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.
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants increased the risk of suicidal thoughts and behavior in children, teenagers, and young adults.
In patients of all ages who are started on antidepressant therapy, watch closely for
worsening depression and for suicidal thoughts and behaviors. Families and caregivers
of patients on antidepressants should talk with the patient's doctor if depression becomes worse.
FETZIMA is not approved for use in patients under 18.
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
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
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
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.