<?xml version="1.0" encoding="UTF-8"?>

<Observation xmlns="http://hl7.org/fhir">
  <id value="TxImp02"/>
  <meta>
    <profile value="http://hl7.org/fhir/uv/genomics-reporting/StructureDefinition/therapeutic-implication"/>
  </meta>
  <text>
    <status value="generated"/><div xmlns="http://www.w3.org/1999/xhtml">Poor metabolizer of Voriconazole</div>
  </text>
  <extension url="http://hl7.org/fhir/StructureDefinition/workflow-relatedArtifact">
    <valueRelatedArtifact>
      <type value="citation"/>
      <url value="https://cpicpgx.org/guidelines/guideline-for-voriconazole-and-cyp2c19/"/>
    </valueRelatedArtifact>
  </extension>
  <status value="final"/>
  <category>
    <coding>
      <system value="http://terminology.hl7.org/CodeSystem/observation-category"/>
      <code value="laboratory"/>
    </coding>
  </category>
  <category>
    <coding>
      <system value="http://terminology.hl7.org/CodeSystem/v2-0074"/>
      <code value="GE"/>
    </coding>
  </category>
  <code>
    <coding>
      <system value="http://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs"/>
      <code value="therapeutic-implication"/>
    </coding>
  </code>
  <subject>
    <reference value="Patient/CGPatientExample01"/>
  </subject>
  <effectiveDateTime value="2019-04-01"/>
  <performer>
    <reference value="Organization/ExampleOrg"/>
  </performer>
  <derivedFrom>
    <reference value="Observation/Pgx-geno-1001"/>
  </derivedFrom>
  <component>
    <code>
      <coding>
        <system value="http://loinc.org"/>
        <code value="51963-7"/>
      </coding>
    </code>
    <valueCodeableConcept>
      <coding>
        <system value="http://www.nlm.nih.gov/research/umls/rxnorm"/>
        <code value="121243"/>
        <display value="voriconazole"/>
      </coding>
    </valueCodeableConcept>
  </component>
  <component>
    <code>
      <coding>
        <system value="http://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs"/>
        <code value="therapeutic-implication"/>
      </coding>
    </code>
    <valueCodeableConcept>
      <coding>
        <system value="http://loinc.org"/>
        <code value="LA9657-3"/>
        <display value="Poor metabolizer"/>
      </coding>
    </valueCodeableConcept>
  </component>
  <component>
    <code>
      <coding>
        <system value="http://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs"/>
        <code value="conclusion-string"/>
      </coding>
    </code>
    <valueString value="For voriconazole, higher dose-adjusted trough concentrations of voriconazole are expected in individuals with this genotype and may increase the probability of adverse events. An alternative agent that is not dependent on CYP2C19 metabolism such as isavuconazole, liposomal amphotericin B, or posaconazole is recommended as primary therapy in lieu of voriconazole. A lower than standard dosage of voriconazole with careful therapeutic drug monitoring is another alternative. Refer to current guidelines for dosage and recommendations at https://cpicpgx.org/guidelines/guideline-for-voriconazole-and-cyp2c19/."/>
  </component>
</Observation>