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Contraindications/Warnings/Precautions
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of PRISTIQ or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. PRISTIQ is not approved for use in pediatric patients.
Contraindications
- PRISTIQ is contraindicated in patients with a known hypersensitivity to PRISTIQ or venlafaxine2
- PRISTIQ must not be used concomitantly with an MAOI or within 14 days of stopping an MAOI. Allow 7 days after stopping PRISTIQ before starting an MAOI2
Warnings/Precautions
- Clinical Worsening/Suicide Risk: Monitor for clinical worsening and suicide risk
- Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-Like Reactions: Serotonin syndrome or NMS-like reactions have been reported with SSRIs and SNRIs. Discontinue PRISTIQ and initiate supportive treatment
- Elevated Blood Pressure: Has occurred with PRISTIQ. Hypertension should be controlled before initiating treatment. Monitor blood pressure regularly during treatment
- Abnormal Bleeding: PRISTIQ may increase the risk of bleeding events. Patients should be cautioned about the risk of bleeding associated with the concomitant use of PRISTIQ and NSAIDs, aspirin, or other drugs that affect coagulation
- Narrow-angle Glaucoma: Mydriasis has occurred with PRISTIQ. Patients with raised intraocular pressure or those at risk of angle-closure glaucoma should be monitored
- Activation of Mania/Hypomania: Has occurred. Use cautiously in patients with Bipolar Disorder. Caution patients about the risk of activation of mania/hypomania
- Cardiovascular/Cerebrovascular Disease: Use cautiously in patients with cardiovascular or cerebrovascular disease
- Cholesterol and Triglyceride Elevation: Have occurred. Use cautiously in patients with lipid metabolism disorders. Consider monitoring serum cholesterol and triglyceride
- Discontinuation Symptoms: Have occurred. Taper the dose when possible and monitor for discontinuation symptoms
- Renal Impairment: Reduces the clearance of PRISTIQ. Dosage adjustment is necessary in severe and ESRD. In moderate renal impairment, the dose should not exceed 50 mg/day
- Seizure: Can occur. Use cautiously in patients with seizure disorder.
- Hyponatremia: Can occur in association with SIADH
- Drugs Containing Desvenlafaxine or Venlafaxine: Should not be used concomitantly with PRISTIQ
- Interstitial Lung Disease and Eosinophilic Pneumonia: Can occur.
Please see full Prescribing Information, including boxed warning, and Important Safety Information.
Discontinuation Rate
Discontinuation Rate Due to Adverse Events with PRISTIQ 50 mg Comparable to Placebo in 8-week Clinical Studies2,5
Pooled data from 5 double-blind, randomized, placebo-controlled, fixed-dose 8-week studies of 50, 100, 200, and 400 mg q.d. of PRISTIQ in adults aged 18 years or older with MDD (N=2,001). Data from 50 mg (n=317) and placebo (n=636) arms shown.2
Adverse Reactions
- The most commonly observed adverse reactions in patients taking PRISTIQ vs placebo for MDD in short-term fixed-dose premarketing studies (incidence ≥5% and at least twice the rate of placebo in the 50-mg dose group) were:2
Pooled data from 5 double-blind, randomized, placebo-controlled, fixed-dose, 8-week studies of 50, 100, 200, and 400 mg q.d. of PRISTIQ in adults aged 18 or older with MDD (N=2,001). Data from 50-mg (n=317) and placebo (n=636) arms shown.2,3
Sexual Function
PRISTIQ 50 mg Demonstrated a Low Incidence of Spontaneously Reported Sexual Function Adverse Reactions in 8-week Studies2,3
- Self-reported sexual adverse reaction rates observed in clinical studies may not reflect rates observed in practice
- Physicians should routinely inquire about possible sexual side effects
Changes in ASEX* Scores Were Comparable Between PRISTIQ 50 mg and Placebo in Both Men and Women3
The ASEX Scale prospectively measures6:
- Sex Drive
- Arousal
- Ability to Achieve Erection/Lubrication
- Ease of Reaching Orgasm
- Orgasm Satisfaction
*ASEX is a validated, self-administered questionnaire that measures 5 items relating to sexual functioning.6
†Last observation carried forward.
Weight
No significant mean weight gain vs placebo in 4 clinical studies2,3,13
Short-Term Studies
- In two 8-week studies, no significant mean weight gain with PRISTIQ 50 mg vs placebo
(–0.968 lb vs –0.066 lb)
Click to View Study Description 
- In one 12-week study, no significant mean weight gain with PRISTIQ 50 mg vs placebo
(–0.176 lb vs 0.088 lb)
Click to View Study Description
Long-term study
- In one 6-month study,* no significant mean weight gain with PRISTIQ 200–400 mg (4 times the recommended 50 mg dose) vs placebo (1.78 lb vs 1.06 lb)
– Rates of clinically significant weight gain (≥7% increase from baseline body weight) with PRISTIQ 200–400 mg were comparable to placebo (4.0 lbvs 3.9 lb).
Click to View Study Description
*A double-blind extension study for patients who responded to PRISTIQ in a 12-week open-label phase. There was also no significant difference in rates of clinically significant mean weight gain vs placebo between open-label baseline and double-blind end point (2.6 lb vs 3.0 lb).
Nausea
Nausea was generally mild to moderate and decreased to placebo-like levels between weeks 1 and 23
- In two 8-week clinical studies, the overall incidence of nausea at 50 mg was 22% vs 10% with placebo2
- <1% of patients discontinued due to nausea at the recommended therapeutic dose of 50 mg3
Pooled data from 5 double-blind, randomized, placebo-controlled, fixed-dose 8-week studies of 50, 100, 200, and 400 mg q.d. of PRISTIQ in adults 18 or older with MDD (N=2,001), two of which included the 50-mg dose. Data from 50-mg (n=317) and placebo (n=636) arms shown.3
Blood Pressure and Lipids
Effect on Blood Pressure and Pulse Rate
- Patients receiving PRISTIQ should have regular monitoring of blood pressure, since increases in blood pressure were observed in clinical studies.2
- Pre-existing hypertension should be controlled before starting PRISTIQ. Caution should be exercised in treating patients with pre-existing hypertension or other underlying conditions that might be compromised by increases in blood pressure.2
- Cases of elevated blood pressure requiring immediate treatment have been reported. For patients who experience a sustained increase in blood pressure, either dose reduction or discontinuation should be considered.2
*Sustained hypertension was defined as treatment-emergent supine diastolic blood pressure ≥90 mm Hg and ≥10 mm Hg above baseline for 3 consecutive ontherapy visits. Pooled data from all short-term, fixed-dose studies of 50 mg, 100 mg, 200 mg, and 400 mg q.d. of PRISTIQ (desvenlafaxine) in adults aged 18 or older with MDD. 2
Incidence (%) of Patients with Lipid Abnormalities of Potential Clinical Significance*2,3
- The table shows the percentage of patients who exceeded a predetermined threshold value during placebo-controlled, short-term, premarketing studies in MDD2
- PRISTIQ has not been evaluated systematically in patients with a recent history of myocardial infarction, unstable heart disease, uncontrolled hypertension, or cerebrovascular disease.2
- Use caution in administering PRISTIQ to patients with cardiovascular, cerebrovascular, or lipid metabolism disorders.2
- Elevations in fasting serum total cholesterol, LDL (low density lipoprotein) cholesterol, and triglycerides occurred in the controlled studies. Some of these abnormalities were considered potentially clinically significant.2
Potential Drug-Drug Interactions with PRISTIQ2
- Monoamine oxidase inhibitors (MAOIs) (Contraindicated)
- Central Nervous System (CNS) active agents; serotonergic agents, antipsychotics, or other dopamine antagonists
- Drugs that may interfere with homeostasis (NSAIDs, aspirin, warfarin, anticoagulants)
– Do not use with an MAOI or within 14 days of stopping an MAOI. Allow 7 days after stopping PRISTIQ before starting an MAOI2
– The risk of using PRISTIQ in combination with other CNS-active drugs has not been systematically evaluated. Consequently, caution is advised when PRISTIQ is taken in combination with other CNS-active drugs
– PRISTIQ may increase the risk of bleeding events. Patients should be cautioned about the risk of bleeding associated with the concomitant use of PRISTIQ and NSAIDs, aspirin, or other drugs that affect coagulation
The Metabolism of PRISTIQ is Independent of the
CYP2D6 Pathway in the Liver2
- PRISTIQ consists of ODV (O-desmethylvenlafaxine) formulated as a succinate salt2
- PRISTIQ has high bioavailability (80%) of the active drug2
- Metabolism primarily by conjugation in the liver and, to a minor extent, through oxidative metabolism2
- PRISTIQ 50 mg delivered predictable ODV concentrations regardless of CYP2D6 metabolizer status2,3
- ODV levels after administration of PRISTIQ were largely unaffected by genetic variability in CYP2D6 metabolism2,3
Please see Full Prescribing Information including Boxed Warning & Medication Guide
PRISTIQ Extended-Release Tablets are indicated for the treatment of major depressive disorder in adults.
Important Safety Information for PRISTIQ
WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults
in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of PRISTIQ or any other antidepressant
in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality
with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults
aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of
all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual
changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. PRISTIQ is
not approved for use in pediatric patients.
Contraindications
- PRISTIQ is contraindicated in patients with a known hypersensitivity to PRISTIQ or venlafaxine.
- PRISTIQ must not be used concomitantly with an MAOI or within 14 days of stopping an MAOI. Allow 7 days after stopping PRISTIQ before starting an MAOI.
Warnings and Precautions
- All patients treated with antidepressants should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the first few months of treatment and when changing the dose. Consider changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse or includes symptoms of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, mania, or suicidality that are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Families and caregivers of patients being treated with antidepressants should be alerted about the need to monitor patients.
- Development of a potentially life-threatening serotonin syndrome or Neuroleptic Malignant Syndrome-like reactions have been reported with SNRIs and SSRIs alone, including PRISTIQ treatment, but particularly with concomitant use of serotonergic drugs, including triptans, with drugs that impair the metabolism of serotonin (including MAOIs), or with antipsychotics or other dopamine antagonists. If concomitant use with a triptan is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. Concomitant use of PRISTIQ with serotonin precursors is not recommended.
- Patients receiving PRISTIQ should have regular monitoring of blood pressure since increases in blood pressure were observed in clinical studies. Pre-existing hypertension should be controlled before starting PRISTIQ. Caution should be exercised in treating patients with pre-existing hypertension or other underlying conditions that might be compromised by increases in blood pressure. Cases of elevated blood pressure requiring immediate treatment have been reported. For patients who experience a sustained increase in blood pressure, either dose reduction or discontinuation should be considered.
- SSRIs and SNRIs, including PRISTIQ, may increase the risk of bleeding events. Concomitant use of aspirin, NSAIDs, warfarin, and other anticoagulants may add to this risk.
- Mydriasis has been reported in association with PRISTIQ; therefore, patients with raised intraocular pressure or those at risk of acute narrow-angle glaucoma (angle-closure glaucoma) should be monitored.
- PRISTIQ is not approved for use in bipolar depression. Prior to initiating treatment with an antidepressant, patients should be adequately screened to determine the risk of bipolar disorder.
- As with all antidepressants, PRISTIQ should be used cautiously in patients with a history or family history of mania or hypomania, or with a history of seizure disorder.
- Caution is advised in administering PRISTIQ to patients with cardiovascular, cerebrovascular, or lipid metabolism disorders. Increases in blood pressure and small increases in heart rate were observed in clinical studies with PRISTIQ. PRISTIQ has not been evaluated systematically in patients with a recent history of myocardial infarction, unstable heart disease, uncontrolled hypertension, or cerebrovascular disease.
- Dose-related elevations in fasting serum total cholesterol, LDL (low density lipoprotein) cholesterol, and triglycerides were observed in clinical studies. Measurement of serum lipids should be considered during PRISTIQ treatment.
- On discontinuation, adverse events, some of which may be serious, have been reported with PRISTIQ and other SSRIs and SNRIs. Abrupt discontinuation of PRISTIQ has been associated with the appearance of new symptoms. Patients should be monitored for symptoms when discontinuing treatment. A gradual reduction in dose rather than abrupt cessation is recommended whenever possible.
- The recommended dose in patients with severe renal impairment or end-stage renal disease (ESRD) is 50 mg every other day. The dose should not be escalated in patients with moderate or severe renal impairment or ESRD.
- Products containing desvenlafaxine and products containing venlafaxine should not be used concomitantly with PRISTIQ.
- Hyponatremia may occur as a result of treatment with SSRIs and SNRIs, including PRISTIQ. Discontinuation of PRISTIQ should be considered in patients with symptomatic hyponatremia.
- Interstitial lung disease and eosinophilic pneumonia associated with venlafaxine (the parent drug of PRISTIQ) therapy have been rarely reported.
Adverse Reactions
- The most commonly observed adverse reactions in patients taking PRISTIQ vs placebo for MDD in short-term fixed-dose premarketing studies (incidence ≥5% and at least twice the rate of placebo in the 50-mg dose group) were nausea (22% vs 10%), dizziness (13% vs 5%), hyperhidrosis (10% vs 4%), constipation (9% vs 4%), and decreased appetite (5% vs 2%).
PQP00126
