SAMPLE REPORT - Admera Health · SAMPLE REPORT. Action Drug Impacted ... URINE DRUG SCREENING ... alternative method to confirm positive screening tests for THC …

Comprehensive Drug Information for Smith, JohnICD-10: G89.4 Chronic pain syndrome; M51.15 Intvrt disc disorders w radiculopathy, thoracolumbar region; M54.12 Radiculopathy, cervical region; M54.16 Radiculopathy, lumbar region

Codeine (Codeine®)

Oxycodone (Oxycontin®)

CONSIDER ALTERNATIVES

Tramadol hydrochloride/Acetaminophen (Ultracet®)

Tramadol (Ultram®)

Cyclobenzaprine (Flexeril®)

INCREASE DOSE

Tramadol hydrochloride/Acetaminophen (Ultracet®)

Tramadol (Ultram®)

Methadone (Methadose®)

DECREASE DOSE

Celecoxib (Celebrex®)

Diclofenac (Voltaren®)

Meloxicam (Mobic®)

NORMAL RESPONSE EXPECTED

Dexamethasone (Maxidex®)

Methylprednisolone (Medrol®)

Prednisolone (Omnipred®)

Cyclobenzaprine (Flexeril®)

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: 43Sex: Male

Address: 126 Corporate Blvd.South Plainfield, NJ 07080

SAMPLEDate Collected: November 1, 2016Date Received: November 1, 2016

Case ID: PGXPL16-000212Source: Buccal Swabs

REFERRING PHYSICIANName: Jane Doe, MD

Institution: Local HospitalPhone: 123-456-7890

PGxOne™ Plus Report for Smith, John Laboratory Director: Dr. James Dermody CLIS ID: 0005783 CLIA ID: 31D2038676 Page 1 of 27

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

+1-908-222-0533 · [email protected]

SAMPLE REPORT

Action Drug Impacted Clinical Interpretation Gene Genotype Phenotype

Opioids:Codeine (Codeine®), Oxycodone (Oxycontin®)

CONSIDER ALTERNATIVES(e.g., acetaminophen, NSAID, morphine,

CYP2D6 *4/*10 Intermediate Metabolizer

Opioids:Tramadol hydrochloride/Acetaminophen (Ultracet®), Tramadol (Ultram®)

CONSIDER ALTERNATIVESlike morphine and non-opioid analgesics

OR


INCREASE DOSE

Opioids:Methadone (Methadose®)

DECREASE DOSE CYP2B6 *6/*6 Poor Metabolizer

Muscle Relaxants:Cyclobenzaprine (Flexeril®)

INCREASE DOSE

OR

CYP1A2 *1A/*1F Ultrarapid Metabolizer

USE CAUTIONdue to the risk of decreased exposure to the drug leading to lower effectiveness

Calcium Channel Blockers:Verapamil (Calan®)


NOS1AP WT/WT Normal Responder

Glucocorticoids:Dexamethasone (Maxidex®), Methylprednisolone (Medrol®), Prednisolone (Omnipred®), Prednisone (Deltasone®)


ABCB1 WT/WT Normal Responder

Nonsteroidal Antiinflammatory Drugs (NSAIDs):Celecoxib (Celebrex®), Diclofenac (Voltaren®), Meloxicam (Mobic®)


CYP2C9 *1/*1 Normal Metabolizer


Opioids:Codeine (Codeine®), Oxycodone (Oxycontin®)



Opioids:Tramadol hydrochloride/Acetaminophen (Ultracet®), Tramadol (Ultram®)


OR


INCREASE DOSE

Opioids:Methadone (Methadose®)


Muscle Relaxants:Cyclobenzaprine (Flexeril®)

INCREASE DOSE

OR



Calcium Channel Blockers:Verapamil (Calan®)



Glucocorticoids:Dexamethasone (Maxidex®), Methylprednisolone (Medrol®), Prednisolone (Omnipred®), Prednisone (Deltasone®)



Nonsteroidal Antiinflammatory Drugs (NSAIDs):Celecoxib (Celebrex®), Diclofenac (Voltaren®), Meloxicam (Mobic®)



Patient Specific Genotype Resultsand Comprehensive Drug Information forSmith, JohnICD-10: G89.4 Chronic pain syndrome;M51.15 Intvrt disc disorders w radiculopathy, thoracolumbar region;M54.12 Radiculopathy, cervical region;M54.16 Radiculopathy, lumbar region




SAMPLE REPORT


Proton Pump Inhibitors (PPIs):Dexlansoprazole (Dexilant®), Esomeprazole (Nexium®), Lansoprazole (Prevacid®), Omeprazole (Prilosec®), Pantoprazole (Protonix®), Rabeprazole (Aciphex®)


CYP2C19 *1/*2 Intermediate Metabolizer


Proton Pump Inhibitors (PPIs):Dexlansoprazole (Dexilant®), Esomeprazole (Nexium®), Lansoprazole (Prevacid®), Omeprazole (Prilosec®), Pantoprazole (Protonix®), Rabeprazole (Aciphex®)






SAMPLE REPORT


Muscle Relaxants:Cyclobenzaprine

INCREASE DOSE

OR



Calcium Channel Blockers:Calan



Glucocorticoids:Dexamethasone



Nonsteroidal Antiinflammatory Drugs (NSAIDs):Diclofenac



Proton Pump Inhibitors (PPIs):Pantoprazole




Muscle Relaxants:Cyclobenzaprine

INCREASE DOSE

OR



Calcium Channel Blockers:Calan



Glucocorticoids:Dexamethasone



Nonsteroidal Antiinflammatory Drugs (NSAIDs):Diclofenac



Proton Pump Inhibitors (PPIs):Pantoprazole



Current Medication Information forSmith, John




SAMPLE REPORT

Drug-Drug Interactions forSmith, John

Severity Drugs Warning Documentation Clinical Management

CYCLOBENZAPRINE HYDROCHLORIDE --VERAPAMIL HYDROCHLORIDE

MAJORConcurrent use of CYCLOBENZAPRINE and VERAPAMIL may result in increased cyclobenzaprine exposure and increased risk of serotonin syndrome.

FAIR Coadministration of cyclobenzaprine and verapamil may result in a life-threatening condition called serotonin syndrome. If concurrent use is necessary, monitor patients closely for serotonin syndrome, especially during treatment initiation and dose increases. Symptoms of serotonin syndrome include neuromuscular abnormalities (eg, hyperreflexia, tremor, and ataxia), autonomic instability (eg, tachycardia, diaphoresis, and hyperthermia), gastrointestinal symptoms (eg, nausea, vomiting, diarrhea), or mental status changes (eg, agitation and confusion). Discontinue both drugs immediately if these symptoms occur and initiate supportive therapy (Prod Info AMRIX® oral extended-release capsules, 2013; Prod Info FLEXERIL® oral tablets, 2013).




SAMPLE REPORT

Drug-Food Interactions forSmith, John


PANTOPRAZOLE SODIUM --CRANBERRY

MODERATEConcurrent use of PROTON PUMP INHIBITORS and CRANBERRY may result in reduced effectiveness of proton pump inhibitors.

GOOD Advise patients to avoid regular use of cranberry juice while taking a proton pump inhibitor. Occasional use of cranberry juice is not likely to have a clinical effect on proton pump inhibitor effectiveness. The effect of cranberry extract supplements on gastric acid is not known, caution is advised.

VERAPAMIL HYDROCHLORIDE --GRAPEFRUIT JUICE

MODERATEConcurrent use of VERAPAMIL and GRAPEFRUIT JUICE may result in an increased risk of verapamil adverse effects (flushing, edema, hypotension, myocardial ischemia).

EXCELLENT Counsel patients to avoid grapefruit juice while taking verapamil. Orange juice may be substituted in place of grapefruit juice (Ho et al, 2000).

VERAPAMIL HYDROCHLORIDE --CAFFEINE

MODERATEConcurrent use of CAFFEINE and VERAPAMIL may result in increased caffeine serum concentrations and enhanced CNS stimulation.

FAIR Monitor blood pressure and for signs of caffeine toxicity.




SAMPLE REPORT

Drug-Alcohol Interactions forSmith, John


VERAPAMIL HYDROCHLORIDE --ETHANOL

MODERATEConcurrent use of VERAPAMIL and ETHANOL may result in enhanced ethanol intoxication (impaired psychomotor functioning).

EXCELLENT Patients receiving verapamil therapy should not ingest ethanol, or at least cautiously limit their intake of ethanol. Patients should also be warned that verapamil may enhance the sedative and depressive effects of ethanol, and extra caution is needed when doing activities which require mental alertness.




SAMPLE REPORT

Drug-Lab Interactions forSmith, John


CYCLOBENZAPRINE HYDROCHLORIDE --TRICYCLIC ANTIDEPRESSANT MEASUREMENT

MODERATECYCLOBENZAPRINE may result in false positive tricyclic antidepressants assay results due to structurally similarity of cyclobenzaprine to the tricyclic antidepressant class.

EXCELLENT Cyclobenzaprine is often falsely identified as a tricyclic antidepressant on toxicology assays. Chromatographic techniques such as thin-layer chromatography (TLC), gas chromatography (GC), and high-pressure liquid chromatography (HPLC) have poor sensitivity for differentiating structurally similar molecules like cyclobenzaprine and tricyclic antidepressants. When an assay is positive for tricyclic antidepressants and there is no history of their use, techniques such as ultraviolet (UV) spectroscopy, UV absorbance ratio, or mass spectroscopy should be considered as these methods can identify individual molecules with higher specificity (VanHoey, 2005).

PANTOPRAZOLE SODIUM --URINE DRUG SCREENING

MODERATEPROTON PUMP INHIBITORS may result in false-positive urine screening tests for tetrahydrocannabinol (THC) due to unknown.

GOOD Proton pump inhibitors may cause false positive urine screening tests for tetrahydrocannabinol (THC). Use an alternative method to confirm positive screening tests for THC (Prod Info DEXILANT(TM) oral delayed-release capsules, 2016; Prod Info PRILOSEC® oral delayed-release capsules, 2016; Prod Info PROTONIX® I.V. intravenous injection, 2014).




SAMPLE REPORT

Therapeutic Action Drug Impacted Clinical Interpretation Gene Genotype Phenotype

Cardiology Antianginal Drugs:Ivabradine (Corlentor®)

CONSIDER ALTERNATIVES CYP3A4 *1A/*1B Intermediate Metabolizer

Cardiology Antiarrhythmic Drugs:Dronedarone (Multaq®)


Cardiology Antiarrhythmic Drugs:Propafenone (Rythmol®)

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


Cardiology Antiplatelets:Clopidogrel (Plavix®)

CONSIDER ALTERNATIVES CYP2C19 *1/*2 Intermediate Metabolizer

Cardiology Antiplatelets:Ticagrelor (Brilinta®)


Cardiology Beta Blockers:Metoprolol (Lopressor®)

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

OR


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

Cardiology Statins:Simvastatin (Zocor®)


OR

SLCO1B1 *1/*5 Intermediate Activity

DECREASE DOSEto 40mg daily

Cardiology Antiarrhythmic Drugs:Flecainide (Tambocor®)

DECREASE DOSEby 25%


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

DECREASE DOSE SLCO1B1 *1/*5 Intermediate Activity

Cardiology Beta Blockers:Atenolol (Tenormin®)

USE CAUTIONdue to decreased response

ADRA2A WT/c.-217G>A

rs1800545 A Allele Carrier


Cardiology Antianginal Drugs:Ivabradine (Corlentor®)


Cardiology Antiarrhythmic Drugs:Dronedarone (Multaq®)


Cardiology Antiarrhythmic Drugs:Propafenone (Rythmol®)

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


Cardiology Antiplatelets:Clopidogrel (Plavix®)

CONSIDER ALTERNATIVES CYP2C19 *1/*2 Intermediate Metabolizer

Cardiology Antiplatelets:Ticagrelor (Brilinta®)


Cardiology Beta Blockers:Metoprolol (Lopressor®)

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

OR


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

Cardiology Statins:Simvastatin (Zocor®)


OR


DECREASE DOSEto 40mg daily

Cardiology Antiarrhythmic Drugs:Flecainide (Tambocor®)

DECREASE DOSEby 25%


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

DECREASE DOSE SLCO1B1 *1/*5 Intermediate Activity

Cardiology Beta Blockers:Atenolol (Tenormin®)


ADRA2A WT/c.-217G>A


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




SAMPLE REPORT


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

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

CYP3A4 *1A/*1B Intermediate Metabolizer

Cardiology ACE Inhibitors:Benazepril (Lotensin®), Captopril (Capoten®), Perindopril (Aceon®), Quinapril (Accupril®)


ACE WT/WT Normal Responder

Cardiology ACE Inhibitors:Captopril (Capoten®), Perindopril (Aceon®)


AGTR1 WT/WT Normal Responder

Cardiology Angiotensin II Receptor Blockers:Candesartan (Atacand®), Losartan (Cozaar®)



Cardiology Angiotensin II Receptor Blockers:Irbesartan (Avapro®)



Cardiology Antianginal Drugs:Ranolazine (Ranexa®)



Cardiology Antiarrhythmic Drugs:Amiodarone (Cordarone®)



Cardiology Antiarrhythmic Drugs:Digoxin (Digox®)



Cardiology Anticoagulants:Phenprocoumon (Marcoumar®)


CYP4F2 *1/*1 Normal Metabolizer

Cardiology Anticoagulants:Rivaroxaban (Xarelto®)



Cardiology Anticoagulants:Warfarin (Coumadin®)

NORMAL DOSEWarfarin daily dose 5-7mg




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


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

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


Cardiology ACE Inhibitors:Benazepril (Lotensin®), Captopril (Capoten®), Perindopril (Aceon®), Quinapril (Accupril®)



Cardiology ACE Inhibitors:Captopril (Capoten®), Perindopril (Aceon®)



Cardiology Angiotensin II Receptor Blockers:Candesartan (Atacand®), Losartan (Cozaar®)



Cardiology Angiotensin II Receptor Blockers:Irbesartan (Avapro®)



Cardiology Antianginal Drugs:Ranolazine (Ranexa®)



Cardiology Antiarrhythmic Drugs:Amiodarone (Cordarone®)



Cardiology Antiarrhythmic Drugs:Digoxin (Digox®)



Cardiology Anticoagulants:Phenprocoumon (Marcoumar®)



Cardiology Anticoagulants:Rivaroxaban (Xarelto®)












SAMPLE REPORT


Cardiology Beta Blockers:Carvedilol (Coreg®)



Cardiology Calcium Channel Blockers:Amlodipine (Norvasc®)



Cardiology Calcium Channel Blockers:Verapamil (Calan®)



Cardiology Diuretics:Bumetanide (Bumex®), Furosemide (Lasix®), Hydrochlorothiazide (Microzide®), Spironolactone (Aldactone®), Torasemide (Demadex®)



Cardiology Diuretics:Hydrochlorothiazide (Microzide®)



Cardiology Phosphodiesterase Inhibitors:Cilostazol (Pletal®)



Cardiology Statins:Atorvastatin (Lipitor®)


APOE WT/WT Normal Responder

Cardiology Statins:Fluvastatin (Lescol®)



Cardiology Statins:Lovastatin (Mevacor®)


CYP3A5 *1A/*3A Expresser

Cardiology Statins:Pravastatin (Pravachol®)


KIF6 WT/WT Normal Activity

Cardiology Vasodilators:Nitroprusside (Nipride®)



Dentistry Cholinergic Agonists:Cevimeline (Evoxac®)




Cardiology Beta Blockers:Carvedilol (Coreg®)



Cardiology Calcium Channel Blockers:Amlodipine (Norvasc®)



Cardiology Calcium Channel Blockers:Verapamil (Calan®)



Cardiology Diuretics:Bumetanide (Bumex®), Furosemide (Lasix®), Hydrochlorothiazide (Microzide®), Spironolactone (Aldactone®), Torasemide (Demadex®)



Cardiology Diuretics:Hydrochlorothiazide (Microzide®)



Cardiology Phosphodiesterase Inhibitors:Cilostazol (Pletal®)



Cardiology Statins:Atorvastatin (Lipitor®)



Cardiology Statins:Fluvastatin (Lescol®)



Cardiology Statins:Lovastatin (Mevacor®)



Cardiology Statins:Pravastatin (Pravachol®)



Cardiology Vasodilators:Nitroprusside (Nipride®)



Dentistry Cholinergic Agonists:Cevimeline (Evoxac®)






SAMPLE REPORT


Endocrinology Biguanides:Metformin (Glucophage®)


ATM WT/WT rs11212617 CC genotype

Endocrinology Hormones:Oral-Contraceptives


F2 WT/WT Wild Type

Endocrinology Meglitinides:Repaglinide (Prandin®)



Endocrinology Sulfonylureas:Chlorpropamide (Diabinese®), Glimepiride (Amaryl®), Glipizide (Glucotrol®), Glyburide (Glynase®), Tolbutamide (Orinase®)


G6PD WT/WT Normal G6PD Efficiency

Endocrinology Thiazolidinediones:Rosiglitazone (Avandia®)



Gastroenterology Proton Pump Inhibitors (PPIs):Dexlansoprazole (Dexilant®), Esomeprazole (Nexium®), Lansoprazole (Prevacid®), Omeprazole (Prilosec®), Pantoprazole (Protonix®), Rabeprazole (Aciphex®)



Gastroenterology Sulfa Agents:Sulfasalazine (Azulfidine®)



Hematology Platelet Stimulating Agents:Eltrombopag (Promacta®)


F5 WT/WT Non Factor V Leiden Carrier

Immunology Immunomodulators:Thalidomide (Thalomid®)


ERCC1 WT/WT Normal Responder

Immunology Immunosuppressants:Cyclosporine (Neoral®)



Immunology Immunosuppressants:Sirolimus (Rapamune®)




Endocrinology Biguanides:Metformin (Glucophage®)



Endocrinology Hormones:Oral-Contraceptives


F2 WT/WT Wild Type

Endocrinology Meglitinides:Repaglinide (Prandin®)



Endocrinology Sulfonylureas:Chlorpropamide (Diabinese®), Glimepiride (Amaryl®), Glipizide (Glucotrol®), Glyburide (Glynase®), Tolbutamide (Orinase®)



Endocrinology Thiazolidinediones:Rosiglitazone (Avandia®)



Gastroenterology Proton Pump Inhibitors (PPIs):Dexlansoprazole (Dexilant®), Esomeprazole (Nexium®), Lansoprazole (Prevacid®), Omeprazole (Prilosec®), Pantoprazole (Protonix®), Rabeprazole (Aciphex®)



Gastroenterology Sulfa Agents:Sulfasalazine (Azulfidine®)



Hematology Platelet Stimulating Agents:Eltrombopag (Promacta®)



Immunology Immunomodulators:Thalidomide (Thalomid®)



Immunology Immunosuppressants:Cyclosporine (Neoral®)



Immunology Immunosuppressants:Sirolimus (Rapamune®)






SAMPLE REPORT


Immunology Immunosuppressants:Sirolimus (Rapamune®), Tacrolimus (Protopic®)



Infectious Diseases Antiviral Drugs:Boceprevir (Victrelis®), Peginterferon alfa-2b (PegIntron®), Ribavirin (Copegus®), Telaprevir (Incivo®)


IFNL3 39738787C>T/39743165T>

G

Unfavorable Response Genotype

Infectious Diseases Antiviral Drugs:Efavirenz (Sustiva®), Nevirapine (Viramune®)

USE CAUTIONdue to increased frequency and severity of adverse events

CYP2B6 *6/*6 Poor Metabolizer

Infectious Diseases Antiviral Drugs:Peginterferon alfa-2b (PegIntron®), Ribavirin (Copegus®), Telaprevir (Incivo®)

USE CAUTIONdue to increase risk of ribavirin-induced hemolytic anemia

ITPA WT/WT Non-protective Wild Type

Infectious Diseases Antibiotics:Dapsone (Aczone®), Sulfamethoxazole/Trimethoprim (Bactrim®)



Infectious Diseases Antibiotics:Isoniazid (Hydra®), Pyrazinamide (Rifater®), Rifampin (Rifadin®)


NAT2 *4/*12 Normal Metabolizer

Infectious Diseases Antibiotics:Nalidixic Acid (Neggram®), Nitrofurantoin (Furadantin®)



Infectious Diseases Antimalarial Drugs:Chloroquine (Aralen®), Primaquine Phosphate (Primaquine®)



Infectious Diseases Antiretroviral Agents:Abacavir (Ziagen®)


HLA-B WT/WT Wild Type

Infectious Diseases Protease Inhibitors:Atazanavir (Reyataz®)


UGT1A1 *1/*28 *28 Allele Carrier

Neurology Anticonvulsant Drugs:Carbamazepine (Tegretol®), Fosphenytoin (Cerebyx®), Oxcarbazepine (Trileptal®), Phenytoin (Dilantin®)




Immunology Immunosuppressants:Sirolimus (Rapamune®), Tacrolimus (Protopic®)



Infectious Diseases Antiviral Drugs:Boceprevir (Victrelis®), Peginterferon alfa-2b (PegIntron®), Ribavirin (Copegus®), Telaprevir (Incivo®)


IFNL3 39738787C>T/39743165T>

G

Unfavorable Response Genotype

Infectious Diseases Antiviral Drugs:Efavirenz (Sustiva®), Nevirapine (Viramune®)

USE CAUTIONdue to increased frequency and severity of adverse events


Infectious Diseases Antiviral Drugs:Peginterferon alfa-2b (PegIntron®), Ribavirin (Copegus®), Telaprevir (Incivo®)

USE CAUTIONdue to increase risk of ribavirin-induced hemolytic anemia


Infectious Diseases Antibiotics:Dapsone (Aczone®), Sulfamethoxazole/Trimethoprim (Bactrim®)



Infectious Diseases Antibiotics:Isoniazid (Hydra®), Pyrazinamide (Rifater®), Rifampin (Rifadin®)



Infectious Diseases Antibiotics:Nalidixic Acid (Neggram®), Nitrofurantoin (Furadantin®)



Infectious Diseases Antimalarial Drugs:Chloroquine (Aralen®), Primaquine Phosphate (Primaquine®)



Infectious Diseases Antiretroviral Agents:Abacavir (Ziagen®)



Infectious Diseases Protease Inhibitors:Atazanavir (Reyataz®)



Neurology Anticonvulsant Drugs:Carbamazepine (Tegretol®), Fosphenytoin (Cerebyx®), Oxcarbazepine (Trileptal®), Phenytoin (Dilantin®)






SAMPLE REPORT


Neurology Anticonvulsant Drugs:Fosphenytoin (Cerebyx®), Phenytoin (Dilantin®)



Neurology Anticonvulsant Drugs:Lamotrigine (Lamictal®), Topiramate (Topamax®)


SCN2A WT/WT Normal Responder

Neurology Barbiturates:Phenobarbital (Levsin®)



Neurology Monoamine Depletors:Tetrabenazine (Xenazine®)



OBGYN Hormonal Contraceptives:Norelgestromin/Ethinyl Estradiol (Evra®)



Oncology Estrogen Antagonists:Tamoxifen (Soltamox®)

CONSIDER ALTERNATIVESlike aromatase inhibitor for postmenopausal women due to increased risk for relapse of breast cancer


Oncology Antineoplastic Agents:Carboplatin (Paraplatin®), Cyclophosphamide (Endoxan®), Leucovorin (Wellcovorin®), Oxaliplatin (Eloxatin®), Pemetrexed (Alimta®)

USE CAUTIONdue to decreased response and increased risk of toxicity

MTHFR C677T/A1298C

C677T Heterozygous

Mutation/A1298C Heterozygous

Mutation

Oncology Antineoplastic Agents:Fluorouracil (Carac®)

USE CAUTIONdue to worse outcome such as lower overall survival and progression-free survival

NQO1 c.559C>T/c.559C>T

rs1800566 AA genotype

Oncology Antineoplastic Agents:Fluorouracil (Carac®), Oxaliplatin (Eloxatin®)

USE CAUTIONdue to poorer treatment outcome such as reduced responsiveness, lower overall survival time and increased risk of death

GSTP1 WT/WT rs1695 AA Genotype

Oncology Antineoplastic Agents:Mitotane (Lysodren®)



Oncology Antineoplastic Agents:Cabazitaxel (Jevtana®)



Oncology Antineoplastic Agents:Capecitabine (Xeloda®), Pyrimidinedione (Tegafur®)


DPYD *5/*9A/c.496A>G/IVS10-

15T>C

Normal Metabolizer


Neurology Anticonvulsant Drugs:Fosphenytoin (Cerebyx®), Phenytoin (Dilantin®)



Neurology Anticonvulsant Drugs:Lamotrigine (Lamictal®), Topiramate (Topamax®)



Neurology Barbiturates:Phenobarbital (Levsin®)



Neurology Monoamine Depletors:Tetrabenazine (Xenazine®)



OBGYN Hormonal Contraceptives:Norelgestromin/Ethinyl Estradiol (Evra®)



Oncology Estrogen Antagonists:Tamoxifen (Soltamox®)

CONSIDER ALTERNATIVESlike aromatase inhibitor for postmenopausal women due to increased risk for relapse of breast cancer


Oncology Antineoplastic Agents:Carboplatin (Paraplatin®), Cyclophosphamide (Endoxan®), Leucovorin (Wellcovorin®), Oxaliplatin (Eloxatin®), Pemetrexed (Alimta®)


MTHFR C677T/A1298C

C677T Heterozygous


Mutation

Oncology Antineoplastic Agents:Fluorouracil (Carac®)

USE CAUTIONdue to worse outcome such as lower overall survival and progression-free survival

NQO1 c.559C>T/c.559C>T

rs1800566 AA genotype

Oncology Antineoplastic Agents:Fluorouracil (Carac®), Oxaliplatin (Eloxatin®)

USE CAUTIONdue to poorer treatment outcome such as reduced responsiveness, lower overall survival time and increased risk of death


Oncology Antineoplastic Agents:Mitotane (Lysodren®)



Oncology Antineoplastic Agents:Cabazitaxel (Jevtana®)



Oncology Antineoplastic Agents:Capecitabine (Xeloda®), Pyrimidinedione (Tegafur®)


DPYD *5/*9A/c.496A>G/IVS10-

15T>C

Normal Metabolizer




SAMPLE REPORT


Oncology Antineoplastic Agents:Cisplatin (Platinol®)





XRCC1 WT/WT Normal Responder

Oncology Antineoplastic Agents:Cytarabine (Depocyt®)


CDA WT/WT Normal Responder

Oncology Antineoplastic Agents:Docetaxel (Taxotere®)


OPRM1 WT/WT Normal Responder

Oncology Antineoplastic Agents:Doxorubicin (Doxil®), Methotrexate (Trexall®), Paclitaxel (Abraxane®), Vincristine (Marqibo®)



Oncology BRAF Inhibitors:Dabrafenib (Tafinlar®)



Oncology Enzymes:Rasburicase (Elitek®)



Oncology Kinase Inhibitors:Erlotinib (Tarceva®), Nilotinib (Tasigna®), Pazopanib (Votrient®)



Oncology Kinase Inhibitors:Gefitinib (Iressa®)



Oncology Kinase Inhibitors:Ruxolitinib (Jakavi®)



Oncology Kinase Inhibitors:Sunitinib (Sutent®)



Oncology Purine Antagonists:Mercaptopurine (Purinethol®), Thioguanine (Tabloid®)


TPMT *1/*1 Normal Metabolizer

Oncology Serotonin-3 Receptor Antagonists:Granisetron (Sancuso®)










Oncology Antineoplastic Agents:Cytarabine (Depocyt®)



Oncology Antineoplastic Agents:Docetaxel (Taxotere®)



Oncology Antineoplastic Agents:Doxorubicin (Doxil®), Methotrexate (Trexall®), Paclitaxel (Abraxane®), Vincristine (Marqibo®)



Oncology BRAF Inhibitors:Dabrafenib (Tafinlar®)



Oncology Enzymes:Rasburicase (Elitek®)



Oncology Kinase Inhibitors:Erlotinib (Tarceva®), Nilotinib (Tasigna®), Pazopanib (Votrient®)



Oncology Kinase Inhibitors:Gefitinib (Iressa®)



Oncology Kinase Inhibitors:Ruxolitinib (Jakavi®)



Oncology Kinase Inhibitors:Sunitinib (Sutent®)



Oncology Purine Antagonists:Mercaptopurine (Purinethol®), Thioguanine (Tabloid®)



Oncology Serotonin-3 Receptor Antagonists:Granisetron (Sancuso®)






SAMPLE REPORT


Oncology Serotonin-3 Receptor Antagonists:Ondansetron (Zofran®)



Oncology Topoisomerase I Inhibitors:Irinotecan (Camptosar®)



Ophthalmology Nonsteroidal Antiinflammatory Drugs (NSAIDs):Flurbiprofen (Ocufen®)



Pain Management Opioids:Codeine (Codeine®), Oxycodone (Oxycontin®)


OR


Pain Management Opioids:Tramadol hydrochloride/Acetaminophen (Ultracet®), Tramadol (Ultram®)


OR


INCREASE DOSE

Pain Management Opioids:Methadone (Methadose®)


Pain Management Muscle Relaxants:Cyclobenzaprine (Flexeril®)

INCREASE DOSE

OR



Pain Management Anesthetics:Ketamine (Ketalar®), Propofol (Diprivan®)

USE CAUTIONdue to the risk of increased exposure to the drug leading to adverse events


Pain Management Anesthetics:Lidocaine (Lidoderm®), Ropivacaine (Naropin®)

USE CAUTIONdue to the increased risk for loss of efficacy


Pain Management Central Alpha-2 Adrenergic Agonists:Tizanidine (Zanaflex®)




Oncology Serotonin-3 Receptor Antagonists:Ondansetron (Zofran®)



Oncology Topoisomerase I Inhibitors:Irinotecan (Camptosar®)



Ophthalmology Nonsteroidal Antiinflammatory Drugs (NSAIDs):Flurbiprofen (Ocufen®)



Pain Management Opioids:Codeine (Codeine®), Oxycodone (Oxycontin®)


OR


Pain Management Opioids:Tramadol hydrochloride/Acetaminophen (Ultracet®), Tramadol (Ultram®)


OR


INCREASE DOSE

Pain Management Opioids:Methadone (Methadose®)


Pain Management Muscle Relaxants:Cyclobenzaprine (Flexeril®)

INCREASE DOSE

OR



Pain Management Anesthetics:Ketamine (Ketalar®), Propofol (Diprivan®)



Pain Management Anesthetics:Lidocaine (Lidoderm®), Ropivacaine (Naropin®)



Pain Management Central Alpha-2 Adrenergic Agonists:Tizanidine (Zanaflex®)






SAMPLE REPORT


Pain Management Opioids:Buprenorphine (Subutex®), Fentanyl (Duragesic®), Sufentanil (Sufenta®)



Pain Management Anesthetics:Dolasetron (Anzemet®)



Pain Management Muscle Relaxants:Carisoprodol (Soma®)



Pain Management Nonsteroidal Antiinflammatory Drugs (NSAIDs):Celecoxib (Celebrex®), Diclofenac (Voltaren®), Meloxicam (Mobic®)



Pain Management Nonsteroidal Antiinflammatory Drugs (NSAIDs):Ibuprofen (Advil®), Naproxen (Aleve®)



Pain Management Opioids:Alfentanil (Alfenta®), Hydrocodone (Vicodin®), Morphine (Duramorph®)



Pain Management Opioids Antagonists:Naloxone (Evzio®), Naltrexone (Revia®)



Pain Management Serotonin Receptor Agonists:Eletriptan (Relpax®), Zolmitriptan (Zomig®)



Psychiatry Antipsychotics:Risperidone (Risperdal®)

CONSIDER ALTERNATIVES(e.g., quetiapine, olanzapine, clozapine)


Psychiatry Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs):Venlafaxine (Effexor®)

CONSIDER ALTERNATIVES(e.g., citalopram, sertraline)


Psychiatry Supplements:Folic Acid, Vitamin B-Complex

CONSIDER ALTERNATIVES(e.g., supplements containing methylfolate) due to reduced folic acid conversion

MTHFR C677T/A1298C

C677T Heterozygous


Mutation

Psychiatry Antipsychotics:Lurasidone (Latuda®)

DECREASE DOSE CYP3A4 *1A/*1B Intermediate Metabolizer


Pain Management Opioids:Buprenorphine (Subutex®), Fentanyl (Duragesic®), Sufentanil (Sufenta®)



Pain Management Anesthetics:Dolasetron (Anzemet®)



Pain Management Muscle Relaxants:Carisoprodol (Soma®)



Pain Management Nonsteroidal Antiinflammatory Drugs (NSAIDs):Celecoxib (Celebrex®), Diclofenac (Voltaren®), Meloxicam (Mobic®)



Pain Management Nonsteroidal Antiinflammatory Drugs (NSAIDs):Ibuprofen (Advil®), Naproxen (Aleve®)



Pain Management Opioids:Alfentanil (Alfenta®), Hydrocodone (Vicodin®), Morphine (Duramorph®)



Pain Management Opioids Antagonists:Naloxone (Evzio®), Naltrexone (Revia®)



Pain Management Serotonin Receptor Agonists:Eletriptan (Relpax®), Zolmitriptan (Zomig®)




CONSIDER ALTERNATIVES(e.g., quetiapine, olanzapine, clozapine)


Psychiatry Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs):Venlafaxine (Effexor®)

CONSIDER ALTERNATIVES(e.g., citalopram, sertraline)


Psychiatry Supplements:Folic Acid, Vitamin B-Complex

CONSIDER ALTERNATIVES(e.g., supplements containing methylfolate) due to reduced folic acid conversion

MTHFR C677T/A1298C

C677T Heterozygous


Mutation

Psychiatry Antipsychotics:Lurasidone (Latuda®)

DECREASE DOSE CYP3A4 *1A/*1B Intermediate Metabolizer




SAMPLE REPORT


Psychiatry Tetracyclic Antidepressants:Maprotiline (Ludiomil®)

DECREASE DOSE CYP2D6 *4/*10 Intermediate Metabolizer

Psychiatry Tricyclic Antidepressants:Amitriptyline (Elavil®), Clomipramine (Anafranil®), Desipramine (Norpramin®), Doxepin (Deptran®), Imipramine (Tofranil®), Nortriptyline (Pamelor®), Protriptyline (Vivactil®), Trimipramine (Surmontil®)

DECREASE DOSEby 25%


Psychiatry Aldehyde Dehydrogenase Inhibitors:Disulfiram (Antabuse®)


ANKK1 WT/c.2137G>A

rs1800497 CT genotype



MTHFR C677T/A1298C

C677T Heterozygous


Mutation

Psychiatry Antidepressants:Bupropion (Wellbutrin®)



Psychiatry Antidepressants:Mirtazapine (Remeron®)

USE CAUTIONdue to the increased drug response leading to possible dosage adjustment


Psychiatry Antipsychotics:Clozapine (Clozaril®), Nemonapride (Emilace®), Olanzapine (Zalasta®), Valproic acid (Depakote®)

USE CAUTIONdue to the increased risk of side effects including hyperprolactinemia and weight gain

ANKK1 WT/c.2137G>A


Psychiatry Antipsychotics:Clozapine (Clozaril®), Olanzapine (Zalasta®)

USE CAUTIONdue to the increased risk of developing metabolic syndrome

HTR2C WT/WT rs1414334 CC genotype

Psychiatry Benzodiazepines:Alprazolam (Xanax®), Diazepam (Valium®)



Psychiatry Benzodiazepines:Clobazam (Onfi®), Diazepam (Valium®)



Psychiatry Benzodiazepines:Lorazepam (Ativan®), Oxazepam (Serax®)


UGT2B15 *1/*2 Intermediate Metabolizer


Psychiatry Tetracyclic Antidepressants:Maprotiline (Ludiomil®)

DECREASE DOSE CYP2D6 *4/*10 Intermediate Metabolizer

Psychiatry Tricyclic Antidepressants:Amitriptyline (Elavil®), Clomipramine (Anafranil®), Desipramine (Norpramin®), Doxepin (Deptran®), Imipramine (Tofranil®), Nortriptyline (Pamelor®), Protriptyline (Vivactil®), Trimipramine (Surmontil®)

DECREASE DOSEby 25%




ANKK1 WT/c.2137G>A




MTHFR C677T/A1298C

C677T Heterozygous


Mutation

Psychiatry Antidepressants:Bupropion (Wellbutrin®)



Psychiatry Antidepressants:Mirtazapine (Remeron®)

USE CAUTIONdue to the increased drug response leading to possible dosage adjustment


Psychiatry Antipsychotics:Clozapine (Clozaril®), Nemonapride (Emilace®), Olanzapine (Zalasta®), Valproic acid (Depakote®)

USE CAUTIONdue to the increased risk of side effects including hyperprolactinemia and weight gain

ANKK1 WT/c.2137G>A


Psychiatry Antipsychotics:Clozapine (Clozaril®), Olanzapine (Zalasta®)

USE CAUTIONdue to the increased risk of developing metabolic syndrome


Psychiatry Benzodiazepines:Alprazolam (Xanax®), Diazepam (Valium®)



Psychiatry Benzodiazepines:Clobazam (Onfi®), Diazepam (Valium®)



Psychiatry Benzodiazepines:Lorazepam (Ativan®), Oxazepam (Serax®)






SAMPLE REPORT


Psychiatry Cannabinoids:Cannabis

USE CAUTIONdue to the risk of increased drug dependence

CNR1 c.*3475A>G/c.*3475A>G

rs806368 TT genotype

Psychiatry Ethanol:Ethanol

USE CAUTIONdue to the increased risk of alcoholism

ANKK1 WT/c.2137G>A


Psychiatry Selective Serotonin Reuptake Inhibitors (SSRIs):Fluoxetine (Prozac®), Fluvoxamine (Luvox®), Paroxetine (Paxil®)

USE CAUTIONdue to elevated risk for drug overdose resulting in adverse events and drug interaction


Psychiatry Selective Serotonin Reuptake Inhibitors (SSRIs):Sertraline (Zoloft®)

USE CAUTIONwith high alert to adverse drug events


Psychiatry Stimulants:Cocaine


CNR1 c.*3475A>G/c.*3475A>G


Psychiatry Antianxiety Agents:Buspirone (Buspar®)


HTR1A WT/WT Normal Responder

Psychiatry Antimanic Agents:Lithium (Lithane®)



Psychiatry Antipsychotics:Aripiprazole (Abilify®), Iloperidone (Fanapt®), Pimozide (Orap®)



Psychiatry Antipsychotics:Haloperidol (Haldol®)



Psychiatry Antipsychotics:Quetiapine (Seroquel®)


FAAH WT/WT Normal Responder



DRD2 WT/WT Normal Responder

Psychiatry Cannabinoids:Tetrahydrocannabinol



Psychiatry Sedatives:Dexmedetomidine (Precedex®)


ADRA2A WT/c.-217G>A



Psychiatry Cannabinoids:Cannabis


CNR1 c.*3475A>G/c.*3475A>G


Psychiatry Ethanol:Ethanol

USE CAUTIONdue to the increased risk of alcoholism

ANKK1 WT/c.2137G>A


Psychiatry Selective Serotonin Reuptake Inhibitors (SSRIs):Fluoxetine (Prozac®), Fluvoxamine (Luvox®), Paroxetine (Paxil®)

USE CAUTIONdue to elevated risk for drug overdose resulting in adverse events and drug interaction


Psychiatry Selective Serotonin Reuptake Inhibitors (SSRIs):Sertraline (Zoloft®)

USE CAUTIONwith high alert to adverse drug events


Psychiatry Stimulants:Cocaine


CNR1 c.*3475A>G/c.*3475A>G


Psychiatry Antianxiety Agents:Buspirone (Buspar®)



Psychiatry Antimanic Agents:Lithium (Lithane®)



Psychiatry Antipsychotics:Aripiprazole (Abilify®), Iloperidone (Fanapt®), Pimozide (Orap®)



Psychiatry Antipsychotics:Haloperidol (Haldol®)



Psychiatry Antipsychotics:Quetiapine (Seroquel®)






Psychiatry Cannabinoids:Tetrahydrocannabinol



Psychiatry Sedatives:Dexmedetomidine (Precedex®)


ADRA2A WT/c.-217G>A





SAMPLE REPORT


Psychiatry Selective Serotonin Reuptake Inhibitors (SSRIs):Citalopram (Celexa®)


GRIK4 WT/WT Normal Responder




Psychiatry Selective Serotonin Reuptake Inhibitors (SSRIs):Citalopram (Celexa®), Escitalopram (Lexapro®)





SLC6A4 LA/LA Normal Responder

Psychiatry Selective Serotonin Reuptake Inhibitors (SSRIs):Vilazodone (Viibryd®)



Psychiatry Selective Serotonin Reuptake Inhibitors (SSRIs):Vortioxetine (Brintellix®)



Psychiatry Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs):Atomoxetine (Strattera®)



Psychiatry Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs):Duloxetine (Cymbalta®)



Psychiatry Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs):Levomilnacipran (Fetzima®), Reboxetine (Edronax®), Trazodone (Desyrel®)



Psychiatry Serotonin Antagonist and Reuptake Inhibitor:Nefazodone (Nefadar®)



Psychiatry Stimulants:Amphetamine (Adderall®), Dextroamphetamine (Adderall®)
















Psychiatry Selective Serotonin Reuptake Inhibitors (SSRIs):Vilazodone (Viibryd®)



Psychiatry Selective Serotonin Reuptake Inhibitors (SSRIs):Vortioxetine (Brintellix®)



Psychiatry Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs):Atomoxetine (Strattera®)



Psychiatry Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs):Duloxetine (Cymbalta®)



Psychiatry Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs):Levomilnacipran (Fetzima®), Reboxetine (Edronax®), Trazodone (Desyrel®)



Psychiatry Serotonin Antagonist and Reuptake Inhibitor:Nefazodone (Nefadar®)



Psychiatry Stimulants:Amphetamine (Adderall®), Dextroamphetamine (Adderall®)






SAMPLE REPORT


Psychiatry Stimulants:Dexmethylphenidate (Focalin®), Lisdexamfetamine (Vyvanse®)


COMT WT/WT Normal Responder

Psychiatry Stimulants:Dextroamphetamine (Adderall®), Methylphenidate (Ritalin®)



Psychiatry Stimulants:Methamphetamine (Desoxyn®)



Psychiatry Stimulants:Methylphenidate (Ritalin®)


CES1 WT/WT Normal Responder

Psychiatry Stimulants:Nicotine (Nicoderm®)



Rheumatology Glucocorticoids:Dexamethasone (Maxidex®), Methylprednisolone (Medrol®), Prednisolone (Omnipred®), Prednisone (Deltasone®)



Rheumatology Immunosuppressive Drugs:Azathioprine (Imuran®)



Rheumatology Uricosurics:Pegloticase (Krystexxa®), Probenecid (Probalan®)



Rheumatology Xanthine oxidase inhibitors:Allopurinol (Zyloprim®)



Urology Alpha Blockers:Dutasteride/Tamsulosin (Jalyn®), Tamsulosin (Flomax®)



Urology Alpha Blockers:Silodosin (Rapaflo®)



Urology Muscarinic Receptor Antagonists:Darifenacin (Enablex®), Tolterodine (Detrol®)




Psychiatry Stimulants:Dexmethylphenidate (Focalin®), Lisdexamfetamine (Vyvanse®)



Psychiatry Stimulants:Dextroamphetamine (Adderall®), Methylphenidate (Ritalin®)



Psychiatry Stimulants:Methamphetamine (Desoxyn®)



Psychiatry Stimulants:Methylphenidate (Ritalin®)



Psychiatry Stimulants:Nicotine (Nicoderm®)



Rheumatology Glucocorticoids:Dexamethasone (Maxidex®), Methylprednisolone (Medrol®), Prednisolone (Omnipred®), Prednisone (Deltasone®)



Rheumatology Immunosuppressive Drugs:Azathioprine (Imuran®)



Rheumatology Uricosurics:Pegloticase (Krystexxa®), Probenecid (Probalan®)



Rheumatology Xanthine oxidase inhibitors:Allopurinol (Zyloprim®)



Urology Alpha Blockers:Dutasteride/Tamsulosin (Jalyn®), Tamsulosin (Flomax®)



Urology Alpha Blockers:Silodosin (Rapaflo®)



Urology Muscarinic Receptor Antagonists:Darifenacin (Enablex®), Tolterodine (Detrol®)






SAMPLE REPORT

Patient PGxOne™ Plus Genotype and Phenotype Resultsfor Smith, John

Gene Genotype Phenotype



ADRA2A WT/c.-217G>A rs1800545 A Allele Carrier


ANKK1 WT/c.2137G>A rs1800497 CT genotype





CNR1 c.*3475A>G/c.*3475A>G rs806368 TT genotype











DPYD *5/*9A/c.496A>G/IVS10-15T>C Normal Metabolizer




F2 WT/WT Wild Type




SAMPLE REPORT

Gene Genotype Phenotype










IFNL3 39738787C>T/39743165T>G Unfavorable Response Genotype



MTHFR C677T/A1298C C677T Heterozygous Mutation/A1298C Heterozygous Mutation



NQO1 c.559C>T/c.559C>T rs1800566 AA genotype













SAMPLE REPORT

Gene Allele Type Alleles

ABCB1 Decreased Activity rs1045642, rs2032582

ACE Decreased Activity rs1799752

ADRA2A Decreased Activity rs1800544, rs1800545

AGTR1 Decreased Activity rs5186

ANKK1 Decreased Activity rs1800497

APOE Decreased Activity rs7412

ATM Decreased Metformin Response rs11212617

CDA Decreased Activity rs532545

CES1 Decreased Activity rs71647871

CNR1 Decreased Activity rs806368

COMT Decreased Activity rs4680

CYP1A2

Active *1A

Increased Activity *1F

Decreased Activity *1C, *1K, *3, *4, *7

Inactive *6

CYP2B6 Decreased Activity *6, *18

CYP2C19

Active *1

Increased Activity *17

Decreased Activity *9, *10

Inactive *2, *3, *4, *5, *6, *7, *8, *12

CYP2C8 Decreased Activity *3

CYP2C9

Active *1

Decreased Activity *2, *3, *4, *5, *8, *9, *11, *12, *13, *14, *16

Inactive *6, *15

CYP2D6

Active *1, *2, *35

Decreased Activity *9, *10, *17, *29, *41

Inactive *3, *4, *6, *7, *8, *11, *12, *14, *19, *20, *21, *38, *40, *44

Deletion *5

Amplification *1XN, *2XN, *4XN, *10XN, *17XN, *29xN, *35xN, *41XN

CYP3A4Active *1A

Decreased Activity *1B, *2, *3, *12, *17

CYP3A5

Active *1A

Decreased Activity *2, *7, *8, *9

Inactive *3A, *3B, *6

PGxOne™ Plus 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 50 genes and 211 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.




SAMPLE REPORT

CYP4F2Active *1

Decreased Activity *3

DPYD

Active *1, *4, *5, *6, *9A

Decreased Activity *9B, *10

Inactive *2A, *3, *7, *8, *11, *12, *13, 496A>G, IVS10-15T>C, 1845G>T, 2846A>T

DRD1 Decreased Activity rs4532

DRD2 Decreased Activity rs1799978

ERCC1 Decreased Activity rs3212986, rs11615, rs735482

F2 Prothrombin Mutation G20210A

F5 Increased Activity rs6025

FAAH Decreased Activity rs324420

G6PD Decreased Activity

A, A-202A_376G, A-376G_968C, Alhambra, Andalus, Beverly Hills, Canton, Cassano, Chatham, Chinese-3, Chinese-4, Coimbra, Cosenza, Fushan, Guadalajara, Ilesha, Iowa, Kaiping, Kalyan, Lagosanto, Mahidol, Mediterranean, Metaponto, Minnesota, Mt. Sinai, Nara, Nashville, Olomouc, Pawnee, Plymouth, Praba, Puetro Limon, Santamaria, Santiago, Santiago de Cuba, Sao Boria, Shinshu, Sibari, Telti, Tomah, Ube, Union, Viangchan, West Virginia

GRIK4 Decreased Activity rs1954787

GSTP1 Decreased Activity rs1695

HLA-B

Carbamazepine ADR *1502

Abacavir Hypersensitivity *5701

Allopurinol ADR *5801

HTR1A Decreased Activity rs1800044, rs6295

HTR2A Decreased Activity rs7997012

HTR2C Decreased Activity rs1414334, rs3813929

IFNL3 Decreased Activity rs12979860, rs8099917

ITPA Decreased Activity rs1127354, rs7270101

KIF6 Decreased Activity rs20455

MTHFR Decreased Activity C677T, A1298C

NAT2Active *4, *12, *13

Inactive *5, *6, *7

NOS1AP Decreased Activity rs10494366, rs10800397, rs10919035

NQO1 Decreased Activity rs1800566

OPRM1 Decreased Activity rs1799971, rs510769

SCN2A Decreased Activity rs2304016

SLC6A4 Decreased Activity 5-HTTLPR LA, 5-HTTLPR LG, 5-HTTLPR S

SLCO1B1 Decreased Activity *5

TPMTActive *1

Inactive *2, *3A, *3B, *3C, *4

UGT1A1 Decreased Activity *28

UGT2B15 Decreased Activity rs1902023

VKORC1 Increased Warfarin Sensitivity -1639G>A

XRCC1 Decreased Activity rs25487




SAMPLE REPORT

Warnings & Precautions for PGxOne™ Plus Recommended Drugs:

Celecoxib (Celebrex®): http://www.rxlist.com/cgi/generic/coxib.htm

Dexamethasone (Maxidex®): http://www.rxlist.com/cgi/generic/dexameth.htm

Dexlansoprazole (Dexilant®): http://www.rxlist.com/dexilant-drug.htm

Diclofenac (Voltaren®): http://www.rxlist.com/cgi/generic/diclofen.htm

Esomeprazole (Nexium®): http://www.rxlist.com/cgi/generic3/esomeprazole.htm

Lansoprazole (Prevacid®): http://www.rxlist.com/cgi/generic/lansop.htm

Meloxicam (Mobic®): http://www.rxlist.com/cgi/generic/mobic.htm

Methylprednisolone (Medrol®): http://www.rxlist.com/cgi/generic/methprd.htm

Omeprazole (Prilosec®): http://www.rxlist.com/cgi/generic/omepra.htm

Pantoprazole (Protonix®): http://www.rxlist.com/cgi/generic3/protonix.htm

Prednisolone (Omnipred®): http://www.rxlist.com/cgi/generic/prednisolone.htm

Prednisone (Deltasone®): http://www.rxlist.com/cgi/generic/pred.htm

Rabeprazole (Aciphex®): http://www.rxlist.com/cgi/generic3/aciphex.htm

Verapamil (Calan®): http://www.rxlist.com/cgi/generic/verapsr.htm

Assay Methodology and Limitations for PGxOne™ Plus Panel:Pharmacogenomics testing to assess how a patient may respond to prescribed drugs was performed by massively parallel Next Generation Sequencing (NGS). PGxOne™ Plus 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. PGxOne™ Plus 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 PGxOne™ Plus 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.

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

4. Warfarin dosing guideline: Clinical Pharmacogenetics Implementation Consortium Guidelines for CYP2C9 and VKORC1 Genotypes and Warfarin Dosing




SAMPLE REPORT

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.




SAMPLE REPORT

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