PRISTIQ® Highlights

(desvenlafaxine succinate)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use PRISTIQ safely and effectively. See full prescribing information for PRISTIQ.

PRISTIQ (desvenlafaxine) Extended-Release Tablets, for oral use
Initial U.S. Approval: 2008

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

See full prescribing information for complete boxed warning.

•
Increased the risk of suicidal thoughts and behaviors in children, adolescents and young adults taking antidepressants (5.1).
•
Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors (5.1).
•
PRISTIQ is not approved for use in pediatric patients (8.4).

RECENT MAJOR CHANGES

Warnings and Precautions (5.2, 5.4)

8/2023

INDICATIONS AND USAGE

PRISTIQ is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with major depressive disorder (MDD) (1).

DOSAGE AND ADMINISTRATION

•
Recommended dose: 50 mg once daily with or without food (2.1).
•
There was no evidence that doses greater than 50 mg per day confer any additional benefit (2.1).
•
The 25 mg per day dose is intended for a gradual reduction in dose when discontinuing treatment or dosing in severe renal and end-stage renal disease patients (2.1).
•
Discontinuation: Reduce dose gradually whenever possible (2.1).
•
Take tablets whole; do not divide, crush, chew, or dissolve (2.1).
•
Moderate renal impairment: Maximum dose 50 mg per day (2.2).
•
Severe renal impairment and end-stage renal disease: Maximum dose 25 mg per day or 50 mg every other day (2.2).
•
Moderate to severe hepatic impairment: Maximum dose 100 mg per day (2.3).

DOSAGE FORMS AND STRENGTHS

•
PRISTIQ extended-release tablets: 25 mg, 50 mg and 100 mg (3).
•
Each tablet contains 38 mg, 76 mg or 152 mg of desvenlafaxine succinate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively (3).

CONTRAINDICATIONS

•
Hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or any excipients in the PRISTIQ formulation (4).
•
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 linezolid or intravenous methylene blue (4).

WARNINGS AND PRECAUTIONS

•
Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents, but also when taken alone. If it occurs, discontinue PRISTIQ and serotonergic agents and initiate supportive treatment (5.2).
•
Elevated Blood Pressure: Control hypertension before initiating treatment. Monitor blood pressure regularly during treatment (5.3).
•
Increased Risk of Bleeding: Concomitant use of aspirin, NSAIDs, other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk (5.4).
•
Angle Closure Glaucoma: Avoid use of antidepressants, including PRISTIQ, in patients with untreated anatomically narrow angles treated (5.5).
•
Activation of Mania/Hypomania: Use cautiously in patients with Bipolar Disorder. Caution patients about risk of activation of mania/hypomania (5.6).
•
Discontinuation Syndrome: Taper dose when possible and monitor for discontinuation symptoms (5.7).
•
Seizure: Can occur. Use cautiously in patients with seizure disorder (5.8).
•
Hyponatremia: Can occur in association with SIADH (5.9).
•
Interstitial Lung Disease and Eosinophilic Pneumonia: Can occur (5.10).
•
Sexual Dysfunction: PRISTIQ may cause symptoms of sexual dysfunction (5.11).

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥5% and twice the rate of placebo in the 50 or 100 mg dose groups) were: nausea, dizziness, insomnia, hyperhidrosis, constipation, somnolence, decreased appetite, anxiety, and specific male sexual function disorders (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS

•
Pregnancy: Third trimester use may result in neonatal discontinuation syndrome (8.1).
•
Geriatric Use: There is an increased incidence of orthostatic hypotension in desvenlafaxine treated patients ≥ 65 years (6.1 and 8.5).

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 8/2023

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use PRISTIQ safely and effectively. See full prescribing information for PRISTIQ.

PRISTIQ (desvenlafaxine) Extended-Release Tablets, for oral use
Initial U.S. Approval: 2008

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

See full prescribing information for complete boxed warning.

•
Increased the risk of suicidal thoughts and behaviors in children, adolescents and young adults taking antidepressants (5.1).
•
Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors (5.1).
•
PRISTIQ is not approved for use in pediatric patients (8.4).

RECENT MAJOR CHANGES

Warnings and Precautions (5.2, 5.4)

8/2023

INDICATIONS AND USAGE

PRISTIQ is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with major depressive disorder (MDD) (1).

DOSAGE AND ADMINISTRATION

•
Recommended dose: 50 mg once daily with or without food (2.1).
•
There was no evidence that doses greater than 50 mg per day confer any additional benefit (2.1).
•
The 25 mg per day dose is intended for a gradual reduction in dose when discontinuing treatment or dosing in severe renal and end-stage renal disease patients (2.1).
•
Discontinuation: Reduce dose gradually whenever possible (2.1).
•
Take tablets whole; do not divide, crush, chew, or dissolve (2.1).
•
Moderate renal impairment: Maximum dose 50 mg per day (2.2).
•
Severe renal impairment and end-stage renal disease: Maximum dose 25 mg per day or 50 mg every other day (2.2).
•
Moderate to severe hepatic impairment: Maximum dose 100 mg per day (2.3).

DOSAGE FORMS AND STRENGTHS

•
PRISTIQ extended-release tablets: 25 mg, 50 mg and 100 mg (3).
•
Each tablet contains 38 mg, 76 mg or 152 mg of desvenlafaxine succinate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively (3).

CONTRAINDICATIONS

•
Hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or any excipients in the PRISTIQ formulation (4).
•
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 linezolid or intravenous methylene blue (4).

WARNINGS AND PRECAUTIONS

•
Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents, but also when taken alone. If it occurs, discontinue PRISTIQ and serotonergic agents and initiate supportive treatment (5.2).
•
Elevated Blood Pressure: Control hypertension before initiating treatment. Monitor blood pressure regularly during treatment (5.3).
•
Increased Risk of Bleeding: Concomitant use of aspirin, NSAIDs, other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk (5.4).
•
Angle Closure Glaucoma: Avoid use of antidepressants, including PRISTIQ, in patients with untreated anatomically narrow angles treated (5.5).
•
Activation of Mania/Hypomania: Use cautiously in patients with Bipolar Disorder. Caution patients about risk of activation of mania/hypomania (5.6).
•
Discontinuation Syndrome: Taper dose when possible and monitor for discontinuation symptoms (5.7).
•
Seizure: Can occur. Use cautiously in patients with seizure disorder (5.8).
•
Hyponatremia: Can occur in association with SIADH (5.9).
•
Interstitial Lung Disease and Eosinophilic Pneumonia: Can occur (5.10).
•
Sexual Dysfunction: PRISTIQ may cause symptoms of sexual dysfunction (5.11).

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥5% and twice the rate of placebo in the 50 or 100 mg dose groups) were: nausea, dizziness, insomnia, hyperhidrosis, constipation, somnolence, decreased appetite, anxiety, and specific male sexual function disorders (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS

•
Pregnancy: Third trimester use may result in neonatal discontinuation syndrome (8.1).
•
Geriatric Use: There is an increased incidence of orthostatic hypotension in desvenlafaxine treated patients ≥ 65 years (6.1 and 8.5).

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 8/2023
Medication Guide

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