Pristiq Extended-Release

Pristiq Extended-Release is an FDA-registered drug product whose active ingredient is DESVENLAFAXINE SUCCINATE. It is labelled by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 0008-1210, application NDA021992, label effective 20260428. It is one of 10 FDA drug label records sharing the active ingredient DESVENLAFAXINE SUCCINATE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing DESVENLAFAXINE SUCCINATE are most often described in connection with: treatment adults, major depressive, disorder mdd, usage pristiq, see clinical, norepinephrine reuptake, inhibitor snri. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE PRISTIQ is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14) ] . PRISTIQ is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with major depressive disorder (MDD) ( 1 ).

2 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 ). 2.1 General Instructions for Use The recommended dose for PRISTIQ is 50 mg once daily, with or without food. The 50 mg dose is both a starting dose and the therapeutic dose. 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. In clinical studies, doses of 10 mg to 400 mg per day were studied. In clinical studies, doses of 50 mg to 400 mg per day were shown to be effective, although no additional benefit was demonstrated at doses greater than 50 mg per day and adverse reactions and discontinuations were more frequent at higher doses. The 25 mg per day dose is intended for a gradual reduction in dose when discontinuing treatment. When discontinuing therapy, gradual dose reduction is recommended whenever possible to minimize discontinuation symptoms [see Dosage and Administration (2.5) and Warnings and Precautions (5.7) ] . 2.2 Dosage Recommendations for Patients with Renal Impairment The maximum recommended dose in patients with moderate renal impairment (24-hr creatinine clearance [Cl Cr ] = 30 to 50 mL/min, Cockcroft-Gault [C-G]) is 50 mg per day. The maximum recommended dose in patients with severe renal impairment (Cl Cr 15 to 29 mL/min, C-G) or end-stage renal disease (ESRD, Cl Cr < 15 mL/min, C-G) is 25 mg every day or 50 mg every other day. Supplemental doses should not be given to patients after dialysis [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ] . 2.3 Dosage Recommendations for Patients with Hepatic Impairment The recommended dose in patients with moderate to severe hepatic impairment (Child-Pugh score 7 to 15) is 50 mg per day. Dose escalation above 100 mg per day is not recommended [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3) ] . 2.4 Maintenance/Continuation/Extended Treatment It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy. Longer-term efficacy of PRISTIQ (50–400 mg) was established in two maintenance trials [see Clinical Studies (14) ] . Patients should be periodically reassessed to determine the need for continued treatment. 2.5 Discontinuing PRISTIQ Adverse reactions may occur upon discontinuation of PRISTIQ [see Warnings and Precautions (5.7) ]. Gradually reduce the dosage rather than stopping PRISTIQ abruptly when discontinuing therapy with PRISTIQ. In some patients, discontinuation may need to occur over a period of several months. 2.6 Switching Patients From Other Antidepressants to PRISTIQ Discontinuation symptoms have been reported when switching patients from other antidepressants, including venlafaxine, to PRISTIQ. Tapering of the initial antidepressant may be necessary to minimize discontinuation symptoms. 2.7 Switching Patients to or from a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with PRISTIQ. Conversely, at least 7 days should be allowed after stopping PRISTIQ before starting an MAOI intended to treat psychiatric disorders [see Contraindications (4) ] . 2.8 Use of PRISTIQ with other MAOIs such as Linezolid or Methylene Blue Do not start PRISTIQ in a patient who is being treated with linezolid or intravenous methylene blue because there is increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see Contraindications (4) ] . In some cases, a patient already receiving PRISTIQ therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, PRISTIQ should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 7 days or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with PRISTIQ may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see Warnings and Precautions (5.2) ] . The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with PRISTIQ is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see Warnings and Precautions (5.2) ] .

4 CONTRAINDICATIONS • Hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or to any excipients in the PRISTIQ formulation. Angioedema has been reported in patients treated with PRISTIQ [see Adverse Reactions (6.1) ] . • The use of MAOIs intended to treat psychiatric disorders with PRISTIQ or within 7 days of stopping treatment with PRISTIQ is contraindicated because of an increased risk of serotonin syndrome. The use of PRISTIQ within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated [see Dosage and Administration (2.7) and Warnings and Precautions (5.2) ]. • Starting PRISTIQ in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see Dosage and Administration (2.8) and Warnings and Precautions (5.2) ]. • 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 ).

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label. • Hypersensitivity [see Contraindications (4) ] • Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients [see Warnings and Precautions (5.1) ] • Serotonin Syndrome [see Warnings and Precautions (5.2) ] • Elevated Blood Pressure [see Warnings and Precautions (5.3) ] • Increased Risk of Bleeding [see Warnings and Precautions (5.4) ] • Angle Closure Glaucoma [see Warnings and Precautions (5.5) ] • Activation of Mania/Hypomania [see Warnings and Precautions (5.6) ] • Discontinuation Syndrome [see Warnings and Precautions (5.7) ] • Seizure [see Warnings and Precautions (5.8) ] • Hyponatremia [see Warnings and Precautions (5.9) ] • Interstitial Lung Disease and Eosinophilic Pneumonia [see Warnings and Precautions (5.10) ] • Sexual Dysfunction [see Warnings and Precautions (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 . 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. Patient Exposure PRISTIQ was evaluated for safety in 8,394 patients diagnosed with major depressive disorder who participated in multiple-dose pre-marketing studies, representing 2,784 patient-years of exposure. Of the total 8,394 patients exposed to at least one dose of PRISTIQ; 2,116 were exposed to PRISTIQ for 6 months, representing 1,658 patient-years of exposure, and 421 were exposed for one year, representing 416 patient-years of exposure. Adverse Reactions Reported as Reasons for Discontinuation of Treatment In the pre-marketing pooled 8-week placebo-controlled studies in patients with MDD, 1,834 patients were exposed to PRISTIQ (50 to 400 mg). Of the 1,834 patients, 12% discontinued treatment due to an adverse reaction, compared with 3% of the 1,116 placebo-treated patients. At the recommended dose of 50 mg, the discontinuation rate due to an adverse reaction for PRISTIQ (4.1%) was similar to the rate for placebo (3.8%). For the 100 mg dose of PRISTIQ the discontinuation rate due to an adverse reaction was 8.7%. The most common adverse reactions leading to discontinuation in at least 2% and at a rate greater than placebo of the PRISTIQ treated patients in the short-term studies, up to 8 weeks, were: nausea (4%); dizziness, headache and vomiting (2% each). In a longer-term study, up to 9 months, the most common was vomiting (2%). Common Adverse Reactions in Placebo-Controlled MDD Studies The most commonly observed adverse reactions in PRISTIQ treated MDD patients in pre-marketing pooled 8-week, placebo-controlled, fixed-dose studies (incidence ≥ 5% and at least 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. Table 2 shows the incidence of common adverse reactions that occurred in ≥ 2% of PRISTIQ treated MDD patients and twice the rate of placebo at any dose in the pre-marketing pooled 8-week, placebo-controlled, fixed dose clinical studies. Table 2: Common Adverse Reactions (≥ 2% in any Fixed-Dose Group and Twice the Rate of Placebo) in Pre-marketing Pooled MDD 8-Week Placebo-Controlled Studies Percentage of Patients Reporting Reaction PRISTIQ System Organ Class Preferred Term Placebo (n=636) 50 mg (n=317) 100 mg (n=424) 200 mg (n=307) 400 mg (n=317) Cardiac disorders Blood pressure increased 1 1 1 2 2 Gastrointestinal disorders Nausea 10 22 26 36 41 Dry mouth 9 11 17 21 25 Constipation 4 9 9 10 14 Vomiting 3 3 4 6 9 General disorders and administration site conditions Fatigue 4 7 7 10 11 Chills 1 1 <1 3 4 Feeling jittery 1 1 2 3 3 Metabolism and nutrition disorders Decreased appetite 2 5 8 10 10 Nervous system disorders Dizziness 5 13 10 15 16 Somnolence 4 4 9 12 12 Tremor 2 2 3 9 9 Disturbance in attention <1 <1 1 2 1 Psychiatric disorders Insomnia 6 9 12 14 15 Anxiety 2 3 5 4 4 Nervousness 1 <1 1 2 2 Abnormal dreams 1 2 3 2 4 Renal and urinary disorders Urinary hesitation 0 <1 1 2 2 Respiratory, thoracic and mediastinal disorders Yawning <1 1 1 4 3 Skin and subcutaneous tissue disorders Hyperhidrosis 4 10 11 18 21 Special Senses Vision blurred 1 3 4 4 4 Mydriasis <1 2 2 6 6 Vertigo 1 2 1 5 3 Tinnitus 1 2 1 1 2 Dysgeusia 1 1 1 1 2 Vascular disorders Hot flush <1 1 1 2 2 Sexual Function Adverse Reactions Table 3 shows the incidence of sexual function adverse reactions that occurred in ≥ 2% of PRISTIQ treated MDD patients in any fixed-dose group (pre-marketing pooled 8-week, placebo-controlled, fixed -dose, clinical studies) [ s ee Warnings and Precautions (5.11) ] . Table 3: Sexual Function Adverse Reactions (≥ 2% in Men or Women in any PRISTIQ Group) During the On-Therapy Period PRISTIQ Placebo (n=239) 50 mg (n=108) 100 mg (n=157) 200 mg (n=131) 400 mg (n=154) Men only Anorgasmia 0 0 3 5 8 Libido decreased 1 4 5 6 3 Orgasm abnormal 0 0 1 2 3 Ejaculation delayed <1 1 5 7 6 Erectile dysfunction 1 3 6 8 11 Ejaculation disorder 0 0 1 2 5 Ejaculation failure 0 1 0 2 2 Sexual dysfunction 0 1 0 0 2 PRISTIQ Placebo (n=397) 50 mg (n=209) 100 mg (n=267) 200 mg (n=176) 400 mg (n=163) Women only Anorgasmia 0 1 1 0 3 Other Adverse Reactions Observed in Premarketing and Postmarketing Clinical Studies Other infrequent adverse reactions, not described elsewhere in the label, occurring at an incidence of < 2% in MDD patients treated with PRISTIQ were: Cardiac disorders – Tachycardia. General disorders and administration site conditions – Asthenia. Investigations – Weight increased, liver function test abnormal, blood prolactin increased. Musculoskeletal and connective tissue disorders – Musculoskeletal stiffness. Nervous system disorders – Syncope, convulsion, dystonia. Psychiatric disorders – Depersonalization, bruxism. Renal and urinary disorders – Urinary retention. Skin and subcutaneous tissue disorders – Rash, alopecia, photosensitivity reaction, angioedema. In clinical studies, there were uncommon reports of ischemic cardiac adverse reactions, including myocardial ischemia, myocardial infarction, and coronary occlusion requiring revascularization; these patients had multiple underlying cardiac risk factors. More patients experienced these events during PRISTIQ treatment as compared to placebo. Laboratory, ECG and Vital Sign Changes Observed in MDD Clinical Studies The following changes were observed in pre-marketing placebo-controlled, short-term MDD studies with PRISTIQ. Lipids Elevations in fasting serum total cholesterol, LDL (low density lipoproteins) cholesterol, and triglycerides occurred in the controlled studies. Some of these abnormalities were considered potentially clinically significant. The percentage of patients who exceeded a predetermined threshold value is shown in Table 4. Table 4: Incidence (%) of Patients With Lipid Abnormalities of Potential Clinical Significance* PRISTIQ Placebo 50 mg 100 mg 200 mg 400 mg Total Cholesterol *(Increase of ≥ 50 mg/dl and an absolute value of ≥ 261 mg/dl) 2 3 4 4 10 LDL Cholesterol *(Increase ≥ 50 mg/dl and an absolute value of ≥ 190 mg/dl) 0 1 0 1 2 Triglycerides, fasting *(Fasting: ≥ 327 mg/dl) 3 2 1 4 6 Proteinuria Proteinuria, greater than or equal to trace, was observed in the pre-marketing fixed-dose controlled studies (see Table 5). This proteinuria was not associated with increases in BUN or creatinine and was generally transient. Table 5: Incidence (%) of Patients with Proteinuria in the Fixed-dose Clinical Studies PRISTIQ Placebo 50 mg 100 mg 200 mg 400 mg Proteinuria 4 6 8 5 7 Vital Sign Changes Table 6 summarizes the changes that were observed in placebo-controlled, short-term, pre-marketing studies with PRISTIQ in patients with MDD (doses 50 to 400 mg). Table 6: Mean Changes in Vital Signs at Final on Therapy for All Short-term, Fixed-dose Controlled Studies PRISTIQ Placebo 50 mg 100 mg 200 mg 400 mg Blood pressure Supine systolic bp (mm Hg) -1.4 1.2 2.0 2.5 2.1 Supine diastolic bp (mm Hg) -0.6 0.7 0.8 1.8 2.3 Pulse rate Supine pulse (bpm) -0.3 1.3 1.3 0.9 4.1 Weight (kg) 0.0 -0.4 -0.6 -0.9 -1.1 Treatment with PRISTIQ at all doses from 50 mg per day to 400 mg per day in controlled studies was associated with sustained hypertension, defined as treatment-emergent supine diastolic blood pressure (SDBP) ≥90 mm Hg and ≥10 mm Hg above baseline for 3 consecutive on-therapy visits (see Table 7). Analyses of patients in PRISTIQ pre-marketing short-term controlled studies who met criteria for sustained hypertension revealed a consistent increase in the proportion of patients who developed sustained hypertension. This was seen at all doses with a suggestion of a higher rate at 400 mg per day. Table 7: Proportion of Patients with Sustained Elevation of Supine Diastolic Blood Pressure Treatment Group Proportion of Patients with Sustained Hypertension Placebo 0.5% PRISTIQ 50 mg per day 1.3% PRISTIQ 100 mg per day 0.7% PRISTIQ 200 mg per day 1.1% PRISTIQ 400 mg per day 2.3% Orthostatic Hypotension In the pre-marketing short-term, placebo-controlled clinical studies with doses of 50 to 400 mg, systolic orthostatic hypotension (decrease ≥30 mm Hg from supine to standing position) occurred more frequently in patients ≥65 years of age receiving PRISTIQ (8%, 7/87) versus placebo (2.5%, 1/40), compared to patients <65 years of age receiving PRISTIQ (0.9%, 18/1,937) versus placebo (0.7%, 8/1,218). 6.2 Postmarketing Experience The following adverse reaction has been identified during post-approval use of PRISTIQ. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Skin and subcutaneous tissue disorders – Stevens-Johnson syndrome Gastrointestinal disorders – Pancreatitis acute Cardiovascular system – Takotsubo cardiomyopathy Respiratory, thoracic and mediastinal disorders - Anosmia, hyposmia

FDA lists 10 drug label records with DESVENLAFAXINE SUCCINATE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Pristiq Extended-Release used for?
1 INDICATIONS AND USAGE PRISTIQ is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14) ] . PRISTIQ is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with major depressive disorder (MDD) ( 1 ).

Who makes Pristiq Extended-Release?
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. is the labeler of record for Pristiq Extended-Release. 10 FDA label records share the active ingredient DESVENLAFAXINE SUCCINATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Pristiq Extended-Release come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Pristiq Extended-Release prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing DESVENLAFAXINE SUCCINATE?
Yes. 10 FDA drug label records list DESVENLAFAXINE SUCCINATE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Pristiq Extended-Release been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.