Levomilnacipran is a serotonin and norepinephrine reuptake inhibitor antidepressant (SNRI).

Levomilnacipran is used to treat major depressive disorder.

A similar medicine called milnacipran (Savella) is used to treat a chronic pain disorder called fibromyalgia. Levomilnacipran (Fetzima) should not be used to treat fibromyalgia.

Levomilnacipran may also be used for purposes not listed in this medication guide.

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.

Do not stop using levomilnacipran without first asking your doctor.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Take the medicine at the same time each day, with or without food.

Swallow the 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 levomilnacipran 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.

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.

Use: Treatment of major depressive disorder (MDD)

You should not use levomilnacipran if you are allergic to levomilnacipran or milnacipran (Savella).

Do not use levomilnacipran 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, and tranylcypromine.

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.

Tell your doctor if you have ever had:

• glaucoma;

• heart problems, high blood pressure;

• a stroke;

• bleeding problems;

• urination problems;

• sexual problems;

• kidney disease;

• a seizure;

• low levels of sodium in your blood;

• bipolar disorder (manic depression);

• if there is a history of depression, manic behavior, or suicide in your family; or

• if you drink alcohol.

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.

Taking this medicine during pregnancy could harm the baby, but stopping the medicine may not be safe for you. Do not start or stop levomilnacipran without asking your doctor.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of levomilnacipran on the baby.

If you are breastfeeding, tell your doctor if your baby is agitated or irritable and has feeding problems or trouble gaining weight.

Not approved for use by anyone younger than 18 years old.

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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unless your doctor tells you otherwise, continue your normal diet.

Avoid driving or hazardous activity until you know how levomilnacipran 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.

Get emergency medical help if you have signs of an allergic reaction: skin rash or hives; difficult breathing; 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.

Levomilnacipran may cause serious side effects. Call your doctor at once if you have:

• blurred vision, tunnel vision, eye pain or swelling, eye redness;

• painful or difficult urination;

• easy bruising, unusual bleeding, purple or red spots under your skin;

• pounding heartbeats or fluttering in your chest;

• seizure (convulsions);

• manic episodes--racing thoughts, increased energy, decreased need for sleep, risk-taking behavior, being agitated or talkative; or

• 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.

Common side effects of levomilnacipran may include:

• nausea, vomiting, constipation;

• irregular heartbeats;

• sweating; or

• decreased sex drive, impotence, or difficulty having an orgasm.

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 FDA at 1-800-FDA-1088.

Using levomilnacipran 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:

• any other antidepressant;

• sibutramine;

• St. John's wort;

• tryptophan (sometimes called L-tryptophan);

• a diuretic or "water pill";

• a blood thinner (warfarin, Coumadin, Jantoven);

• diet pills, stimulants, or medicine to treat attention deficit hyperactivity disorder (ADHD) such as Adderall or Ritalin;

• pain medication--fentanyl, tramadol;

• medicine to treat anxiety, mood disorders, thought disorders, or mental illness--buspirone, lithium, and many others; or

• migraine headache medicine--sumatriptan, rizatriptan, zolmitriptan, and others.

This list is not complete. Other drugs may affect levomilnacipran, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor and the laboratory.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.