MEDICATION GUIDE

Desvenlafaxine Extended-Release Tablets
(des VEN la FAX een)

What is the most important information I should know about desvenlafaxine?

Desvenlafaxine 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 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?

o  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.

o  Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.

o  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:

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

What is desvenlafaxine?

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

Do not take desvenlafaxine 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.

Before taking desvenlafaxine 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 during pregnancy.

          o    Tell your healthcare provider if you become pregnant or think you are pregnant during treatment with desvenlafaxine.
          o     If you become pregnant during treatment with desvenlafaxine, 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 can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with desvenlafaxine.

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

Desvenlafaxine and other medicines may affect each other causing possible serious side effects. Desvenlafaxine may affect the way other medicines work and other medicines may affect the way desvenlafaxine works.

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 with your other medicines.

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

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?

• Take desvenlafaxine exactly as your healthcare provider tells you to.
• Take desvenlafaxine 1 time a day at about the same time each day.
• Desvenlafaxine may be taken either with or without food.
• Swallow desvenlafaxine tablets whole, with fluid. Do not divide, crush, chew, or dissolve desvenlafaxine tablets.
• When you take desvenlafaxine, 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?

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

What are the possible side effects of desvenlafaxine?

Desvenlafaxine can cause serious side effects, including:

• See, "What  is the most important information I should know about desvenlafaxine?”
• Serotonin syndrome. Apotentially life-threatening problem called serotonin syndrome can happen when you take desvenlafaxine with certain other medicines. See, “Do not take desvenlafaxine if you:” 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:
  

  o  agitation	o  seeing or hearing things that are not real (hallucinations)
  o  confusion	o  coma
  o  fast heart beat	o  changes in blood pressure
  o  dizziness	o  sweating
  o  flushing	o  high body temperature (hyperthermia)
  o  tremors, stiff muscles, or muscle twitching	o  loss of coordination
  o  seizures	o  nausea, vomiting, diarrhea

  
  • New or worsened high blood pressure (hypertension). Your healthcare provider should check your blood pressure before and during treatment with desvenlafaxine. If you have high blood pressure, it should be controlled before you start treatment with desvenlafaxine.
  • Increased chance of bleeding or bruising. Taking desvenlafaxine 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, 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 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 the following, some of which can be severe and last for a long time:
  

  o   dizziness	o   ringing in your ears (tinnitus)	o   headache
  o   irritability and agitation	o   nausea	o   diarrhea
  o   anxiety	o   problems sleeping	o   abnormal dreams
  o   aggressiveness (including hostility, rage)	o   tiredness	o   changes in your mood
  o   tremor	o   confusion	o   hypomania
  o   sweating	o   electric shock sensation (paresthesia)	o   problems with eyesight (such as blurred vision and trouble focusing)
  o   seizures		o   increase in blood pressure

• Seizures (convulsions).
• Low sodium levels in your blood (hyponatremia). Low sodium levels can happen during treatment with desvenlafaxine. 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 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.
• Sexual Problems (dysfunction). Taking serotonin and norepinephrine reuptake inhibitors (SNRIs), including desvenlafaxine, may cause sexual problems.
  Symptoms in males may include:
  o Delayed ejaculation or inability to have an ejaculation
  o Decreased sex drive
  o Problems getting or keeping an erection
  Symptoms in females may include:
  o Decreased sex drive
  o Delayed orgasm or inability to have an orgasm
  Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with desvenlafaxine. There may be treatments your healthcare provider can suggest.
  

The most common side effects of desvenlafaxine include:

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

These are not all the possible side effects of desvenlafaxine.

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?

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

General Information about the safe and effective use of desvenlafaxine

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take desvenlafaxine for a condition for which it was not prescribed. Do not give desvenlafaxine 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 desvenlafaxine that is written for healthcare professionals.

For more information call Breckenridge Pharmaceutical, Inc. at 1-800-367-3395 or go to www.bpirx.com.

What are the ingredients in desvenlafaxine extended-release tablets?

Active ingredient: desvenlafaxine

Inactive ingredients:

25 mg tablet: hypromellose, magnesium stearate, microcrystalline cellulose, povidone, talc and film coating, which consists of hypromellose, iron oxide yellow, iron oxide red, iron oxide black, polyethylene glycol, talc, and titanium dioxide.

50 mg tablet: hypromellose, magnesium stearate, microcrystalline cellulose, povidone, talc and film coating, which consists of hypromellose, iron oxide red, polyethylene glycol, talc, and titanium dioxide.

100 mg tablet: hypromellose, magnesium stearate, microcrystalline cellulose, povidone, talc and film coating, which consists of hypromellose, iron oxide black, iron oxide red, polyethylene glycol, talc, and titanium dioxide.

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

Distributed by:

Breckenridge Pharmaceutical, Inc.
Berlin, CT 06037

Manufactured by:

Alembic Pharmaceuticals Limited(Formulation Division),

Village Panelav, P. O. Tajpura, Near Baska,

Taluka-Halol, Panchmahal, Gujarat, India.

Revised: 12/2021