Fetzima Titration Pack

In the U.S.

• Fetzima
• Fetzima Titration Pack

Available Dosage Forms:

• Capsule, Extended Release

Therapeutic Class: Antidepressant

Pharmacologic Class: Serotonin/Norepinephrine Reuptake Inhibitor

Levomilnacipran is used to treat depression. It belongs to a group of medicines known as serotonin and norepinephrine reuptake inhibitors (SNRIs). These medicines are thought to work by increasing the activity of chemicals called serotonin and norepinephrine in the brain.

This medicine is available only with your doctor's prescription.

This section provides information on the proper use of a number of products that contain levomilnacipran. It may not be specific to Fetzima Titration Pack. Please read with care.

Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Take this medicine with or without food, and at the same time every day.

Swallow the extended-release capsule whole. Do not open, crush, or chew it.

Do not take the extended-release capsule with alcohol. This may cause the contents of the capsule to be released too soon.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (extended-release capsules):
  • For depression:
    • Adults—At first, 20 milligrams (mg) once a day. After 2 days, the dose will be increased to 40 mg once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 120 mg per day.
    • Children—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Difficult urination
• fast, pounding, or irregular heartbeat or pulse

• Anxiety
• arm, back, or jaw pain
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain or discomfort
• chest tightness or heaviness
• cloudy urine
• confusion
• decrease in the frequency of urination
• difficulty in passing urine (dribbling)
• difficulty with speaking
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drooling
• dry mouth
• fainting
• headache
• irritability
• loss of balance control
• muscle trembling, jerking, or stiffness
• nausea
• painful urination
• pounding in the ears
• rapid or irregular heartbeat
• restlessness
• shaking
• shortness of breath
• shuffling walk
• slow heartbeat
• stiffness of the limbs
• sweating
• trouble sleeping
• twisting movements of the body
• uncontrolled movements, especially of the face, neck, and back
• unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Difficulty having a bowel movement (stool)
• increased sweating
• loss in sexual ability, desire, drive, or performance
• vomiting

• Abdominal or stomach pain
• bloated or full feeling
• decreased appetite
• dry eyes
• dry skin
• feeling of warmth
• headache, severe and throbbing
• hives or welts, itching, or rash
• passing gas
• red eye
• red face, neck, arms, and occasionally, upper chest
• sudden sweating
• thirst
• yawning

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Commonly reported side effects of levomilnacipran include: erectile dysfunction, nausea, and orthostatic hypotension. Other side effects include: constipation, ejaculatory disorder, epididymitis, increased heart rate, palpitations, premature ejaculation, sinus tachycardia, tachycardia, testicular pain, urinary hesitancy, vomiting, delayed ejaculation, ejaculation failure, and hyperhidrosis. See below for a comprehensive list of adverse effects.

Mild hepatic dysfunction (Child-Pugh 1 to 6): No adjustment recommended
Moderate hepatic dysfunction (Child-Pugh 7 to 9): No adjustment recommended
Severe hepatic dysfunction (Child-Pugh 10 to 13): No adjustment recommended

Mild renal dysfunction (CrCl 60 to 89 mL/min): No adjustment recommended
Moderate renal dysfunction (CrCl 30 to 59 mL/min): Maintenance dose should not exceed 80 mg once a day
Severe renal dysfunction (CrCl 15 to 29 mL/min): Maintenance dose should not exceed 40 mg once a day
End stage renal disease: Not recommended