Fetzima

(Levomilnacipran Hydrochloride ER)

The active ingredient in Fetzima is levomilnacipran, a serotonin-norepinephrine reuptake inhibitor (SNRI). Levomilnacipran works by increasing the levels of serotonin and norepinephrine, two chemicals in the brain involved in emotional balance and mood. By helping regulate these chemicals, Fetzima may improve symptoms such as low mood, lack of interest, low energy, and impaired concentration.

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

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Fetzima. However, the following is a synopsis of the general guidelines for the use of Fetzima:

-Fetzima is taken by mouth once daily, at about the same time each day.

-It comes as extended-release capsules and should be swallowed whole. Do not crush, chew, or open the capsules.

-Fetzima may be taken with or without food.

-Your healthcare provider will usually start you on a low dose and increase it gradually to reduce side effects.

-Do not stop taking Fetzima suddenly without medical advice, as discontinuation symptoms may occur.

Some mild or common side effects of Fetzima seen in clinical trials as compared to placebo include:

-Nausea, vomiting

-Constipation or diarrhea

-Trouble sleeping

-Increased heart rate or palpitations

-Increased blood pressure or hypertension

-Increased sweating

-Erectile dysfunction or ejaculation problems

-Decreased appetite

Some individuals may experience serious side effects while using Fetzima. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

-Suicidal thoughts or worsening depression, especially in young adults

-Symptoms of serotonin syndrome, such as agitation, hallucinations, fever, muscle stiffness, fast heartbeat (tachycardia), or confusion

-Severe allergic reaction, including hives, swelling, or trouble breathing

-Eye pain or vision changes, which may be linked to glaucoma

-Bleeding problems, especially if taken with warfarin, nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen, or other medications that affect clotting

These are not all of the possible side effects of Fetzima. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Fetzima, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

-Bipolar disorder or a history of mania

-Hypertension (high blood pressure) or heart disease

-Increased heart rate or rhythm problems

-Glaucoma or eye pain

-Problems with urination or retention

-Low sodium levels or conditions that increase the risk of hyponatremia

-A history of bleeding problems

-Kidney disease

Boxed Warning

-Fetzima may cause an increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults, especially during the early stages of treatment or during dosage changes. Caregivers and family members should closely monitor for worsening symptoms, unusual behavior, or sudden mood changes and report them to a healthcare provider right away.

Fetzima should not be used in people who:

-Are allergic to levomilnacipran, milnacipran, or any inactive ingredient of this formulation.

-Are currently taking, or have recently taken, monoamine oxidase inhibitors (MAOIs). This includes isocarboxazid, phenelzine, selegiline, tranylcypromine, linezolid, or methylene blue. Using Fetzima with MAOIs can cause serotonin syndrome, which may be life-threatening. Fetzima should not be used within 14 days of a MOAi.

-Are under 18 years old.

Like other SNRIs and antidepressants, Fetzima does not work immediately and must be taken consistently. Some people may notice small improvements in energy or sleep within the first 1 to 2 weeks. However, full benefits for major depressive disorder may take several weeks. It is important to continue taking Fetzima as prescribed, even if you do not feel better right away.

When Fetzima is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

-MAOIs or monoamine oxidase inhibitors

-Other antidepressants, such as selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs)

-Serotonergic drugs, including triptans, tramadol, lithium, buspirone, amphetamines, opioids, and tryptophan

-St. John’s Wort or other supplements

-NSAIDs, aspirin, warfarin, or other drugs that increase bleeding risk

-Clarithromycin or ketoconazole

-Medications that affect blood pressure or heart rate

-Alcohol, as drinking alcohol may worsen side effects

Fetzima is available in the following dosage forms and strengths: 20 mg, 40 mg, 80 mg, and 120 mg extended-release capsules.

Store Fetzima at room temperature, away from excess heat and moisture. Keep the capsules in their original container and out of reach of children.

Fetzima is manufactured by AbbVie Inc.

No, there is no generic version of Fetzima available at the moment.

Do not stop taking Fetzima suddenly. Stopping too quickly may cause discontinuation symptoms such as dizziness, sensory disturbances, irritability, headache, or sleep problems. Discontinuation symptoms may also lead to seizures and be life-threatening. Your healthcare provider will guide you on how to slowly reduce your dose if needed.

Fetzima has not been well studied in pregnant women. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you, based on the potential benefits and risks.

Fetzima has not been well studied in people who breastfeed. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. Levomilnacipran may pass into breast milk, and your healthcare provider can help determine the safest option for you and your baby.