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Important Safety Information

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older.

In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers 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. Angioedema has been reported in patients treated with PRISTIQ.
  • 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 an MAOI such as linezolid or intravenous methylene blue.

Selected 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.
  • The development of a potentially life-threatening 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, amphetamines, and St. John's Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). If such events occur, immediately discontinue PRISTIQ and any concomitant serotonergic agents, 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 increase.
  • 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, cardiovascular or cerebrovascular 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.
  • The pupillary dilation that occurs following use of many antidepressant drugs including PRISTIQ may trigger an angle closure attack in a patient with anatomically narrow angles (Angle Closure Glaucoma) who does not have a patent iridectomy.
  • 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.
  • PRISTIQ should be used cautiously in patients with a history or family history of mania or hypomania or with a history of seizure disorder.
  • 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.
  • 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%).

Indication

PRISTIQ Extended-Release Tablets are indicated for the treatment of major depressive disorder in adults.

Please see full Prescribing Information, including BOXED WARNING, and Medication Guide.

Tolerability

PRISTIQ 50 mg tolerability is comparable to placebo across several indicators8-10

Summary

Low discontinuation rates in a pooled analysis of 8-week studies

PRISTIQ 50 mg 4.1% vs 3.8% Placebo

Low incidence of sexual dysfunction across 8-week studies

PRISTIQ 50 mg 1% vs 0% Placebo 12-Week Study

No clinical difference in weight gain in 8-week studies

PRISTIQ 50 mg -0.97 lb vs -0.07 lb Placebo 12-Week Study

There are serious risks associated with PRISTIQ. For more details, please see the BOXED WARNING and Important Safety Information.

Discontinuation Rate

PRISTIQ 50 mg showed low discontinuation rates in a pooled analysis of 8-week studies

Low discontinuation rates in a pooled analysis of 8-week studies

PRISTIQ 50 mg 4.1% vs 3.8% Placebo

Most commonly observed adverse reactions

PRISTIQ 50 mg (n=317) Placebo (n=636)
Nausea 22% 10%
Dizziness 13% 5%
Hyperhidrosis 10% 4%
Constipation 9% 4%
Decreased appetite 5% 2%

Pooled analysis of five 8-week studies. Of the five studies, two examined 50 mg and 100 mg; one examined 100 mg, 200 mg, and 400 mg; and two examined 200 mg and 400 mg.8 Adverse reactions shown are for patients taking PRISTIQ 50 mg vs placebo in 8-week studies (incidence ≥5% and ≥2x the rate of placebo).

8-week study description

Pooled 50 mg data (n=317) vs placebo (n=636) from five double-blind, randomized, placebo-controlled, fixed-dose, 8-week studies of 50 mg, 100 mg, 200 mg, and 400 mg qd of PRISTIQ in adults aged 18 or older with MDD (N=2001).8 The primary end point was the change in HAM-D17 total score vs placebo from baseline at week 8.1 Sexual function adverse reactions were recorded throughout the study for patients on placebo and PRISTIQ 50 mg.1,8

Sexual Function

Data from a double-blind, randomized, placebo-controlled, fixed-dose, 12-week study of PRISTIQ 50 mg qd (n=281) vs placebo (n=141) in adults aged 18 or older with MDD. The primary end point was the change in HAM-D17 total score vs placebo from baseline at week 12. The key secondary end point was SDS total score at week 12. Recording of sexual function was completed using the ASEX questionnaire at prespecified time points of baseline, 4, 8, and 12 weeks for patients on placebo and PRISTIQ 50 mg. Although the ASEX analysis was part of the a priori statistical plan, the study was not specifically powered to evaluate changes in sexual function.9,11 Observed cases analysis.

PRISTIQ 50 mg showed low incidence of sexual dysfunction across 8-week studies

Low incidence of sexual dysfunction across 8-week studies

PRISTIQ 50 mg 1% vs 0% Placebo 12-Week Study

Women PRISTIQ 50 mg (n=209) Placebo (n=397)
Anorgasmia 1% 0%
Men PRISTIQ 50 mg (n=108) Placebo (n=239)
Anorgasmia 0% 0%
Libido decreased 4% 1%
Orgasm abnormal 0% 0%
Ejaculation delayed 1% <1%
Erectile dysfunction 3% 1%
Ejaculation disorder 0% 0%
Ejaculation failure 1% 0%
Sexual dysfunction 1% 0%

Pooled analysis of five 8-week studies. Of the five studies, two examined 50 mg and 100 mg; one examined 100 mg, 200 mg, and 400 mg; and two examined 200 mg and 400 mg.8 Incidence of sexual function adverse reactions increased with higher doses.

8-week study description

Pooled 50-mg data (n=317) vs placebo (n=636) from five double-blind, randomized, placebo-controlled, fixed-dose, 8-week studies of 50 mg, 100 mg, 200 mg, and 400 mg qd of PRISTIQ in adults aged 18 or older with MDD (N=2001). The primary end point was the change in HAM-D17 total score vs placebo from baseline at week 8. Sexual function adverse reactions were recorded throughout the study for patients on placebo and PRISTIQ 50 mg.8

Weight

Data from a double-blind, randomized, placebo-controlled, fixed-dose, 12-week study of PRISTIQ 50 mg qd (n=282) vs placebo (n=141) in adults aged 18 or older with MDD. The primary end point was the change in HAM-D17 total score vs placebo from baseline at week 12. Weight gain was measured at prespecified time points during the course of these studies. Statistical significance was calculated vs placebo (P>0.05) based on change from baseline to end point; observed cases analysis.5,10

In a pooled analysis of 8-week studies,

PRISTIQ 50 mg—Weight change vs placebo

No clinical difference in weight gain in 8-week studies

PRISTIQ 50 mg -0.97 lb vs -0.07 lb Placebo 12-Week Study

Weight Change Chart

Rates of clinically significant weight change* vs placebo

  • The rates of clinically significant weight gain reported in patients with PRISTIQ 50 mg and placebo were 1.0% and 0.8%, respectively5
  • Additionally, the rates of clinically significant weight loss reported in patients with PRISTIQ 50 mg and placebo were 1.6% and 0.8%, respectively5

Pooled analysis of five 8-week studies. Of the five studies, two examined 50 mg and 100 mg; one examined 100 mg, 200 mg, and 400 mg; and two examined 200 mg and 400 mg.8

*Clinically significant weight gain or loss was defined as an increase or decrease of >7% from baseline. Weight change was measured at prespecified time points during the course of these studies.8

8-week study description

Pooled 50 mg data (n=308) vs placebo (n=623) from five double-blind, randomized, placebo-controlled, fixed-dose, 8-week studies of 50 mg, 100 mg, 200 mg, and 400 mg qd of PRISTIQ in adults aged 18 or older with MDD (N=2001). The primary end point was the change in HAM-D17 total score vs placebo from baseline at week 8. Weight gain was measured at prespecified time points during the course of these studies. Statistical significance was calculated vs placebo (P<0.05) based on change from baseline to end point; observed cases analysis.5,8 Clinically significant weight change reflects analysis from two pooled studies of PRISTIQ 50 mg (n=308) vs placebo (n=623).5,8

Most Common Adverse Reactions

Most commonly observed adverse reactions

PRISTIQ 50 mg (n=317) Placebo (n=636)
Nausea 22% 10%
Dizziness 13% 5%
Hyperhidrosis 10% 4%
Constipation 9% 4%
Decreased appetite 5% 2%

Adverse reactions shown are for patients taking PRISTIQ 50 mg vs placebo in 8-week studies (incidence ≥5% and ≥2x the rate of placebo).