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In 8-week clinical studies of PRISTIQ, the 50 mg dose showed:

• Discontinuation rate due to adverse events comparable to placebo¹
• Nausea generally mild to moderate, decreased to placebo-like levels within 1 week²
• No significant mean weight gain in 3 clinical studies^1,2
  • No statistical difference in mean weight change over 6 months with PRISTIQ vs. placebo at 4-8 times the recommended 50 mg dose¹
• Low incidence of spontaneously reported sexual function disorders in men and women^1,2

Discontinuation rate due to adverse events with PRISTIQ 50 mg comparable to placebo in 8-week clinical studies¹

Pooled data from 5 double-blind, randomized, placebo-controlled, fixed-dose 8-week trials 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 shown²

Most commonly observed adverse reactions

Adverse reaction rates observed in clinical studies may not reflect rates observed in practice.

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:¹

Pooled data from 5 double-blind, randomized, placebo-controlled, fixed-dose, 8-week trials 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.^1,2

Nausea was generally mild to moderate and decreased to placebo-like levels within 1 week²

• In two 8-week clinical studies, the overall incidence of nausea at 50 mg was 22%
• 1% of patients discontinued due to nausea at the recommended therapeutic dose of 50 mg²

Pooled data from 5 double-blind, randomized, placebo-controlled, fixed-dose 8-week trials 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.²

No significant mean weight gain in two 8-week studies with PRISTIQ 50 mg vs placebo^1,2

*Pooled data from 2 double-blind, randomized, placebo-controlled, fixed-dose, 8-week studies of PRISTIQ 50 mg/day.^1,2

No significant mean weight change in one long-term study with PRISTIQ¹

Sexual function disorders: Adverse reactions (≥2% in men^‡ or women^†) during the on-therapy period

* Pooled data from 2 double-blind, randomized, placebo-controlled, fixed-dose 8-week studies of
PRISTIQ 50 mg/day.
†Sample size, women: placebo, n=397; PRISTIQ 50 mg, n=209.
‡Sample size, men: placebo, n=239; PRISTIQ 50 mg, n=108.

• 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.

Next: Safety Profile

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PRISTIQ is 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% ).