sample report - Admera Health
Transcription
sample report - Admera Health
SAMPLE REPORT Admera Health, LLC 126 Corporate Boulevard • South Plainfield, NJ 07080 +1-908-222-0533 • [email protected] PATIENT INFORMATION Name: Smith, John DOB: April 22, 1973 Age: 42 Sex: Male SAMPLE Date Collected: Date Received: Case ID: Source: REFERRING PHYSICIAN Name: Jane Doe, MD Institution: Local Hospital July 15, 2015 July 15, 2015 PLUS15-000535 Buccal Swabs Comprehensive Drug Information for Smith, John ICD-10: F30.11 Manic episode without psychotic symptoms, mild; I10 Essential (primary) hypertension; M12.9 Arthropathy, unspecified Codeine (Codeine®) CONSIDER ALTERNATIVES Hydrocodone (Vicodin®) Oxycodone (Oxycontin®) Tramadol hydrochloride/ Acetaminophen (Ultracet®) INCREASE DOSE Alfentanil (Alfenta®) DECREASE DOSE E Buprenorphine (Subutex®) Metoprolol (Lopressor®) Fentanyl (Duragesic®) Risperidone (Risperdal®) PL Methadone (Methadose®) Tramadol hydrochloride/ Acetaminophen (Ultracet®) Aripiprazole (Abilify®) Aripiprazole (Abilify®) SA M Sufentanil (Sufenta®) NORMAL RESPONSE EXPECTED Alfentanil (Alfenta®) USE CAUTION Buprenorphine (Subutex®) Iloperidone (Fanapt®) Fentanyl (Duragesic®) Pimozide Methadone (Methadose® Atenolol (Tenormin®) Sufentanil )(Sufenta® Azathioprine (Imuran®) Amlodipine ) (Norvasc®) 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. PGxOneTM Plus Report for Smith, John Laboratory Director: Dr. James Dermody CLIS ID: 0005783 CLIA ID: 31D2038676 Page 1 of 25 SAMPLE REPORT Admera Health, LLC 126 Corporate Boulevard • South Plainfield, NJ 07080 +1-908-222-0533 • [email protected] Patient Specific Genotype Results and Comprehensive Drug Information for Smith, John ICD-10: F30.11 Manic episode without psychotic symptoms, mild; I10 Essential (primary) hypertension; M12.9 Arthropathy, unspecified Drug Impacted Clinical Interpretation Phenotype *4/*35 Intermediate Metabolizer CYP2D6 *4/*35 Intermediate Metabolizer CYP2D6 *4/*35 Intermediate Metabolizer CYP2D6 *4/*35 Intermediate Metabolizer CYP2D6 *4/*35 Intermediate Metabolizer CYP2D6 *4/*35 Intermediate Metabolizer M OR Genotype PL Antipsychotics: CONSIDER Risperidone (Risperdal®) ALTERNATIVES (e.g., quetiapine, olanzapine, clozapine) Opiates: CONSIDER Codeine (Codeine®), ALTERNATIVES Hydrocodone (Vicodin®), (e.g., acetaminophen, Oxycodone (Oxycontin®) NSAID, morphine--not opioids) Serotonin and CONSIDER Norepinephrine ALTERNATIVES Reuptake Inhibitors (e.g., citalopram, (SNRIs): sertraline) Venlafaxine (Effexor®) Beta Blockers: CONSIDER Metoprolol (Lopressor®) ALTERNATIVES (e.g., bisoprolol, carvedilol) Gene CYP2D6 E Action SA DECREASE DOSE by 50% due to heart failure caused by the decreased drug cardioselectivity Opiates: CONSIDER Tramadol ALTERNATIVES hydrochloride/Acetaminop like morphine and nonhen (Ultracet®) opioid analgesics OR INCREASE DOSE Tetracyclic Antidepressants: Maprotiline (Ludiomil®) PGxOneTM Plus Report for Smith, John DECREASE DOSE Laboratory Director: Dr. James Dermody CLIS ID: 0005783 CLIA ID: 31D2038676 Page 2 of 25 SAMPLE REPORT Admera Health, LLC 126 Corporate Boulevard • South Plainfield, NJ 07080 +1-908-222-0533 • [email protected] Drug Impacted Clinical Interpretation DECREASE DOSE by 25% Tricyclic Antidepressants: Amitriptyline (Elavil®), Clomipramine (Anafranil®), Desipramine (Norpramin®), Doxepin (Deptran®), Imipramine (Tofranil®), Nortriptyline (Pamelor®), Protriptyline (Vivactil®), Trimipramine (Surmontil®) Opiates: DECREASE DOSE Alfentanil (Alfenta®), Buprenorphine (Subutex®), Fentanyl OR (Duragesic®), Methadone (Methadose®), Sufentanil (Sufenta®) Gene Genotype Phenotype CYP2D6 *4/*35 Intermediate Metabolizer CYP3A4 *1A/*1B Intermediate Metabolizer E Action CYP3A4 *1A/*1B Intermediate Metabolizer M DECREASE DOSE to lowest necessary dose daily due to Increased risk for myopathy and rhabdomyolysis SA Statins: Atorvastatin (Lipitor®), Lovastatin (Mevacor®), Simvastatin (Zocor®) PL USE CAUTION due to the risk of increased exposure to the drug leading to adverse events OR USE CAUTION due to increased risk of adverse reactions Calcium Channel Blockers: Amlodipine (Norvasc®), Diltiazem (Cardizem®), Felodipine (Plendil®), Lercanidipine (Zanidip®), Nifedipine (Adalat®), Nisoldipine (Sular®), Nitrendipine (Nitrepin®), Verapamil (Calan®) Selective Serotonin Reuptake Inhibitors (SSRIs): Fluoxetine (Prozac®), Fluvoxamine (Luvox®), Paroxetine (Paxil®) USE CAUTION due to significant increase in drug exposure and therefore clinical monitoring and dose adjustment may thus be required CYP3A4 *1A/*1B Intermediate Metabolizer USE CAUTION due to elevated risk for drug overdose resulting in adverse events and drug interaction CYP2D6 *4/*35 Intermediate Metabolizer Selective Serotonin Reuptake Inhibitors (SSRIs): Sertraline (Zoloft®) USE CAUTION with high alert to adverse drug events CYP2C19 *1/*2 Intermediate Metabolizer PGxOneTM Plus Report for Smith, John Laboratory Director: Dr. James Dermody CLIS ID: 0005783 CLIA ID: 31D2038676 Page 3 of 25 SAMPLE REPORT Admera Health, LLC 126 Corporate Boulevard • South Plainfield, NJ 07080 +1-908-222-0533 • [email protected] Drug Impacted Gene Genotype Phenotype NORMAL RESPONSE EXPECTED CYP3A4 *1A/*1B Intermediate Metabolizer Antipsychotics: Aripiprazole (Abilify®), Iloperidone (Fanapt®), Pimozide (Orap®) Antipsychotics: Haloperidol (Haldol®) NORMAL RESPONSE EXPECTED CYP2D6 *4/*35 Intermediate Metabolizer NORMAL RESPONSE EXPECTED CYP2D6 *4/*35 Intermediate Metabolizer Antipsychotics: Olanzapine (Zalasta®) NORMAL RESPONSE EXPECTED CYP1A2 *1A/*1F Ultrarapid Metabolizer Beta Blockers: Atenolol (Tenormin®) NORMAL RESPONSE EXPECTED LDLR c.1773C>T/c.1773C> T rs688 TT Genotype genotype Beta Blockers: Carvedilol (Coreg®) NORMAL RESPONSE EXPECTED CYP2D6 *4/*35 Intermediate Metabolizer ATM WT/WT rs11212617 CC genotype TPMT *1/*1 Normal Metabolizer E Clinical Interpretation Antipsychotics: Aripiprazole (Abilify®) PL Action M Biguanides: NORMAL RESPONSE Metformin (Glucophage®) EXPECTED NORMAL RESPONSE EXPECTED Metabolic Inhibitors: Methotrexate (Trexall®) NORMAL RESPONSE EXPECTED ITPA WT/WT Non-protective Wild Type Nonsteroidal Antiinflammatory Drugs (NSAIDs): Celecoxib (Celebrex®), Diclofenac (Cataflam®), Meloxicam (Mobic®) Nonsteroidal Antiinflammatory Drugs (NSAIDs): Ibuprofen (Advil®), Naproxen (Aleve®) NORMAL RESPONSE EXPECTED CYP2C9 *1/*1 Normal Metabolizer NORMAL RESPONSE EXPECTED CYP2C9 *1/*1 Normal Metabolizer SA Immunosuppressive Drugs: Azathioprine (Imuran®) PGxOneTM Plus Report for Smith, John Laboratory Director: Dr. James Dermody CLIS ID: 0005783 CLIA ID: 31D2038676 Page 4 of 25 SAMPLE REPORT Admera Health, LLC 126 Corporate Boulevard • South Plainfield, NJ 07080 +1-908-222-0533 • [email protected] Gene Genotype Phenotype NORMAL RESPONSE EXPECTED CYP2C19 *1/*2 Intermediate Metabolizer NORMAL RESPONSE EXPECTED CYP2C19 *1/*2 Intermediate Metabolizer Selective Serotonin NORMAL RESPONSE Reuptake Inhibitors EXPECTED (SSRIs): Escitalopram (Lexapro®) CYP2C19 *1/*2 Intermediate Metabolizer Selective Serotonin Reuptake Inhibitors (SSRIs): Vilazodone (Viibryd®) NORMAL RESPONSE EXPECTED CYP3A4 Selective Serotonin Reuptake Inhibitors (SSRIs): Vortioxetine (Brintellix®) NORMAL RESPONSE EXPECTED Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs): Duloxetine (Cymbalta®) NORMAL RESPONSE EXPECTED Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs): Levomilnacipran (Fetzima®) Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs): Reboxetine (Edronax®), Trazodone (Desyrel®) Statins: Pitavastatin (Livalo®), Pravastatin (Pravachol®), Rosuvastatin (Crestor®) PGxOneTM Plus Report for Smith, John *1A/*1B CYP2D6 Intermediate Metabolizer *4/*35 Intermediate Metabolizer CYP1A2 *1A/*1F Ultrarapid Metabolizer NORMAL RESPONSE EXPECTED CYP3A4 *1A/*1B Intermediate Metabolizer NORMAL RESPONSE EXPECTED CYP3A4 *1A/*1B Intermediate Metabolizer NORMAL RESPONSE EXPECTED SLCO1B1 *1/*1 Normal Activity SA Proton Pump Inhibitors (PPIs): Dexlansoprazole (Dexilant®), Esomeprazole (Nexium®), Lansoprazole (Prevacid®), Omeprazole (Prilosec®), Pantoprazole (Protonix®), Rabeprazole (Aciphex®) Selective Serotonin Reuptake Inhibitors (SSRIs): Citalopram (Celexa®) E Clinical Interpretation PL Drug Impacted M Action Laboratory Director: Dr. James Dermody CLIS ID: 0005783 CLIA ID: 31D2038676 Page 5 of 25 SAMPLE REPORT Admera Health, LLC 126 Corporate Boulevard • South Plainfield, NJ 07080 +1-908-222-0533 • [email protected] Current Medication Information for Smith, John Action Drug Impacted Opiates: Hydrocodone Beta Blockers: Metoprolol Clinical Interpretation CONSIDER ALTERNATIVES (e.g., acetaminophen, NSAID, morphine--not opioids) CONSIDER ALTERNATIVES (e.g., bisoprolol, carvedilol) Gene Genotype Phenotype CYP2D6 *4/*35 Intermediate Metabolizer CYP2D6 *4/*35 Intermediate Metabolizer OR PL E DECREASE DOSE by 50% due to heart failure caused by the decreased drug cardioselectivity DECREASE DOSE by 25% CYP2D6 *4/*35 Intermediate Metabolizer DECREASE DOSE to lowest necessary dose daily due to Increased risk for myopathy and rhabdomyolysis CYP3A4 *1A/*1B Intermediate Metabolizer ATM WT/WT rs11212617 CC genotype Nonsteroidal NORMAL RESPONSE Antiinflammatory Drugs EXPECTED (NSAIDs): Meloxicam CYP2C9 *1/*1 Normal Metabolizer Proton Pump Inhibitors NORMAL RESPONSE (PPIs): EXPECTED Lansoprazole CYP2C19 *1/*2 Intermediate Metabolizer Benzodiazepines: Diazepam CYP2C19 *1/*2 Intermediate Metabolizer M Tricyclic Antidepressants: Amitriptyline Statins: Simvastatin SA OR USE CAUTION due to increased risk of adverse reactions Biguanides: Metformin PGxOneTM Plus Report for Smith, John NORMAL RESPONSE EXPECTED CLINICAL EVIDENCE NOT SUFFICIENT Laboratory Director: Dr. James Dermody CLIS ID: 0005783 CLIA ID: 31D2038676 Page 6 of 25 SAMPLE REPORT Admera Health, LLC 126 Corporate Boulevard • South Plainfield, NJ 07080 +1-908-222-0533 • [email protected] Clinical Interpretation Gene Genotype Phenotype ACE Inhibitors: Lisinopril Drug Impacted CLNICAL INTERPRETATION NOT AVAILABLE NA NA NA Antiemetics: Promethazine PHARMACOGENOMICS EVIDENCE NOT AVAILABLE NA NA NA Nitrate Vasodilators: Nitroglycerin PHARMACOGENOMICS EVIDENCE NOT AVAILABLE NA NA NA SA M PL E Action PGxOneTM Plus Report for Smith, John Laboratory Director: Dr. James Dermody CLIS ID: 0005783 CLIA ID: 31D2038676 Page 7 of 25 SAMPLE REPORT Admera Health, LLC 126 Corporate Boulevard • South Plainfield, NJ 07080 +1-908-222-0533 • [email protected] Drug-Drug Interactions for Smith, John Drugs Warning Clinical Management Excellent Caution is advised if NSAIDs and tricyclic antidepressants are coadministered. Concomitant use of NSAIDs and tricyclic antidepressants may cause an increased risk of bleeding, including intracranial hemorrhage (Shin et al, 2015). When NSAIDs and tricyclic antidepressants are given concurrently, monitor the patient for signs of increased bleeding. AMITRIPTYLINE -- MAJOR PROMETHAZINE Concurrent use of AMITRIPTYLINE and PROMETHAZINE may result in an increased risk of QT interval prolongation. HYDROCODONE -- MAJOR DIAZEPAM Concurrent use of HYDROCODONE and CNS DEPRESSANTS may result in increased risk of CNS depression (ie, respiratory depression, profound sedation, coma). Fair Use caution when using amitriptyline and promethazine concomitantly due to a potential for additive effects on the QT interval and increased risk of serious cardiovascular effects (Prod Info amitriptyline HCl oral tablet, 2010). HYDROCODONE -- MAJOR PROMETHAZINE Concurrent use of HYDROCODONE and CNS DEPRESSANTS may result in increased risk of CNS depression (ie, respiratory depression, profound sedation, coma). Fair The concomitant use of hydrocodone and a CNS depressant may result in additive CNS effects and increase the risk of respiratory depression, profound sedation, coma, and/or death. If combination therapy is required, reduce the initial hydrocodone dose by 20% to 30% and use a lower dose of the concomitant CNS depressant. Monitor patients for signs of respiratory depression, sedation, or hypotension (Prod Info Zohydro(TM) ER oral extended-release capsules, 2013). AMITRIPTYLINE -- MODERATE DIAZEPAM Concurrent use of AMITRIPTYLINE and DIAZEPAM may result in psychomotor deficits (decreased reaction time, decreased vigilance). Good If coadministration of amitriptyline with diazepam is necessary, patients should be warned that they may experience additive psychomotor impairment that may affect driving or other tasks requiring complex motor skills. Fair E Documentation AMITRIPTYLINE -- MAJOR MELOXICAM Concurrent use of NSAID and TRICYCLIC ANTIDEPRESSANTS may result in an increased risk of bleeding. The concomitant use of hydrocodone and a CNS depressant may result in additive CNS effects and increase the risk of respiratory depression, profound sedation, coma, and/or death. If combination therapy is required, reduce the initial hydrocodone dose by 20% to 30% and use a lower dose of the concomitant CNS depressant. Monitor patients for signs of respiratory depression, sedation, or hypotension (Prod Info Zohydro(TM) ER oral extended-release capsules, 2013). SA M PL Severity PGxOneTM Plus Report for Smith, John Laboratory Director: Dr. James Dermody CLIS ID: 0005783 CLIA ID: 31D2038676 Page 8 of 25 SAMPLE REPORT Admera Health, LLC 126 Corporate Boulevard • South Plainfield, NJ 07080 +1-908-222-0533 • [email protected] Drugs Warning MELOXICAM -LISINOPRIL MODERATE Concurrent use of ACE INHIBITORS and NSAIDS may result in renal dysfunction or decreased antihypertensive efficacy. METFORMIN -LISINOPRIL MODERATE Concurrent use of ACE INHIBITORS and ANTIDIABETIC AGENTS may result in increased risk of hypoglycemia. METFORMIN -PROMETHAZINE MODERATE Concurrent use of ANTIDIABETIC AGENTS and PHENOTHIAZINES may result in loss of glycemic control. Documentation Clinical Management Excellent Use caution if ACE inhibitors and NSAIDs are coadministered. When concomitant use is required, monitor for antihypertensive efficacy and assess renal function periodically for signs of renal deterioration or failure (Prod Info VIMOVO(TM) delayed release oral tablets, 2010; Prod Info SPRIX(TM) nasal spray, 2009), especially in patients who are elderly, volumedepleted, or with preexisting renal dysfunction (Prod Info PRESTALIA® oral tablets, 2015). Coadministration of ACE inhibitors with antidiabetic agents may increase the risk of hypoglycemia (Prod Info TOUJEO® subcutaneous injection, 2015; Prod Info AFREZZA® oral inhalation powder, 2014; Prod Info Zestril® oral tablets, 2014). If concomitant use is required, conduct more frequent glucose monitoring, both during treatment and after withdrawal of an ACE inhibitor (Prod Info AMARYL® oral tablets, 2013). Insulin dose adjustments may also be needed (Prod Info TOUJEO® subcutaneous injection, 2015; Prod Info AFREZZA® oral inhalation powder, 2014). Phenothiazines tend to produce hyperglycemia, and loss of glycemic control may occur in patients receiving concomitant antidiabetic medications (Prod Info TOUJEO® subcutaneous injection, 2015; Prod Info GLUMETZA® oral extended-release tablets, 2013; Prod Info GLUCOTROL® oral tablets, 2013). More frequent monitoring of blood glucose levels may be necessary in these patients. Also, adjust the dose of the antidiabetic agent if necessary (Prod Info TOUJEO® subcutaneous injection, 2015). Monitor for hypoglycemia upon withdrawal of the phenothiazine agent (Prod Info GLUCOTROL® oral tablets, 2013). Fair PL E Severity SA M Fair METOPROLOL -METFORMIN PGxOneTM Plus Report for Smith, John MODERATE Concurrent use of ANTIDIABETIC AGENTS and BETAADRENERGIC BLOCKERS may result in hypoglycemia or hyperglycemia; decreased symptoms of hypoglycemia. Good Concurrent use of antidiabetic agents with betablockers may increase or decrease the blood glucose lowering effect of the antidiabetic agent, and may decrease or obscure signs and symptoms of hypoglycemia. Increased frequency of glucose monitoring or dose adjustment of the antidiabetic agent may be required (Prod Info TOUJEO® subcutaneous injection, 2015; Prod Info AMARYL® oral tablets, 2013). Closely monitor for hypoglycemia with concurrent use, and if the beta-blocker is withdrawn, observe for signs of loss of glycemic control (Prod Info Glynase® PresTab® oral micronized tablets, 2013). Laboratory Director: Dr. James Dermody CLIS ID: 0005783 CLIA ID: 31D2038676 Page 9 of 25 SAMPLE REPORT Admera Health, LLC 126 Corporate Boulevard • South Plainfield, NJ 07080 +1-908-222-0533 • [email protected] Severity Drugs MODERATE Concurrent use of BETA-ADRENERGIC BLOCKERS and NONSTEROIDAL ANTIINFLAMMATOR Y AGENTS may result in decreased antihypertensive effect. Documentation Clinical Management 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 betablocker. SA M PL E METOPROLOL -MELOXICAM Warning PGxOneTM Plus Report for Smith, John Laboratory Director: Dr. James Dermody CLIS ID: 0005783 CLIA ID: 31D2038676 Page 10 of 25 SAMPLE REPORT Admera Health, LLC 126 Corporate Boulevard • South Plainfield, NJ 07080 +1-908-222-0533 • [email protected] Portable Patient PGxOneTM Plus Genotype Results and Drug Information by Specialty for Smith, John Therapeutic Therapeutic Action Action Drug Drug Impacted Impacted Clinical Clinical Interpretation Interpretation Gene Gene Genotype Genotype Phenotype Phenotype *1A/*1B Intermediate Metabolizer Cardiology Antianginal Drugs: CONSIDER ALTERNATIVES Ivabradine (Corlentor®) CYP3A4 Cardiology Antiarrhythmic Drugs: CONSIDER ALTERNATIVES Amiodarone (Cordarone®), Dronedarone (Multaq®) Antiarrhythmic Drugs: CONSIDER ALTERNATIVES Propafenone (e.g., sotalol, disopyramide, (Rythmol®) quinidine, amiodarone) CYP3A4 *1A/*1B Intermediate Metabolizer CYP2D6 *4/*35 Intermediate Metabolizer *1/*2 Intermediate Metabolizer CYP3A4 *1A/*1B Intermediate Metabolizer CYP2D6 *4/*35 Intermediate Metabolizer Antiarrhythmic Drugs: DECREASE DOSE Flecainide (Tambocor®) by 25% CYP2D6 *4/*35 Intermediate Metabolizer Statins: Atorvastatin (Lipitor®), Lovastatin (Mevacor®), Simvastatin (Zocor®) CYP3A4 *1A/*1B Intermediate Metabolizer Cardiology Antiplatelets: Clopidogrel (Plavix®) CONSIDER ALTERNATIVES CYP2C19 Cardiology Antiplatelets: Ticagrelor (Brilinta®) CONSIDER ALTERNATIVES Cardiology Beta Blockers: CONSIDER ALTERNATIVES Metoprolol (Lopressor®) (e.g., bisoprolol, carvedilol) PL E Cardiology Cardiology Cardiology SA M OR DECREASE DOSE by 50% due to heart failure caused by the decreased drug cardioselectivity DECREASE DOSE to lowest necessary dose daily due to Increased risk for myopathy and rhabdomyolysis OR USE CAUTION due to increased risk of adverse reactions PGxOneTM Plus Report for Smith, John Laboratory Director: Dr. James Dermody CLIS ID: 0005783 CLIA ID: 31D2038676 Page 11 of 25 SAMPLE REPORT Admera Health, LLC 126 Corporate Boulevard • South Plainfield, NJ 07080 +1-908-222-0533 • [email protected] Therapeutic Therapeutic Action Action Drug Drug Impacted Impacted Clinical Clinical Interpretation Interpretation Gene Gene Genotype Genotype Phenotype Phenotype *1A/*1B Intermediate Metabolizer USE CAUTION due to significant increase in drug exposure and therefore clinical monitoring and dose adjustment may thus be required NORMAL RESPONSE EXPECTED CYP2D6 *4/*35 Intermediate Metabolizer Cardiology Anticoagulants: Phenprocoumon (Marcoumar®) NORMAL RESPONSE EXPECTED CYP4F2 *1/*1 Normal Metabolizer Cardiology Anticoagulants: NORMAL RESPONSE Rivaroxaban (Xarelto®) EXPECTED CYP3A4 *1A/*1B Intermediate Metabolizer Cardiology Anticoagulants: Warfarin (Coumadin®) NORMAL DOSE Warfarin daily dose 5-7mg CYP2C9 *1/*1 Normal Metabolizer Cardiology Anticoagulants: Warfarin (Coumadin®) NORMAL DOSE Warfarin daily dose 5-7mg VKORC1 WT/-1639G>A Cardiology Beta Blockers: Atenolol (Tenormin®) NORMAL RESPONSE EXPECTED LDLR c.1773C>T/c. 1773C>T rs688 TT Genotype genotype Beta Blockers: Carvedilol (Coreg®) NORMAL RESPONSE EXPECTED CYP2D6 *4/*35 Intermediate Metabolizer Cardiology Phosphodiesterase Inhibitors: Cilostazol (Pletal®) NORMAL RESPONSE EXPECTED CYP3A4 *1A/*1B Intermediate Metabolizer Cardiology Statins: Atorvastatin (Lipitor®), Lovastatin (Mevacor®), Simvastatin (Zocor®) Statins: Pitavastatin (Livalo®), Pravastatin (Pravachol®), Rosuvastatin (Crestor®) Statins: Simvastatin (Zocor®) NORMAL RESPONSE EXPECTED CYP3A5 *1A/*3A Expresser NORMAL RESPONSE EXPECTED SLCO1B1 *1/*1 Normal Activity NORMAL RESPONSE EXPECTED SLCO1B1 *1/*1 Normal Activity Cardiology Cardiology Cardiology PL M Cardiology SA Cardiology E Calcium Channel Blockers: Amlodipine (Norvasc®), Diltiazem (Cardizem®), Felodipine (Plendil®), Lercanidipine (Zanidip®), Nifedipine (Adalat®), Nisoldipine (Sular®), Nitrendipine (Nitrepin®), Verapamil (Calan®) Antianginal Drugs: Ranolazine (Ranexa®) CYP3A4 PGxOneTM Plus Report for Smith, John Laboratory Director: Dr. James Dermody CLIS ID: 0005783 rs9923231 A Allele Carrier CLIA ID: 31D2038676 Page 12 of 25 SAMPLE REPORT Admera Health, LLC 126 Corporate Boulevard • South Plainfield, NJ 07080 +1-908-222-0533 • [email protected] Therapeutic Therapeutic Action Action Drug Drug Impacted Impacted Clinical Clinical Interpretation Interpretation Gene Gene Genotype Genotype Phenotype Phenotype CYP2D6 *4/*35 Intermediate Metabolizer Cholinergic Agonists: NORMAL RESPONSE Cevimeline (Evoxac®) EXPECTED Endocrinology Biguanides: Metformin (Glucophage®) NORMAL RESPONSE EXPECTED ATM WT/WT rs11212617 CC genotype Endocrinology Hormones: Oral-Contraceptives NORMAL RESPONSE EXPECTED F2 WT/WT Wild Type Endocrinology Sulfonylureas: NORMAL RESPONSE Chlorpropamide EXPECTED (Diabinese®), Glimepiride (Amaryl®), Glipizide (Glucotrol®), Glyburide (Glynase®), Tolbutamide (Orinase®) CYP2C9 *1/*1 Normal Metabolizer Endocrinology Sulfonylureas: Chlorpropamide (Diabinese®), Glimepiride (Amaryl®), Glipizide (Glucotrol®), Glyburide (Glynase®), Tolbutamide (Orinase®) Biguanides: Metformin (Glucophage®) NORMAL RESPONSE EXPECTED G6PD WT/WT Normal G6PD Efficiency More likely to achieve higher insulin sensitivity and metformin efficacy STK11 Proton Pump Inhibitors (PPIs): Dexlansoprazole (Dexilant®), Esomeprazole (Nexium®), Lansoprazole (Prevacid®), Omeprazole (Prilosec®), Pantoprazole (Protonix®), Rabeprazole (Aciphex®) Platelet Stimulating Agents: Eltrombopag (Promacta®) Immunosuppressants: Sirolimus (Rapamune®) NORMAL RESPONSE EXPECTED CYP2C19 *1/*2 Intermediate Metabolizer NORMAL RESPONSE EXPECTED F5 WT/WT Non Factor V Leiden Carrier NORMAL RESPONSE EXPECTED CYP3A4 *1A/*1B Intermediate Metabolizer Immunosuppressants: NORMAL RESPONSE Sirolimus EXPECTED (Rapamune®), Tacrolimus (Protopic®) CYP3A5 *1A/*3A Expresser PL SA Gastroenterology M Endocrinology Hematology Immunology Immunology E Dentistry PGxOneTM Plus Report for Smith, John Laboratory Director: Dr. James Dermody CLIS ID: 0005783 c.290+2512C rs8111699 GG genotype >G/c.290+251 2C>G CLIA ID: 31D2038676 Page 13 of 25 SAMPLE REPORT Admera Health, LLC 126 Corporate Boulevard • South Plainfield, NJ 07080 +1-908-222-0533 • [email protected] Therapeutic Therapeutic Infectious Diseases Action Action Drug Drug Impacted Impacted Clinical Clinical Interpretation Interpretation Antiviral Drugs: Boceprevir (Victrelis®), Peginterferon alfa-2b (PegIntron®), Ribavirin (Copegus®), Telaprevir (Incivo®) Antiviral Drugs: Ribavirin (Copegus®) USE CAUTION due to increase risk of ribavirin-induced hemolytic anemia Gene Gene Genotype Genotype Phenotype Phenotype ITPA WT/WT Non-protective Wild Type DDRGK1 WT/c.510+36 4T>G rs6051639 AC genotype CYP2C19 *1/*2 Intermediate Metabolizer G6PD WT/WT Normal G6PD Efficiency Protease Inhibitors: Atazanavir (Reyataz®) Infectious Diseases Antibiotics: Dapsone (Aczone®) NORMAL RESPONSE EXPECTED Infectious Diseases Antibiotics: Isoniazid (Hydra®), Pyrazinamide (Rifater®), Rifampin (Rifadin®) Antibiotics: Nalidixic Acid (Neggram®), Nitrofurantoin (Furadantin®) NORMAL RESPONSE EXPECTED NAT2 *4/*12 Normal Metabolizer NORMAL RESPONSE EXPECTED G6PD WT/WT Normal G6PD Efficiency Antimalarial Drugs: Chloroquine (Aralen®), Primaquine Phosphate (Primaquine®) Antiretroviral Agents: Abacavir (Ziagen®) NORMAL RESPONSE EXPECTED G6PD WT/WT Normal G6PD Efficiency NORMAL RESPONSE EXPECTED HLA-B WT/WT Wild Type Antiviral Drugs: Boceprevir (Victrelis®), Peginterferon alfa-2b (PegIntron®), Ribavirin (Copegus®), Telaprevir (Incivo®) Anticonvulsant Drugs: Carbamazepine (Tegretol®), Phenytoin (Dilantin®) Benzodiazepines: Clobazam (Onfi®) NORMAL RESPONSE EXPECTED IFNL3 39738787C>T /39743165T> G Unfavorable Response Genotype NORMAL RESPONSE EXPECTED HLA-B WT/WT Wild Type NORMAL RESPONSE EXPECTED CYP2C19 *1/*2 Intermediate Metabolizer Monoamine Depletors: NORMAL RESPONSE Tetrabenazine EXPECTED (Xenazine®) CYP2D6 *4/*35 Intermediate Metabolizer Infectious Diseases Infectious Diseases Neurology Neurology Neurology PL M Infectious Diseases SA Infectious Diseases E Infectious Diseases USE CAUTION due to treatment-induced anemia USE CAUTION due to a loss of both voriconazole and atazanavir efficacy when co-treated with voriconazole which needs close clinical monitoring Infectious Diseases PGxOneTM Plus Report for Smith, John Laboratory Director: Dr. James Dermody CLIS ID: 0005783 CLIA ID: 31D2038676 Page 14 of 25 SAMPLE REPORT Admera Health, LLC 126 Corporate Boulevard • South Plainfield, NJ 07080 +1-908-222-0533 • [email protected] Therapeutic Therapeutic Action Action Drug Drug Impacted Impacted Clinical Clinical Interpretation Interpretation Gene Gene Genotype Genotype Phenotype Phenotype *1/*1 Normal Metabolizer WT/WT Non Factor V Leiden Carrier *4/*35 Intermediate Metabolizer *1/*28 *28 Allele Carrier Neurology Nicotinic receptor antagonists: Nicotine (Nicoderm®) NORMAL RESPONSE EXPECTED CYP2A6 OBGYN Hormonal Contraceptives: Norelgestromin/Ethinyl Estradiol (Evra®) Estrogen Antagonists: Tamoxifen (Soltamox®) NORMAL RESPONSE EXPECTED F5 Topoisomerase I Inhibitors: Irinotecan (Camptosar®) Oncology Antineoplastic Agents: Carboplatin (Paraplatin®), Cyclophosphamide (Endoxan®), Fluorouracil (Carac®), Leucovorin (Wellcovorin®), Oxaliplatin (Eloxatin®) Kinase Inhibitors: Erlotinib (Tarceva®), Nilotinib (Tasigna®), Pazopanib (Votrient®) USE CAUTION due to an increased risk of toxicity MTHFR A1298C C677T/A1298 Mutation/C677T C Mutation Oncology USE CAUTION due to increased risk of hyperbilirubinemia UGT1A1 *1/*28 *28 Allele Carrier Antineoplastic NORMAL RESPONSE Agents: EXPECTED Cabazitaxel (Jevtana®) CYP3A4 *1A/*1B Intermediate Metabolizer SA Oncology M PL Oncology CONSIDER ALTERNATIVES CYP2D6 like aromatase inhibitor for postmenopausal women due to increased risk for relapse of breast cancer UGT1A1 DECREASE DOSE at start by at least one level due to increased risk for neutropenia E Oncology Antineoplastic Agents: Capecitabine (Xeloda®), Fluorouracil (Carac®), Pyrimidinedione (Tegafur®) BRAF Inhibitors: Dabrafenib (Tafinlar®) NORMAL RESPONSE EXPECTED DPYD *5/*9A/c.496A >G/IVS1015T>C Normal Metabolizer NORMAL RESPONSE EXPECTED G6PD WT/WT Normal G6PD Efficiency Oncology Enzymes: Rasburicase (Elitek®) NORMAL RESPONSE EXPECTED G6PD WT/WT Normal G6PD Efficiency Oncology Estrogen Antagonists: NORMAL RESPONSE Tamoxifen (Soltamox®) EXPECTED F2 WT/WT Wild Type Oncology Oncology PGxOneTM Plus Report for Smith, John Laboratory Director: Dr. James Dermody CLIS ID: 0005783 CLIA ID: 31D2038676 Page 15 of 25 SAMPLE REPORT Admera Health, LLC 126 Corporate Boulevard • South Plainfield, NJ 07080 +1-908-222-0533 • [email protected] Therapeutic Therapeutic Action Action Drug Drug Impacted Impacted Clinical Clinical Interpretation Interpretation Gene Gene Genotype Genotype Phenotype Phenotype *1A/*1B Intermediate Metabolizer Oncology Kinase Inhibitors: Gefitinib (Iressa®) NORMAL RESPONSE EXPECTED CYP3A4 Oncology Kinase Inhibitors: Ruxolitinib (Jakavi®) NORMAL RESPONSE EXPECTED CYP3A4 *1A/*1B Intermediate Metabolizer Oncology Kinase Inhibitors: Sunitinib (Sutent®) NORMAL RESPONSE EXPECTED CYP3A4 *1A/*1B Intermediate Metabolizer Oncology Purine Antagonists: NORMAL RESPONSE Mercaptopurine EXPECTED (Purinethol®), Thioguanine (Tabloid®) TPMT *1/*1 Normal Metabolizer Ophthalmology Nonsteroidal Antiinflammatory Drugs (NSAIDs): Flurbiprofen (Ocufen®) Opiates: Codeine (Codeine®), Hydrocodone (Vicodin®), Oxycodone (Oxycontin®) Opiates: Tramadol hydrochloride/Acetamin ophen (Ultracet®) CYP2C9 *1/*1 Normal Metabolizer CONSIDER ALTERNATIVES CYP2D6 (e.g., acetaminophen, NSAID, morphine--not opioids) *4/*35 Intermediate Metabolizer CYP2D6 *4/*35 Intermediate Metabolizer CYP3A4 *1A/*1B Intermediate Metabolizer E CONSIDER ALTERNATIVES like morphine and non-opioid analgesics M Pain Management PL Pain Management NORMAL RESPONSE EXPECTED Pain Management SA OR Opiates: Alfentanil (Alfenta®), Buprenorphine (Subutex®), Fentanyl (Duragesic®), Methadone (Methadose®), Sufentanil (Sufenta®) INCREASE DOSE DECREASE DOSE OR USE CAUTION due to the risk of increased exposure to the drug leading to adverse events PGxOneTM Plus Report for Smith, John Laboratory Director: Dr. James Dermody CLIS ID: 0005783 CLIA ID: 31D2038676 Page 16 of 25 SAMPLE REPORT Admera Health, LLC 126 Corporate Boulevard • South Plainfield, NJ 07080 +1-908-222-0533 • [email protected] Therapeutic Therapeutic Pain Management Action Action Drug Drug Impacted Impacted Clinical Clinical Interpretation Interpretation INCREASE DOSE Muscle Relaxants: Cyclobenzaprine (Flexeril®) Gene Gene Genotype Genotype Phenotype Phenotype CYP1A2 *1A/*1F Ultrarapid Metabolizer CYP1A2 *1A/*1F Ultrarapid Metabolizer CYP1A2 *1A/*1F Ultrarapid Metabolizer CYP2C19 *1/*2 Intermediate Metabolizer OR USE CAUTION due to the risk of decreased exposure to the drug leading to lower effectiveness Pain Management Pain Management USE CAUTION due to the increased risk for loss of efficacy USE CAUTION Local Anesthetics: Lidocaine (Lidoderm®), due to the increased risk for Ropivacaine (Naropin®) loss of efficacy Muscle Relaxants: NORMAL RESPONSE Carisoprodol (SOMA®) EXPECTED Central Alpha-2 Adrenergic Agonists: Tizanidine (Zanaflex®) E Pain Management NORMAL RESPONSE EXPECTED CYP2C9 *1/*1 Normal Metabolizer NORMAL RESPONSE EXPECTED CYP2C9 *1/*1 Normal Metabolizer NORMAL RESPONSE EXPECTED CYP3A4 *1A/*1B Intermediate Metabolizer Antipsychotics: Risperidone (Risperdal®) CONSIDER ALTERNATIVES (e.g., quetiapine, olanzapine, clozapine) CYP2D6 *4/*35 Intermediate Metabolizer Psychiatry Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs): Venlafaxine (Effexor®) CONSIDER ALTERNATIVES (e.g., citalopram, sertraline) CYP2D6 *4/*35 Intermediate Metabolizer Psychiatry DECREASE DOSE Tetracyclic Antidepressants: Maprotiline (Ludiomil®) CYP2D6 *4/*35 Intermediate Metabolizer Pain Management Psychiatry M SA Pain Management PL Nonsteroidal Antiinflammatory Drugs (NSAIDs): Celecoxib (Celebrex®), Diclofenac (Cataflam®), Meloxicam (Mobic®) Nonsteroidal Antiinflammatory Drugs (NSAIDs): Ibuprofen (Advil®), Naproxen (Aleve®) Serotonin Receptor Agonists: Eletriptan (Relpax®), Zolmitriptan (Zomig®) Pain Management PGxOneTM Plus Report for Smith, John Laboratory Director: Dr. James Dermody CLIS ID: 0005783 CLIA ID: 31D2038676 Page 17 of 25 SAMPLE REPORT Admera Health, LLC 126 Corporate Boulevard • South Plainfield, NJ 07080 +1-908-222-0533 • [email protected] Therapeutic Therapeutic Psychiatry Psychiatry Action Action Drug Drug Impacted Impacted Clinical Clinical Interpretation Interpretation DECREASE DOSE Tricyclic by 25% Antidepressants: Amitriptyline (Elavil®), Clomipramine (Anafranil®), Desipramine (Norpramin®), Doxepin (Deptran®), Imipramine (Tofranil®), Nortriptyline (Pamelor®), Protriptyline (Vivactil®), Trimipramine (Surmontil®) Benzodiazepines: DECREASE DOSE Alprazolam (Xanax®) Gene Gene Genotype Genotype Phenotype Phenotype CYP2D6 *4/*35 Intermediate Metabolizer CYP3A4 *1A/*1B Intermediate Metabolizer E OR PL USE CAUTION USE CAUTION due to greater risk of drug toxicity and drug abuse CYP2D6 *4/*35 Intermediate Metabolizer Selective Serotonin Reuptake Inhibitors (SSRIs): Fluoxetine (Prozac®), Fluvoxamine (Luvox®), Paroxetine (Paxil®) Selective Serotonin Reuptake Inhibitors (SSRIs): Sertraline (Zoloft®) Antipsychotics: Aripiprazole (Abilify®) USE CAUTION due to elevated risk for drug overdose resulting in adverse events and drug interaction CYP2D6 *4/*35 Intermediate Metabolizer CYP2C19 USE CAUTION with high alert to adverse drug events *1/*2 Intermediate Metabolizer NORMAL RESPONSE EXPECTED CYP3A4 *1A/*1B Intermediate Metabolizer Antipsychotics: Aripiprazole (Abilify®), Iloperidone (Fanapt®), Pimozide (Orap®) Antipsychotics: Haloperidol (Haldol®) NORMAL RESPONSE EXPECTED CYP2D6 *4/*35 Intermediate Metabolizer NORMAL RESPONSE EXPECTED CYP2D6 *4/*35 Intermediate Metabolizer Psychiatry Antipsychotics: Olanzapine (Zalasta®) NORMAL RESPONSE EXPECTED CYP1A2 *1A/*1F Ultrarapid Metabolizer Psychiatry Selective Serotonin Reuptake Inhibitors (SSRIs): Citalopram (Celexa®) NORMAL RESPONSE EXPECTED CYP2C19 *1/*2 Intermediate Metabolizer Phenethylamines: Amphetamine (Adderall®) Psychiatry Psychiatry Psychiatry Psychiatry SA Psychiatry M Psychiatry PGxOneTM Plus Report for Smith, John Laboratory Director: Dr. James Dermody CLIS ID: 0005783 CLIA ID: 31D2038676 Page 18 of 25 SAMPLE REPORT Admera Health, LLC 126 Corporate Boulevard • South Plainfield, NJ 07080 +1-908-222-0533 • [email protected] Therapeutic Therapeutic Action Action Drug Drug Impacted Impacted Clinical Clinical Interpretation Interpretation Gene Gene Genotype Genotype Phenotype Phenotype *1/*2 Intermediate Metabolizer Psychiatry Selective Serotonin Reuptake Inhibitors (SSRIs): Escitalopram (Lexapro®) NORMAL RESPONSE EXPECTED CYP2C19 Psychiatry Selective Serotonin Reuptake Inhibitors (SSRIs): Vilazodone (Viibryd®) NORMAL RESPONSE EXPECTED CYP3A4 *1A/*1B Intermediate Metabolizer Psychiatry Selective Serotonin NORMAL RESPONSE Reuptake Inhibitors EXPECTED (SSRIs): Vortioxetine (Brintellix®) CYP2D6 *4/*35 Intermediate Metabolizer Psychiatry Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs): Atomoxetine (Strattera®) CYP2D6 *4/*35 Intermediate Metabolizer Psychiatry Serotonin and NORMAL RESPONSE Norepinephrine EXPECTED Reuptake Inhibitors (SNRIs): Duloxetine (Cymbalta®) CYP1A2 *1A/*1F Ultrarapid Metabolizer Psychiatry Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs): Levomilnacipran (Fetzima®) NORMAL RESPONSE EXPECTED CYP3A4 *1A/*1B Intermediate Metabolizer Psychiatry Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs): Reboxetine (Edronax®), Trazodone (Desyrel®) Tricyclic Antidepressants: Amitriptyline (Elavil®), Clomipramine (Anafranil®), Desipramine (Norpramin®), Doxepin (Deptran®), Imipramine (Tofranil®), Nortriptyline (Pamelor®), Protriptyline (Vivactil®), Trimipramine (Surmontil®) Immunosuppressive Drugs: Azathioprine (Imuran®) NORMAL RESPONSE EXPECTED CYP3A4 *1A/*1B Intermediate Metabolizer NORMAL RESPONSE EXPECTED CYP2C19 *1/*2 Intermediate Metabolizer NORMAL RESPONSE EXPECTED TPMT *1/*1 Normal Metabolizer Rheumatology E PL M SA Psychiatry NORMAL RESPONSE EXPECTED PGxOneTM Plus Report for Smith, John Laboratory Director: Dr. James Dermody CLIS ID: 0005783 CLIA ID: 31D2038676 Page 19 of 25 SAMPLE REPORT Admera Health, LLC 126 Corporate Boulevard • South Plainfield, NJ 07080 +1-908-222-0533 • [email protected] Clinical Clinical Interpretation Interpretation Gene Gene Genotype Genotype Phenotype Phenotype Metabolic Inhibitors: NORMAL RESPONSE Methotrexate (Trexall®) EXPECTED ITPA WT/WT Non-protective Wild Type Rheumatology Uric Acid-specific Enzymes: Pegloticase (Krystexxa®) NORMAL RESPONSE EXPECTED G6PD WT/WT Normal G6PD Efficiency Rheumatology Xanthine oxidase NORMAL RESPONSE inhibitors: EXPECTED Allopurinol (Zyloprim®) HLA-B WT/WT Wild Type Urology Alpha Blockers: NORMAL RESPONSE Dutasteride/Tamsulosin EXPECTED (Jalyn®) CYP2D6 *4/*35 Intermediate Metabolizer Urology Alpha Blockers: Silodosin (Rapaflo®) NORMAL RESPONSE EXPECTED CYP3A4 *1A/*1B Intermediate Metabolizer Urology Muscarinic Receptor NORMAL RESPONSE Antagonists: EXPECTED Darifenacin (Enablex®) CYP2D6 *4/*35 Intermediate Metabolizer Urology Muscarinic Receptor Antagonists: Tolterodine (Detrol®) CYP2D6 *4/*35 Intermediate Metabolizer E Drug Drug Impacted Impacted PL Action Action NORMAL RESPONSE EXPECTED SA M Therapeutic Therapeutic Rheumatology PGxOneTM Plus Report for Smith, John Laboratory Director: Dr. James Dermody CLIS ID: 0005783 CLIA ID: 31D2038676 Page 20 of 25 SAMPLE REPORT Admera Health, LLC 126 Corporate Boulevard • South Plainfield, NJ 07080 +1-908-222-0533 • [email protected] Patient PGxOne™ Plus Genotype and Phenotype Results for Smith, John Gene Genotype Phenotype WT/WT rs11212617 CC genotype CYP1A2 *1A/*1F Ultrarapid Metabolizer CYP2A6 *1/*1 Normal Metabolizer CYP2C19 *1/*2 Intermediate Metabolizer CYP2C9 *1/*1 Normal Metabolizer CYP2D6 *4/*35 Intermediate Metabolizer CYP3A4 *1A/*1B Intermediate Metabolizer CYP3A5 *1A/*3A CYP4F2 *1/*1 DDRGK1 WT/c.510+364T>G rs6051639 AC genotype DPYD *5/*9A/c.496A>G/IVS10-15T>C Normal Metabolizer F2 WT/WT Wild Type F5 WT/WT Non Factor V Leiden Carrier G6PD WT/WT Normal G6PD Efficiency WT/WT Wild Type 39738787C>T/39743165T>G Unfavorable Response Genotype WT/WT Non-protective Wild Type LDLR c.1773C>T/c.1773C>T rs688 TT Genotype genotype MTHFR C677T/A1298C A1298C Mutation/C677T Mutation NAT2 *4/*12 Normal Metabolizer SLCO1B1 *1/*1 Normal Activity STK11 c.290+2512C>G/c.290+2512C>G rs8111699 GG genotype TPMT *1/*1 Normal Metabolizer UGT1A1 *1/*28 *28 Allele Carrier VKORC1 WT/-1639G>A rs9923231 A Allele Carrier IFNL3 ITPA PL Expresser M Normal Metabolizer SA HLA-B E ATM PGxOneTM Plus Report for Smith, John Laboratory Director: Dr. James Dermody CLIS ID: 0005783 CLIA ID: 31D2038676 Page 21 of 25 SAMPLE REPORT Admera Health, LLC 126 Corporate Boulevard • South Plainfield, NJ 07080 +1-908-222-0533 • [email protected] PGxOneTM 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 25 genes and 196 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 ATM Allele Type Alleles Decreased Metformin Response rs11212617 Active *1A Increased Activity *1F Decreased Activity *1C, *1K, *3, *4, *7 Inactive *6 Active *1, *8 Decreased Activity *9, *12, *19, *27 Inactive *2, *5 Active *1 Increased Activity *17 Decreased Activity Inactive Active CYP2C9 Decreased Activity Inactive Active CYP2D6 CYP3A4 CYP3A5 *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 SA Decreased Activity PL CYP2C19 M CYP2A6 E CYP1A2 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 Active *1A Decreased Activity *1B, *2, *3, *12, *17 Active *1A Decreased Activity *2, *7, *8, *9 Inactive *3A, *3B, *6 Active *1 Decreased Activity *3 Ribavirin ADR rs6051639 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 CYP4F2 DDRGK1 DPYD PGxOneTM Plus Report for Smith, John Laboratory Director: Dr. James Dermody CLIS ID: 0005783 CLIA ID: 31D2038676 Page 22 of 25 SAMPLE REPORT Admera Health, LLC 126 Corporate Boulevard • South Plainfield, NJ 07080 +1-908-222-0533 • [email protected] Prothrombin Mutation G20210A F5 Increased Activity rs6025 Decreased Activity A, A-202A_376G, A- 376G_680T, A-376G_968C, Alhambra, Andalus, Aures, Beverly Hills, Canton, Cassano, Chatham, Chinese-1, Chinese-3, Chinese-4, Chinese-5, Cleveland, Coimbra, Cosenza, Fushan, Gaohe, Georgia, Guadalajara, Harilaou, Ierapetra, Ilesha, Iowa, Japan, Kaiping, Kalyan, Lagosanto, Loma Linda, Mahidol, Mediterranean, Metaponto, Mexico City, Minnesota, Montalbano, Mt. Sinai, Nara, Nashville, Olomouc, Pawnee, Plymouth, Praba, Puetro Limon, Riverside, Santamaria, Santiago, Santiago de Cuba, Sao Boria, Seattle, Shinshu, Sibari, Stonybrook, Sunderland, Telti, Tokyo, Tomah, Ube, Union, Vancouver, Viangchan, Wayne, West Virginia Carbamazepine ADR *1502 Abacavir Hypersensitivity *5701 Allopurinol ADR *5801 IFNL3 Decreased Activity rs12979860, rs8099917 ITPA Decreased Activity rs1127354, rs7270101 LDLR Decreased Activity rs688, rs5925, rs2738466 MTHFR Decreased Activity C677T, A1298C Active *4, *12, *13 G6PD HLA-B E F2 PL NAT2 Inactive SLCO1B1 Decreased Activity STK11 Decreased Activity *5, *6, *7 *2, *3, *5, *6, *9 rs8111699 Active *1 TPMT *2, *3A, *3B, *3C, *4 M Inactive UGT1A1 Decreased Activity VKORC1 Increased Warfarin Sensitivity *28 SA -1639G>A PGxOneTM Plus Report for Smith, John Laboratory Director: Dr. James Dermody CLIS ID: 0005783 CLIA ID: 31D2038676 Page 23 of 25 SAMPLE REPORT Admera Health, LLC 126 Corporate Boulevard • South Plainfield, NJ 07080 +1-908-222-0533 • [email protected] 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. Warnings & Precautions for PGxOne™ Plus Recommended Drugs: Aripiprazole (Abilify®): http://www.rxlist.com/cgi/generic/abilify.htm Atenolol (Tenormin®): http://www.rxlist.com/cgi/generic/atenolol.htm Azathioprine (lmuran®): http://www.rxlist.com/cgi/generic/azathioprine.htm E Carvedilol (Coreg®): http://www.rxlist.com/cgi/generic3/carvedilol.htm Celecoxib (Celebrex®): http://www.rxlist.com/cgi/generic/coxib.htm Citalopram (Celexa®): http://www.rxlist.com/cgi/generic/citalo.htm PL Dexlansoprazole (Dexilant®): http://www.rxlist.com/dexilant-drug.htm Diclofenac (Cataflam®): http://www.rxlist.com/cgi/generic/diclofen.htm Duloxetine (Cymbalta®): http://www.rxlist.com/cgi/generic/cymbalta.htm Escitalopram (Lexapro®): http://www.rxlist.com/cgi/generic/lexapro.htm M Esomeprazole (Nexium®): http://www.rxlist.com/cgi/generic3/esomeprazole.htm Haloperidol (Haldol®): http://www.rxlist.com/cgi/generic/haloper.htm SA lbuprofen (Advil®): http://www.rxlist.com/cgi/generic/ibup.htm lloperidone (Fanapt®): http://www.rxlist.com/fanapt-drug.htm Lansoprazole (Prevacid®): http://www.rxlist.com/cgi/generic/lansop.htm Meloxicam (Mobic®) : http://www.rxlist.com/cgi/generic/mobic.htm Metformin (Glucophage®): http://www.rxlist.com/cgi/generic4/glumetza.htm Methotrexate (Trexall®): http://www.rxlist.com/cgi/generic/mtx.htm Naproxen (Aleve®) : http://www.rxlist.com/cgi/generic/naproxsod.htm Olanzapine (Zalasta®): http://www.rxlist.com/cgi/generic3/symbyax.htm Omeprazole (Prilosec®): http://www.rxlist.com/cgi/generic/omepra.htm Pantoprazole (Protonix®): http://www.rxlist.com/cgi/generic3/protonix.htm Pimozide (Orap®): http://www.rxlist.com/cgi/generic3/orap.htm Pitavastatin (Livalo®): http://www.rxlist.com/livalo-drug.htm Pravastatin (Pravachol®): http://www.rxlist.com/cgi/generic/pravast.htm Rabeprazole (Aciphex®): http://www.rxlist.com/cgi/generic3/aciphex.htm Rosuvastatin (Crestor®): http://www.rxlist.com/cgi/generic/crestor.htm Trazodone (Desyrel®) : http://www.rxlist.com/cgi/generic/traz.htm Vilazodone (Viibryd®): http://www.rxlist.com/viibryd-drug.htm PGxOneTM Plus Report for Smith, John Laboratory Director: Dr. James Dermody CLIS ID: 0005783 CLIA ID: 31D2038676 Page 24 of 25 SAMPLE REPORT Admera Health, LLC 126 Corporate Boulevard • South Plainfield, NJ 07080 +1-908-222-0533 • [email protected] 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 Electronic Signature SA M Laboratory Director ABMG Certified, Clinical Molecular Genetics PL E 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. PGxOneTM Plus Report for Smith, John Laboratory Director: Dr. James Dermody CLIS ID: 0005783 CLIA ID: 31D2038676 Page 25 of 25
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