FETZIMA INDICATION AND USAGE

FETZIMA (levomilnacipran) extended-release capsules is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of Major Depressive Disorder (MDD) in adults.

FETZIMA is not approved for the management of fibromyalgia, and its efficacy and safety have not been established for that use.

IMPORTANT RISK INFORMATION

What is the most important information I should know about depression, antidepressant medicines, other serious mental illnesses, suicidal thoughts or actions and serotonin syndrome?

FETZIMA and other antidepressant medicines may cause serious side effects.

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

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

Serotonin Syndrome: A rare, but potentially life-threatening condition can happen when medicines such as FETZIMA are taken with certain other medicines. Serotonin syndrome can cause serious changes in how your brain, muscles, heart and blood vessels, and digestive system work. Symptoms of serotonin syndrome may include: agitation; hallucinations; coma or other changes in mental status; coordination problems or muscle twitching; fast heartbeat; high or low blood pressure; sweating or fever; nausea; vomiting or diarrhea; or muscle stiffness or tightness

Who should not take FETZIMA?

DO NOT take FETZIMA if you:

• Are allergic to levomilnacipran, milnacipran HCl, or any of the ingredients in FETZIMA
• Have taken any drugs known as monoamine oxidase inhibitors (MAOIs) within the last 14 days, including the antibiotic linezolid or intravenous methylene blue

What should I tell my healthcare provider before taking FETZIMA?

Tell your healthcare provider if you:

• Have high blood pressure or tend to have a fast heart rate
• Have heart or kidney problems
• Have or had bleeding problems. FETZIMA may increase your risk of bleeding or bruising
• Have or had trouble urinating
• Have or had mania, bipolar disorder (manic depression), seizures or convulsions
• Have low salt (sodium) levels in your blood
• Drink alcohol
• Are pregnant, nursing, or are planning to become pregnant or to breastfeed

Tell your healthcare provider about all prescription, over-the-counter medicines, vitamins and herbal supplements you are taking or plan to take, especially:

• Triptans used to treat migraine headaches; medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, SSRIs, SNRIs, buspirone, amphetamines, or antipsychotics; tramadol, fentanyl; over-the-counter supplements such as tryptophan or St. John's Wort, to avoid a potentially life-threatening condition
• Aspirin, non-steroidal anti-inflammatory drug (NSAID) pain relievers, or blood thinners (eg, warfarin, Coumadin^®, or Jantoven^®) because they may increase the risk of bleeding
• Diuretics (water pills)

What should I avoid while taking FETZIMA?

• Until you know how FETZIMA affects you, you should not drive, operate heavy machinery, or engage in other dangerous activities
• Avoid drinking alcohol while taking FETZIMA

What are the possible side effects of FETZIMA?

FETZIMA may cause serious side effects, including:

• High blood pressure and/or increased heart rate
• Abnormal bleeding: FETZIMA and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take blood thinners (eg, warfarin, Coumadin, or Jantoven), a non-steroidal anti-inflammatory drug (NSAID), or aspirin
• Visual problems: Eye pain; changes in vision; swelling or redness in or around the eye. Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are
• Trouble urinating
• Hypomania (manic episodes): Greatly increased energy; severe trouble sleeping; racing thoughts; reckless behavior; unusually grand ideas; excessive happiness or irritability, or talking more or faster than usual
• Seizures or convulsions
• Discontinuation symptoms: Do not stop FETZIMA without first talking to your healthcare provider. Stopping FETZIMA suddenly may cause serious symptoms, including: anxiety; irritability; high or low mood; feeling restless or sleepy; headache; sweating; nausea; dizziness; electric shock-like sensations; tremor; or confusion
• Low salt (sodium) levels in the blood: Symptoms may include headache, difficulty concentrating, memory changes, confusion, weakness, and unsteadiness on your feet. Severe or sudden cases may produce hallucinations (seeing or hearing things that are not real), fainting, seizures, and coma. If not treated, severe low sodium levels could cause death. Elderly people may be at greater risk

The most common side effects of FETZIMA include:

• Nausea or vomiting, constipation, sweating, increased heart rate, erectile dysfunction, and palpitations

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of FETZIMA. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects.

Please also see the Medication Guide within the full Prescribing Information.