|This Medication Guide has been approved by the U.S. Food and Drug Administration.||Revised: 7/2021|
|What is the most important information I should know about PRISTIQ?|
PRISTIQ can cause serious side effects, including:
|What is PRISTIQ?|
|Do not take PRISTIQ if you:|
|Before taking PRISTIQ tell your healthcare provider about all your medical conditions, including if you:|
PRISTIQ and other medicines may affect each other causing possible serious side effects. PRISTIQ may affect the way other medicines work and other medicines may affect the way PRISTIQ works.
Especially tell your healthcare provider if you take:
Do not start or stop any other medicines during treatment with PRISTIQ without talking to your healthcare provider first. Stopping PRISTIQ suddenly may cause you to have serious side effects. See, "What are the possible side effects of PRISTIQ?"
Know the medicines you take. Keep a list of them to show to your healthcare providers when you get a new medicine.
|How should I take PRISTIQ?|
|What should I avoid while taking PRISTIQ?|
|What are the possible side effects of PRISTIQ?|
PRISTIQ can cause serious side effects, including:
|These are not all the possible side effects of PRISTIQ. |
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
|How should I store PRISTIQ?|
|General Information about the safe and effective use of PRISTIQ|
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take PRISTIQ for a condition for which it was not prescribed. Do not give PRISTIQ to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about PRISTIQ that is written for healthcare professionals.
|What are the ingredients in PRISTIQ?|
Active ingredient: desvenlafaxine
This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.
LAB-0539-12.0For more information, go to www.pristiq.com or call 1-888-PRISTIQ (774-7847).
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Suicidal Thoughts and Behaviors
Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dose is adjusted up or down, and instruct them to report such symptoms to the healthcare provider [see Boxed Warning and Warnings and Precautions (5.1)].
Advise patients taking PRISTIQ not to use concomitantly other products containing desvenlafaxine or venlafaxine. Healthcare professionals should instruct patients not to take PRISTIQ with an MAOI or within 14 days of stopping an MAOI and to allow 7 days after stopping PRISTIQ before starting an MAOI [see Contraindications (4)].
Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of PRISTIQ with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, amphetamines, tryptophan, buspirone, and St. John's Wort supplements) [see Warnings and Precautions (5.2)].
Elevated Blood Pressure
Advise patients that they should have regular monitoring of blood pressure when taking PRISTIQ [see Warnings and Precautions (5.3)].
Increased Risk of Bleeding
Inform patients about the concomitant use of PRISTIQ with NSAIDs, aspirin, other antiplatelet drugs, warfarin, or other coagulants because the combined use of has been associated with an increased risk of bleeding. Advise patients to inform their healthcare providers if they are taking or planning to take any prescription or over-the-counter medications that increase the risk of bleeding [see Warnings and Precautions (5.4)].
Activation of Mania/Hypomania
Advise patients, their families and caregivers to observe for signs of activation of mania/hypomania [see Warnings and Precautions (5.6)].
Advise patients not to abruptly stop taking PRISTIQ without talking first with their healthcare professional. Patients should be aware that discontinuation effects may occur when stopping PRISTIQ, and a dose of 25 mg per day is available for discontinuing therapy [see Warnings and Precautions (5.7) and Adverse Reactions (6.1)].
Advise patients that use of PRISTIQ may cause symptoms of sexual dysfunction in both male and female patients. Inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider [see Warnings and Precautions (5.11)].
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.
Interference with Cognitive and Motor Performance
Caution patients about operating hazardous machinery, including automobiles, until they are reasonably certain that PRISTIQ therapy does not adversely affect their ability to engage in such activities.
Advise patients to avoid alcohol while taking PRISTIQ [see Drug Interactions (7.3].
Advise patients to notify their physician if they develop allergic phenomena such as rash, hives, swelling, or difficulty breathing.
Advise patients to notify their physician if they become pregnant or intend to become pregnant during therapy. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to PRISTIQ during pregnancy [see Use in Specific Populations (8.1)].