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Medications: Pristiq® – desvenlafaxine

MEDICATIONS

Prestiq® – desvenlafaxine (View the FDA label)

PRISTIQ, is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of major depressive disorder (MDD) (1).

DOSAGE AND ADMINISTRATION

  • Recommended dose: 50 mg once daily with or without food (2.1).
  • There was no evidence that doses greater than 50 mg per day confer any additional benefit (2.1).
  • Discontinuation: Reduce dose gradually whenever possible (2.1).
  • Take tablets whole; do not divide, crush, chew, or dissolve (2.1).
  • Moderate renal impairment: Maximum dose 50 mg per day (2.2).
  • Severe renal impairment and end-stage renal disease: Maximum dose 50 mg every other day (2.2).
  • Moderate to severe hepatic impairment: Maximum dose 100 mg per day (2.2).

Most common adverse reactions (incidence ≥5% and twice the rate of placebo in the 50 or 100 mg dose groups) were: nausea, dizziness, insomnia, hyperhidrosis, constipation, somnolence, decreased appetite, anxiety, and specific male sexual function disorders (6.1).

  • Clinical Worsening/Suicide Risk: Monitor for clinical worsening and suicide risk (5.1).
  • Serotonin Syndrome: Serotonin syndrome has been reported with SSRIs and SNRIs, including with PRISTIQ, both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort). If such symptoms occur, discontinue PRISTIQ and initiate supportive treatment. If concomitant use of PRISTIQ with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases (5.2).
  • Elevated Blood Pressure: Control hypertension before initiating treatment. Monitor blood pressure regularly during treatment (5.3).
  • Abnormal Bleeding: PRISTIQ may increase risk of bleeding events. Caution patients about risk of bleeding associated with concomitant use of PRISTIQ and NSAIDs, aspirin, or other drugs that affect coagulation (5.4).
  • Narrow-angle Glaucoma: Mydriasis has occurred with PRISTIQ. Monitor patients with raised intraocular pressure or those at risk of angle-closure glaucoma (5.5).
  • Activation of Mania/Hypomania: Use cautiously in patients with Bipolar Disorder. Caution patients about risk of activation of mania/hypomania (5.6).
  • Discontinuation Syndrome: Taper dose when possible and monitor for discontinuation symptoms (5.7).
  • Seizure: Can occur. Use cautiously in patients with seizure disorder (5.8).
  • Hyponatremia: Can occur in association with SIADH (5.9).
  • Interstitial Lung Disease and Eosinophilic Pneumonia: Can occur (5.10).

Monoamine Oxidase Inhibitors (MAOI)

[see Dosage and Administration (2.6 ), Contraindications (4) and Warnings and Precautions (5.2)]

Serotonergic Drugs

[see Dosage and Administration (2.6), Contraindications (4) and Warnings and Precautions (5.2)]

Drugs that Interfere with Hemostasis (e.g., NSAIDs, Aspirin, and Warfarin)

Serotonin release by platelets plays an important role in hemostasis. Epidemiological studies of case-control and cohort design that have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding. These studies have also shown that concurrent use of an NSAID or aspirin may potentiate this risk of bleeding. Altered anticoagulant effects, including increased bleeding, have been reported when SSRIs and SNRIs are co-administered with warfarin. Patients receiving warfarin therapy should be carefully monitored when PRISTIQ is initiated or discontinued [see Warnings and Precautions (5.4)].

Potential for Desvenlafaxine to Affect Other Drugs

Clinical studies have shown that desvenlafaxine does not have a clinically relevant effect on CYP2D6 metabolism at the dose of 100 mg daily. Substrates primarily metabolized by CYP2D6 (e.g., desipramine , atomoxetine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine) should be dosed at the original level when co-administered with PRISTIQ 100 mg or lower. Reduce the dose of these substrates by one-half if co-administered with 400 mg of PRISTIQ. The substrate dose should be increased to the original level when 400 mg of PRISTIQ is discontinued.

Other Drugs Containing Desvenlafaxine or Venlafaxine

Avoid use of PRISTIQ with other desvenlafaxine-containing products or venlafaxine products. The concomitant use of PRISTIQ with other desvenlafaxine-containing products or venlafaxine will increase desvenlafaxine blood levels and increase dose-related adverse reactions [see Adverse Reactions (6)].

Ethanol

A clinical study has shown that PRISTIQ does not increase the impairment of mental and motor skills caused by ethanol. However, as with all CNS-active drugs, patients should be advised to avoid alcohol consumption while taking PRISTIQ.

Human Experience with Overdosage
There is limited clinical trial experience with desvenlafaxine succinate overdosage in humans. However, desvenlafaxine (PRISTIQ) is the major active metabolite of venlafaxine. Overdose experience reported with venlafaxine (the parent drug of PRISTIQ) is presented below; the identical information can be found in the Overdosage section of the venlafaxine package insert.

In postmarketing experience, overdose with venlafaxine (the parent drug of PRISTIQ) has occurred predominantly in combination with alcohol and/or other drugs. The most commonly reported events in overdosage include tachycardia, changes in level of consciousness (ranging from somnolence to coma), mydriasis, seizures, and vomiting. Electrocardiogram changes (e.g., prolongation of QT interval, bundle branch block, QRS prolongation), sinus and ventricular tachycardia, bradycardia, hypotension, rhabdomyolysis, vertigo, liver necrosis, serotonin syndrome, and death have been reported.

Published retrospective studies report that venlafaxine overdosage may be associated with an increased risk of fatal outcomes compared to that observed with SSRI antidepressant products, but lower than that for tricyclic antidepressants. Epidemiological studies have shown that venlafaxine-treated patients have a higher pre-existing burden of suicide risk factors than SSRItreated patients. The extent to which the finding of an increased risk of fatal outcomes can be attributed to the toxicity of venlafaxine in overdosage, as opposed to some characteristic(s) of venlafaxine-treated patients, is not clear.

Management of Overdosage
No specific antidotes for PRISTIQ are known. In managing over dosage, consider the possibility of multiple drug involvement. In case of overdose, call Poison Control Center at 1­ 800-222-1222 for latest recommendations.

Uses

PRISTIQ, is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of major depressive disorder (MDD) (1).

DOSAGE AND ADMINISTRATION

  • Recommended dose: 50 mg once daily with or without food (2.1).
  • There was no evidence that doses greater than 50 mg per day confer any additional benefit (2.1).
  • Discontinuation: Reduce dose gradually whenever possible (2.1).
  • Take tablets whole; do not divide, crush, chew, or dissolve (2.1).
  • Moderate renal impairment: Maximum dose 50 mg per day (2.2).
  • Severe renal impairment and end-stage renal disease: Maximum dose 50 mg every other day (2.2).
  • Moderate to severe hepatic impairment: Maximum dose 100 mg per day (2.2).
Side Effects

Most common adverse reactions (incidence ≥5% and twice the rate of placebo in the 50 or 100 mg dose groups) were: nausea, dizziness, insomnia, hyperhidrosis, constipation, somnolence, decreased appetite, anxiety, and specific male sexual function disorders (6.1).

Precautions
  • Clinical Worsening/Suicide Risk: Monitor for clinical worsening and suicide risk (5.1).
  • Serotonin Syndrome: Serotonin syndrome has been reported with SSRIs and SNRIs, including with PRISTIQ, both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort). If such symptoms occur, discontinue PRISTIQ and initiate supportive treatment. If concomitant use of PRISTIQ with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases (5.2).
  • Elevated Blood Pressure: Control hypertension before initiating treatment. Monitor blood pressure regularly during treatment (5.3).
  • Abnormal Bleeding: PRISTIQ may increase risk of bleeding events. Caution patients about risk of bleeding associated with concomitant use of PRISTIQ and NSAIDs, aspirin, or other drugs that affect coagulation (5.4).
  • Narrow-angle Glaucoma: Mydriasis has occurred with PRISTIQ. Monitor patients with raised intraocular pressure or those at risk of angle-closure glaucoma (5.5).
  • Activation of Mania/Hypomania: Use cautiously in patients with Bipolar Disorder. Caution patients about risk of activation of mania/hypomania (5.6).
  • Discontinuation Syndrome: Taper dose when possible and monitor for discontinuation symptoms (5.7).
  • Seizure: Can occur. Use cautiously in patients with seizure disorder (5.8).
  • Hyponatremia: Can occur in association with SIADH (5.9).
  • Interstitial Lung Disease and Eosinophilic Pneumonia: Can occur (5.10).
Interactions

Monoamine Oxidase Inhibitors (MAOI)

[see Dosage and Administration (2.6 ), Contraindications (4) and Warnings and Precautions (5.2)]

Serotonergic Drugs

[see Dosage and Administration (2.6), Contraindications (4) and Warnings and Precautions (5.2)]

Drugs that Interfere with Hemostasis (e.g., NSAIDs, Aspirin, and Warfarin)

Serotonin release by platelets plays an important role in hemostasis. Epidemiological studies of case-control and cohort design that have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding. These studies have also shown that concurrent use of an NSAID or aspirin may potentiate this risk of bleeding. Altered anticoagulant effects, including increased bleeding, have been reported when SSRIs and SNRIs are co-administered with warfarin. Patients receiving warfarin therapy should be carefully monitored when PRISTIQ is initiated or discontinued [see Warnings and Precautions (5.4)].

Potential for Desvenlafaxine to Affect Other Drugs

Clinical studies have shown that desvenlafaxine does not have a clinically relevant effect on CYP2D6 metabolism at the dose of 100 mg daily. Substrates primarily metabolized by CYP2D6 (e.g., desipramine , atomoxetine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine) should be dosed at the original level when co-administered with PRISTIQ 100 mg or lower. Reduce the dose of these substrates by one-half if co-administered with 400 mg of PRISTIQ. The substrate dose should be increased to the original level when 400 mg of PRISTIQ is discontinued.

Other Drugs Containing Desvenlafaxine or Venlafaxine

Avoid use of PRISTIQ with other desvenlafaxine-containing products or venlafaxine products. The concomitant use of PRISTIQ with other desvenlafaxine-containing products or venlafaxine will increase desvenlafaxine blood levels and increase dose-related adverse reactions [see Adverse Reactions (6)].

Ethanol

A clinical study has shown that PRISTIQ does not increase the impairment of mental and motor skills caused by ethanol. However, as with all CNS-active drugs, patients should be advised to avoid alcohol consumption while taking PRISTIQ.

Overdose

Human Experience with Overdosage
There is limited clinical trial experience with desvenlafaxine succinate overdosage in humans. However, desvenlafaxine (PRISTIQ) is the major active metabolite of venlafaxine. Overdose experience reported with venlafaxine (the parent drug of PRISTIQ) is presented below; the identical information can be found in the Overdosage section of the venlafaxine package insert.

In postmarketing experience, overdose with venlafaxine (the parent drug of PRISTIQ) has occurred predominantly in combination with alcohol and/or other drugs. The most commonly reported events in overdosage include tachycardia, changes in level of consciousness (ranging from somnolence to coma), mydriasis, seizures, and vomiting. Electrocardiogram changes (e.g., prolongation of QT interval, bundle branch block, QRS prolongation), sinus and ventricular tachycardia, bradycardia, hypotension, rhabdomyolysis, vertigo, liver necrosis, serotonin syndrome, and death have been reported.

Published retrospective studies report that venlafaxine overdosage may be associated with an increased risk of fatal outcomes compared to that observed with SSRI antidepressant products, but lower than that for tricyclic antidepressants. Epidemiological studies have shown that venlafaxine-treated patients have a higher pre-existing burden of suicide risk factors than SSRItreated patients. The extent to which the finding of an increased risk of fatal outcomes can be attributed to the toxicity of venlafaxine in overdosage, as opposed to some characteristic(s) of venlafaxine-treated patients, is not clear.

Management of Overdosage
No specific antidotes for PRISTIQ are known. In managing over dosage, consider the possibility of multiple drug involvement. In case of overdose, call Poison Control Center at 1­ 800-222-1222 for latest recommendations.

Interpreting the GeneSight® Test:
Gene-Drug Interaction Chart

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