Fetzima Titration Pack (Oral)

Levomilnacipran is used to treat depression. It is part of a group of medicines called serotonin-norepinephrine reuptake inhibitors (SNRIs). These medicines are believed to work by boosting the levels of chemicals called serotonin and norepinephrine in the brain.

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

It is very important that your doctor checks your progress at regular visits to ensure this medicine is working properly.

Do not take levomilnacipran with a monoamine oxidase (MAO) inhibitor (for example, isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Do not start taking levomilnacipran during the 2 weeks after stopping a MAO inhibitor. Wait 1 week after stopping levomilnacipran before starting a MAO inhibitor. Do not use this medicine if you are taking certain MAOIs (for example, linezolid [Zyvox®], methylene blue injection). If you take them together or do not wait the proper amount of time, you may experience confusion, agitation, restlessness, stomach or intestinal symptoms, a sudden high body temperature, extremely high blood pressure, or severe seizures.

Levomilnacipran may cause some teenagers and young adults to feel agitated, irritable, or show other unusual behaviors. It may also lead some people to have suicidal thoughts or to feel more depressed. Some individuals may have trouble sleeping, become easily upset, experience a significant increase in energy, or act recklessly. If you or your caregiver notice any of these unwanted effects, contact your doctor immediately. Inform the doctor if you or anyone in your family has bipolar disorder (manic-depressive) or has attempted suicide.

Levomilnacipran may lead to a serious condition called serotonin syndrome if taken with certain other medicines. Do not use levomilnacipran with buspirone (Buspar®), fentanyl (Abstral®, Duragesic®), lithium (Eskalith®, Lithobid®), tryptophan, St. John's wort, amphetamines, or some pain or migraine medications (for example, meperidine, methadone, rizatriptan, sumatriptan, tramadol, Demerol®, Methadose®, Frova®, Imitrex®, Maxalt®, Relpax®, Ultram®, Zomig®). Always check with your doctor before taking any other medicines with levomilnacipran.

This medicine may increase your risk of bleeding problems. Inform your doctor if you are also taking other medications that thin the blood, including aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) (for example, diclofenac, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Voltaren®), or warfarin (Coumadin®, Jantoven®).

Do not stop taking this medicine without first consulting your doctor. Your doctor may want you to gradually reduce the dose before stopping it completely to lower the chance of withdrawal effects. Some examples of withdrawal effects include agitation, breathing problems, chest pain, confusion, diarrhea, dizziness or lightheadedness, fast heartbeat, headaches, increased sweating, muscle pain, nausea, restlessness, runny nose, trouble sleeping, trembling or shaking, unusual tiredness or weakness, vision changes, or vomiting.

This medicine may cause hyponatremia (low sodium in the blood). This is more common in older patients, those taking diuretic medicines, or those with low fluid levels due to severe diarrhea or vomiting. Contact your doctor immediately if you experience confusion, headache, memory problems, trouble concentrating, weakness, or feel unsteady when standing.

This medicine may cause some people to feel dizzy, drowsy, or less alert than usual. Make sure you know how you react to this medicine before driving, operating machines, or doing anything else that could be dangerous if you are not alert.

Contact your doctor immediately if you have decreased interest in sexual intercourse, delayed or inability to have an orgasm in women, inability to have or maintain an erection in men, or loss of sexual ability, desire, drive, or performance. These could be signs of sexual dysfunction.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or over-the-counter (OTC) medicines, herbal products (for example, St. John's wort), or vitamin supplements.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the beneficial it will do. This is a decision you and your physician will make. For this drug, the following should be considered:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this drug or any other medicines. Also inform your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of levomilnacipran in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of levomilnacipran in the elderly. Nevertheless, elderly patients are more likely to have hyponatremia (low sodium in the blood) and age-related kidney issues, which may require an adjustment in the dose for patients receiving levomilnacipran.

Breast Feeding

There are no adequate studies in women for determining infant chance when using this medication during breastfeeding. Weigh the potential benefits against the potential chances prior to using this medicine while breastfeeding.

Interactions with Medications

Although certain drugs should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your physician may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are using any of the drugs listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this drug with any of the following medications is not recommended. Your physician may decide not to treat you with this drug or change some of the other drugs you take.

• Isocarboxazid
• Linezolid
• Methylene Blue
• Metoclopramide
• Ozanimod
• Phenelzine
• Procarbazine
• Rasagiline
• Safinamide
• Selegiline
• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medications are prescribed together, your clinician may change the dose or how often you use one or both of the drugs.

• Abciximab
• Aceclofenac
• Acemetacin
• Acenocoumarol
• Alfentanil
• Almotriptan
• Amifampridine
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amphetamine
• Amtolmetin Guacil
• Anagrelide
• Anileridine
• Apixaban
• Ardeparin
• Argatroban
• Aspirin
• Bemiparin
• Benzhydrocodone
• Benzphetamine
• Betrixaban
• Bivalirudin
• Boceprevir
• Bromfenac
• Brompheniramine
• Bufexamac
• Buprenorphine
• Bupropion
• Buspirone
• Butorphanol
• Cangrelor
• Carbamazepine
• Celecoxib
• Ceritinib
• Certoparin
• Chlorpheniramine
• Choline Salicylate
• Cilostazol
• Citalopram
• Clarithromycin
• Clomipramine
• Clonixin
• Clopidogrel
• Cobicistat
• Cocaine
• Codeine
• Conivaptan
• Cyclobenzaprine
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Desipramine
• Desirudin
• Desvenlafaxine
• Dexibuprofen
• Dexketoprofen
• Dextroamphetamine
• Dextromethorphan
• Dibenzepin
• Diclofenac
• Difenoxin
• Diflunisal
• Dihydrocodeine
• Diphenoxylate
• Dipyridamole
• Dipyrone
• Dolasetron
• Donepezil
• Doxepin
• Droxicam
• Duloxetine
• Edoxaban
• Eletriptan
• Enoxaparin
• Epoprostenol
• Eptifibatide
• Escitalopram
• Ethylmorphine
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenfluramine
• Fenoprofen
• Fentanyl
• Fepradinol
• Feprazone
• Floctafenine
• Fluconazole
• Flufenamic Acid
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Fondaparinux
• Frovatriptan
• Gepirone
• Granisetron
• Heparin
• Hydrocodone
• Hydromorphone
• Hydroxyamphetamine
• Hydroxytryptophan
• Ibuprofen
• Idelalisib
• Iloprost
• Imipramine
• Indinavir
• Indomethacin
• Iobenguane I 131
• Itraconazole
• Josamycin
• Ketobemidone
• Ketoconazole
• Ketoprofen
• Ketorolac
• Lasmiditan
• Lepirudin
• Levorphanol
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lonafarnib
• Lopinavir
• Lorcaserin
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Melitracen
• Meloxicam
• Meperidine
• Metaxalone
• Methadone
• Methamphetamine
• Mibefradil
• Mifepristone
• Milnacipran
• Mirtazapine
• Morniflumate
• Morphine
• Morphine Sulfate Liposome
• Nabumetone
• Nadroparin
• Nalbuphine
• Naproxen
• Naratriptan
• Nefazodone
• Nelfinavir
• Nepafenac
• Nialamide
• Nicomorphine
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nortriptyline
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Oxaprozin
• Oxycodone
• Oxymorphone
• Oxyphenbutazone
• Palonosetron
• Papaveretum
• Parecoxib
• Paregoric
• Parnaparin
• Paroxetine
• Pentazocine
• Phenindione
• Phenprocoumon
• Phenylbutazone
• Piketoprofen
• Piritramide
• Piroxicam
• Posaconazole
• Pranoprofen
• Prasugrel
• Proglumetacin
• Propyphenazone
• Proquazone
• Protein C
• Protriptyline
• Remifentanil
• Reviparin
• Ribociclib
• Ritonavir
• Rivaroxaban
• Rizatriptan
• Rofecoxib
• Salicylic Acid
• Salsalate
• Saquinavir
• Selexipag
• Sertraline
• Sibutramine
• Simeprevir
• Sodium Salicylate
• St John's Wort
• Sufentanil
• Sulfinpyrazone
• Sulindac
• Sulodexide
• Sumatriptan
• Tapentadol
• Telaprevir
• Telithromycin
• Tenoxicam
• Tianeptine
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tilidine
• Tinzaparin
• Tirofiban
• Tolfenamic Acid
• Tolmetin
• Tramadol
• Trazodone
• Treprostinil
• Trimipramine
• Troleandomycin
• Tryptophan
• Tucatinib
• Valdecoxib
• Venlafaxine
• Vilazodone
• Vorapaxar
• Voriconazole
• Vortioxetine
• Warfarin
• Ziprasidone
• Zolmitriptan

Interactions with Food/Tobacco/Alcohol

Certain drugs should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain drugs may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is typically not advised, but may be unavoidable in some cases. If used together, your doctor may change the dose or how frequently you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol
• Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you inform your doctor if you have any other medical problems, especially:

• Bipolar disorder (manic-depressive disorder), or chance of or
• Bleeding problems or
• Glaucoma, angle-closure or
• Heart or blood vessel disease or
• Heart rhythm issues or
• Hypertension (high blood pressure) or
• Hyponatremia (low sodium levels in the blood) or
• Mania, history of or
• Seizures, history of or
• Stroke or
• Tachycardia (fast heart rate) or
• Trouble urinating or
• Urinary bladder blockage—Use with caution. May make these conditions worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

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

More common

• Decreased interest in sexual intercourse
• Difficult urination
• Fast, pounding, or irregular heartbeat or pulse
• Inability to have or keep an erection
• Loss in sexual ability, desire, drive, or performance

Less common

• Anxiety
• Arm, back, or jaw pain
• Blurred vision
• Burning, crawling, itching, numbness, prickling, "pins and needles," or tingling feelings
• Chest pain, discomfort, heaviness, or tightness
• 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
• Shuffling walk
• Slow heartbeat
• Stiffness of the limbs
• Sweating
• Trouble breathing
• Trouble sleeping
• Twisting movements of the body
• Uncontrolled movements, especially of the face, neck, and back
• Unusual tiredness or weakness

Incidence not known

• Delayed or inability to have an orgasm

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:

More common

• Difficulty having a bowel movement (stool)
• Increased sweating
• Vomiting

Less common

• Bloated or full feeling
• Decreased appetite
• Dry eyes
• Dry skin
• Feeling of warmth
• Severe and throbbing headache
• Hives or welts, itching, or rash
• Passing gas
• Red eye
• Red face, neck, arms, and occasionally, upper chest
• Stomach pain
• Sudden sweating
• Thirst
• Yawning

Incidence not known

• Decrease in smell
• Loss of sense of smell

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.

In the U.S.

• Fetzima
• Fetzima Titration Pack

Available Dosage Forms:

• Capsule, Extended Release

Therapeutic Class: Antidepressant

Pharmacologic Class: Serotonin/Norepinephrine Reuptake Inhibitor

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.

• Does Fetzima cause weight loss or weight gain?
• Does Fetzima cause hair loss?