Safety and Tolerability

Contraindications/Selected
Warnings/Precautions

  • View contraindications, selected warnings, and precautions when administering PRISTIQ to patients

Discontinuation Rate

  • Discontinuation rate due to adverse reactions with PRISTIQ 50 mg

Sexual Function

  • View 8- and 12-week studies about sexual function while taking PRISTIQ 50 mg

Weight

  • View 8-week and 12-week study data

Nausea

  • Learn more about prevalence of nausea over time with
    PRISTIQ 50 mg

Drowsiness

  • Rates of somnolence compared to placebo with PRISTIQ 50 mg

Blood Pressure and Lipids

  • Effect on blood pressure/pulse rate and lipid abnormalities

The most commonly observed adverse reactions with PRISTIQ 50 mg vs placebo include nausea (22% vs 10%), dizziness (13% vs 5%), hyperhidrosis (10% vs 4%), constipation (9% vs 4%), and decreased appetite (5% vs 2%).


Contraindications/Selected Warnings/Precautions

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

  • Hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride, or any excipients in the PRISTIQ formulation. 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

  • Suicidal Thoughts and Behaviors in Adolescents and Young Adults: Monitor closely for worsening and for emergence of suicidal thoughts and behaviors
  • Serotonin Syndrome: 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, and St. John's Wort). If such symptoms occur, discontinue PRISTIQ 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 increases
  • Elevated Blood Pressure: Control hypertension before initiating treatment. Monitor blood pressure regularly during treatment
  • Abnormal Bleeding: PRISTIQ may increase risk of bleeding events. Patients should be cautioned about risk of bleeding associated with concomitant use of PRISTIQ and NSAIDs, aspirin, or other drugs that affect coagulation
  • Narrow-angle Glaucoma: Mydriasis has occurred with PRISTIQ. Monitor patients with raised intraocular pressure or those at risk of angle-closure glaucoma
  • Activation of Mania/Hypomania: Use cautiously in patients with Bipolar Disorder. Caution patients about risk of activation of mania/hypomania
  • Discontinuation Syndrome: Taper dose when possible and monitor for discontinuation symptoms
  • Seizure: Can occur. Use cautiously in patients with seizure disorder
  • Hyponatremia: Can occur in association with SIADH
  • Interstitial Lung Disease and Eosinophilic Pneumonia: Can occur

Please see full Prescribing Information, including boxed warning and Medication Guide


Discontinuation Rate

In a pooled analysis of 8-week studies,

PRISTIQ 50 mg demonstrated a discontinuation rate due to adverse reactions comparable to placebo5


The most commonly observed adverse reactions in patients taking
PRISTIQ 50 mg vs placebo in 8-week studies (incidence ≥5% and ≥2x
the rate of placebo)


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.5


In a pooled analysis of 8-week studies: PRISTIQ 50 mg—Discontinuation-Emergent Signs and Symptoms (DESS)

Discontinuation symptoms were measured using the DESS checklist, a validated, clinician-rated instrument that includes 43 signs and symptoms associated with discontinuation or interruption of antidepressant treatment.2


In a pooled analysis of two 8-week studies:

  • During the first week after stopping PRISTIQ 50 mg, patients reported a mean score of 2.54 new or worsening symptoms vs 1.05 symptoms with placebo


The most common discontinuation symptoms experienced with PRISTIQ 50 mg were dizziness, nausea, diarrhea, and irritability.2

The Discontinuation-Emergent Signs and Symptoms (DESS) checklist is a validated, clinician-rated instrument that includes 43 items of signs and symptoms associated with discontinuation or interruption of antidepressant treatment. Patients are asked if they experienced a change in any of the symptoms on the list during the past 7 days. They are asked to characterize each symptom as new, old (but worse), old (but improved), or unchanged or not present. One point is scored for each new or worsened symptom, with a maximum score of 43.2

Click to View Study Description


Sexual Function

PRISTIQ 50 mg showed a low incidence of sexual function adverse reactions in clinical studies vs placebo5


In a pooled analysis of 8-week studies:


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.5


In a 12-week study, changes in ASEX scores were comparable between PRISTIQ 50 mg and placebo in both men and women2,6


ASEX was a predefined safety assessment. ASEX is a validated, self-administered questionnaire that measures 5 items relating to sexual functioning.11

The ASEX prospectively measures11:

  • Sex drive
  • Arousal
  • Ability to achieve erection (men)/lubrication (women)
  • Ease of reaching orgasm
  • Orgasm satisfaction

Arizona Sexual Experiences Scale (ASEX)
Total possible scores range from 5 to 30, with the higher scores representing more sexual dysfunction. The ASEX scale is a validated, self-administered questionnaire that prospectively measures the following 5 items relating to sexual functioning: sex drive, arousal, ability to achieve erection (men)/lubrication (women), ease of reaching orgasm, and orgasm satisfaction.11


Click to View Study Descriptions


Weight

PRISTIQ 50 mg—No clinical difference in weight gain** vs placebo in 8-week and 12-week studies2,5


In a pooled analysis of 8-week studies

In a separate 12-week study

  • The mean weight changes from baseline with PRISTIQ 50 mg and placebo were -0.18 lb and
    0.09 lb, respectively2

PRISTIQ 50 mg—Rates of clinically significant weight change‡‡ in 8-week and 12-week clinical studies


In a pooled analysis of 8-week studies

  • Additionally, the rates of clinically significant weight loss reported with PRISTIQ 50 mg and placebo were 1.6% and 0.8%, respectively12

In a separate 12-week study

  • The rates of clinically significant weight gain reported with PRISTIQ 50 mg and placebo were 1.4% and 2.1%, respectively2
  • Additionally, the rates of clinically significant weight loss reported with PRISTIQ 50 mg and placebo were 1.4% and 1.4%, respectively2


  • Click to View Study Description


    **Weight gain was measured at prespecified time points during the course of these studies; observed cases analysis.2 Statistical significance was calculated vs placebo based on change from baseline to end point; observed cases.2,7

    ††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 mg5

    ‡‡Clinically significant weight change 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.2


    Nausea

    PRISTIQ 50 mg—Overall incidence of nausea


    In a pooled analysis of 8-week studies



    Click to View Study Description


    Drowsiness

    Rates of somnolence comparable to placebo

    In a pooled analysis of 8-week studies:


    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.5

    In PRISTIQ clinical studies, drowsiness as an adverse event was autocoded to the MedDRA term "somnolence."


    Click to View Study Description


    Blood Pressure and Lipids

    Mean changes in blood pressure and pulse rate5


    Pooled data from five 8-week, fixed-dose studies of 50 mg, 100 mg, 200 mg and 400 mg qd of PRISTIQ in adults aged 18 or older with MDD.5

    Sustained hypertension was defined as treatment-emergent supine diastolic blood pressure ≥90 mm Hg and
      ≥10 mm Hg above baseline for 3 consecutive on-therapy visits.


    • 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 initiating treatment with 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 with PRISTIQ. For patients who experience a sustained increase in blood pressure while taking PRISTIQ, either dose reduction or discontinuation should be considered


    Incidence of patients with potentially clinically significant lipid abnormalities (% of patients)5


    Pooled data from five 8-week, fixed-dose studies of 50 mg, 100 mg, 200 mg and 400 mg qd of PRISTIQ in adults aged 18 or older with MDD.5


    • The table shows the percentage of patients who exceeded a predetermined threshold value during placebo-controlled, short-term studies in MDD. N values represent range of patients for whom variables were evaluated
    • 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

    Click to View Study Description







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Next: Dosage & Administration

Please see full Prescribing Information, including boxed warning and Medication Guide


Indication

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

Important Safety Information for PRISTIQ

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, 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.
  • 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.
  • 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%).

PQP00463B/PQP454504

Please scroll for Important Safety Information and Indication

Important Safety Information for PRISTIQ (desvenlafaxine)

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, 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.
  • 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.
  • 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.