INDICATION AND USES:
PRISTIQ, is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with 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).
- The 25 mg per day dose is intended for a gradual reduction in dose when discontinuing treatment or dosing in severe renal and end-stage renal disease patients (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 25 mg per day or 50 mg every other day (2.2).
- Moderate to severe hepatic impairment: Maximum dose 100 mg per day (2.3).
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).
CONTRAINDICATIONS:
- Hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or any excipients in the PRISTIQ formulation (4).
- Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with PRISTIQ or within 7 days of stopping treatment with PRISTIQ. Do not use PRISTIQ within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start PRISTIQ in a patient who is being treated with linezolid or intravenous methylene blue (4).
WARNINGS AND PRECAUTIONS:
- Serotonin Syndrome: Increased risk when co-adminstered with other serotonergic agents (e.g., SSRI, SNRI, triptans), but also when taken alone. If it occurs, discontinue PRISTIQ and initiate supportive treatment (5.2).
- Elevated Blood Pressure: Control hypertension before initiating treatment. Monitor blood pressure regularly during treatment (5.3).
- Increased Risk of Bleeding: Concomitant use of aspirin, NSAIDs, other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk (5.4).
- Angle Closure Glaucoma: Avoid use of antidepressants, including PRISTIQ, in patients with untreated anatomically narrow angles treated. (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).
DRUG INTERACTIONS:
| Monoamine Oxidase Inhibitors (MAOI) | |
| Clinical Impact | The concomitant use of SSRIs and SNRIs including PRISTIQ with MAOIs increases the risk of serotonin syndrome. |
| Intervention | Concomitant use of PRISTIQ is contraindicated:
[see Dosage and Administration (2.7), Contraindications (4) and Warnings and Precautions (5.2)]. |
| Examples | selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue |
| Other Serotonergic Drugs | |
| Clinical Impact | Concomitant use of PRISTIQ with other serotonergic drugs increases the risk of serotonin syndrome |
| Intervention | Monitor for symptoms of serotonin syndrome when PRISTIQ is used concomitantly with other drugs that may affect the serotonergic neurotransmitter systems. If serotonin syndrome occurs, consider discontinuation of PRISTIQ and/or concomitant serotonergic drugs [see Warnings and Precautions (5.2)]. |
| Examples | other SNRIs, SSRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, amphetamines, tryptophan, and St. John’s Wort |
| Drugs that Interfere with Hemostasis | |
| Clinical Impact | Concomitant use of PRISTIQ with an antiplatelet or anticoagulant drug may potentiate the risk of bleeding. This may be due to the effect of PRISTIQ on the release of serotonin by platelets. |
| Intervention | Closely monitor for bleeding for patients receiving an antiplatelet or anticoagulant drug when PRISTIQ is initiated or discontinued [see Warnings and Precautions (5.4)]. |
| Examples | NSAIDs, aspirin, and warfarin |
| Drugs that are Primarily Metabolized by CYP2D6 | |
| Clinical Impact | Concomitant use of PRISTIQ increases CMAX and AUC of a drug primarily metabolized by CYP2D6 which may increase the risk of toxicity of the CYP2D6 substrate drug [see Clinical Pharmacology (12.3)]. |
| Intervention | Original dose should be taken when co-administered with PRISTIQ 100 mg or lower. Reduce the dose of these drugs by up to one-half if co-administered with 400 mg of PRISTIQ. |
| Examples | desipramine, atomoxetine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine |
OVERDOSE:
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 SSRI-treated 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
-
INDICATION AND USES:
PRISTIQ, is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with 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).
- The 25 mg per day dose is intended for a gradual reduction in dose when discontinuing treatment or dosing in severe renal and end-stage renal disease patients (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 25 mg per day or 50 mg every other day (2.2).
- Moderate to severe hepatic impairment: Maximum dose 100 mg per day (2.3).
- Side Effects
-
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
-
CONTRAINDICATIONS:
- Hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or any excipients in the PRISTIQ formulation (4).
- Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with PRISTIQ or within 7 days of stopping treatment with PRISTIQ. Do not use PRISTIQ within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start PRISTIQ in a patient who is being treated with linezolid or intravenous methylene blue (4).
WARNINGS AND PRECAUTIONS:
- Serotonin Syndrome: Increased risk when co-adminstered with other serotonergic agents (e.g., SSRI, SNRI, triptans), but also when taken alone. If it occurs, discontinue PRISTIQ and initiate supportive treatment (5.2).
- Elevated Blood Pressure: Control hypertension before initiating treatment. Monitor blood pressure regularly during treatment (5.3).
- Increased Risk of Bleeding: Concomitant use of aspirin, NSAIDs, other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk (5.4).
- Angle Closure Glaucoma: Avoid use of antidepressants, including PRISTIQ, in patients with untreated anatomically narrow angles treated. (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
-
DRUG INTERACTIONS:
Monoamine Oxidase Inhibitors (MAOI) Clinical Impact The concomitant use of SSRIs and SNRIs including PRISTIQ with MAOIs increases the risk of serotonin syndrome. Intervention Concomitant use of PRISTIQ is contraindicated: - With an MAOI intended to treat psychiatric disorders or within 7 days of stopping treatment with PRISTIQ.
- Within 14 days of stopping an MAOI intended to treat psychiatric disorders
- In a patient who is being treated with linezolid or intravenous methylene blue.
[see Dosage and Administration (2.7), Contraindications (4) and Warnings and Precautions (5.2)].
Examples selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Other Serotonergic Drugs Clinical Impact Concomitant use of PRISTIQ with other serotonergic drugs increases the risk of serotonin syndrome Intervention Monitor for symptoms of serotonin syndrome when PRISTIQ is used concomitantly with other drugs that may affect the serotonergic neurotransmitter systems. If serotonin syndrome occurs, consider discontinuation of PRISTIQ and/or concomitant serotonergic drugs [see Warnings and Precautions (5.2)]. Examples other SNRIs, SSRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, amphetamines, tryptophan, and St. John’s Wort Drugs that Interfere with Hemostasis Clinical Impact Concomitant use of PRISTIQ with an antiplatelet or anticoagulant drug may potentiate the risk of bleeding. This may be due to the effect of PRISTIQ on the release of serotonin by platelets. Intervention Closely monitor for bleeding for patients receiving an antiplatelet or anticoagulant drug when PRISTIQ is initiated or discontinued [see Warnings and Precautions (5.4)]. Examples NSAIDs, aspirin, and warfarin Drugs that are Primarily Metabolized by CYP2D6 Clinical Impact Concomitant use of PRISTIQ increases CMAX and AUC of a drug primarily metabolized by CYP2D6 which may increase the risk of toxicity of the CYP2D6 substrate drug [see Clinical Pharmacology (12.3)]. Intervention Original dose should be taken when co-administered with PRISTIQ 100 mg or lower. Reduce the dose of these drugs by up to one-half if co-administered with 400 mg of PRISTIQ. Examples desipramine, atomoxetine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine - Overdose
-
OVERDOSE:
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 SSRI-treated 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.
Learn More about GeneSight® Testing.
Are you interested in taking the GeneSight test or becoming registered to provide the GeneSight test to your patients? Fill in your information below and we will send you a response via email providing additional resources and help you take your next step.
The GeneSight test must be ordered by a registered clinician. If you are a patient/caregiver who would like your current clinician to be contacted, please include their name and contact information. To find a clinician in your area that already offers the GeneSight test, visit our Find a Provider page.
Thank you for your interest in the GeneSight test!
Take the Next Step - PD
Sorry, this form is not available.
By submitting your information in this form, you agree that your personal information may be stored and processed in any country where we have facilities or service providers, and by using our “Take the Next Step” page you agree to the possible transfer of information to countries outside of your country of residence, including to the United States, which may provide for different data protection rules than in your country. The information you submit will be utilized for the sole purpose it was submitted for and governed by our Privacy Notice.