admera health, llc...good weigh the benefit of further alteration in lipid levels relative to the...

Comprehensive Drug Information for Smith, JohnICD-10: I10 Essential (primary) hypertension; I25.10 Athscl heart disease of native coronary artery w/o ang pctrs

Atorvastatin (Lipitor®)

Lovastatin (Mevacor®)

Simvastatin (Zocor®)

CONSIDER ALTERNATIVES

Ivabradine (Corlentor®)

Metoprolol (Lopressor®)

Ticagrelor (Brilinta®)

Metoprolol (Lopressor®)

DECREASE DOSEby 50%

Atorvastatin (Lipitor®)

Lovastatin (Mevacor®)

Simvastatin (Zocor®)

DECREASE DOSEto lowest necessary dose daily

Warfarin (Coumadin®)

NORMAL DOSEWarfarin daily dose 5-7mg

Atenolol (Tenormin®)

NORMAL RESPONSE EXPECTED

Carvedilol (Coreg®)

Clopidogrel (Plavix®)

Phenprocoumon (Marcoumar®)

Amlodipine (Norvasc®)

Diltiazem (Cardizem®)

Felodipine (Plendil®)

Lercanidipine (Zanidip®)

Nifedipine (Adalat®)

Nisoldipine (Sular®)

USE CAUTION

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.

PATIENT INFORMATION Name: Smith, John

DOB: April 22, 1973Age: 42Sex: Male

SAMPLEDate Collected: March 21, 2016Date Received: March 21, 2016

Case ID: CARDI16-000001Source: Buccal Swabs

REFERRING PHYSICIANName: Jane Doe, MD

Institution: Local Hospital

PGxCardio™ Report for Smith, John Laboratory Director: Dr. James Dermody CLIS ID: 0005783 CLIA ID: 31D2038676 of 11

Admera Health, LLC126 Corporate Blvd · South Plainfield, NJ 07080

+1-908-222-0533 · [email protected]

Action Drug Impacted Clinical Interpretation Gene Genotype Phenotype

Antianginal Drugs:Ivabradine (Corlentor®)


CYP3A4 *1B/*1B Poor Metabolizer

Antiplatelets:Ticagrelor (Brilinta®)



Beta Blockers:Metoprolol (Lopressor®)

CONSIDER ALTERNATIVES(e.g., bisoprolol, carvedilol)

OR

CYP2D6 *10/*41 Intermediate Metabolizer

DECREASE DOSEby 50% due to heart failure caused by the decreased drug cardioselectivity

Statins:Atorvastatin (Lipitor®), Lovastatin (Mevacor®), Simvastatin (Zocor®)

CONSIDER ALTERNATIVES(e.g., pitavastatin, pravastatin, rosuvastatin)

OR


DECREASE DOSEto lowest necessary dose daily due to Increased risk for myopathy and rhabdomyolysis

Anticoagulants:Rivaroxaban (Xarelto®)

USE CAUTIONdue to increased bleeding risk


Calcium Channel Blockers:Amlodipine (Norvasc®), Diltiazem (Cardizem®), Felodipine (Plendil®), Lercanidipine (Zanidip®), Nifedipine (Adalat®), Nisoldipine (Sular®), Nitrendipine (Nitrepin®), Verapamil (Calan®)

USE CAUTIONdue to significant increase in drug exposure and therefore clinical monitoring and dose adjustment may thus be required


Antianginal Drugs:Ranolazine (Ranexa®)




Antianginal Drugs:Ivabradine (Corlentor®)



Antiplatelets:Ticagrelor (Brilinta®)



Beta Blockers:Metoprolol (Lopressor®)


OR



Statins:Atorvastatin (Lipitor®), Lovastatin (Mevacor®), Simvastatin (Zocor®)


OR



Anticoagulants: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®)



Patient Specific Genotype Resultsand Comprehensive Drug Information forSmith, JohnICD-10: I10 Essential (primary) hypertension;I25.10 Athscl heart disease of native coronary artery w/o ang pctrs





Anticoagulants:Phenprocoumon (Marcoumar®)


CYP4F2 *1/*1 Normal Metabolizer

Anticoagulants:Warfarin (Coumadin®)


CYP2C9 *1/*1 Normal Metabolizer



VKORC1 WT/-1639G>A rs9923231 A Allele Carrier

Antiplatelets:Clopidogrel (Plavix®)


CYP2C19 *1/*17 Ultrarapid Metabolizer

Beta Blockers:Atenolol (Tenormin®)


LDLR WT/c.*773A>G rs2738466 G Allele Carrier

Beta Blockers:Carvedilol (Coreg®)



Statins:Pitavastatin (Livalo®), Pravastatin (Pravachol®), Rosuvastatin (Crestor®)


SLCO1B1 *1/*1 Normal Activity


Anticoagulants:Phenprocoumon (Marcoumar®)









Antiplatelets:Clopidogrel (Plavix®)



Beta Blockers:Atenolol (Tenormin®)



Beta Blockers:Carvedilol (Coreg®)



Statins:Pitavastatin (Livalo®), Pravastatin (Pravachol®), Rosuvastatin (Crestor®)








OR







Analgesic:Aspir 81

CLINICAL EVIDENCE NOT SUFFICIENT

CYP2D6

Vitamins:Niacin

CLINICAL INTERPRETATION NOT AVAILABLE

NA NA NA


Beta BlockersBeta Blockers::Metoprolol


OR



Calcium ChannelCalcium Channel BlockersBlockers::Norvasc



StatinsStatins::Crestor



Analgesic:Aspir 81

CLINICAL EVIDENCE NOT SUFFICIENT

CYP2D6

Vitamins:Niacin

CLINICAL INTERPRETATION NOT AVAILABLE

NA NA NA

Current Medication Information forSmith, John




**10/*4110/*41 Intermediate MetabolizerIntermediate Metabolizer

Drug-Drug Interactions forSmith, John

Severity Drugs Warning Documentation Clinical Management

Rosuvastatin --Niacin

MAJORConcurrent use of ROSUVASTATIN and NIACIN may result in an increased risk of myopathy or rhabdomyolysis.

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.

Metoprolol --Aspir 81

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

Good 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.




Therapeutic Action Drug Impacted Clinical Interpretation Gene Genotype Phenotype

Cardiology Antianginal Drugs:Ivabradine (Corlentor®)

CONSIDER ALTERNATIVES CYP3A4 *1B/*1B Poor Metabolizer

Cardiology Antiarrhythmic Drugs:Amiodarone (Cordarone®), Dronedarone (Multaq®)


Cardiology Antiarrhythmic Drugs:Propafenone (Rythmol®)

CONSIDER ALTERNATIVES(e.g., sotalol, disopyramide, quinidine, amiodarone)


Cardiology Antiplatelets:Ticagrelor (Brilinta®)


Cardiology Beta Blockers:Metoprolol (Lopressor®)


OR



Cardiology Statins:Atorvastatin (Lipitor®), Lovastatin (Mevacor®), Simvastatin (Zocor®)


OR



Cardiology Antiarrhythmic Drugs:Flecainide (Tambocor®)

DECREASE DOSEby 25%


Cardiology Phosphodiesterase Inhibitors:Cilostazol (Pletal®)

DECREASE DOSEby 50%


Cardiology Anticoagulants:Rivaroxaban (Xarelto®)




Cardiology Antianginal Drugs:Ivabradine (Corlentor®)


Cardiology Antiarrhythmic Drugs:Amiodarone (Cordarone®), Dronedarone (Multaq®)


Cardiology Antiarrhythmic Drugs:Propafenone (Rythmol®)

CONSIDER ALTERNATIVES(e.g., sotalol, disopyramide, quinidine, amiodarone)


Cardiology Antiplatelets:Ticagrelor (Brilinta®)


Cardiology Beta Blockers:Metoprolol (Lopressor®)


OR





OR



Cardiology Antiarrhythmic Drugs:Flecainide (Tambocor®)

DECREASE DOSEby 25%


Cardiology Phosphodiesterase Inhibitors:Cilostazol (Pletal®)

DECREASE DOSEby 50%


Cardiology Anticoagulants:Rivaroxaban (Xarelto®)



Portable Patient PGxCardio™ Genotype Results and Drug Information by Specialty forSmith, John





Cardiology Calcium Channel Blockers:Amlodipine (Norvasc®), Diltiazem (Cardizem®), Felodipine (Plendil®), Lercanidipine (Zanidip®), Nifedipine (Adalat®), Nisoldipine (Sular®), Nitrendipine (Nitrepin®), Verapamil (Calan®)




USE CAUTIONdue to impaired efficacy

CYP3A5 *1A/*1A High Expresser

Cardiology Antianginal Drugs:Ranolazine (Ranexa®)



Cardiology Anticoagulants:Phenprocoumon (Marcoumar®)



Cardiology Anticoagulants:Warfarin (Coumadin®)






Cardiology Antiplatelets:Clopidogrel (Plavix®)



Cardiology Beta Blockers:Atenolol (Tenormin®)


LDLR WT/c.*773A>G

rs2738466 G Allele Carrier

Cardiology Beta Blockers:Carvedilol (Coreg®)



Cardiology Statins:Pitavastatin (Livalo®), Pravastatin (Pravachol®), Rosuvastatin (Crestor®)



Cardiology Statins:Simvastatin (Zocor®)




Cardiology Calcium Channel Blockers:Amlodipine (Norvasc®), Diltiazem (Cardizem®), Felodipine (Plendil®), Lercanidipine (Zanidip®), Nifedipine (Adalat®), Nisoldipine (Sular®), Nitrendipine (Nitrepin®), Verapamil (Calan®)




USE CAUTIONdue to impaired efficacy


Cardiology Antianginal Drugs:Ranolazine (Ranexa®)



Cardiology Anticoagulants:Phenprocoumon (Marcoumar®)









Cardiology Antiplatelets:Clopidogrel (Plavix®)



Cardiology Beta Blockers:Atenolol (Tenormin®)


LDLR WT/c.*773A>G

rs2738466 G Allele Carrier

Cardiology Beta Blockers:Carvedilol (Coreg®)



Cardiology Statins:Pitavastatin (Livalo®), Pravastatin (Pravachol®), Rosuvastatin (Crestor®)



Cardiology Statins:Simvastatin (Zocor®)






Patient PGxCardio™ Genotype and Phenotype Results for Smith, John

Gene Genotype Phenotype
















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

*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

LDLR rs688

SLCO1B1

Active

Increased Activity

Decreased Activity

Inactive

Active

Decreased Activity

Inactive

Active

Decreased Activity

Inactive

Deletion

Amplification

Active

Decreased Activity

Active

Decreased Activity

Inactive

Active

Decreased Activity

Decreased Activity

Decreased Activity *5

VKORC1 Increased Warfarin Sensitivity -1639G>A

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®): http://www.rxlist.com/cgi/generic/atenolol.htm

Carvedilol (Coreg®): http://www.rxlist.com/cgi/generic3/carvedilol.htm

Clopidogrel (Plavix®): http://www.rxlist.com/cgi/generic/clopidog.htm

Pitavastatin (Livalo®): http://www.rxlist.com/livalo-drug.htm

Pravastatin (Pravachol®): http://www.rxlist.com/cgi/generic/pravast.htm

Ranolazine (Ranexa®): http://www.rxlist.com/cgi/generic/ranexa.htm

Rosuvastatin (Crestor®): http://www.rxlist.com/cgi/generic/crestor.htm

Warfarin (Coumadin®): http://www.rxlist.com/cgi/generic/warfarin.htm

General Pharmacogenomics References:1. Drug labels with pharmacogenomics information:

https://www.pharmgkb.org/view/drug-labels.do

2. Pharmacogenomics drug dosing guidelines:https://www.pharmgkb.org/view/dosing-guidelines.do

3. FDA Orange Book Search Engine:http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm




https://www.pharmgkb.org/view/drug-labels.do

https://www.pharmgkb.org/view/dosing-guidelines.do

http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm

Electronic Signature

Laboratory DirectorABMG Certified, Clinical Molecular Genetics

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.




admera health, llc...good weigh the benefit of further alteration in lipid levels relative to the...

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