Fetzima
Pronunciation: fet-ZEE-muh
Generic name: levomilnacipran
Dosage form: extended-release capsules
Drug class: Serotonin-norepinephrine reuptake inhibitors
What is Fetzima?
Fetzima (levomilnacipran) is a selective serotonin and norepinephrine reuptake inhibitor antidepressant (SNRI). Levomilnacipran affects chemicals in the brain that may be unbalanced in people with depression.
Fetzima is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) that blocks the reuptake of serotonin (5-HT) and norepinephrine by the nerves of the central nervous system, which enhances serotonergic and norepinephrine activity. The exact way it works in depression is unclear.
Fetzima extended-release capsules are used to treat major depressive disorder. A similar medicine called milnacipran (Savella) is used to treat a chronic pain disorder called fibromyalgia. Fetzima should not be used to treat fibromyalgia.
Fetzima was FDA-approved on July 25, 2013.
Fetzima side effects
Common Fetzima side effects may include:
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nausea, vomiting, constipation;
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irregular heartbeats;
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sweating; or
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decreased sex drive, impotence, or difficulty having an orgasm.
Serious side effects
Get emergency medical help if you have signs of an allergic reaction to Fetzima such as skin rash or hives; difficulty breathing; or swelling of your face, lips, tongue, or throat.
Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.
Call your doctor at once if you have:
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blurred vision, tunnel vision, eye pain or swelling, eye redness;
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painful or difficult urination;
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easy bruising, unusual bleeding, purple or red spots under your skin;
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pounding heartbeats or fluttering in your chest;
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seizure (convulsions);
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manic episodes - racing thoughts, increased energy, decreased need for sleep, risk-taking behavior, being agitated or talkative; or
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low sodium level - headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady.
Serious side effects may be more likely in older adults.
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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Warnings
You should not use Fetzima if you have untreated or uncontrolled narrow-angle glaucoma.
Do not use Fetzima within 7 days before or 14 days after you have taken an MAO inhibitor, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, and tranylcypromine.
People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting a medicine to treat depression. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.
SSRIs, including Fetzima, may cause sexual problems. Symptoms in males may include delayed ejaculation or inability to have an ejaculation, decreased sex drive, and problems getting or keeping an erection. Symptoms in females may include decreased sex drive, delayed orgasm, or inability to have an orgasm. Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with Fetzima. There may be treatments your healthcare provider can suggest.
Do not stop using Fetzima without first asking your doctor.
Fetzima is not approved for use by anyone younger than 18 years old.
Before taking this medicine
You should not use Fetzima if you are allergic to levomilnacipran, Fetzima, any inactive ingredients in the tablets, or milnacipran (Savella).
Do not use Fetzima within 7 days before or 14 days after you have taken an MAO inhibitor. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine, and others.
Tell your doctor if you also use stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. An interaction with levomilnacipran could cause a serious condition called serotonin syndrome.
To make sure Fetzima is safe for you, tell your doctor if you have ever had:
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heart problems, high blood pressure;
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a stroke;
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bleeding problems;
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urination problems;
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sexual problems;
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kidney disease;
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a seizure;
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low levels of sodium in your blood;
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bipolar disorder (manic depression);
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if there is a history of depression, manic behavior, or suicide in your family; or
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if you drink alcohol.
Ask your doctor about taking this medicine if you are pregnant, intending to become pregnant, or breastfeeding.
People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting a medicine to treat depression. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.
Fetzima is not approved for use by anyone younger than 18 years old.
Pregnancy
Taking an SNRI antidepressant during the last 3 months of pregnancy could increase your risk of excessive bleeding just after you give birth, and may cause serious medical complications in the baby. However, you may have a relapse of depression if you stop taking your antidepressant. Tell your doctor right away if you become pregnant. Do not start or stop taking this medicine without your doctor's advice. There is a less than 2-fold increased risk for severe bleeding after delivery (postpartum hemorrhage) in mothers exposed to SSRIs, particularly in the month before delivery.
If you are pregnant, there is a pregnancy registry for women who are exposed to Fetzima during pregnancy. The purpose of the registry is to collect information about the health of women exposed to Fetzima and their baby. If you become pregnant during treatment, 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/research/pregnancyregistry/antidepressants.
Breastfeeding
If you are breastfeeding while taking Fetzima, tell your doctor if your baby is agitated or irritable and has feeding problems or trouble gaining weight.
How should I take Fetzima?
Take Fetzima exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.
Take Fetzima at the same time each day, with or without food.
Swallow the Fetzima extended-release capsule whole and do not crush, chew, break, or open it.
Your blood pressure and heart rate will need to be checked often.
Tell your doctor if you have any changes in sexual function, such as loss of interest in sex, trouble having an orgasm, or (in men) problems with erections or ejaculation. Some sexual problems can be treated.
Do not stop using Fetzima suddenly, or you could have unpleasant symptoms (such as agitation, confusion, tingling or electric shock feelings). Ask your doctor before stopping the medicine.
Store at room temperature away from moisture and heat.
Dosing information
Usual Adult Dose for Depression:
Initial dose: 20 mg orally once a day for 2 days, then increase to 40 mg orally once a day
Maintenance dose: 40 to 120 mg orally once a day
Maximum dose: 120 mg/day
Comments:
-The dose may be increased in increments of 40 mg at intervals of 2 or more days based on tolerability and efficacy.
-Efficacy was established in trials lasting 5 weeks.
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What to avoid
Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.
Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin, ibuprofen, naproxen, Advil, Aleve, Motrin, and others. Using an NSAID with levomilnacipran may cause you to bruise or bleed easily.
Avoid drinking alcohol. It may raise your blood levels of levomilnacipran.
What other drugs will affect Fetzima?
Using Fetzima with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.
Tell your doctor about all your other medicines, especially:
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any other antidepressant;
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sibutramine;
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tryptophan (sometimes called L-tryptophan);
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a diuretic or "water pill";
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diet pills, stimulants, or medicine to treat attention deficit hyperactivity disorder (ADHD) such as Adderall or Ritalin;
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medicine to treat anxiety, mood disorders, thought disorders, or mental illness - buspirone, lithium, and many others; or
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migraine headache medicine - sumatriptan, rizatriptan, zolmitriptan, and others.
SSRIs, including Fetzima, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone, amphetamines, and St. John’s Wort) and with drugs that impair metabolism of serotonin, such as MAOIs. Serotonin syndrome can also occur when these drugs are used alone.
This list is not complete. Other drugs may interact with levomilnacipran, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Storage
Store at room temperature between 68°F to 77°F (20°C to 25°C).
Keep out of the reach of children.
Ingredients
Active ingredient: levomilnacipran hydrochloride
Inactive ingredients: ethylcellulose, hypromellose, povidone, sugar spheres, talc, titanium dioxide, triethyl citrate, black iron oxide, red iron oxide (80 mg and 120 mg capsules only) shellac glaze, yellow iron oxide (20 mg and 40 mg capsules only).
Who makes Fetzima?
AbbVie, Inc. makes Fetzima.
Popular FAQ
Does Fetzima help with anxiety?
Although Fetzima is not FDA approved to treat anxiety, it is sometimes used off-label for this condition. Research has suggested that Fetzima does appear to help with anxiety because an improvement was seen in anxiety symptoms monitored in tools such as the MADRS for inner tension and the Hamilton Depression Rating Scale (HAMD17) that were used in several clinical trials for depression. Unfortunately, most trials of Fetzima excluded people from participating if they had a comorbid anxiety disorder unless it was social anxiety disorder, generalized anxiety disorder, or a specific phobia, but even then the effect of Fetzima on allowable anxiety disorders was never analyzed. Continue reading
How long does it take Fetzima to leave your system?
Fetzima takes approximately 60 hours or 2.5 days to leave your system following the last dose. Experts calculate this period using the half-life of a drug. The half-life of Fetzima is about 12 hours and experts agree that it takes up to 5 half-lives for a drug without active metabolites to be completely removed from the body. This calculates out to 60 hours for Fetzima. Continue reading
Does Fetzima cause weight loss or weight gain?
Research has shown that Fetzima has no overall effect on weight and does not cause weight gain or loss in studies that followed people for up to one year. Data pooled from short-term trials show an average overall weight loss of 0.59kg with Fetzima and a weight gain of 0.02kg with placebo. The number of patients who reported a more than 7% increase in their weight was 0.6% with Fetzima and 0.9% with placebo. The number of patients reporting a weight loss of more than 7% was 1.6% with Fetzima and 1% with placebo. In a 1-year, unblinded safety study, an average weight loss of 0.55kg was reported with Fetzima. Generally, there was a trend towards weight loss with Fetzima but this was not considered significant. Continue reading
Does Fetzima cause hair loss?
Hair loss is not a common side effect of Fetzima and is not listed in the product information but post-marketing reports indicate hair loss has been reported in approximately 1.2% of people who reported side effects while taking Fetzima. Hair loss was more likely to occur in women, with 54% of cases documented in those aged 50 to 59. Continue reading
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