NAME: SPECIMEN TYPE: Buccal Swab Christian Tagwerker, Ph.D ... · 3703 Camino del Rio South, 100-A Alcala Testing and Analysis Services -- 619-450-5870 DO NOT DISTRIBUTE Lab Director:

Comprehensive Pharmacogenetic Report with DDIComments: None provided.

Current Patient MedicationsPlavix, Metoprolol, Simvastatin, Celexa, Prilosec, Prandin

EVIDENCE LEVEL 1Insufficient Response to Citalopram (CYP2C19: Ultra-Rapid Metabolizer)Celexa | CITALOPRAM

At standard label-recommended dosage, citalopram plasma concentrations levels are expected to be low which may result in a lossof efficacy. Consider an alternative medication. If citalopram is warranted, consider increasing the dose to a maximum of 150% andtitrate based on the clinical response and tolerability.

EVIDENCE LEVEL 1Significantly Increased Sensitivity to Metoprolol (CYP2D6: Poor Metabolizer)Metoprolol | LOPRESSOR

Based on the genotype result, this patient is at risk of excessive beta-blockade when taking metoprolol at standard dosage. HeartFailure: Consider alternative beta-blockers such as bisoprolol or carvedilol, or prescribe metoprolol at a lower dose. Whencompared to a normal metabolizer, a poor metabolizer may require a 75% dose reduction. Other indications: Consider alternativebeta-blockers such as bisoprolol or atenolol, or prescribe metoprolol at a lower dose. When compared to a normal metabolizer, apoor metabolizer may require a 75% dose reduction. If metoprolol is prescribed, be alert to adverse events (e.g., bradycardia or coldextremities).

EVIDENCE LEVEL 1Increased Response to Clopidogrel (CYP2C19: Ultra-Rapid Metabolizer)Plavix | CLOPIDOGREL

Clopidogrel can be prescribed at standard label-recommended dosage. Individuals with the *17 allele may have an increased risk ofbleeding while taking clopidogrel.

EVIDENCE LEVEL 1Insufficient Response to Omeprazole (CYP2C19: Ultra-Rapid Metabolizer)Prilosec | OMEPRAZOLE

Helicobacter pylori eradication: increase dose by 100-200% and be alert to insufficient response.•Other: be extra alert to insufficient response and consider dose increase of 100-200%.•

EVIDENCE LEVEL 2Altered Response to Simvastatin (CYP3A4: Intermediate Metabolizer)Simvastatin | ZOCOR

The genotype result indicates that the patient carries the CYP3A4*22 allele (this allele is associated with lower CYP3A4 enzymeactivity). Preliminary studies have shown that patients carrying the CYP3A4*22 allele may achieve an optimal lipid control goal withlower simvastatin dose requirements.

EVIDENCE LEVEL 2Normal Sensitivity to Repaglinide (SLCO1B1: Normal Function)Prandin | REPAGLINIDE

The patient carries two copies of SLCO1B1 rs4149056 T allele, which is associated with normal transporter function. Repaglinide canbe prescribed at label-recommended standard dosage and administration.

Pharmacogenetic Interactions

DOB: 1/1/1900SEX:

PATIENT INFORMATION ORDERED BYSPECIMEN DETAILS

Sample Report Alcala - Cardiology

NAME: SPECIMEN TYPE:

RECEIVED DATE:COLLECTION DATE:

REPORT DATE:1/1/19001/1/1900

10/4/2016

Christian Tagwerker, Ph.D.

ACC #:

Buccal Swab

Cardiology

MaleSan Diego, CA 981023703 Camino del Rio South, 100-A

www.alcalalabs.com

619-450-5870Alcala Testing and Analysis Services -- DO NOT DISTRIBUTE

Lab Director: Dr. David J. Smith, MD | CLIA: 05D2027247 | 3703 Camino del Rio South, 100-A, San Diego CA 98102 | www.alcalalabs.com | 619-450-5870Genetic Test Results For Sample Report Alcala - Cardiology

Page 1 of 31

Prandin & Plavix SEVEREBased upon results of a published clinical trial, Health Canada and the Canadian manufacturer of repaglinide state that concurrentuse of clopidogrel and repaglinide is contraindicated due to the risk for hypoglycemia from unanticipated lowering of serumglucose concentrations. Alternative antiplatelet agents (e.g. prasugrel, ticagrelor) and antidiabetic agents are not known to inhibitCYP2C8 or OATP1B1.If concomitant use is deemed medically necessary:- Hypoglycemic risk is greatest when clopidogrel is added toexisting repaglinide therapy. Frequent monitoring of serum/blood glucose is needed to monitor patient response as the magnitudeof glucose lowering varies between patients.- In patients stabilized on clopidogrel when repaglinide is initiated, increased sensitivityto the hypoglycemic effect of repaglinide would be expected. In addition, because repaglinide half-life is prolonged in the presenceof clopidogrel, maximal effects of repaglinide may be delayed - slower than usual dose titration would be prudent.Separating thetiming of drug administration would not be expected to decrease interaction risk as the clopidogrel metabolite (clopidogrel acyl-beta-D-glucuronide) is an irreversible inhibitor of CYP2C8.

Celexa & Prilosec SERIOUSThe dose of citalopram should be limited to 20 mg in patients receiving concurrent therapy with an inhibitor of CYP P-450-2C19.Evaluate patient for other drugs, diseases and conditions which increase risk for QT prolongation and correct risk factors (e.g.correct hypokalemia, discontinue other QT prolonging drugs) when possible. Weigh the specific benefits versus risks for eachpatient. The US manufacturer recommends ECG monitoring for citalopram patients with congestive heart failure, bradyarrhythmias,taking concomitant QT prolonging medications or receiving concurrent therapy. Citalopram should be discontinued in patients withpersistent QTc measurements greater than 500 ms.If concurrent therapy is warranted, consider obtaining serum calcium,magnesium, and potassium levels and monitoring ECG at baseline and at regular intervals. Correct any electrolyte abnormalities.Instruct patients to report any irregular heartbeat, dizziness, or fainting.

Plavix & Prilosec SERIOUSEvaluate patient risk for gastrointestinal(GI) bleeding. When PPIs are needed, use dexlansoprazole, lansoprazole, pantoprazole orrabeprazole as they have a lower interaction risk. Consider the use of H2 blockers (such as famotidine, nizatidine, or ranitidine) inpatients with a low bleeding risk and reserve the use of PPIs for patients at higher risk of GI bleeding.US manufacturers forclopidogrel and omeprazole state concurrent use of clopidogrel esomeprazole and omeprazole should be avoided. Asesomeprazole and omeprazole are irreversible inhibitors of CYP2C19, separating clopidogrel from esomeprazole or omeprazoleadministration times does not change the magnitude of this interaction.

Celexa & Prilosec MODERATEThe dose of citalopram should be limited to 20 mg in patients receiving concurrent therapy with an inhibitor of CYP P-450-2C19.Evaluate patient for other drugs, diseases and conditions which increase risk for QT prolongation and correct risk factors (e.g.correct hypokalemia, hypocalcemia, hypomagnesemia, discontinue other QT prolonging drugs) when possible. Weigh the specificbenefits versus risks for each patient. The US manufacturer recommends ECG monitoring for citalopram patients with congestiveheart failure, bradyarrhythmias, taking concomitant QT prolonging medications or receiving concurrent therapy. Citalopram shouldbe discontinued in patients with persistent QTc measurements greater than 500 ms.Instruct patients to report any irregularheartbeat, dizziness, or fainting.

Celexa & Plavix MODERATESelective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors and agents that affect coagulation shouldbe used concurrently with caution.If concurrent therapy is warranted, monitor patients receiving concurrent therapy for signs ofblood loss, including decreased hemoglobin, hematocrit, fecal occult blood, and/or decreased blood pressure and promptlyevaluate patients with any symptoms.When applicable, perform agent-specific laboratory test (e.g. INR, aPTT) to monitor efficacyand safety of anticoagulation. Discontinue anticoagulation in patients with active pathologic bleeding.Instruct patients to report anysigns and symptoms of bleeding, such as unusual bleeding from the gums or nose; unusual bruising; red or black, tarry stools; red,pink or dark brown urine; acute abdominal or joint pain and/or swelling.

Drug-Drug Interactions

DOB: 1/1/1900SEX:





REPORT DATE:1/1/19001/1/1900

10/4/2016


ACC #:

Buccal Swab

Cardiology


www.alcalalabs.com



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Metoprolol & Celexa MODERATEMonitor patients receiving concurrent therapy with metoprolol and inhibitors of CYP2D6. The dosage of metoprolol may need to beadjusted.

Highly elevated risk for indicated condition or adverse drug reaction. Medication can be prescribed withmonitoring; alternative therapy may be needed.Moderately elevated risk for indicated condition or adverse drug reaction. Medication can be prescribed withmonitoring; therapy adjustment may be needed.Typical risk for indicated condition or adverse drug reaction. Medication can be prescribed according tostandard dosing guidelines.

EVIDENCELEVEL 1

Recommendations are suitable for implementation in a clinical setting. Recommendations extracted from evidence based guidelines issued by international pharmacogenetic consortia, professional societies or regulatory bodies (CPIC, DPWG, FDA, EMA, CPNDA, ACMG).

EVIDENCELEVEL 2

Recommendations are informative and implementation in a clinical setting is optional. The evidence documenting these drug-gene associations may be limited or insufficient and may require further investigation. There are no established evidence based guidelines issued by international pharmacogenetic consortia, professional societies or regulatory bodies.

MODERATE Drug interactions of moderate severity. The clinician should assess the patient’s characteristics and take action as needed.

SERIOUSSevere drug interaction or contraindicated drug combination which may produces serious consequences in most patients. This drug combination generally should not be dispensed or administered to the same patient. Action is required to reduce risk of severe adverse interaction.

PHARMACOGENETIC RESULTS

DRUG-DRUG INTERACTIONS

Unrecognized Medications: None

DOB: 1/1/1900SEX:





REPORT DATE:1/1/19001/1/1900

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ACC #:

Buccal Swab

Cardiology


www.alcalalabs.com



Page 3 of 31

Test DetailsGene Genotype Phenotype Alleles TestedCYP2C19 *17/*17 Ultra-Rapid Metabolizer *2, *3, *4, *4B, *5, *6, *7, *8, *9, *10, *12, *14, *15, *17

CYP2C9 *2/*3 Poor Metabolizer *2, *3, *4, *5, *6, *7, *8, *11, *14, *27

CYP2D6 *5/*6 Poor Metabolizer*2, *31, *33, *4, *4M, *46, *49, *53, *6, *7, *8, *9, *10, *11, *12, *14A, *14B, *15, *17, *29, *35, *41, *44, *5 (gene deletion), XN (gene duplication)

CYP3A5 *1/*3 Intermediate Metabolizer *1D, *2, *3, *3B, *3C, *4, *6, *7, *8, *9

VKORC1 -1639G>A A/A High Warfarin Sensitivity -1639G>A, 1542G>C, 5808T>G, 1173C>T, , , 698C>T, 2255C>T, 3730G>A

SLCO1B1 521T>C TT Normal Function 388A>G, , , , 467A>G, , -11187G>A, 521T>C, , 1865+248G>A

COMT Val158Met AG Intermediate COMT Activity Val158Met

OPRM1 A118G AA Normal OPRM1 Function A118G

CYP3A4 *22/*22 Intermediate Metabolizer *2, *4, *5, *8, *11, *12, *13, *16A, *16B, *17, *18A, *18B, *20, *22

HTR2C -759C>T C/C Homozygous for the C allele (rs3813929) -759C>T, 2565G>C

SLC6A4 S/S Low Serotonin Transporter Expression La, S, Lg

ADRA2A C-1291G C/C Homozygous for C Allele C-1291G

SLC6A4 463T>G C/A Heterozygous for the C Allele La, S, Lg

HTR2A rs7997012 A/G Heterozygous for the A allele (rs7997012) -1438G>A, 102C>T, rs7997012

HTR2C 2565G>C C/C Homozygous for the C allele (rs1414334) -759C>T, 2565G>C

HTR2A -1438G>A C/C Homozygous for the C allele (rs6311) -1438G>A, 102C>T, rs7997012

DRD2 -241A>G T/T Homozygous for rs1799978 T Allele -241A>G, rs2283265, 939T>C, 957C>T

DRD2 rs2283265 C/C Homozygous for rs2283265 C allele -241A>G, rs2283265, 939T>C, 957C>T

CYP1A2 *1B/*1F Normal Metabolizer - Higher Inducibility *1C, *1D, *1E, *1F, *1J, *1B, *1K, *1L, *1V, *1W, *7, *1G

MTHFR 1298A>C CC677C>T TTUnknown Risk of Hyperhomocysteinemia 1298A>C, 677C>T, 1305C>T

MTHFR 677C>T TT Reduced MTHFR Activity 1298A>C, 677C>T, 1305C>T

Factor IIFactor V Leiden

20210G>A AA1691G>A AA Unknown Risk of Thrombosis 20210G>A, 1691G>A

DOB: 1/1/1900SEX:





REPORT DATE:1/1/19001/1/1900

10/4/2016


ACC #:

Buccal Swab

Cardiology


www.alcalalabs.com



Page 4 of 31

METHODOLOGY

Genomic DNA is extracted from dry buccal swabs using magnetic particle processing. DNA from patient samples are amplified with primers specific for genes such asABCB1, ABCG2, ADRA2A, DRB1, AGT, CACNA1C, CEP72, CES1, CFTR, COMT, CYP1A2, CYP2C19, CYP2D6, CYP3A4, CYP3A5, CYP2C9, DPYD, DRD2, DRD3, EDN1, F2, F5,G6PD, GNB3, GRIK4, GSTA1, HTR1A, HTR2A, HTR2C, IFNL3, KCNIP1, LDLR, MTHFR, NAT1, NR1H3, OPRM1, RYR1, SLC6A2, SLC6A4, SLCO1B1, TPMT, UGT1A1, UGT2B7,VKORC1 depending on the selected panel, using Nested Patch PCR (Varley, et. al.), Oligo-directed or Illumina TSCA Extension Ligation protocols and are used to detectalleles and genotypes listed in this report with known clinical significance at analytical sensitivity and specificity >99%. Positive and negative controls are used with each run.Patient samples, positive, and negative controls are sequenced using a MiSeq (Illumina). Sequences are analyzed using alignment and base call algorithms with GATK1.6,Illumina Variantstudio and Kailos Blue Software for the presence or absence of single nucleotide base changes, insertions and deletions. LR-PCR utilized for confirmation ofCYP2D6 duplications and deletions. Results and recommendations are compiled as part of a medical report. Genetic testing was performed in the Alcala Testing & AnalysisServices facility at 3703 Camino del Rio South #100-A; San Diego, CA. 92108. CLIA#: 05D2027247. Medical Director: Dr. David J. Smith, MD. This report was reviewed andapproved for release by the Medical Director: Dr. David J. Smith, MD.

LAB DISCLAIMER

The information presented on this report is provided as supplementary health information. The results presented are intended for use by a physician, pharmacist or otherhealthcare professional to advise a patient on the use of prescribed medications. This test is not a 510k cleared test, but managed by CMS and FDA under the ClinicalLaboratory Improvement Amendment (CLIA) as a LDT. The ordering physician is responsible for the diagnosis and management of disease and decisions based on the dataprovided. Results are dependent on adequate specimen collection and processing.

This test will not detect all the known alleles that result in altered or inactive tested genes. This test does not account for all individual variations in the individual tested.Absence of a detectable gene mutation does not rule out the possibility that a patient has different phenotypes due to the presence of an undetected polymorphism or dueto other factors such as drug-drug interactions, comorbidities and lifestyle habits.

The pharmacogenetic report is one of multiple pieces of information that clinicians should consider in guiding their therapeutic choice for each patient. It remains theresponsibility of the health-care provider to determine the best course of treatment for a patient. Adherence to dose guidelines does not necessarily assure a successfulmedical outcome.The pharmacogenetic assay involves non-FDA approved interpretational software and genotype-phenotype associations.

TRANSLATIONAL SOFTWARE DISCLAIMER

The information presented on this report is provided as general educational health information. The content is not intended to be a substitute for professional medicaladvice, diagnosis, or treatment. Only a physician, pharmacist or other healthcare professional should advise a patient on the use of the medications prescribed.

The pharmacogenetic assay involves use of reporting software and genotype-phenotype associations performed by Translational Software (www.translationalsoftware.com).The software has not been evaluated by the Food and Drug Administration. The software, and the report generated by the software, is not intended to diagnose, treat, cure,or prevent any disease. A qualified designee within the lab uses Translational Software to generate and subsequently review the report. The pharmacogenetic report is oneof multiple pieces of information that clinicians should consider in guiding their therapeutic choice for each patient. It remains the responsibility of the health-care providerto determine the best course of treatment for a patient. Adherence to dose guidelines does not necessarily assure a successful medical outcome.

The Drug interaction report is provided via a third party agreement with First Data Bank (FDB). FDB is entirely responsible for the accuracy of the drug interaction data. Thereport is solely intended to be used by a medical professional. The drug interaction report is based on patient reported medications and does not account for other factorssuch as smoking history, tobacco use, diet and other underlying chronic conditions like diabetes or heart disease. The treating medical professional bears the ultimateresponsibility for all the treatment decisions made in regards to a patient and including any decisions based on the drug interaction report.

DOB: 1/1/1900SEX:





REPORT DATE:1/1/19001/1/1900

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Buccal Swab

Cardiology


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Page 5 of 31

Risk ManagementHyperhomocysteinemia - DepressionIncreased Risk of Hyperhomocysteinemia

Patients diagnosed with depression : as lower folate levels are associated with poorer antidepressant response, and baseline levels of folatewithin the normal range predict antidepressant response, this patient is likely to benefit from methylfolate as an antidepressant-augmentingagent. Testing for homocysteine levels and serum folate levels may be informative for this patient. Although methylfolate may substantiallybenefit this patient, it should not replace the antidepressant therapy and methylfolate should always be used as an adjuvant to antidepressantmedication.

Patients diagnosed with depression often have low folate levels and homocysteine is a highly sensitive marker of folate status. Functionalfolate deficiency is indicated by elevated homocysteine. This patient exhibits significantly reduced MTHFR activity, which is a risk factor forhyperhomocysteinemia. Low MTHFR activity may further exacerbate folate deficiency in patients with depression and may increase the risk ofdepressive relapse or delay the response to antidepressants.

The patient carries two MTHFR C677T mutations (homozygous). MTHFR enzyme activity is severely reduced (30% of normal activity).

ThrombophiliaUnknown Risk of Thrombosis

The patient's thrombosis risk is unknown. This genotype has never been reported. Consult with a genetic counselor for further information.The patient's thrombotic risk is unknown

The patient carries two Factor V Leiden G1691A mutations (homozygous carrier) and two Factor II G20210A mutations (homozygous carrier).This genotype has never been reported.

Hyperhomocysteinemia - ThrombosisUnknown Risk of Hyperhomocysteinemia

The patient's genotype has never been reported. Because the patient's risk for hyperhomocysteinemia is not well documented, considerconsulting a genetic counselor for more information.

The patient's risk for hyperhomocysteinemia is unknown.The patient carries two MTHFR C677T mutations and two MTHFR A1298C mutations. This genotype has never been reported.

DOB: 1/1/1900SEX:





REPORT DATE:1/1/19001/1/1900

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ACC #:

Buccal Swab

Cardiology


www.alcalalabs.com



Page 6 of 31

Potentially Impacted Medications

CLASS DRUG* High Risk

INTERACTING DRUGSPHARMACOGENETIC RESULTS

5-Alpha Reductase Inhibitors for Benign

Prostatic Hyperplasia

Dutasteride (Avodart)

Finasteride (Proscar)

Alpha-Blockers for Benign Prostatic

Hyperplasia

Alfuzosin (UroXatral) Celexa

Doxazosin (Cardura)

Silodosin (Rapaflo)

Tamsulosin (Flomax)

Terazosin (Hytrin)

Angiotensin II Receptor

Antagonists

Azilsartan (Edarbi, Edarbyclor)

Candesartan (Atacand)

Eprosartan (Teveten)

Irbesartan (Avapro)

Losartan (Cozaar, Hyzaar)

Olmesartan (Benicar)

Telmisartan (Micardis)

Valsartan (Diovan, Entresto)

Antiaddictives Naltrexone (Vivitrol, Contrave)

Anti-ADHD Agents

Amphetamine (Adderall)Celexa

Prilosec

Atomoxetine (Strattera) Celexa

Clonidine (Kapvay) Metoprolol

Dexmethylphenidate (Focalin)

Dextroamphetamine (Dexedrine)Celexa

Prilosec

Guanfacine (Intuniv)

Lisdexamfetamine (Vyvanse) Celexa

Methylphenidate (Ritalin)

Antianginal Agents Ranolazine (Ranexa)

Celexa

Metoprolol

Simvastatin

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Buccal Swab

Cardiology


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Antiarrhythmics

Flecainide (Tambocor) Celexa

Mexiletine (Mexitil)

Propafenone (Rythmol)Celexa

Metoprolol

Anticoagulants

Apixaban (Eliquis)Celexa

Plavix

Dabigatran Etexilate (Pradaxa)Celexa

Plavix

Edoxaban (Savaysa)Celexa

Plavix

Fondaparinux (Arixtra) Plavix

Rivaroxaban (Xarelto)Celexa

Plavix

Warfarin (Coumadin)

Celexa

Plavix

Simvastatin

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Anticonvulsants

Brivaracetam (Briviact)

Carbamazepine (Tegretol, Carbatrol, Epitol) Simvastatin

Eslicarbazepine (Aptiom) Simvastatin

Ethosuximide (Zarontin)

Ezogabine (Potiga) Celexa

Felbamate (Felbatol)Celexa

Plavix

Fosphenytoin (Cerebyx) Prilosec

Gabapentin (Neurontin)

Lacosamide (Vimpat)

Lamotrigine (Lamictal)

Levetiracetam (Keppra)

Oxcarbazepine (Trileptal, Oxtellar XR)Celexa

Simvastatin

Perampanel (Fycompa)

Phenobarbital (Luminal) Metoprolol

Phenytoin (Dilantin) Prilosec

Pregabalin (Lyrica)

Primidone (Mysoline) Metoprolol

Rufinamide (Banzel)

Tiagabine (Gabitril)

Topiramate (Topamax)

Valproic Acid (Depakote, Depakene)

Vigabatrin (Sabril)

Zonisamide (Zonegran)

Antidementia Agents

Donepezil (Aricept) Celexa

Galantamine (Razadyne)

Memantine (Namenda)

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Antidepressants

Amitriptyline (Elavil)

Amoxapine (Amoxapine)

Citalopram (Celexa)

Plavix

Prilosec

Metoprolol

Clomipramine (Anafranil) Celexa

Desipramine (Norpramin) Celexa

Desvenlafaxine (Pristiq) Plavix

Doxepin (Silenor)

Duloxetine (Cymbalta)Metoprolol

Plavix

Escitalopram (Lexapro)

Celexa

Metoprolol

Plavix

Prilosec

Fluoxetine (Prozac, Sarafem)

Celexa

Metoprolol

Plavix

Fluvoxamine (Luvox)Celexa

Plavix

Imipramine (Tofranil) Celexa

Levomilnacipran (Fetzima) Plavix

Maprotiline (Ludiomil)

Mirtazapine (Remeron)

Nefazodone (Serzone) Simvastatin

Nortriptyline (Pamelor) Celexa

Paroxetine (Paxil, Brisdelle)Metoprolol

Plavix

Protriptyline (Vivactil)

Sertraline (Zoloft)Metoprolol

Plavix

Trimipramine (Surmontil) Celexa

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Venlafaxine (Effexor)Celexa

Plavix

Vilazodone (Viibryd) Plavix

Vortioxetine (Trintellix) Plavix

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Antiemetics

Dolasetron (Anzemet) Celexa

Metoclopramide (Reglan) Celexa

Ondansetron (Zofran, Zuplenz) Celexa

Palonosetron (Aloxi)

Antifolates Methotrexate (Trexall) Prilosec

Antifungals Voriconazole (Vfend)

Celexa

Plavix

Prilosec

Simvastatin

Antimalarials Proguanil (Malarone)

Antiplatelets

Clopidogrel (Plavix)

Celexa

Prilosec

Prandin

Prasugrel (Effient) Celexa

Ticagrelor (Brilinta)Celexa

Simvastatin

Vorapaxar (Zontivity)

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Antipsychotics

Aripiprazole (Abilify)

Asenapine (Saphris) Celexa

Brexpiprazole (Rexulti)

Chlorpromazine (Thorazine) Celexa

Clozapine (Clozaril) Celexa

Fluphenazine (Prolixin)

Haloperidol (Haldol) Celexa

Iloperidone (Fanapt) Celexa

Loxapine (Loxitane, Adasuve)

Lurasidone (Latuda)

Olanzapine (Zyprexa)

Paliperidone (Invega) Celexa

Perphenazine (Trilafon)

Pimavanserin (Nuplazid)

Pimozide (Orap) Celexa

Quetiapine (Seroquel) Celexa

Risperidone (Risperdal) Celexa

Tetrabenazine (Xenazine) Celexa

Thioridazine (Mellaril) Celexa

Thiothixene (Navane)

Trazodone (Oleptro) Celexa

Trifluoperazine (Stelazine)

Ziprasidone (Geodon) Celexa

Antispasmodics for Overactive Bladder

Darifenacin (Enablex)

Fesoterodine (Toviaz)

Mirabegron (Myrbetriq) Metoprolol

Oxybutynin (Ditropan)

Solifenacin (Vesicare)

Tolterodine (Detrol)

Trospium (Sanctura)

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Benzodiazepines

Alprazolam (Xanax)

Clobazam (Onfi) Prilosec

Clonazepam (Klonopin)

Diazepam (Valium)

Beta Blockers

Carvedilol (Coreg)

Labetalol (Normodyne, Trandate)

Metoprolol (Lopressor) Celexa

Nebivolol (Bystolic)

Propranolol (Inderal)

Timolol (Timoptic)

Diuretics Torsemide (Demadex)

Fibromyalgia Agents Milnacipran (Savella) Plavix

Immunomodulators

Apremilast (Otezla)

Leflunomide (Arava) Prandin

Tofacitinib (Xeljanz)

Immunosupressants Tacrolimus (Prograf)Celexa

Prilosec

MeglitinidesNateglinide (Starlix)

Repaglinide (Prandin, Prandimet) Plavix

Muscle Relaxants

Carisoprodol (Soma)

Cyclobenzaprine (Flexeril, Amrix)

Metaxalone (Skelaxin)

Methocarbamol (Robaxin)

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NSAIDs

Celecoxib (Celebrex)Celexa

Metoprolol

Diclofenac (Voltaren)Celexa

Plavix

Flurbiprofen (Ansaid)

Celexa

Metoprolol

Plavix

Ibuprofen (Advil, Motrin)

Celexa

Metoprolol

Plavix

Indomethacin (Indocin)

Celexa

Metoprolol

Plavix

Ketoprofen (Orudis)Celexa

Plavix

Ketorolac (Toradol)Celexa

Plavix

Meloxicam (Mobic)

Celexa

Metoprolol

Plavix

Nabumetone (Relafen)Celexa

Plavix

Naproxen (Aleve)

Celexa

Metoprolol

Plavix

Piroxicam (Feldene)

Celexa

Metoprolol

Plavix

Sulindac (Clinoril)

Celexa

Metoprolol

Plavix

DOB: 1/1/1900SEX:





REPORT DATE:1/1/19001/1/1900

10/4/2016


ACC #:

Buccal Swab

Cardiology


www.alcalalabs.com



Page 15 of 31



Opioids

Alfentanil (Alfenta)

Buprenorphine (Butrans, Buprenex)

Codeine (Codeine; Fioricet with Codeine)

Dihydrocodeine (Synalgos-DC)

Fentanyl (Actiq) Celexa

Hydrocodone (Vicodin)

Hydromorphone (Dilaudid, Exalgo)

Levorphanol (Levo Dromoran)

Meperidine (Demerol) Celexa

Morphine (MS Contin)

Oxycodone (Percocet, Oxycontin)

Oxymorphone (Opana, Numorphan)

Sufentanil (Sufenta)

Tapentadol (Nucynta) Celexa

Tramadol (Ultram) Celexa

Other Neurological Agents

Dextromethorphan / Quinidine (Nuedexta)Celexa

Metoprolol

Flibanserin (Addyi)

Phosphodiesterase Inhibitors for

Erectile Dysfunction

Avanafil (Stendra)

Sildenafil (Viagra)

Tadalafil (Cialis)

Vardenafil (Levitra) Celexa

Proton Pump Inhibitors

Dexlansoprazole (Dexilant, Kapidex)

Esomeprazole (Nexium)Celexa

Plavix

Lansoprazole (Prevacid) Celexa

Omeprazole (Prilosec)Celexa

Plavix

Pantoprazole (Protonix)

Rabeprazole (Aciphex)

DOB: 1/1/1900SEX:





REPORT DATE:1/1/19001/1/1900

10/4/2016


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Buccal Swab

Cardiology


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Page 16 of 31

*Current patient medications are listed in bold whereas italicized drug names indicate drugs with no pharmacogenetic guidance



Statins

Atorvastatin (Lipitor)

Fluvastatin (Lescol)

Lovastatin (Mevacor, Altoprev, Advicor)

Pitavastatin (Livalo)

Pravastatin (Pravachol)

Rosuvastatin (Crestor)

Simvastatin (Zocor)

Sulfonylureas

Chlorpropamide (Diabenese)

Glimepiride (Amaryl)

Glipizide (Glucotrol)

Glyburide (Micronase)

Tolbutamide (Orinase)

DOB: 1/1/1900SEX:





REPORT DATE:1/1/19001/1/1900

10/4/2016


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Buccal Swab

Cardiology


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Page 17 of 31

Dosing Guidance

Amitriptyline Increased Sensitivity to Amitriptyline (CYP2D6: Poor Metabolizer)Select an alternative drug, or consider prescribing amitriptyline at a reduced dose (50% reduction) with monitoring ofplasma concentrations of amitriptyline and nortriptyline.

EVIDENCE LEVEL 1

Elavil

Amitriptyline Increased Sensitivity to Amitriptyline (CYP2C19: Ultra-Rapid Metabolizer)Consider an alternative drug, or consider prescribing amitriptyline at standard dose and monitor the plasmaconcentrations of amitriptyline and nortriptyline to guide dose adjustments.

EVIDENCE LEVEL 2

Elavil

Citalopram Insufficient Response to Citalopram (CYP2C19: Ultra-Rapid Metabolizer)At standard label-recommended dosage, citalopram plasma concentrations levels are expected to be low which mayresult in a loss of efficacy. Consider an alternative medication. If citalopram is warranted, consider increasing the dose to amaximum of 150% and titrate based on the clinical response and tolerability.

EVIDENCE LEVEL 1

Celexa

Clomipramine Increased Sensitivity to Clomipramine (CYP2D6: Poor Metabolizer)Consider an alternative drug, or prescribe clomipramine at 50% of the recommended standard starting dose. Monitorplasma concentrations of clomipramine and desmethylclomipramine, and titrate accordingly until a favorable response isachieved.

EVIDENCE LEVEL 1

Anafranil

Clomipramine Increased Sensitivity to Clomipramine (CYP2C19: Ultra-Rapid Metabolizer)Consider an alternative drug, or consider prescribing clomipramine at standard dose and monitor the plasmaconcentrations of clomipramine and desmethyl-clomipramine to guide dose adjustments.

EVIDENCE LEVEL 2

Anafranil

Codeine Non-Response to Codeine (CYP2D6: Poor Metabolizer)Greatly reduced morphine levels are expected, and the patient may not experience adequate pain relief when takingcodeine. Avoid prescribing codeine, and consider alternative opioids other than tramadol, or a non-opioid analgesic suchas a NSAID or a COX-2 inhibitor. Unless contraindicated, available alternative opioids not sensitive to CYP2D6 functioninclude: fentanyl, morphine, hydromorphone, oxymorphone, and tapentadol.

EVIDENCE LEVEL 1

Codeine; Fioricet with Codeine

Desipramine Increased Sensitivity to Desipramine (CYP2D6: Poor Metabolizer)Consider an alternative drug, or prescribe desipramine at 50% of recommended standard starting dose. Monitor plasmaconcentrations of desipramine and metabolites and titrate accordingly until a favorable response is achieved.

EVIDENCE LEVEL 1

Norpramin

Doxepin Increased Sensitivity to Doxepin (CYP2D6: Poor Metabolizer)Consider an alternative drug or reduce doxepin starting dose by 50%. Adjust maintenance dose according to nordoxepinplasma concentrations.

EVIDENCE LEVEL 1

Silenor

Doxepin Increased Sensitivity to Doxepin (CYP2C19: Ultra-Rapid Metabolizer)Consider an alternative drug, or consider prescribing doxepin at standard dose and monitor the plasma concentrations ofdoxepin and desmethyl-doxepin to guide dose adjustments.

EVIDENCE LEVEL 2

Silenor

DOB: 1/1/1900SEX:





REPORT DATE:1/1/19001/1/1900

10/4/2016


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Buccal Swab

Cardiology


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Page 18 of 31

Escitalopram Insufficient Reponse to Escitalopram (CYP2C19: Ultra-Rapid Metabolizer)At standard label-recommended dosage, escitalopram plasma concentrations levels are expected to be low which mayresult in a loss of efficacy. Consider an alternative medication. If escitalopram is warranted, consider increasing the doseto a maximum of 150% and titrate based on the clinical response and tolerability.

EVIDENCE LEVEL 1

Lexapro

Haloperidol Increased Sensitivity to Haloperidol (CYP2D6: Poor Metabolizer)Haloperidol is metabolized by CYP2D6, CYP3A4, and other enzymes. Decreased CYP2D6 activity results in higherhaloperidol concentrations, potentially leading to more adverse events. Consider an alternative drug, or prescribehaloperidol at 50% of the usual starting dose, then adjust dosage to achieve a favorable clinical response.

EVIDENCE LEVEL 1

Haldol

Imipramine Increased Sensitivity to Imipramine (CYP2D6: Poor Metabolizer)Consider an alternative drug, or consider a 50% reduction of the imipramine recommended starting dose, then titrate inresponse to imipramine and desipramine plasma concentrations.

EVIDENCE LEVEL 1

Tofranil

Imipramine Increased Sensitivity to Imipramine (CYP2C19: Ultra-Rapid Metabolizer)Consider an alternative drug, or consider prescribing imipramine at the standard dose and monitor the plasmaconcentrations of imipramine and desipramine to guide dose adjustments.

EVIDENCE LEVEL 2

Tofranil

Metoprolol Significantly Increased Sensitivity to Metoprolol (CYP2D6: Poor Metabolizer)Based on the genotype result, this patient is at risk of excessive beta-blockade when taking metoprolol at standarddosage. Heart Failure: Consider alternative beta-blockers such as bisoprolol or carvedilol, or prescribe metoprolol at alower dose. When compared to a normal metabolizer, a poor metabolizer may require a 75% dose reduction. Otherindications: Consider alternative beta-blockers such as bisoprolol or atenolol, or prescribe metoprolol at a lower dose.When compared to a normal metabolizer, a poor metabolizer may require a 75% dose reduction. If metoprolol isprescribed, be alert to adverse events (e.g., bradycardia or cold extremities).

EVIDENCE LEVEL 1

Lopressor

Nortriptyline Increased Sensitivity to Nortriptyline (CYP2D6: Poor Metabolizer)Select an alternative drug, or consider prescribing nortriptyline at a reduced dose (50% reduction) with monitoring ofplasma concentrations of nortriptyline and metabolites.

EVIDENCE LEVEL 1

Pamelor

Paroxetine Increased Sensitivity to Paroxetine (CYP2D6: Poor Metabolizer)At standard label-recommended dosage, paroxetine levels are expected to be high, and adverse events may occur.Consider an alternative medication. If paroxetine is warranted, consider a 50% decrease of the initial dose and titratebased on the clinical response and tolerability. Some studies show that compared to normal metabolizers, poormetabolizers may experience more sexual dysfunction.

EVIDENCE LEVEL 2

Paxil, Brisdelle

Protriptyline Increased Sensitivity to Protriptyline (CYP2D6: Poor Metabolizer)Consider alternative or prescribe protriptyline at 50% of recommended standard starting dose. Monitor plasmaconcentrations of protriptyline and metabolites and titrate accordingly until a favorable response is achieved.

EVIDENCE LEVEL 1

Vivactil

Risperidone Significantly Increased Sensitivity to Risperidone (CYP2D6: Poor Metabolizer)Consider an alternative drug, OR prescribe risperidone at a reduced dose, be extra alert of adverse events, and adjustdosage in response to clinical response and tolerability.

EVIDENCE LEVEL 1

Risperdal

DOB: 1/1/1900SEX:





REPORT DATE:1/1/19001/1/1900

10/4/2016


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Buccal Swab

Cardiology


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Page 19 of 31

Thioridazine Increased Sensitivity to Thioridazine (CYP2D6: Poor Metabolizer)Reduced cytochrome CYP2D6 activity results in elevated plasma levels of thioridazine, would be expected to augment theprolongation of the QTc interval associated with thioridazine, and may increase the risk of serious, potentially fatal,cardiac arrhythmias, such as Torsades de pointes-type arrhythmias. Such an increased risk may result also from theadditive effect of coadministering thioridazine with other agents that prolong the QTc interval. Therefore, thioridazine iscontraindicated in patients with reduced levels of CYP2D6 activity.

EVIDENCE LEVEL 1

Mellaril

Tramadol Non-Response to Tramadol (CYP2D6: Poor Metabolizer)The patient will not experience adequate pain relief when taking tramadol. Avoid prescribing tramadol, and consideralternative opioids other than codeine or a non-opioid analgesic such as a NSAID or a COX-2 inhibitor. Unlesscontraindicated, available alternative opioids not sensitive to CYP2D6 function include: fentanyl, morphine,hydromorphone, oxymorphone, and tapentadol.

EVIDENCE LEVEL 1

Ultram

Trimipramine Increased Sensitivity to Trimipramine (CYP2D6: Poor Metabolizer)Consider an alternative drug, or consider a 50% reduction of the trimipramine recommended starting dose, then titrate inresponse to trimipramine plasma concentrations.

EVIDENCE LEVEL 1

Surmontil

Trimipramine Increased Sensitivity to Trimipramine (CYP2C19: Ultra-Rapid Metabolizer)Consider an alternative drug, or consider prescribing trimipramine at standard dose and monitor the plasmaconcentrations of trimipramine and desmethyl-trimipramine to guide dose adjustments.

EVIDENCE LEVEL 2

Surmontil

Venlafaxine Significantly Increased Sensitivity to Venlafaxine (CYP2D6: Poor Metabolizer)The patient has an increased risk of side effects when taking standard doses of venlafaxine. Consider an alternative drug,OR prescribe venlafaxine, be extra alert of adverse events, and adjust dosage in response to clinical response andtolerability. Monitor O-desmethylvenlafaxine plasma concentrations.

EVIDENCE LEVEL 1

Effexor

Amoxapine Possible Sensitivity to Amoxapine (CYP2D6: Poor Metabolizer)Like other tricyclic and tetracyclic antidepressants, amoxapine is metabolized by CYP2D6. However, the overallcontribution of this enzyme in the metabolism of this drug is not well documented. Decreased CYP2D6 activity may resultin higher amoxapine concentrations potentially leading to higher adverse events. There are no established dosingadjustments for patients with decreased CYP2D6 function; therapy must be initiated cautiously and adjusted according tothe patient's response.

EVIDENCE LEVEL 2

Amoxapine

Aripiprazole Increased Sensitivity to Aripiprazole (CYP2D6: Poor Metabolizer)Poor metabolizers have a significantly reduced capacity to metabolize aripiprazole and its active metabolite, andshould receive lower doses. Careful titration is recommended until a favorable response is achieved.

Daily dosing (oral or intramuscular): aripiprazole dose should initially be reduced to one-half (50%) of the usual dose,then adjusted to achieve a favorable clinical response. Reduce the maximum dose to 10 mg/day (67% of the maximumrecommended daily dose). The dose of aripiprazole for poor metabolizers who are administered a strong CYP3A4inhibitor should be reduced to one-quarter (25%) of the usual dose.

Monthly dosing (intramuscular): the starting and maintenance monthly recommended dose is lower than the usuallyrecommended dose, and should be 300 mg. Some patients may benefit from a reduction to 200 mg. Reduce themonthly dose to 200 mg if a CYP3A4 inhibitor is prescribed to CYP2D6 poor metabolizers receiving 300 mg ofaripiprazole.

EVIDENCE LEVEL 1

Abilify

DOB: 1/1/1900SEX:





REPORT DATE:1/1/19001/1/1900

10/4/2016


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Buccal Swab

Cardiology


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Page 20 of 31

Atomoxetine Increased Sensitivity to Atomoxetine (CYP2D6: Poor Metabolizer)When given a standard atomoxetine dose, CYP2D6 poor metabolizers are likely to have higher plasma levels of the drug,which may lead to a higher rate of adverse events. Careful titration and dosing adjustment are recommended withmonitoring for toxicity until a favorable response is achieved . In children and adolescents up to 70 kg body weight ,atomoxetine should be initiated at standard dosing of 0.5 mg/kg/day, and only increased to the usual target dose of 1.2mg/kg/day if symptoms fail to improve after 4 weeks and the initial dose is well tolerated. In children and adolescentsover 70 kg body weight and adults , atomoxetine should be initiated at standard dosing of 40 mg/day, and only increasedto the usual target dose of 80 mg/day if symptoms fail to improve after 4 weeks and the initial dose is well tolerated.

EVIDENCE LEVEL 1

Strattera

Atorvastatin Altered Response to Atorvastatin (CYP3A4: Intermediate Metabolizer)The genotype result indicates that the patient carries the CYP3A4*22 allele (this allele is associated with lower CYP3A4enzyme activity). Preliminary studies have shown that patients carrying the CYP3A4*22 allele may achieve an optimal lipidcontrol goal with lower atorvastatin dose requirements.

EVIDENCE LEVEL 2

Lipitor

Brexpiprazole Increased Sensitivity to Brexpiprazole (CYP2D6: Poor Metabolizer)The exposure to brexpiprazole in CYP2D6 poor metabolizers is 120% higher than the exposure in CYP2D6 normalmetabolizers. Because the incidence of akathisia is dose-related in patients suffering from schizophrenia or majordepressive disorders, it is recommended to prescribe half of the usual doses of brexpiprazole to CYP2D6 poormetabolizers. Careful titration is recommended until a favorable response is achieved.

Adjunctive Treatment of Major Depression Disorder : the recommended starting doses should be reduced by half (0.25mg or 0.5 mg once daily). The daily maintenance doses and maximum recommended dose are 0.5-1 mg and 1.5 mg,respectively. Schizophrenia: the recommended starting dose is 0.5 mg once daily. The daily maintenance doses andmaximum recommended dose are 1-2 mg and 2 mg, respectively.

Dose adjustments with comedications : Administer a quarter of the usual dose if a strong/moderate CYP3A4 inhibitor iscoadministered. Double usual dose over 1 to 2 weeks if a strong CYP3A4 inducer is coadministered.

EVIDENCE LEVEL 1

Rexulti

Carisoprodol Altered Sensitivity to Carisoprodol (CYP2C19: Ultra-Rapid Metabolizer)There is insufficient data to allow calculation of dose adjustment. If carisoprodol is prescribed, it is recommended to use alower dose, and to carefully monitor the patient for side effects.

EVIDENCE LEVEL 2

Soma

Carvedilol Moderate Sensitivity to Carvedilol (CYP2D6: Poor Metabolizer)Carvedilol can be prescribed at standard label-recommended dosage and administration. CYP2D6 poor metabolizers mayexperience dizziness during up-titration. Careful titration is recommended with monitoring until a favorable response isachieved.

EVIDENCE LEVEL 1

Coreg

Celecoxib High Sensitivity to Celecoxib (CYP2C9: Poor Metabolizer)Consider starting at half the lowest recommended dose, and evaluate response the first week. Be alert to gastrointestinaladverse events. Consider alternative medication for the management of Juvenile Rheumatoid Arthritis.

EVIDENCE LEVEL 1

Celebrex

Chlorpromazine Increased Sensitivity to Chlorpromazine (CYP2D6: Poor Metabolizer)Chlorpromazine is metabolized by CYP2D6, CYP3A4 and flavin-containing monooxygenases. Decreased CYP2D6 activityresults in higher chlorpromazine concentrations potentially leading to higher adverse events. Consider prescribingchlorpromazine at a lower starting dose and then adjust dosage to achieve a favorable clinical response.

EVIDENCE LEVEL 2

Thorazine

DOB: 1/1/1900SEX:





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10/4/2016


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Buccal Swab

Cardiology


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Page 21 of 31

Chlorpropamide Possible Sensitivity to Chlorpropamide (CYP2C9: Poor Metabolizer)Subjects with reduced CYP2C9 activity may have increased chlorpropamide plasma drug concentrations at standarddoses, leading to hypoglycemic episodes. Because there is insufficient data to whether such changes have a significantclinical impact, chlorpropamide can be prescribed according to standard label-recommended dosage and administration,with frequent monitoring of plasma glucose levels.

EVIDENCE LEVEL 2

Diabenese

Clozapine Unfavorable Response to Clozapine (HTR2A: Homozygous for the C allele (rs6311))The patient does not carry the HTR2A variant rs6311. Preliminary studies suggest that this genotype may be associatedwith an unfavorable response to clozapine in patients with European ancestry.

EVIDENCE LEVEL 2

Clozaril

Clozapine Risk of Metabolic Syndrome with Clozapine (HTR2C: Homozygous for the C allele (rs1414334))Genetic variations in the Serotonin 2C Receptor (HTR2C) gene in known to be partially involved in the adverse effects toatypical antipsychotic medications. The patient is homozygous for C allele of HTR2C variant rs1414334. The patient mayhave an increased risk of developing metabolic syndrome when treated with clozapine.

EVIDENCE LEVEL 2

Clozaril

Darifenacin Possible Sensitivity to Darifenacin (CYP2D6: Poor Metabolizer)Darifenacin exposure is increased 30% in CYP2D6 poor metabolizers. Although dose adjustment may not be needed inthese patients, monitor patients for increased side effects when darifenacin is prescribed at standard label-recommendeddosage and administration.

EVIDENCE LEVEL 1

Enablex

Dexlansoprazole Insufficient Response to Dexlansoprazole (CYP2C19: Ultra-Rapid Metabolizer)Helicobacter pylori eradication: increase dose by 200% and be alert to insufficient response.•Other: be extra alert to insufficient response and consider dose increase of 200%.•

EVIDENCE LEVEL 2

Dexilant, Kapidex

Dexmethylphenidate

Unfavorable Response to Dexmethylphenidate (ADRA2A: Homozygous for C Allele)

The patient carries two C alleles of the ADRA2A –1291 C>G polymorphism. Preliminary studies suggest that this genotypemay be associated with an unfavorable response to dexmethylphenidate in children and adolescents with the attention-deficit and hyperactivity disorder of inattentive type.

EVIDENCE LEVEL 2

Focalin

Dexmethylphenidate

Decreased Response to Dexmethylphenidate (COMT: Intermediate COMT Activity)

The patient's genotype result predicts a less optimal response to dexmethylphenidate. Dosage should be individualizedaccording to the needs and response of the patient. Therapy should be initiated in small doses, with gradual weeklyincrements.

EVIDENCE LEVEL 2

Focalin

Dextromethorphan / Quinidine

Altered Sensitivity to Dextromethorphan-Quinidine (CYP2D6: Poor Metabolizer)

Patients with Pseudobulbar Affect: the quinidine component of dextromethorphan-quinidine is intended to inhibitCYP2D6 so that higher exposure to dextromethorphan can be achieved compared to when dextromethorphan is givenalone. Quinidine does not further inhibit CYP2D6 metabolism in poor metabolizers (PMs) and this component mayexpose PMs to an unnecessary risk since quinidine is not adding any benefit. Prescribers should consider the potentialrisk for quinidine-related adverse events relative to the benefit of administering the dextromethorphan-quinidinecombination product (vs. dextromethorphan alone) in known CYP2D6 poor metabolizers.

EVIDENCE LEVEL 1

Nuedexta

DOB: 1/1/1900SEX:





REPORT DATE:1/1/19001/1/1900

10/4/2016


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Buccal Swab

Cardiology


www.alcalalabs.com



Page 22 of 31

Diazepam Possible Altered Sensitivity to Diazepam (CYP2C19: Ultra-Rapid Metabolizer)CYP2C19 rapid and ultra-rapid metabolizers metabolize diazepam and nordiazepam more rapidly than normalmetabolizers. However, there is insufficient data to allow calculation of dose adjustment when diazepam is prescribed.Monitor the patient's response and adjust the dose accordingly.

EVIDENCE LEVEL 2

Valium

Diclofenac Possible Sensitivity to Diclofenac (CYP2C9: Poor Metabolizer)Diclofenac is extensively metabolized by hydroxylation and direct glucuronidation. About 50% of diclofenac is eliminatedas a 4-hydroxymetabolite, a reaction mediated by CYP2C9. Other CYP enzymes including CYP2C8, CYP2C19 and CYP3A4are also involved in the formation of a 5-hydroxymetabolite. A substantial portion of the drug is also directlyglucuronidated by UGT2B7 and UGT2B4. Individuals with decreased CYP2C9 activity (i.e poor metabolizers) should beclosely monitored for increased gastrointestinal adverse events when prescribed diclofenac and lower doses may be moreappropriate for these patients.

EVIDENCE LEVEL 2

Voltaren

Donepezil Possible Altered Response to Donepezil (CYP2D6: Poor Metabolizer)When compared to a normal metabolizer, a poor metabolizer has a 30% decrease in donepezil clearance. The clinicalsignificance of this decrease is not well documented. Consider using a standard dosing regimen, be alert for adverseevents, and adjust dosage in response to clinical response and tolerability.

EVIDENCE LEVEL 2

Aricept

Duloxetine Possible Sensitivity to Duloxetine (CYP2D6: Poor Metabolizer)Limited data suggest that duloxetine plasma concentrations might be increased in CYP2D6 poor metabolizers. Therefore,duloxetine can be prescribed at standard label-recommended dosage, and careful titration is recommended until afavorable response is achieved.

EVIDENCE LEVEL 2

Cymbalta

Esomeprazole Insufficient Response to Esomeprazole (CYP2C19: Ultra-Rapid Metabolizer)Helicobacter pylori eradication: increase dose by 50-100% and be alert to insufficient response.•Other: be extra alert to insufficient response and consider dose increase of 50-100%.•

EVIDENCE LEVEL 2

Nexium

Flecainide Significantly Increased Sensitivity to Flecainide (CYP2D6: Poor Metabolizer)Consider prescribing a lower flecainide dose. When compared to a CYP2D6 normal metabolizer, a poor metabolizer mayrequire a 50% dose reduction. Careful titration with ECG recording and monitoring of flecainide plasma concentrationsare recommended until a favorable clinical response is achieved.

EVIDENCE LEVEL 1

Tambocor

Fluphenazine Increased Sensitivity to Fluphenazine (CYP2D6: Poor Metabolizer)Fluphenazine is metabolized by CYP2D6, CYP1A2 and other enzymes. Decreased CYP2D6 activity may result in higherfluphenazine concentrations potentially leading to higher adverse events such as extrapyramidal symptoms . Thereare no established dosing adjustments for patients lacking CYP2D6 function therefore, therapy must be initiatedcautiously with oral or parenteral fluphenazine hydrochloride. When the pharmacological effects and an appropriatedosage are apparent, an equivalent dose of fluphenazine decanoate (IM or SC) may be administered and subsequentdosage adjustments may be necessary.

EVIDENCE LEVEL 2

Prolixin

Flurbiprofen Increased Sensitivity to Flurbiprofen (CYP2C9: Poor Metabolizer)At standard dosage, plasma concentrations of flurbiprofen are expected to be high, resulting in an increased risk ofgastrointestinal toxicity. Administer flurbiprofen with caution and reduce dose if necessary.

EVIDENCE LEVEL 1

Ansaid

Fluvastatin Increased Sensitivity to Fluvastatin (CYP2C9: Poor Metabolizer)Increased fluvastatin plasma concentrations due to reduced CYP2C9 activity may occur, resulting inmyotoxicity/hepatotoxicity. Consider monitoring the patient for treatment-related adverse effects, and adjust dose asneeded. Other adverse events and predisposing factors include advanced age (≥65), diabetes, hypothyroidism, renal orhepatic impairments, high statin dose, CYP2C9 inhibitors, ABCG2 inhibitors, and female gender.

EVIDENCE LEVEL 1

Lescol

DOB: 1/1/1900SEX:





REPORT DATE:1/1/19001/1/1900

10/4/2016


ACC #:

Buccal Swab

Cardiology


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Page 23 of 31

Fluvoxamine Increased Sensitivity to Fluvoxamine (CYP2D6: Poor Metabolizer)At standard label-recommended dosage, fluvoxamine levels are expected to be high and adverse events may occur.Consider a 25-50% reduction of recommended starting dose to help prevent concentration-dependent adverse eventsand titrate based on the clinical response and tolerability. An alternative medication may also be considered.

EVIDENCE LEVEL 2

Luvox

Fluvoxamine Delayed Response to Fluvoxamine (SLC6A4: Low Serotonin Transporter Expression)The genotype predicts significantly decreased serotonin transporter levels resulting in less efficient transporter function. Alonger titration period may be required to achieve maximal antidepressant response. The patient may respond tofluvoxamine more slowly (up to 12 weeks) and may experience more side effects. The patient may benefit from non-selective antidepressants.

EVIDENCE LEVEL 2

Luvox

Fosphenytoin High Sensitivity to Fosphenytoin (CYP2C9: Poor Metabolizer)In CYP2C9 poor metabolizers, the plasma concentrations of phenytoin are expected to increase, resulting in an increasedrisk of severe neurological toxicity. This risk increases further in individuals who are also CYP2C19 poor metabolizers. Consider a standard loading dose, and reduce the maintenance dose by 50% . Evaluate response and serumconcentrations after 7-10 days. Be alert to neurological concentration-related adverse events.

EVIDENCE LEVEL 1

Cerebyx

Galantamine Possible Sensitivity to Galantamine (CYP2D6: Poor Metabolizer)A CYP2D6 poor metabolizer has a drug exposure that is approximately 50% higher than the exposure in a normalmetabolizer. Although dosage adjustment is not necessary in a patient identified as a CYP2D6 poor metabolizer as thedose of drug is individually titrated to tolerability, a slower titration can be considered as it may improve tolerability.

EVIDENCE LEVEL 2

Razadyne

Glimepiride Possible Sensitivity to Glimepiride (CYP2C9: Poor Metabolizer)Subjects with reduced CYP2C9 activity may have increased glimepiride plasma drug concentrations at standard doses,leading to hypoglycemic episodes. Because there is insufficient data to whether such changes have a significant clinicalimpact, glimepiride can be prescribed according to standard label-recommended dosage and administration, withfrequent monitoring of plasma glucose levels.

EVIDENCE LEVEL 1

Amaryl

Glipizide Possible Sensitivity to Glipizide (CYP2C9: Poor Metabolizer)Subjects with reduced CYP2C9 activity may have increased glipizide plasma drug concentrations at standard doses,leading to hypoglycemic episodes. Because there is insufficient data to whether such changes have a significant clinicalimpact, glipizide can be prescribed according to standard label-recommended dosage and administration, with frequentmonitoring of glucose plasma levels.

EVIDENCE LEVEL 2

Glucotrol

Glyburide Possible Sensitivity to Glyburide (CYP2C9: Poor Metabolizer)Subjects with reduced CYP2C9 activity may have increased glyburide plasma drug concentrations at standard doses,leading to hypoglycemic episodes. Because there is insufficient data to whether such changes have a significant clinicalimpact, glyburide can be prescribed according to standard label-recommended dosage and administration with frequentmonitoring of glucose plasma levels.

EVIDENCE LEVEL 1

Micronase

Hydrocodone Possible Altered Response to Hydrocodone (CYP2D6: Poor Metabolizer)Decreased conversion of hydrocodone to the more active metabolite hydromorphone is expected in CYP2D6 poormetabolizers. However, there is insufficient evidence whether poor metabolizers have decreased analgesia when takinghydrocodone. Adequate pain relief can be achieved by increasing the dose in response to pain symptoms. Other opioidsnot metabolized by CYP2D6 may also be considered (i.e., morphine, oxymorphone, buprenorphine, fentanyl, methadone,and hydromorphone).

EVIDENCE LEVEL 2

Vicodin

DOB: 1/1/1900SEX:





REPORT DATE:1/1/19001/1/1900

10/4/2016


ACC #:

Buccal Swab

Cardiology


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Page 24 of 31

Ibuprofen Possible Sensitivity to Ibuprofen (CYP2C9: Poor Metabolizer)Ibuprofen is extensively metabolized into hydroxylate or carboxylate metabolites by CYP2C8 and CYP2C9. Diminishedibuprofen clearance has been found in CYP2C9 poor metabolizers and those with decreased CYP2C8 activity. This changein clearance may result in elevated concentrations of the drug inadvertently leading to adverse events. Although, dosageadjustment is not necessary in a patient identified as a CYP2C9 poor metabolizer, a lower dose and a closer monitoringfor increased gastrointestinal adverse events may be considered.

EVIDENCE LEVEL 2

Advil, Motrin

Iloperidone Increased Sensitivity to Iloperidone (CYP2D6: Poor Metabolizer)Iloperidone dose should be reduced by one-half and titrated slowly to avoid orthostatic hypotension . Becauseiloperidone is associated with QTc prolongation, caution is warranted when prescribing the drug in patients with reducedCYP2D6 activity. If patients taking iloperidone experience symptoms that could indicate the occurrence of cardiacarrhythmias (e.g., dizziness, palpitations, or syncope), the prescriber should initiate further evaluation, including cardiacmonitoring.

EVIDENCE LEVEL 1

Fanapt

Indomethacin Possible Sensitivity to Indomethacin (CYP2C9: Poor Metabolizer)Indomethacin is metabolized mainly by O-demethylation to its inactive metabolite O-desmethylindomethacin, a reactioncatalyzed by CYP2C9. At standard dosage, plasma concentrations of indomethacin are expected to be high resulting in anincreased risk of gatrointestinal toxicity. To minimize the potential risk for an adverse event, the lowest effective doseshould be used for the shortest possible duration.

EVIDENCE LEVEL 2

Indocin

Lansoprazole Insufficient Response to Lansoprazole (CYP2C19: Ultra-Rapid Metabolizer)Helicobacter pylori eradication: increase dose by 200% and be alert to insufficient response.•Other: be extra alert to insufficient response and consider dose increase of 200%.•

EVIDENCE LEVEL 2

Prevacid

Losartan Possible Decreased Response to Losartan (CYP2C9: Poor Metabolizer)Losartan is metabolized to its active metabolite by CYP2C9 and CYP3A4. The patient's genotype predicts a reducedexposure to losartan's active metabolite and a possible reduced hypotensive effect. Losartan can be prescribed at label-recommended dosage and administration with additional monitoring of the patient's response.

EVIDENCE LEVEL 2

Cozaar, Hyzaar

Lovastatin Altered Response to Lovastatin (CYP3A4: Intermediate Metabolizer)The genotype result indicates that the patient carries the CYP3A4*22 allele (this allele is associated with lower CYP3A4enzyme activity). Preliminary studies have shown that patients carrying the CYP3A4*22 allele may achieve an optimal lipidcontrol goal with lower lovastatin dose requirements.

EVIDENCE LEVEL 2

Mevacor, Altoprev, Advicor

Maprotiline Increased Sensitivity to Maprotiline (CYP2D6: Poor Metabolizer)Like other tricyclic and tetracyclic antidepressants, maprotiline is metabolized by CYP2D6 as well as CYP1A2. Compared toCYP2D6 normal metabolizers, CYP2D6 poor metabolizers have higher exposure to maprotiline at therapeutic doses whichmay increase the risk of concentration-dependent toxicities. There are no established dosing adjustments for patientswith decreased CYP2D6 function however, it is recommended to initiate maprotiline therapy at a low dosage andgradually adjust the dosing according to the patient's response. The lowest effective dosage should always be consideredduring maintenance therapy.

EVIDENCE LEVEL 2

Ludiomil

Meloxicam Increased sensitivity to Meloxicam (CYP2C9: Poor Metabolizer)CYP2C9 poor metabolizers have a higher risk of experiencing gastrointestinal toxicities when taking meloxicam atstandard doses. To minimize the potential risk of adverse events in these patients, the lowest effective dose should beused for the shortest possible duration.

EVIDENCE LEVEL 2

Mobic

DOB: 1/1/1900SEX:





REPORT DATE:1/1/19001/1/1900

10/4/2016


ACC #:

Buccal Swab

Cardiology


www.alcalalabs.com



Page 25 of 31

Methotrexate Increased risk for methotrexate toxicity (MTHFR: Reduced MTHFR Activity)The patient carries two MTHFR 677 T alleles, resulting in a significantly reduced MTHFR activity. Malignancy: Leukemia orlymphoma patients who are treated with methotrexate standard regimens may have an increased risk of overall toxicity(including mucositis, thrombocytopenia, and hepatic toxicity), and an increased severity of mucositis. Consider at least a50% reduction in methotrexate starting dose, followed by titration based on toxicity. Other genetic and clinical factorsmay also influence the patient's risk for toxicity and response to methotrexate treatment. Nonmalignant conditions: alimited number of studies found an association between the MTHFR 677 T allele and methotrexate-induced toxicity inrheumatoid arthritis patients. However, there is insufficient data to calculate dose adjustment. Monitor patient closely forincreased side effects and adjust the dose accordingly. Other genetic and clinical factors may also influence the patient'srisk for toxicity and response to methotrexate treatment.

EVIDENCE LEVEL 2

Trexall

Methylphenidate Unfavorable Response to Methylphenidate (ADRA2A: Homozygous for C Allele)The patient carries two C alleles of the ADRA2A –1291 C>G polymorphism. Preliminary studies suggest that this genotypemay be associated with an unfavorable response to methylphenidate in children and adolescents with the attention-deficit and hyperactivity disorder of inattentive type.

EVIDENCE LEVEL 2

Ritalin

Methylphenidate Decreased Response to Methylphenidate (COMT: Intermediate COMT Activity)The patient's genotype result predicts a less optimal response to methylphenidate. Dosage should be individualizedaccording to the needs and response of the patient. Therapy should be initiated in small doses, with gradual weeklyincrements.

EVIDENCE LEVEL 2

Ritalin

Metoclopramide Increased Sensitivity to Metoclopramide (CYP2D6: Poor Metabolizer)Metoclopramide is metabolized at a slower rate in CYP2D6 poor metabolizers which results in significantly higher serumconcentrations of the drug. Considering the CNS and extrapyramidal adverse effects of metoclopramide, closemonitoring for toxicity and eventually a dose decrease are recommended. Patients with renal disease at increased risk.

EVIDENCE LEVEL 2

Reglan

Mexiletine Significantly Increased Sensitivity to Mexiletine (CYP2D6: Poor Metabolizer)Consider prescribing a lower mexiletine dose. A slow titration with ECG recording and monitoring of mexiletine plasmaconcentrations are recommended until a favorable clinical response is achieved.

EVIDENCE LEVEL 1

Mexitil

Naltrexone Altered Response to Naltrexone (OPRM1: Normal OPRM1 Function)Treatment of alcohol dependence: the patient has the wild-type genotype for OPRM1 that is associated with a pooreroutcome with naltrexone therapy. Naltrexone-treated patients not carrying the 118A> G mutation are less likely torespond to this drug, and may have higher relapse rates than those who are carriers of this mutation.

EVIDENCE LEVEL 2

Vivitrol, Contrave

Nateglinide Possible Sensitivity to Nateglinide (CYP2C9: Poor Metabolizer)The patient's genotype predicts a reduced CYP2C9 activity, which may result in a slightly increased risk for hypoglycemia.Nateglinide can be prescribed at label-recommended dosage and administration with additional monitoring of thepatient's response.

EVIDENCE LEVEL 2

Starlix

Nefazodone Possible Sensitivity to Nefazodone (CYP2D6: Poor Metabolizer)Nefazodone is metabolized by CYP3A4 to its active metabolite m-chlorophenylpiperazine and other metabolites. The m-chlorophenylpiperazine metabolite which may contribute to adverse events, is further metabolized by CYP2D6.Individuals lacking CYP2D6 activity have higher levels of m-chlorophenylpiperazine metabolite and may experience moremoderate and transient side effects when starting therapy. Consider prescribing nefazodone at a lower dose and adjustdose according to the patient's tolerability and clinical response.

EVIDENCE LEVEL 2

Serzone

DOB: 1/1/1900SEX:





REPORT DATE:1/1/19001/1/1900

10/4/2016


ACC #:

Buccal Swab

Cardiology


www.alcalalabs.com



Page 26 of 31

Olanzapine Increased Risk of Weight Gain with Olanzapine (HTR2C: Homozygous for the C allele (rs3813929))Genetic variations in the Serotonin 2C Receptor (HTR2C) gene in known to be partially involved in the adverse effectsassociated with atypical antipsychotic medications. The patient is homozygous for C allele of HTR2C variant rs3813929.Patients with this genotype may have an increased risk of weight gain when treated with olanzapine.

EVIDENCE LEVEL 2

Zyprexa

Ondansetron Lack of Benefit from Ondansetron Treatment in Early Onset Alcoholism (SLC6A4: Low Serotonin Transporter Expression)Ondansetron has been shown to be effective in inhibiting heavy drinking behaviors in patients with early onsetalcoholism. This patient carries two short or S alleles of SLC6A4 5-HTTLPR variant. Preliminary studies demonstrate thatuse of ondansetron may not benefit patients with this genotype. The abstinence rates from alcohol and the number ofdrinks per drinking day were not significantly different between patients treated with placebo or ondansetron.

EVIDENCE LEVEL 2

Zofran, Zuplenz

Oxycodone Possible Altered Response to Oxycodone (CYP2D6: Poor Metabolizer)Decreased conversion of oxycodone to the more active metabolite oxymorphone is expected in CYP2D6 poormetabolizers. However, there is insufficient evidence whether poor metabolizers have decreased analgesia when takingoxycodone. Adequate pain relief can be achieved by increasing the dose in response to pain symptoms. Other opioidsnot metabolized by CYP2D6 may also be considered (i.e., morphine, oxymorphone, buprenorphine, fentanyl, methadone,and hydromorphone).

EVIDENCE LEVEL 1

Percocet, Oxycontin

Pantoprazole Insufficient Response to Pantoprazole (CYP2C19: Ultra-Rapid Metabolizer)Helicobacter pylori eradication: increase dose by 400% and be alert to insufficient response.•Other: be extra alert to insufficient response and consider dose increase of 400%.•

EVIDENCE LEVEL 1

Protonix

Perphenazine Increased Sensitivity to Perphenazine (CYP2D6: Poor Metabolizer)Patients with a decreased CYP2D6 function will eliminate perphenazine more slowly, which can result in higher drugconcentrations and possibly more adverse events (extrapyramidal symptoms). Consider close monitoring and dosereduction to avoid toxicity.

EVIDENCE LEVEL 1

Trilafon

Phenytoin High Sensitivity to Phenytoin (CYP2C9: Poor Metabolizer)In CYP2C9 poor metabolizers, the plasma concentrations of phenytoin are expected to increase, resulting in an increasedrisk of severe neurological toxicity. This risk increases further in individuals who are also CYP2C19 poor metabolizers. Consider a standard loading dose, and reduce the maintenance dose by 50% . Evaluate response and serumconcentrations after 7-10 days. Be alert to neurological concentration-related adverse events.

EVIDENCE LEVEL 1

Dilantin

Pimozide Increased Sensitivity to Pimozide (CYP2D6: Poor Metabolizer)The pimozide concentrations observed in poor CYP2D6 metabolizers are expected to be high, and the time to achievesteady-state pimozide concentrations is expected to be long (approximately 2 weeks). Consequently, CYP2D6 poormetabolizers are at an increased risk of QT prolongation at standard doses of pimozide. In CYP2D6 poor metabolizers,pimozide doses should not exceed 4 mg/day in adults or 0.05 mg/kg/day in children, and doses should not be increasedearlier than 14 days.

EVIDENCE LEVEL 1

Orap

Piroxicam Increased Sensitivity to Piroxicam (CYP2C9: Poor Metabolizer)At standard dosage, plasma concentrations of piroxicam are expected to be high, resulting in an increased risk ofgastrointestinal toxicity. Administer piroxicam with caution and reduce dose if necessary.

EVIDENCE LEVEL 1

Feldene

Clopidogrel Increased Response to Clopidogrel (CYP2C19: Ultra-Rapid Metabolizer)Clopidogrel can be prescribed at standard label-recommended dosage. Individuals with the *17 allele may have anincreased risk of bleeding while taking clopidogrel.

EVIDENCE LEVEL 1

Plavix

DOB: 1/1/1900SEX:





REPORT DATE:1/1/19001/1/1900

10/4/2016


ACC #:

Buccal Swab

Cardiology


www.alcalalabs.com



Page 27 of 31

Omeprazole Insufficient Response to Omeprazole (CYP2C19: Ultra-Rapid Metabolizer)Helicobacter pylori eradication: increase dose by 100-200% and be alert to insufficient response.•Other: be extra alert to insufficient response and consider dose increase of 100-200%.•

EVIDENCE LEVEL 1

Prilosec

Propafenone Increased Sensitivity to Propafenone (CYP2D6: Poor Metabolizer)Consider reducing the propafenone dose, and monitor ECG. Compared to normal metabolizers, poor metabolizers mayrequire a 70% dose reduction. Consider monitoring for plasma concentrations.

EVIDENCE LEVEL 1

Rythmol

Ranolazine Increased Sensitivity to Ranolazine (CYP2D6: Poor Metabolizer)Ranolazine is metabolized mainly by CYP3A4, and to a lesser extent by CYP2D6. At 500 mg twice daily, subjects lackingCYP2D6 activity (poor metabolizers) had 62% higher ranolazine exposure than subjects with normal CYP2D6 activity. Thecorresponding difference at 1000 mg twice daily dose was 25%.

The risk for increased exposure leading to adverse events is higher in patients lacking CYP2D6 activity (i.e., poormetabolizers). The recommended initial oral dose is 375 mg twice daily. A slower up titration and additionalmonitoring is recommended in these patients. Exposure related side effects might include nausea, vomiting, syncope,and dizziness. If a patient experiences treatment-related adverse events, down titration of the dose to 500 mg or 375 mgtwice daily may be required. If symptoms do not resolve after dose reduction, treatment should be discontinued.

Ranolazine is a QTc prolonging drug. Caution should be observed when treating: 1- patients with a history ofcongenital or a family history of long QT syndrome, 2- patients with known acquired QT interval prolongation, and 3-patients treated with drugs affecting the QTc interval. Administration of CYP3A4 inhibitors increases the exposure ofranolazine significantly. As a consequence, the QTc prolongation by ranolazine in the presence of potent CYP3A inhibitorsis significantly elevated relative to when the drug is administered alone.

EVIDENCE LEVEL 1

Ranexa

Sertraline Possible Reduced Response to Sertraline (CYP2C19: Ultra-Rapid Metabolizer)Sertraline can be prescribed at standard label-recommended dosage and administration. If patient does not respond torecommended maintenance dosing, consider an alternative medication.

EVIDENCE LEVEL 2

Zoloft

Simvastatin Altered Response to Simvastatin (CYP3A4: Intermediate Metabolizer)The genotype result indicates that the patient carries the CYP3A4*22 allele (this allele is associated with lower CYP3A4enzyme activity). Preliminary studies have shown that patients carrying the CYP3A4*22 allele may achieve an optimal lipidcontrol goal with lower simvastatin dose requirements.

EVIDENCE LEVEL 2

Zocor

Tacrolimus Insufficient Response to Tacrolimus (CYP3A5: Intermediate Metabolizer)The genotype result predicts that the patient expresses the CYP3A5 protein. Therefore, the patient may metabolizetacrolimus more rapidly, resulting in low tacrolimus trough levels. Studies have shown patients with this genotype may beat increased risk for acute transplant rejection while taking a standard dose of tacrolimus. Therefore, increasing startingdose 1.5 to 2 times recommended starting dose with close monitoring is strongly reco

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NAME: SPECIMEN TYPE: Buccal Swab Christian Tagwerker, Ph.D ... · 3703 Camino del Rio South, 100-A Alcala Testing and Analysis Services -- 619-450-5870 DO NOT DISTRIBUTE Lab Director: