Desvenlafaxine

Medications such as desvenlafaxine may increase the risk of suicidal thoughts and actions. This increase was found in children, teenagers, and young adults (less than 24 years of age). The risk may be more likely with the first few months of treatment and when the dose is increased.

Call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; or frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to do so.

The doctor or pharmacist will give you the Medication Guide. Read the information carefully and ask your doctor or pharmacist if you have any questions. You also can obtain the Medication Guide from: https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm.

Talk to your doctor about the risks of taking desvenlafaxine.

Desvenlafaxine is used to treat depression. Desvenlafaxine is in a class of medications called selective serotonin and norepinephrine reuptake inhibitors (SNRIs). It works by increasing the amounts of serotonin and norepinephrine, natural substances in the brain that help maintain mental balance.

Desvenlafaxine comes as an extended-release (long-acting) tablet to take by mouth. Take once a day with or without food. Take desvenlafaxine at around the same time every day.

Take desvenlafaxine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole with plenty of water; do not split, chew, crush, or dissolve them.

Desvenlafaxine controls depression, but does not cure it. It may take several weeks before you feel the full benefit of desvenlafaxine. Continue to take desvenlafaxine even if you feel well. Do not stop taking desvenlafaxine without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop taking desvenlafaxine, you may experience withdrawal symptoms such as dizziness; confusion; nausea; headache; ringing in the ears; irritability; aggressive behavior; inability to control emotions; frequent mood changes; abnormally excited, difficulty falling asleep or staying asleep, diarrhea, anxiety; extreme tiredness; unusual dreams; seizures; sweating; uncontrollable shaking of a part of the body; blurred vision; or pain, burning or tingling in the hands or feet. Tell your doctor if you experience any of these symptoms while you are decreasing your dose of desvenlafaxine or soon after you stop taking desvenlafaxine.

Desvenlafaxine is also sometimes used to treat hot flashes (hot flushes; sudden strong feelings of heat and sweating) in women who have experienced menopause ('change of life'; the end of monthly menstrual periods). Talk to your doctor about the risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking desvenlafaxine,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: a monoamine oxidase (MAO) inhibitor, such as isocarboxazid, linezolid, methylene blue, phenelzine, selegiline, and tranylcypromine. Your doctor will probably tell you that you should not take desvenlafaxine. If you stop taking desvenlafaxine, your doctor will tell you that you should wait at least 7 days before you start to take an MAO inhibitor.
• tell your doctor and pharmacist what other prescription and nonprescription medications or vitamins you are taking or plan to take while taking desvenlafaxine. Your doctor may change the doses of these medications or monitor you carefully for side effects.
• the following nonprescription or herbal products may interact with desvenlafaxine: St. John's wort; aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and naproxen; tryptophan; dextromethorphan. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking desvenlafaxine. Do not start any of these medications while taking desvenlafaxine without discussing with your healthcare provider.
• tell your doctor if you drink or have ever drunk large amounts of alcohol or use or have ever used street drugs or have ever overused prescription medications. Also tell your doctor if you have or have ever had bleeding problems; a stroke; high blood pressure; high cholesterol or triglycerides (fats in the blood); seizures; or heart, kidney, or liver disease.
• tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breast-feeding. If you become pregnant while taking desvenlafaxine, call your doctor.
• you should know that desvenlafaxine may make you drowsy and may affect your judgment, thinking, and movements. Do not drive a car or operate machinery until you know how this medication affects you.
• ask your doctor about the safe use of alcoholic beverages while you are taking desvenlafaxine. Alcohol can make the side effects from desvenlafaxine worse.
• you should know that in older adults, desvenlafaxine may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
• you should know that desvenlafaxine may cause angle-closure glaucoma (a condition where the fluid is suddenly blocked and unable to flow out of the eye causing a quick, severe increase in eye pressure which may lead to a loss of vision). Talk to your doctor about having an eye examination before you start taking this medication. If you have nausea, eye pain, changes in vision, such as seeing colored rings around lights, and swelling or redness in or around the eye, call your doctor or get emergency medical treatment right away.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Desvenlafaxine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• constipation
• loss of appetite
• difficulty falling asleep or staying asleep
• sweating
• sexual problems in males; decreased sex drive, inability to get or keep an erection, or delayed or absent ejaculation
• sexual problems in females; decreased sex drive, or delayed orgasm or unable to have an orgasm

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS section, call your doctor immediately:

• rash; hives; difficulty swallowing or breathing; swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• fast heartbeat
• chest, arm, back, neck, or jaw pain
• coma (loss of consciousness for a period of time)
• seizures
• fever, sweating, confusion, fast or irregular heartbeat, severe muscle stiffness or twitching, agitation, hallucinations, loss of coordination, nausea, vomiting, or diarrhea
• unusual bleeding or bruising
• headache; unsteadiness; problems with thinking, concentration, or memory
• fainting

Desvenlafaxine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• vomiting
• agitation, hallucinations, fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, loss of coordination, nausea, vomiting, or diarrhea
• drowsiness
• coma
• seizures
• fast, slow, or irregular heartbeat
• increased size of the pupil (black center of the eye)
• muscle pain or weakness

Keep all appointments with your doctor and the laboratory.

The extended-release tablet does not dissolve in the stomach after swallowing. You may notice the tablet coating in the stool. This is normal and does not mean that you did not receive the complete dose of medication.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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