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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.

Efficacy

PRISTIQ 50 mg delivered effective relief from MDD symptoms and a reduced risk of relapse in PRISTIQ responders1,2

Efficacy Summary

In a pooled analysis of two 8-week trials,

Proven MDD Efficacy

PRISTIQ 50 mg delivered significant improvement in HAM-D17 total score vs placebo at week 8 (P<0.001)—the primary end point1

Improved Functional Outcomes

PRISTIQ demonstrated significant improvement in the Sheehan Disability Scale* total score vs placebo at week 8 (P<0.0001) comprising 3 domains3-5

  • Work
  • Social life/leisure activities
  • Family life/home responsibilities

Reduced Probability of Relapse

In the 6-month, double-blind phase of a maintenance trial, PRISTIQ 50 mg reduced the probability of relapse by more than half vs PRISTIQ responders on placebo at day 185 (P<0.001)2

Estimate Probability of relapse

*A validated, self-rated measure of functional impairment.

Symptom Relief

In a pooled analysis of two 8-week studies,

PRISTIQ 50 mg provided relief from symptoms of MDD

Significant improvement in HAM-D17 total score vs placebo at week 8 (P<0.001)—the primary end point1,5

Symptom Relief

Study description

Pooled data from two double-blind, randomized, placebo-controlled, fixed-dose, 8-week studies of 50 mg qd (n=314) and 100 mg qd (n=305) of PRISTIQ vs placebo (n=311) in adults aged 18 and older with MDD. The primary end point was change in HAM-D17 total score vs placebo from baseline at week 8. Final on‑therapy value was defined as the last on-therapy evaluation, regardless of the number of days on therapy, with last-observation-carried-forward (LOCF) statistical analysis.1 Only 50 mg vs placebo data shown.

The Hamilton Rating Scale for Depression is a 17-item, validated, observer-rated scale that assesses depressive symptoms. It is one of the most widely used instruments for the clinical assessment of depressive states. The rater evaluates the severity of symptoms on the basis of information gained during an interview. Symptoms are rated on either a 5-point or 3-point scale, the latter being used when quantifying the variable is difficult or impossible.6,7

Items comprising HAM-D17 total score for depression5,6

  • Depressed mood
  • Guilt
  • Suicide
  • Insomnia initial
  • Insomnia middle
  • Insomnia delayed
  • Work and interests
  • Retardation
  • Agitation
  • Anxiety-psychic
  • Anxiety-somatic
  • Loss of appetite
  • Somatic symptoms
  • Sexual interest/genital
 symptoms
  • Hypochondriasis
  • Insight
  • Loss of weight

Relapse

In the 6-month, double-blind phase of a maintenance trial,

PRISTIQ 50 mg reduced the probability of relapse by more than half vs PRISTIQ responders on placebo at day 185 (P<0.001)2

Estimate Probability of relapse

Relapse in the double-blind phase was defined as any one or more of the following2:

  • HAM-D17 total score ≥16 at any office visit
  • Discontinuation for unsatisfactory efficacy response
  • Hospitalization for depression
  • Suicide attempt
  • Suicide

Study description

Data from a multicenter, double-blind, placebo-controlled, randomized-withdrawal, parallel-group study in adults aged 18 or older with MDD. The study consisted of a 10-day screening period, 8-week open-label response phase (N=874), 12-week open-label stability phase (N=659), and 26-week placebo-controlled maintenance phase (N=548). Patients who responded to PRISTIQ 50 mg per day in the 8-week phase and had continuing stable response through week 20 were randomly assigned to receive placebo (n=276) or PRISTIQ 50 mg per day (n=272) in the 6-month, double-blind, randomized-withdrawal phase. The primary efficacy end point was time to relapse following randomization compared with placebo. Subjects who relapsed after double-blind day 185 or completed the double-blind therapy without relapse were considered as censored on double-blind day 185.2 Longer-term efficacy of PRISTIQ (50 mg to 400 mg) was established in two maintenance trials.

Chart

Response during the open-label phase was defined as HAM-D17 total score of ≤11 and Clinical Global Impressions Scale-Improvement (CGI-I) ≤2 at day 56 evaluation.2

§Stability was defined as HAM-D17 total score of ≤11 and CGI-I ≤2 at week 20 and not having a HAM-D17 total score of ≥16 or CGI-I score ≥4 at any office visit.2

||Relapse during the double-blind phase was defined as follows: 1) a HAM-D17 total score ≥16 at any office visit, 2) discontinuation for unsatisfactory efficacy response, 3) hospitalization for depression, 4) suicide attempt, or 5) suicide.2

Any subjects who completed the study or discontinued at any time during the OL period or the DB phase were scheduled to enter into the taper/follow-up period.2

Functional Outcomes

In a pooled analysis of two 8-week studies,

PRISTIQ 50 mg improved functional outcomes as measured by the Sheehan Disability Scale (SDS) total score

Significant improvement in SDS total score vs placebo at week 8 (P<0.0001)3,5

Functional Outcomes
  • The SDS is a validated, self-rated measure of functional impairment4
  • The SDS total score consists of the following 3 domains: work, social life/leisure activities, and family life/home responsibilities3

SDS total score was evaluated as a health outcomes assessment.3,5

Study description

Pooled data from two double-blind, randomized, placebo-controlled, fixed-dose, 8-week studies of 50 mg qd (n=314) and 100 mg qd (n=305) of PRISTIQ vs placebo (n=311) in adults aged 18 or older with MDD. Sheehan Disability Scale (SDS) total score was evaluated as a health outcomes assessment. SDS is a patient-rated, 10-point (0=no impairment, 10=extreme impairment) visual analog measure of functional disability on 3 individual domains: work, social life/leisure activities, and family life/home responsibilities. The primary end point was change in HAM-D17 total score vs placebo from baseline at week 8.3 Only 50 mg vs placebo data shown.