions made with regard to a patient including any made on the basis of a patient's genotype. Electronic Signature Laboratory Director ABMG Certified, Clinical Molecular Genetics PGxCardio Report for Smith, John Laboratory Director: Dr. James Dermody CLIS ID: CLIA ID: 31D Page 11 of 11

Dynamic DNA Laboratories, LLC - DO NOT DISTRIBUTE

Dynamic DNA Laboratories, LLC - DO NOT DISTRIBUTE Cardiovascular Pharmacogenetic Report Created for: Patty Pain Patient: Patty Pain DOB: 1/1/1970 Accession #: 988889 SSN: Collection Date: Received Date: Ordering Physician: Report Generated: 1/28/2016