FETZIMA INDICATION AND USAGE

FETZIMA (levomilnacipran) extended-release capsules is a prescription medicine used to treat a certain type of depression called Major Depressive Disorder (MDD) in adults.

It is not known if FETZIMA is safe and effective for use in children.

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

IMPORTANT RISK INFORMATION

FETZIMA may cause serious side effects, including:

Increased risk of suicidal thoughts or actions in some children, adolescents, and young adults. FETZIMA and other antidepressant medicines may increase suicidal thoughts or actions in some children and young adults, especially within the first few months of treatment or when the dose is changed. FETZIMA is not for use in children.

• Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression, bipolar illness (also called manic-depressive illness) or have a history of suicidal thoughts or actions.
• Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the dose is changed.
• Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
• Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call your healthcare provider or get emergency medical help right away if you or your family member 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

FETZIMA may cause serious side effects, including:

• Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when FETZIMA is taken with certain other medicines. Stop taking FETZIMA and call you 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, blood pressure changes, sweating, high body temperature (hyperthermia), loss of coordination, nausea, vomiting, or diarrhea.
• High blood pressure (hypertension). Your healthcare provider should check your blood pressure before you start and during treatment with FETZIMA. If you have high blood pressure, it should be controlled before you start treatment with FETZIMA.
• Increased heart rate. Your healthcare provider should check your heart rate before you start and during treatment with FETZIMA. If you have heart problems or problems with an abnormal heartbeat, your problems should be treated before you start treatment with FETZIMA.
• Increased risk of bleeding: Taking FETZIMA with aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), warfarin 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 FETZIMA, 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.
• Problems with urination: FETZIMA may cause you to have problems with urination including decreased urine flow and being unable to pass any urine. Tell your healthcare provider if you develop any problems with urine flow during treatment with FETZIMA.
• Manic episodes. Manic episodes may happen in people with bipolar disorder who take FETZIMA. Symptoms may include: greatly increased energy, racing thoughts, unusually grand ideas, talking more or faster than usual, severe trouble sleeping, reckless behavior, excessive happiness or irritability.
• Seizures (convulsions)
• Discontinuation symptoms: Suddenly stopping FETZIMA may cause you to have serious side effects. Your healthcare provider may want to decrease your dose slowly. Symptoms may include: changes in your mood, irritability and agitation, dizziness, electric shock sensation (paresthesia), anxiety, confusion, headache, tiredness, problems sleeping, hypomania, ringing in your ears (tinnitus) and seizures.
• Low sodium levels in the blood (hyponatremia): Low sodium levels in your blood may be serious and may cause death. Elderly people may be at greater risk for this. Symptoms may include headache, difficulty concentrating, memory changes, confusion, weakness, and unsteadiness on your feet. In severe or more sudden cases, signs and symptoms include: hallucinations (seeing or hearing things that are not real), fainting, seizures, coma, respiratory arrest, and death.

DO NOT take FETZIMA if you:

• are allergic to levomilnacipran, milnacipran HCl, or any of the ingredients in FETZIMA
• take a monoamine oxidase inhibitor (MAOI)
• have stopped taking an MAOI within the last 14 days
• are being treated with the antibiotic linezolid or intravenous methylene blue

Do not start taking an MAOI for at least 7 days after you stop treatment with FETZIMA.

Before taking FETZIMA, tell your healthcare provider if you:

• have or have a family history of suicide, depression, bipolar disorder, mania, or hypomania
• have high blood pressure
• have or had heart problems or stroke
• have or had bleeding problems
• have glaucoma (high pressure in the eye)
• have or had problems urinating (hesitating) or emptying your bladder (retention)
• have or had seizures (convulsions)
• have low sodium levels in your blood
• have or had kidney problems
• drink alcohol
• are pregnant or plan to become pregnant. FETZIMA may harm your unborn baby. Taking FETZIMA during your third trimester of pregnancy may cause an increased risk of bleeding after delivery and may cause harm to your baby. Talk to your healthcare provider about the risks to you and your baby if you take FETZIMA during pregnancy.
  • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with FETZIMA.
  • There is a pregnancy registry for females who are exposed to FETZIMA during pregnancy. The purpose of the registry is to collect information about the health of females exposed to FETZIMA and their baby. If you become pregnant during treatment with FETZIMA, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visit online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.
• are breastfeeding or plan to breastfeed. It is not known if FETZIMA passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with FETZIMA.
  • If you breastfeed during treatment with FETZIMA, call you healthcare provider right away if your baby develops sleepiness or fussiness, or is not feeding or gaining weight well.

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

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

Especially tell your healthcare provider if you take:

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

Do not start or stop any other medicines during treatment with FETZIMA without talking to your healthcare provider first. Stopping FETZIMA suddenly may cause you to have serious side effects

Avoid drinking alcohol during treatment with FETZIMA Do not drive, operate heavy machinery, or do other dangerous activities until you know how FETZIMA affects you. FETZIMA can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly.

The most common side effects of FETZIMA include:

• Nausea, vomiting, constipation, sweating, abnormal heart beat, and erectile dysfunction.

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.