Desvenlafaxine: Package Insert and Label Information (Page 5 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

Desvenlafaxine Extended-Release Tablets are available as follows:

25 mg, light pink, square, pyramid tablets imprinted with “A112” in black ink on one side

NDC 51407-021-30, bottle of 30 tablets in unit-of-use package

50 mg, light pink, square, pyramid tablets imprinted with “WPI” and “3659” in black ink on one side

NDC 51407-022-30, bottle of 30 tablets in unit-of-use package

NDC 51407-022-90, bottle of 90 tablets in unit-of-use package

100 mg, reddish-orange, square, pyramid tablets imprinted with “WPI” and “3660” in black ink on one side

NDC 51407-023-30, bottle of 30 tablets in unit-of-use package

NDC 51407-023-90, bottle of 90 tablets in unit-of-use package

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

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.

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)] .

Concomitant Medication

Advise patients taking desvenlafaxine extended-release tablets not to use concomitantly other products containing desvenlafaxine or venlafaxine. Healthcare professionals should instruct patients not to take desvenlafaxine extended-release tablets with an MAOI or within 14 days of stopping an MAOI and to allow 7 days after stopping desvenlafaxine extended-release tablets before starting an MAOI [see Contraindications ( 4)] .

Serotonin Syndrome

Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of desvenlafaxine extended-release tablets 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 desvenlafaxine extended-release tablets [see Warnings and Precautions ( 5.3)] .

Increased Risk of Bleeding

Inform patients about the concomitant use of desvenlafaxine extended-release tablets 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 health care 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)] .

Discontinuation

Advise patients not to abruptly stop taking desvenlafaxine extended-release tablets without talking first with their healthcare professional. Patients should be aware that discontinuation effects may occur when stopping desvenlafaxine extended-release tablets, and a dose of 25 mg per day is available for discontinuing therapy [see Warnings and Precautions ( 5.7) and Adverse Reactions ( 6.1)] .

Switching Patients From Other Antidepressants to Desvenlafaxine Extended-Release Tablets

Discontinuation symptoms have been reported when switching patients from other antidepressants, including venlafaxine, to desvenlafaxine extended-release tablets. 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 desvenlafaxine extended-release tablets therapy does not adversely affect their ability to engage in such activities.

Alcohol

Advise patients to avoid alcohol while taking desvenlafaxine extended-release tablets [see Drug Interactions ( 7.3)] .

Allergic Reactions

Advise patients to notify their physician if they develop allergic phenomena such as rash, hives, swelling, or difficulty breathing.

Pregnancy

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 desvenlafaxine extended-release tablets during pregnancy [see Use in Specific Populations (8.1)]. [see Use in Specific Populations ( 8.1)] .

Residual Inert Matrix Tablet

Patients receiving desvenlafaxine extended-release tablets may notice an inert matrix tablet passing in the stool or via colostomy. Patients should be informed that the active medication has already been absorbed by the time the patient sees the inert matrix tablet.

Manufactured by:
Actavis Laboratories FL, Inc.
Fort Lauderdale, FL 33314 USA

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Marketed/Packaged by: GSMS, Inc.

Camarillo, CA USA 93012

Rev. A 10/2019

MEDICATION GUIDE

Desvenlafaxine (des-ven-la-fax-ine) Extended-Release Tablets

What is the most important information I should know about desvenlafaxine extended-release tablets?

Desvenlafaxine extended-release tablets can cause serious side effects, including:

  • Increased risk of suicidal thoughts or actions in some children and young adults within the first few months of treatment. Desvenlafaxine extended-release tablets is not for use in children.
  • Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. How can I watch for and try to prevent suicidal thoughts and actions?
  • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
  • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
  • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call your healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you:

  • thoughts about suicide or dying
  • attempts to commit suicide
  • new or worse depression
  • new or worse anxiety
  • feeling very agitated or restless
  • panic attacks
  • trouble sleeping (insomnia)
  • new or worse irritability
  • acting aggressive, being angry, or violent
  • acting on dangerous impulses
  • an extreme increase in activity and talking (mania)
  • other unusual changes in behavior or mood

What are desvenlafaxine extended-release tablets?

  • Desvenlafaxine extended-release tablets are a prescription medicine used to treat adults with a certain type of depression called major depressive disorder (MDD). Desvenlafaxine extended-release tablets belong to a class of medicines known as serotonin and norepinephrine reuptake inhibitors (SNRIs).

Do not take desvenlafaxine extended-release tablets if you:

  • are allergic to desvenlafaxine succinate, venlafaxine hydrochloride, or any of the ingredients in desvenlafaxine extended-release tablets. See the end of this Medication Guide for a complete list of ingredients in desvenlafaxine extended-release tablets.
  • take a monoamine oxidase inhibitor (MAOI)
  • have stopped taking an MAOI in the last 14 days. Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI.
  • are being treated with the antibiotic linezolid or the intravenous methylene blue

Do not start taking an MAOI for at least 7 days after you stop treatment with desvenlafaxine extended-release tablets.

Before taking desvenlafaxine extended-release tablets tell your healthcare provider about all your medical conditions, including if you:

  • have high blood pressure
  • have heart problems
  • have cerebrovascular problems or had a stroke
  • have or had bleeding problems
  • have, or have a family history of, bipolar disorder, mania or hypomania
  • have high cholesterol or high triglycerides
  • have or had depression, suicidal thoughts or behavior
  • have kidney or liver problems
  • have or had seizures or convulsions
  • have low sodium levels in your blood
  • are pregnant or plan to become pregnant. Talk to your healthcare provider about the risk to your unborn baby if you take desvenlafaxine extended-release tablets during pregnancy.
  • Tell your healthcare provider if you become pregnant or think you are pregnant during treatment with desvenlafaxine extended-release tablets.
  • If you become pregnant during treatment with desvenlafaxine extended-release tablets, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants. You can register by calling 1-844-405-6185.
  • are breastfeeding or plan to breastfeed. Desvenlafaxine extended-release tablets can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with desvenlafaxine extended-release tablets.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter

medicines, vitamins, and herbal supplements.

Desvenlafaxine extended-release tablets and other medicines may affect each other causing possible serious side effects. Desvenlafaxine extended-release tablets may affect the way other medicines work and other medicines may affect the way desvenlafaxine extended-release tablets work.

Especially tell your healthcare provider if you take:

  • other MAOIs
  • medicines to treat migraine headaches known as triptans
  • tricyclic antidepressants
  • fentanyl
  • lithium
  • tramadol
  • tryptophan
  • buspirone
  • amphetamines
  • St. John’s Wort
  • other medicines containing desvenlafaxine or venlafaxine
  • medicines that can affect blood clotting such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin
  • medicines used to treat mood, anxiety, psychotic, or thought disorders, including selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs)

Ask your healthcare provider if you are not sure if you are taking any of these medicines. Your healthcare provider can tell you if it is safe to take desvenlafaxine extended-release tablets with your other medicines.

Do not start or stop any other medicines during treatment with desvenlafaxine extended-release tablets without talking to your healthcare provider first. Stopping desvenlafaxine extended-release tablets suddenly may cause you to have serious side effects. See, “What are the possible side effects of desvenlafaxine extended-release tablets?”

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 desvenlafaxine extended-release tablets?

  • Take desvenlafaxine extended-release tablets exactly as your healthcare provider tells you to.
  • Take desvenlafaxine extended-release tablets 1 time a day at about the same time each day.
  • Desvenlafaxine extended-release tablets may be taken either with or without food.
  • Swallow desvenlafaxine extended-release tablets whole, with fluid. Do not divide, crush, chew, or dissolve desvenlafaxine extended-release tablets.
  • When you take desvenlafaxine extended-release tablets, you may see something in your stool that looks like a tablet. This is the empty shell from the tablet after the medicine has been absorbed by your body.
  • If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 or go to the nearest hospital emergency room right away.

What should I avoid while taking desvenlafaxine extended-release tablets?

  • Do not drive a car or operate heavy machinery until you know how desvenlafaxine extended-release tablets affects you.
  • You should not drink alcohol while taking desvenlafaxine extended-release tablets.

What are the possible side effects of desvenlafaxine extended-release tablets?

Desvenlafaxine extended-release tablets can cause serious side effects, including:

  • See, What is the most important information I should know about desvenlafaxine extended-release tablets?”

Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when you take desvenlafaxine extended-release tablets with certain other medicines. See, “Who should not take desvenlafaxine extended-release tablets?” Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms of serotonin syndrome:

  • agitation
  • confusion
  • fast heart beat
  • dizziness
  • flushing
  • tremors, stiff muscles, or muscle twitching
  • seizures
  • seeing or hearing things that are not real (hallucinations)
  • coma
  • changes in blood pressure
  • sweating
  • high body temperature (hyperthermia)
  • loss of coordination
  • nausea, vomiting, diarrhea
  • New or worsened high blood pressure (hypertension). Your healthcare provider should check your blood pressure before and during treatment with desvenlafaxine extended-release tablets. If you have high blood pressure, it should be controlled before you start treatment with desvenlafaxine extended-release tablets.
  • Increased chance of bleeding or bruising. Taking desvenlafaxine extended-release tablets with aspirin, NSAIDs, or blood thinners may add to this risk. Tell your healthcare provider right away about any unusual bleeding or bruising.
  • Eye problems (angle closure glaucoma). Many antidepressant medicines, including desvenlafaxine extended-release tablets, may cause a certain type of eye problem called angle-closure glaucoma. Call your healthcare provider if you have changes in your vision or eye pain.
  • Discontinuation syndrome. Suddenly stopping desvenlafaxine extended-release tablets when you take higher doses may cause you to have serious side effects. Your healthcare provider may want to decrease your dose slowly. Symptoms may include:
  • dizziness
  • irritability and agitation
  • anxiety
  • sweating
  • seizures
  • ringing in your ears (tinnitus)
  • nausea
  • problems sleeping
  • tiredness
  • confusion
  • electric shock sensation (paresthesia)
  • headache
  • diarrhea
  • abnormal dreams
  • changes in your mood
  • hypomania
  • Seizures (convulsions).
  • Low sodium levels in your blood (hyponatremia). Low sodium levels can happen during treatment with desvenlafaxine extended-release tablets. Low sodium levels in your blood may be serious and may cause death. Signs and Symptoms of low sodium levels in your blood may include:
  • headache
  • difficulty concentrating
  • memory changes
  • confusion
  • weakness and unsteadiness on your feet which can lead to falls

In severe or more sudden cases, signs and symptoms include:

  • hallucinations (seeing or hearing things that are not real)
  • fainting
  • seizures
  • coma
  • Lung problems. Some people who have taken the medicine venlafaxine which is the same kind of medicine as the medicine in desvenlafaxine extended-release tablets have had lung problems. Symptoms of lung problems include difficulty breathing, cough, or chest discomfort. Tell your healthcare provider right away if you have any of these symptoms.

The most common side effects of desvenlafaxine extended-release tablets include:

  • nausea
  • problems sleeping
  • constipation
  • decreased appetite
  • sexual function problems
  • dizziness
  • sweating
  • feeling sleepy
  • anxiety

These are not all the possible side effects of desvenlafaxine extended-release tablets.

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 desvenlafaxine extended-release tablets?

  • Store desvenlafaxine extended-release tablets at room temperature between 68° to 77°F (20° to 25°C).
  • Keep desvenlafaxine extended-release tablets and all medicines out of the reach of children.

General Information about the safe and effective use of desvenlafaxine extended-release tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take desvenlafaxine extended-release tablets for a condition for which they were not prescribed. Do not give desvenlafaxine extended-release tablets to other people, even if they have the same symptoms that you have. They may harm them. You can ask your pharmacist or healthcare provider for information about desvenlafaxine extended-release tablets that is written for healthcare professionals.

What are the ingredients in desvenlafaxine extended-release tablets?

Active ingredient: desvenlafaxine

Inactive ingredients: Inactive ingredients for the 25 mg, 50 mg and 100 mg tablet consist of hypromellose, microcrystalline cellulose, talc, magnesium stearate, polyethylene oxide and colloidal silicon dioxide and film coating, which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and iron oxide yellow and iron oxide red. The imprinting ink contains hypromellose, propylene glycol and iron oxide black.

Manufactured by:

Actavis Laboratories FL, Inc.

Fort Lauderdale, FL 33314 USA

Distributed by:

Actavis Pharma, Inc.

Parsippany, NJ 07054 USA

Rev. A 10/2019

For more information, go to www.actavis.com or call 1-800-272-5525.

Marketed/Packaged by: GSMS, Inc.

Camarillo, CA USA 93012

This Medication Guide has been approved by the U.S. Food and Drug Administration.

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