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

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Recommended dose: 50 mg once daily with or without food (2.1).

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There was no evidence that doses greater than 50 mg per day confer any additional benefit (2.1).

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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).

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Discontinuation: Reduce dose gradually whenever possible (2.1).

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Take tablets whole; do not divide, crush, chew, or dissolve (2.1).

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Moderate renal impairment: Maximum dose 50 mg per day (2.2).

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Severe renal impairment and end-stage renal disease: Maximum dose 25 mg per day or 50 mg every other day (2.2).

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Moderate to severe hepatic impairment: Maximum dose 100 mg per day (2.3).

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PRISTIQ extended-release tablets: 25 mg, 50 mg and 100 mg (3).

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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).

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Hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or any excipients in the PRISTIQ formulation (4).

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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).

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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).

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Elevated Blood Pressure: Control hypertension before initiating treatment. Monitor blood pressure regularly during treatment (5.3).

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Increased Risk of Bleeding: Concomitant use of aspirin, NSAIDs, other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk (5.4).

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Angle Closure Glaucoma: Avoid use of antidepressants, including PRISTIQ, in patients with untreated anatomically narrow angles treated (5.5).

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Activation of Mania/Hypomania: Use cautiously in patients with Bipolar Disorder. Caution patients about risk of activation of mania/hypomania (5.6).

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Discontinuation Syndrome: Taper dose when possible and monitor for discontinuation symptoms (5.7).

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Seizure: Can occur. Use cautiously in patients with seizure disorder (5.8).

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Hyponatremia: Can occur in association with SIADH (5.9).

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Interstitial Lung Disease and Eosinophilic Pneumonia: Can occur (5.10).

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Sexual Dysfunction: PRISTIQ may cause symptoms of sexual dysfunction (5.11).

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.

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Pregnancy: Third trimester use may result in neonatal discontinuation syndrome (8.1).

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Geriatric Use: There is an increased incidence of orthostatic hypotension in desvenlafaxine treated patients ≥ 65 years (6.1 and 8.5).