This pharmacogenomic report summarizes genetic test results for a patient. It finds the patient has various genetic variants that impact drug metabolism for certain medications like warfarin and antidepressants. For warfarin, it recommends a lower starting dose due to increased sensitivity. It also provides risk assessments and recommendations for conditions like thrombosis and hyperhomocysteinemia based on the patient's genetic results.
1. Comprehensive Pharmacogenomic Report
Patient: Ordered By:
Date of Birth:
Collection Date:
test$123, Patient
1/1/1900
1/1/1900Accession #: test$123
Gender: Report Generated: 8/19/2015
Received Date: 1/1/1900
Test Details
Gene Genotype Phenotype
CYP2C19 *1/*2 Intermediate Metabolizer
CYP2C9 *1/*1 Normal Metabolizer
CYP2D6 *4M/*4M XN Poor Metabolizer
CYP3A4 *1/*1 Normal Metabolizer
CYP3A5 *3/*3 Poor Metabolizer
Factor II (20210)
Factor V Leiden (1691)
20210G>A GG
1691G>A GA
Increased Risk of Thrombosis
MTHFR (677, 1298)
1298A>C CC
677C>T CC
No Increased Risk of Hyperhomocysteinemia
VKORC1 (-1639) -1639G>A A/A High Warfarin Sensitivity
WarfarinCurrent and Intended Medications:
Current Patient Medications
Warfarin (Coumadin)
Moderate Sensitivity to Warfarin (CYP2C9 *1/*1 VKORC1 1639G>A A/A)
Initiation Therapy: a dose decrease may be required. Consider using the following warfarin dose range provided in the FDAapproved label: 3-4 mg/day. OR
consider using a personalized dose calculated by a pharmacogenetic algorithm. The estimated time to reach steady state is 45 days.
Evidence Level: Actionable
Actionable Recommendations based upon publications by international pharmacogenetic expert groups, consortia or regulatory bodies (CPIC, DPWG,
FDA, EMA). Recommendations are suitable for implementation in a clinical setting. Guidelines may change as new knowledge arises.
Informative There are insufficient or contradictory findings documenting the impact of a given genetic polymorphism or drug interaction. Recommendations
are informative and implementation in a clinical setting is optional.
Guidance Levels
Evidence Levels
Based upon the patient's genotype, a medication has potentially reduced efficacy or increased toxicity or the patient has an increased risk for the
indicated condition.
Based upon the patient's genotype, guidelines exist for adjusting dosage or increased vigilance or the patient has a moderate risk for the indicated
condition.
Based on this patient's genotype, the medication can be prescribed according to standard regimens or the patient's risk for the indicated condition is
not increased.
Risk Management
9326 Olive Blvd., St. Louis, MO 63132
Ph:314.743.3748 Fax: 314.743.3747
CLIA#: 26D1101943
Pharmacogenomic Test Results For Patient test$123 Page 1 of 24
9. Dabigatran Etexilate (Pradaxa)
Normal Response to Dabigatran
Pharmacogenetic guidance: Dabigatran is eliminated primarily unchanged by the kidneys. After oral administration, dabigatran etexilate is converted
to its active form dabigatran by esterases. A small portion (20%) of dabigatran dose is also conjugated to form pharmacologically active acyl
glucuronides. Dabigatran is not a substrate, inhibitor, or inducer of CYP450 enzymes. Dabigatran etexilate is a substrate of the efflux transporter Pgp
(ABCB1). Common genetic polymorphism of the ABCB1 gene (2677G>T/A and 3435 C>T) do not appear to affect dabigatran exposure.
Polypharmacy guidance: 1-Reduction in Risk of Stroke and Systemic Embolism in Non-valvular AF: In patients with moderate renal impairment
(CrCl 3050 mL/min), concomitant use of the Pgp inhibitor dronedarone or systemic ketoconazole can be expected to produce dabigatran exposure
similar to that observed in severe renal impairment. Consider reducing the dose of dabigatran to 75 mg twice daily. Dose adjustment is not necessary
when coadministered with other Pgp inhibitors. In patients with CrCl<30 mL/min, avoid use of concomitant Pgp inhibitors with dabigatran.
2-Treatment of DVT and PE Reduction in the Risk of Recurrence of DVT and PE: Avoid use of concomitant Pgp inhibitors with dabigatran in patients
with CrCl <50 mL/min.
Evidence Level: Informative
Darifenacin (Enablex)
Possible Sensitivity to Darifenacin (CYP2D6 *4M/*4M XN Poor Metabolizer)
Darifenacin exposure is increased 30% in CYP2D6 poor metabolizers. Although dose adjustment may not be needed in these patients, monitor
patients for increased side effects when darifenacin is prescribed at standard labelrecommended dosage and administration.
Evidence Level: Actionable
Desipramine (Norpramin)
Increased Sensitivity to Desipramine (CYP2D6 *4M/*4M XN Poor Metabolizer)
Consider an alternative drug, or prescribe desipramine at 50% of recommended standard starting dose. Monitor plasma concentrations of
desipramine and metabolites and titrate accordingly until a favorable response is achieved.
Evidence Level: Actionable
Desvenlafaxine (Pristiq)
Normal Sensitivity to Desvenlafaxine (CYP2D6 *4M/*4M XN Poor Metabolizer)
Desvenlafaxine is primarily metabolized by conjugation (mediated by UGT enzymes) and, to a minor extent, through oxidative metabolism (mediated
by CYP3A4). The CYP2D6 enzyme is not involved in its metabolism.
Desvenlafaxine can be prescribed at standard labelrecommended dosage and administration.
Evidence Level: Actionable
Dexlansoprazole (Dexilant, Kapidex)
Normal/Increased Response to Dexlansoprazole (CYP2C19 *1/*2 Intermediate Metabolizer)
Dexlansoprazole can be prescribed at standard labelrecommended dosage and administration. A positive clinical effect is expected in intermediate
metabolizers.
Evidence Level: Actionable
Diazepam (Valium)
Moderate Sensitivity to Diazepam (CYP2C19 *1/*2 Intermediate Metabolizer)
Diazepam can be prescribed at standard labelrecommended dosage and administration.
Evidence Level: Informative
Diclofenac (Voltaren)
Normal Sensitivity to Diclofenac (CYP2C9 *1/*1 Normal Metabolizer)
Individuals with a normal CYP2C9 activity (i.e normal metabolizers) can be prescribed diclofenac according to standard label recommendeddosage
and administration.
Evidence Level: Informative
Dihydrocodeine (Synalgos-DC)
Normal Response to Dihydrocodeine (CYP2D6 *4M/*4M XN Poor Metabolizer)
Decreased conversion of dihydrocodeine to the more active metabolite dihydromorphine is expected in CYP2D6 poor metabolizers. However, there is
insufficient evidence whether these patients have decreased analgesia when taking dihydrocodeine. Adequate pain relief can be achieved by
increasing the dose in response to pain symptoms.
Evidence Level: Informative
Donepezil (Aricept)
Possible Altered Response to Donepezil (CYP2D6 *4M/*4M XN Poor Metabolizer)
When compared to a normal metabolizer, a poor metabolizer has a 30% decrease in donepezil clearance. The clinical significance of this decrease is
not well documented. Consider using a standard dosing regimen, be alert for adverse events, and adjust dosage in response to clinical response and
tolerability.
Evidence Level: Informative
9326 Olive Blvd., St. Louis, MO 63132
Ph:314.743.3748 Fax: 314.743.3747
CLIA#: 26D1101943
Pharmacogenomic Test Results For Patient test$123 Page 9 of 24