• Formulary Coverage
• Patient Financial Support
• Patient Education

• Recommended dose: 50 mg once daily¹
• With PRISTIQ 50 mg, the starting dose is the recommended therapeutic dose, so no titration required1

PRISTIQ 50 mg once daily – One recommended therapeutic dose from the start

Initial Treatment of Major Depressive Disorder

• The recommended dose for PRISTIQ is 50 mg once daily, with or without food.¹
• In clinical studies, doses of 50-400 mg/day were shown to be effective, although no additional benefit was demonstrated at doses greater than 50 mg/day and adverse events and discontinuations were more frequent at higher doses.¹

• PRISTIQ should be taken at approximately the same time each day. Tablets must be swallowed whole with fluid and not divided, crushed, chewed, or dissolved.¹

Special Dosing Considerations¹

• Renal impairment – No dosage adjustment of PRISTIQ is necessary in patients with mild renal impairment. Recommended dose in patients with severe renal impairment or end-stage renal disease (ESRD) is 50 mg every other day. Dose should not be escalated in patients with moderate or severe renal impairment or ESRD.
• Hepatic impairment – Recommended dose in patients with hepatic impairment is 50 mg/day. Dose escalation above 100 mg/day is not recommended.
• Elderly – No dosage adjustment is required based solely on age; however, the possibility of reduced renal clearance of PRISTIQ should be considered when determining the dose.

Discontinuation

• On discontinuation, adverse events, some of which may be serious, have been reported with PRISTIQ and other SSRIs and SNRIs.¹
• 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 the dose, rather than abrupt cessation, is recommended whenever possible.¹
• Discontinuation symptoms have been reported when switching patients from other antidepressants to PRISTIQ. Tapering of the initial antidepressant may be necessary to minimize discontinuation symptoms.¹
• For more information on discontinuation rates due to adverse events, see the Tolerability Profile page

Overdose Information

• There is limited clinical experience with overdosage of PRISTIQ (desvenlafaxine) in humans. In premarketing clinical studies, no cases of fatal acute overdose were reported.
• In pre-marketing trials, adverse reactions reported within 5 days of an overdose >600 mg that were possibly related to PRISTIQ included headache, vomiting, agitation, dizziness, nausea, constipation, diarrhea, dry mouth, paresthesia, and tachycardia.
• To reduce the risk of overdose, prescriptions for PRISTIQ should be written for the smallest quantity of tablets consistent with good patient management.

How Supplied

• PRISTIQ is available as 50 and 100 mg tablets. 50 mg tablets are light pink, square pyramid tablets with “W” over “50” on the flat side. 100 mg tablets are reddish-orange, square pyramid tablets with “W” over “100” on the flat side.

Each 50-mg tablet contains 76 mg of desvenlafaxine succinate equivalent to 50 mg of desvenlafaxine.¹

PRISTIQ is indicated for the treatment of major depressive disorder in adults.

Important Safety Information for PRISTIQ

Contraindications

• PRISTIQ is contraindicated in patients with a known hypersensitivity to PRISTIQ or venlafaxine.
• PRISTIQ must not be used concomitantly with an MAOI or within 14 days of stopping an MAOI.  Allow 7 days after stopping PRISTIQ before starting an MAOI.

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. 
• Development of a potentially life-threatening serotonin syndrome or Neuroleptic Malignant Syndrome-like reactions have been reported with SNRIs and SSRIs alone, including PRISTIQ treatment, but particularly with concomitant use of serotonergic drugs, including triptans, with drugs that impair the metabolism of serotonin (including MAOIs), or with antipsychotics or other dopamine antagonists. If concomitant use with a triptan is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. Concomitant use of PRISTIQ with serotonin precursors is not recommended.
• 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 or other underlying 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.
• As with all antidepressants, PRISTIQ should be used cautiously in patients with a history or family history of mania or hypomania, or with a history of seizure disorder.
• Caution is advised in administering PRISTIQ to patients with cardiovascular, cerebrovascular, or lipid metabolism disorders. Increases in blood pressure and small increases in heart rate were observed in clinical studies with PRISTIQ. PRISTIQ has not been evaluated systematically in patients with a recent history of myocardial infarction, unstable heart disease, uncontrolled hypertension, or cerebrovascular disease.
• Dose-related elevations in fasting serum total cholesterol, LDL (low density lipoprotein) cholesterol, and triglycerides were observed in clinical studies. Measurement of serum lipids should be considered during PRISTIQ treatment.
• 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.
• The recommended dose in patients with severe renal impairment or end-stage renal disease (ESRD) is 50 mg every other day. The dose should not be escalated in patients with moderate or severe renal impairment or ESRD.
• Products containing desvenlafaxine and products containing venlafaxine should not be used concomitantly with PRISTIQ.
• 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%).

PQP00126