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
|Dosage and Administration (2.5)
|Warnings and Precautions (5.2, 5.4, 5.5, 5.7)
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).
- 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 (e.g., SSRI, SNRI, triptans), but also when taken alone. If it occurs, discontinue PRISTIQ 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).
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.