Desvenlafaxine, Oral

________________________________________________________________________

KEY POINTS

• This medicine is taken by mouth to treat depression. Take it exactly as directed.
• This medicine may increase suicidal thoughts or actions in some people.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• This medicine may cause life-threatening problems if you take this medicine with certain other medicines. Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: selective serotonin and norepinephrine reuptake inhibitor (SNRI) antidepressant

Generic and brand names: desvenlafaxine, oral; Khedezla; Pristiq

What is this medicine used for?

This medicine is taken by mouth to treat depression.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A stroke or transient ischemic attack (TIA)
• Bleeding problems
• Glaucoma
• Heart disease or a heart attack
• High blood pressure
• High cholesterol or high triglycerides
• Liver or kidney disease
• Problems with low levels of sodium in the blood
• Problems with bipolar disorder or suicidal thoughts
• Seizures

Do not take this medicine if you have taken an MAO inhibitor in the last 2 weeks. Also, do not start taking an MAO inhibitor within 7 days after stopping this medicine. You could have serious side effects if you do. Talk with your healthcare provider about this.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Taking this medicine in the last 3 months of pregnancy can cause problems for the baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. It is best to take this medicine about the same time each day. During this treatment, your healthcare provider may adjust your dosage depending on your response. Be sure you understand how much medicine to take and when to take it. Do not take more or less than prescribed. It may take several weeks of taking this medicine before you start to feel better.

Check with your healthcare provider before using this medicine in children under age 18.

Do not stop taking this medicine without your healthcare provider's approval, even if you feel better. You may need to reduce your dose slowly to avoid withdrawal symptoms.

You may take this medicine with or without food. Swallow the tablets whole with a full glass of water. Do not divide, crush, or chew them or put them in water.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: headache, large pupils, confusion, vomiting, restlessness, drowsiness, dizziness, nausea, constipation, diarrhea, dry mouth, numbness and tingling, tremors, seizures, fast or irregular heartbeat, coma.

What should I watch out for?

Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment or at times of dose changes. Talk with your provider about this.

Behavior changes may be caused by the medicine or by depression or another mental health problem. Contact your provider right away if you or your family notice any disturbing changes in your thoughts or behavior, such as:

• More outgoing or aggressive behavior than normal
• Confusion
• Hallucinations
• Worsening of depression
• Suicidal thoughts

This medicine may cause a life-threatening problem called serotonin syndrome if you take it with certain other medicines, such as antidepressants, migraine medicines, pain medicines, some cough medicines, and St. John’s wort. Make sure that your providers know ALL of the medicines that you take. Contact your healthcare provider right away if you have:

• Restlessness
• Hallucinations
• Loss of coordination
• Tremor
• Stiff muscles
• Fast heart beat
• Rapid changes in blood pressure
• Increased body temperature, sweating, or flushing
• Dizziness
• Nausea
• Vomiting
• Diarrhea

This medicine may cause drowsiness, dizziness, or blurred vision. Do not drive or operate machinery unless you are fully alert and can see clearly.

This medicine may trigger angle-closure glaucoma. Contact your provider right away if you have eye pain, vision changes, or redness and swelling in or around your eye.

You may feel dizzy or faint when you get up quickly after sitting or lying down. Getting up slowly may help. Adults over the age of 65 may be at greater risk. Talk with your healthcare provider about this.

You may need to check your blood pressure regularly to make sure this medicine does not increase your blood pressure.

This medicine may increase the effects of alcohol and interact with many other medicines. Do not drink alcohol or take any other medicine, including nonprescription products or natural remedies, unless your healthcare provider approves.

You may see something that looks like a tablet in your bowel movements. This is normal and is the empty shell from the tablet after your body has absorbed the medicine.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Seizures, thoughts of suicide, worsening depression, panic attacks, severe restlessness or nervousness, severe confusion, fast or irregular heartbeat, severe headache, chest pain, unusual behavior, trouble breathing or cough, chest infection, unusual bruising or bleeding, hallucinations, severe diarrhea, fever, loss of coordination, unexplained swelling, severe nausea or vomiting, numbness or tingling in hands or feet, muscle twitching or tremors, severe muscle stiffness, blurred vision or enlarged pupils, black or tarry bowel movements, increased sweating, severe weakness.

Other: Nausea, gas, headache, drowsiness, dizziness, trouble sleeping, abnormal dreams, nervousness, constipation, loss of appetite, weight loss, sweating, dry mouth, change in sexual desire or ability, sensitivity to sun.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antianxiety medicines such as alprazolam (Xanax), buspirone, clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), lorazepam (Ativan), and oxazepam
• Antihistamines such as brompheniramine, chlorpheniramine (Chlor-Trimeton), clemastine (Tavist), and diphenhydramine (Benadryl)
• Antipsychotic medicines such as aripiprazole (Abilify), chlorpromazine, clozapine (Clozaril, FazaClo), fluphenazine, haloperidol (Haldol), olanzapine (Zyprexa), perphenazine, quetiapine (Seroquel), risperidone (Risperdal), thioridazine, and ziprasidone (Geodon)
• Atomoxetine (Strattera)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Beta blockers such as carvedilol (Coreg), metoprolol (Lopressor, Toprol), and nebivolol (Bystolic)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Dextromethorphan, an ingredient in many cough, cold, or allergy medicines such as Robitussin-DM
• Dextromethorphan/quinidine (Nuedexta)
• Diuretics (water pills) such as amiloride, bumetanide, chlorothiazide (Diuril), eplerenone (Inspra), furosemide (Lasix), hydrochlorothiazide (Microzide), spironolactone (Aldactone), torsemide (Demadex), and triamterene (Dyrenium)
• Doxepin (Silenor)
• HIV medicines such as delavirdine (Rescriptor), indinavir (Crixivan), and ritonavir (Norvir)
• Ketoconazole (Nizoral)
• Linezolid (Zyvox)
• Lithium (Lithobid)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), aspirin, cilostazol (Pletal), clopidogrel (Plavix), dabigatran (Pradaxa), dipyridamole (Persantine), dipyridamole/aspirin (Aggrenox), prasugrel (Effient), rivaroxaban (Xarelto), ticagrelor (Brilinta), and warfarin (Coumadin)
• Metoclopramide (Metozolv, Reglan)
• Migraine medicines such as almotriptan (Axert), dihydroergotamine (D.H.E. 45, Migranal), eletriptan (Relpax), ergotamine (Ergomar), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Alsuma, Imitrex, Sumavel), and zolmitriptan (Zomig)
• Milnacipran (Savella)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), dantrolene (Dantrium), methocarbamol (Robaxin), and tizanidine (Zanaflex)
• Natural remedies such as alfalfa, anise, bilberry, bladderwrack, cat's claw, celery, chamomile, evening primrose oil, fenugreek, feverfew, garlic, ginger, ginkgo, ginseng, gotu kola, green tea, horse chestnut, kava, licorice, SAMe, St. John's wort, sweet clover, tryptophan, turmeric, valerian, and willow
• Nausea medicines such as prochlorperazine (Compro) and promethazine
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as celecoxib (Celebrex), diclofenac (Cambia, Voltaren, Zipsor), diflunisal, etodolac, ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Other antidepressants such as amitriptyline, citalopram (Celexa), clomipramine, desipramine (Norpramin), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), trazodone, and venlafaxine (Effexor)
• Pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone/acetaminophen (Norco, Vicodin), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), tapentadol (Nucynta), and tramadol (ConZip, Ultram)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Procarbazine (Matulane)
• Products that contain methylene blue (Hyophen, Prosed DS, Urophen, Uta)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Sleeping pills such as flurazepam, temazepam (Restoril), triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)
• Stimulants such as amphetamine/dextroamphetamine (Adderall), dexmethylphenidate (Focalin), dextroamphetamine (Dexedrine), ephedrine, methamphetamine (Desoxyn), and methylphenidate (Concerta, Daytrana, Metadate, Ritalin)
• Tolterodine (Detrol)

Do not drink alcohol while you are taking this medicine.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

---

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.