Levomilnacipran

Levomilnacipran is a serotonin and norepinephrine reuptake inhibitor (SNRI) antidepressant that is used to treat major depressive disorder ¹, ², ³, ⁴, ⁵, ⁶, ⁷, ⁸, ⁹. Levomilnacipran is the most recently available product in the serotonin and norepinephrine reuptake inhibitor (SNRI) line. Levomilnacipran extended-release (Fetzima) was approved by the FDA in 2013 for the treatment of major depression in adults ¹⁰, ¹¹, ¹², ¹³. Additional applications for levomilnacipran are currently under investigation ¹⁴. Levomilnacipran is the more active L-enantiomer of milnacipran ¹³. Levomilnacipran has been developed solely as a extended-release formulation (once per day) ¹⁵, ¹⁰.

Levomilnacipran comes as an extended-release (long-acting) 20 mg, 40 mg, 80 mg and 120 mg capsule to take by mouth. Levomilnacipran is usually taken once daily with or without food. The starting dose is 20 mg daily, and the usual maintenance dose is 40 to 120 mg daily. Take levomilnacipran at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take levomilnacipran exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole; do not open, chew, or crush them.

Your doctor may start you on a low dose of levomilnacipran and gradually increase your dose, not more than once every 2 days.

Levomilnacipran controls depression but does not cure it. It may take several weeks or longer before you feel the full benefit of levomilnacipran. Continue to take levomilnacipran even if you feel well. Do not stop taking levomilnacipran without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop taking levomilnacipran, you may experience withdrawal symptoms such as mood changes, agitation, irritability, dizziness, ringing in the ears, shock-like sensations, anxiety, confusion, tiredness, difficulty falling asleep or staying asleep, numbness or tingling in the arms, legs, hands, or feet, headache, increased sweating, seizures, or nausea. Tell your doctor if you experience any of these symptoms when your dose of levomilnacipran is decreased.

Common side effects of levomilnacipran may include:

• nausea, vomiting, constipation
• irregular heartbeats
• sweating (diaphoresis)
• decreased sex drive, impotence, or difficulty having an orgasm.

Levomilnacipran may cause serious side effects. Serious side effects may be more likely in older adults. See 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 with racing thoughts, increased energy, decreased need for sleep, risk-taking behavior, being agitated or talkative;
• low sodium level (hyponatremia) causing headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady.

Seek medical attention right away if you have symptoms of serotonin syndrome. Serotonin syndrome also called serotonin toxicity, is a potentially life-threatening condition associated with increased serotonergic activity in your brain. Serotonin syndrome can occur when you increase the dose of certain medications or start taking a new drug. Serotonin syndrome is most often caused by combining medications that contain serotonin, such as a migraine medication and an antidepressant. Some illicit drugs and dietary supplements are associated with serotonin syndrome. Serotonin syndrome signs and symptoms can range from mild (shivering and diarrhea) to severe (muscle rigidity, fever and seizures). Severe serotonin syndrome can cause death if not treated.

How does Levomilnacipran work?

Levomilnacipran is in a class of medications called selective serotonin and norepinephrine reuptake inhibitors (SNRIs). Levomilnacipran works by increasing the amount of serotonin and norepinephrine, natural neurotransmitters (chemical messengers) in your brain that helps maintain mental balance. Normally serotonin and norepinephrine (noradrenaline) neurotransmitters in your brain, that play a role in mood, alertness, and other bodily functions, after their release, they’re typically reabsorbed by the sending neuron in a process called reuptake. Selective serotonin and norepinephrine reuptake inhibitors (SNRIs) work by blocking the reuptake of both serotonin and norepinephrine, which increases their levels in the brain neurons ¹⁶, ¹⁷. By blocking (inhibiting) reabsorption or reuptake of both serotonin and norepinephrine neurotransmitters (chemical messengers) in your brain, more serotonin and norepinephrine are active in your brain contributing to the therapeutic effects of SNRIs in depression and anxiety, however, the exact mechanism is not known. Levomilnacipran is reported to inhibit >90% of norepinephrine reuptake and >80% of serotonin at or above a daily dose of 40 mg ¹⁸.

Unlike more commonly prescribed serotonin and norepinephrine reuptake inhibitor (SNRI), levomilnacipran shows significant selectivity for inhibition of norepinephrine reuptake compared with serotonin (2:1 inhibition ratio) ¹³. Levomilnacipran’s selectivity for norepinephrine as opposed to serotonin is 17 times higher than venlafaxine and 27 times higher than duloxetine ¹⁸, ¹⁹, ²⁰. This is a dose-related phenomenon, and at higher doses, levomilnacipran inhibits norepinephrine and serotonin transporters equally ²¹, ²². Levomilnacipran does not appear to have activity at other receptor types, such as dopaminergic, muscarinic, or adrenergic receptors ¹², ²³. Similar to the other antidepressants, levomilnacipran has a higher rate of nausea (17%) as compared with other common antidepressants ¹⁰.

Levomilnacipran is primarily metabolized via the CYP3A4 isoenzyme. Test tube studies have observed interactions with potent CYP3A4 inhibitors, such as ketoconazole, clarithromycin, and ritonavir ³. A recent healthy human study showed a significant increase in levomilnacipran concentrations when it was coadministered with ketoconazole ²⁴. However, the study did not show a significant decrease in levomilnacipran concentrations when it was coadministered with the strong CYP3A4 inducer carbamazepine ²⁴. Although the evidence is limited, the manufacturer advises using a lower dosage of levomilnacipran with strong CYP3A4 inhibitors, specifically 80 mg daily or less ²⁵. In most cases, a dosage decrease would not be warranted if the CYP3A4 inhibitor is used short-term, such as in the case of a short course of ketoconazole as an antifungal. Still, symptoms of levomilnacipran toxicity, including tachycardia and hypertension, should be monitored ²⁵. In addition, despite the lack of evidence for carbamazepine-induced rapid clearance, levomilnacipran requires closer monitoring for a decrease in or loss of efficacy with strong CYP3A4 inducers ²⁴. Levomilnacipran is not known to induce or inhibit any CYP enzymes significantly. In addition, levomilnacipran, like other SNRIs, can be involved in drug interactions if concomitantly given with inhibitors or inducers of CYP3A4 ²⁴. Like vilazodone, genetic polymorphisms in CYP3A4 activity are minimal and usually not as clinically relevant as drug–drug interactions involving CYP3A4 ²⁶.

The half-life of levomilnacipran is approximately 12 hours ¹¹. Levomilnacipran undergoes desethylation, which is primarily through the 3A4 isoenzyme, as well as hydroxylation ¹¹. The resulting metabolites are inactive ¹¹. Nearly 60 percent of levomilnacipran is excreted unchanged in the urine ¹¹.

Levomilnacipran Uses

Levomilnacipran is FDA approved to treat Major Depressive Disorder ¹⁰, ¹¹.

What to know before taking Levomilnacipran

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make.

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

Levomilnacipran may cause some teenagers and young adults to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Some people may have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. If you or your caregiver notice any of these unwanted effects, tell your doctor right away. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.

Levomilnacipran may cause a serious condition called serotonin syndrome if taken together with some 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 medicines (eg, meperidine, methadone, rizatriptan, sumatriptan, tramadol, Demerol, Methadose, Frova, Imitrex, Maxalt, Relpax, Ultram, Zomi®). Check with your doctor first before taking any other medicines with levomilnacipran.

Levomilnacipran may increase your risk for bleeding problems. Make sure your doctor knows if you are also taking other medicines that thin the blood, including aspirin, nonsteroidal antiinflammatory agents, also called NSAIDs (eg, diclofenac, ibuprofen, naproxen, Advil, Aleve, Celebrex, Voltaren), or warfarin (Coumadin, Jantoven).

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.

Levomilnacipran may cause some people to become dizzy, drowsy, or less alert than they are normally. Make sure you know how you react to levomilnacipran before you drive, use machines, or do anything else that could be dangerous if you are not alert.

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

• Bipolar disorder (manic-depressive disorder)
• Bleeding problems
• Angle-closure glaucoma. You should know that Levomilnacipran may cause angle-closure glaucoma, a condition where the fluid is suddenly blocked and unable to flow out of the eye causing a quick, severe increase in eye pressure which may lead to a loss of vision. Talk to your doctor about having an eye examination before you start taking Levomilnacipran. If you have nausea, eye pain, changes in vision, such as seeing colored rings around lights, and swelling or redness in or around the eye, see your doctor or get emergency medical treatment right away.
• Heart or blood vessel disease
• Heart rhythm problems
• Hypertension (high blood pressure)
• Hyponatremia (low sodium levels in the blood). This is more common in elderly patients, those who are taking diuretic medicines, or those who have less fluid in the body due to severe diarrhea or vomiting. Check with your doctor right away if you have confusion, a headache, memory problems, trouble concentrating, weakness, or feel unsteady when standing.
• Mania
• Seizures
• Stroke
• Tachycardia (fast heart rate)
• Trouble urinating
• 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.

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to Levomilnacipran or any other medicines. Also tell 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.

Children

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

Elderly

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

Pregnancy

Tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking levomilnacipran, see your doctor. If you are pregnant, your name may be listed on a pregnancy registry to track the effects of levomilnacipran on the baby.

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

Breastfeeding

Levomilnacipran has not been studied in nursing mothers ²⁷. However, the racemic form of milnacipran has low levels in breastmilk and would not be expected to cause any adverse effects in breastfed infants. Until more data become available, levomilnacipran should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant ²⁷. Monitor breastfed infants for agitation, irritability, poor feeding and poor weight gain ²⁷.

Eight lactating women who were at least 12 weeks following childbirth and weaning their infants received a single oral dose of racemic milnacipran 50 mg. The average peak milk level of milnacipran was 262 mcg/L at an average of 4 hours and the average milk level was 122 mcg/L. The relative infant dosage was estimated to be 2.8% of the weight-adjusted maternal dosage. Milnacipran was eliminated from milk with an average half-life of 7.5 hours ²⁸, ²⁹.

Drug Interactions

Although certain medicines 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 doctor may want to change the dose, or other precautions may be necessary. When you are taking Levomilnacipran, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using Levomilnacipran with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

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

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

• 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
• Plus many more not on this list.

Levomilnacipran Dosage

The dose of Levomilnacipran 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 Levomilnacipran. 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. In general, the higher doses of levomilnacipran (i.e., between 80 to 120 mg/day) have been more effective than the lower doses have (i.e., around 40 mg/day) ³⁰.
  • Children: Use is not recommended.

Missed Dose

If you miss a dose of Levomilnacipran, 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.

Levomilnacipran side effects

Levomilnacipran may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• constipation
• excessive sweating
• vomiting
• sexual problems in males; decreased sex drive, inability to get or keep an erection, or delayed or absent ejaculation
• sexual problems in females; decreased sex drive, or delayed orgasm or unable to have an orgasm. Check with your doctor right away if you have decreased interest in sexual intercourse, delayed or inability to have an orgasm in women, inability to have or keep an erection in men, or loss in sexual ability, desire, drive, or performance. These could be symptoms of sexual dysfunction.
• decreased appetite

Some side effects can be serious. If you experience any of these symptoms, stop taking levomilnacipran and call your doctor immediately or get emergency medical treatment:

• rash
• hives
• swelling
• difficulty breathing or swallowing
• hallucinations (seeing things or hearing voices that do not exist)
• confusion
• memory problems
• difficulty concentrating
• agitation, fever, sweating, confusion, fast or irregular heartbeat, severe muscle stiffness or twitching, loss of coordination, nausea, vomiting, or diarrhea
• unsteady walking that may cause falling
• seizures
• fainting
• coma (loss of consciousness for a period of time)
• abnormal bleeding or bruising
• difficulty urinating or unable to urinate
• rapid, pounding, or irregular heartbeat

Levomilnacipran may cause other side effects. Call your doctor if you have any unusual problems while taking levomilnacipran.

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