Levomilnacipran Extended-Release Capsules

What is this medication?

LEVOMILNACIPRAN (le vo mil NA si pran) treats depression. It increases the amount of serotonin and norepinephrine in the brain, substances that help regulate mood. It belongs to a group of medications called SNRIs.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): FETZIMA

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Bleeding disorders
• Frequently drink alcohol
• Glaucoma
• Heart disease
• High blood pressure
• History of irregular heartbeat
• Kidney disease
• Low levels of sodium in the blood
• Mania or bipolar disorder
• Seizures
• Suicidal thoughts, plans, or attempt by you or a family member
• Take MAOIs such as Azilect, Carbex, Eldepryl, Marplan, Nardil, and Parnate
• Take medications that treat or prevent blood clots
• Trouble passing urine
• An unusual or allergic reaction to levomilnacipran, other medications, foods, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a drink of water. This medication may be taken with or without food. Swallow whole; do not crush, cut, or chew the capsule. Follow the directions on the prescription label. Take your doses at regular intervals. Do not take your medication more often than directed. Do not stop taking this medication suddenly except upon the advice of your care team. Stopping this medication too quickly may cause serious side effects or your condition may worsen.

Contact your care team about the use of this medication in children. Special care may be needed.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Desvenlafaxine
• Duloxetine
• Linezolid
• MAOIs, such as Marplan, Nardil, and Parnate
• Methylene blue injected into a vein
• Milnacipran
• Venlafaxine

This medication may also interact with the following:

• Alcohol
• Amphetamines
• Aspirin and aspirin-like medications
• Certain medications for mental health conditions
• Certain medications for migraine headache, such as almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan
• Certain medications for sleep
• Certain medications that treat or prevent blood clots, such as warfarin, enoxaparin, and dalteparin
• Clarithromycin
• Diuretics
• Fentanyl
• Furazolidone
• Isoniazid
• Ketoconazole
• Lithium
• Medications for heart rhythm or blood pressure
• NSAIDS, medications for pain and inflammation, such as ibuprofen or naproxen
• Procarbazine
• Rasagiline
• Ritonavir
• Sibutramine
• St. John's Wort
• Stimulant medications for ADHD, weight loss, or staying awake
• Tramadol
• Tryptophan

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your care team if your symptoms do not get better or if they get worse. Visit your care team for regular checks on your progress. Because it may take several weeks to see the full effects of this medication, it is important to continue your treatment as prescribed by your care team. Do not stop taking except on your care team's advice. You may develop a severe reaction. Your care team will tell you how much medication to take.

Patients and their families should watch out for new or worsening thoughts of suicide or depression. Also watch out for sudden changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, especially at the beginning of treatment or after a change in dose, call your care team.

This medication can cause an increase in blood pressure. Check with your care team for instructions on monitoring your blood pressure while taking this medication.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

Your mouth may get dry. Chewing sugarless gum, sucking hard candy and drinking plenty of water will help. Contact your care team if the problem does not go away or is severe.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• Heart palpitations—rapid, pounding, or irregular heartbeat
• Increase in blood pressure
• Irritability, confusion, fast or irregular heartbeat, muscle stiffness, twitching muscles, sweating, high fever, seizure, chills, vomiting, diarrhea, which may be signs of serotonin syndrome
• Low sodium level—muscle weakness, fatigue, dizziness, headache, confusion
• Seizures
• Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss
• Thoughts of suicide or self-harm, worsening mood, or feelings of depression
• Trouble passing urine

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Change in sex drive or performance
• Constipation
• Excessive sweating
• Nausea
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.