WARNING

Fetzima (levomilnacipran) is a prescription medication primarily used to treat major depressive disorder (MDD) in adults. Like all medications, Fetzima comes with potential risks and side effects. Here are some of the main risks associated with taking Fetzima:

• Suicidal Thoughts and Behavior: Antidepressants, including Fetzima, may increase the risk of suicidal thoughts and behavior, particularly in children, adolescents, and young adults. Close monitoring by healthcare providers is essential, especially when starting or changing the dosage of Fetzima.
• Serotonin Syndrome: Fetzima, like other serotonin-norepinephrine reuptake inhibitors (SNRIs), can increase serotonin levels in the brain. In some cases, this can lead to serotonin syndrome, a potentially life-threatening condition characterized by symptoms such as agitation, hallucinations, rapid heart rate, high blood pressure, fever, excessive sweating, shivering or shaking, blurred vision, muscle spasm or stiffness, tremor, incoordination, stomach cramp, nausea, vomiting, and diarrhea. Serotonin syndrome requires immediate medical attention.
• Increased Blood Pressure and Heart Rate: Fetzima may cause increases in blood pressure and heart rate, which can be problematic for individuals with pre-existing cardiovascular conditions.
• Liver Damage: There have been reports of liver damage associated with Fetzima use. Liver function should be monitored regularly during treatment.
• Hyponatremia: Fetzima can cause low sodium levels in the blood, known as hyponatremia, which can be serious, leading to symptoms such as headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which can progress to seizures, hallucinations, fainting, respiratory arrest, and death.
• Allergic Reactions: Some individuals may experience allergic reactions to Fetzima, which can manifest as skin rash, itching, hives, swelling of the face, lips, or tongue, difficulty breathing, or swallowing.
• Withdrawal Symptoms: Abrupt discontinuation of Fetzima may lead to withdrawal symptoms such as dizziness, headache, nausea, vomiting, irritability, and sweating. It is important to taper off the medication under medical supervision.
• Other Side Effects: Additional side effects of Fetzima may include insomnia, drowsiness, fatigue, constipation, decreased appetite, sexual dysfunction, and urinary retention.

It’s crucial for individuals considering or currently taking Fetzima to discuss the potential risks and benefits with their healthcare provider. Monitoring for side effects and adherence to the prescribed dosage are essential for safe and effective use of this medication.

Why is this medication prescribed?

Fetzima (levomilnacipran) is prescribed primarily for the treatment of major depressive disorder (MDD) in adults. It belongs to a class of medications known as serotonin-norepinephrine reuptake inhibitors (SNRIs), which work by increasing the levels of serotonin and norepinephrine in the brain, thereby improving mood.

How should this medicine be used?

Here are some key points on how Fetzima is typically used:

• Dosage: The recommended starting dose of Fetzima for most adults with MDD is 20 mg once daily. Depending on individual response and tolerability, the dosage may be increased gradually by 20 mg increments at intervals of at least two days, up to a maximum dose of 120 mg per day.
• Administration: Fetzima is usually taken orally, with or without food. It is important to take Fetzima exactly as prescribed by a healthcare provider.
• Monitoring: Healthcare providers typically monitor patients closely, especially during the initial weeks of treatment and whenever the dosage is adjusted. This monitoring helps to assess the response to treatment and identify any potential side effects.
• Duration of Treatment: The duration of treatment with Fetzima varies depending on individual response to the medication. It is important to continue taking Fetzima even if symptoms improve, unless otherwise directed by a healthcare provider.
• Discontinuation: Abrupt discontinuation of Fetzima may lead to withdrawal symptoms. Therefore, it is important to taper off the medication gradually under the guidance of a healthcare provider, especially if the decision is made to stop treatment.
• Special Populations: Dosage adjustments may be necessary for individuals with hepatic impairment or severe renal impairment. Fetzima is not recommended for use in individuals with end-stage renal disease.
• Storage: Fetzima should be stored at room temperature away from moisture and heat. It should be kept out of reach of children.

As with any medication, it is important for individuals prescribed Fetzima to follow their healthcare provider’s instructions carefully, report any side effects or concerns promptly, and attend regular follow-up appointments for monitoring and adjustment of treatment as needed.

Other uses for this medicine

Some potential off-label uses may include:

• Generalized Anxiety Disorder (GAD): Some healthcare providers may prescribe Fetzima off-label for the treatment of generalized anxiety disorder.
• Chronic Pain: Fetzima’s mechanism of action involves increasing levels of serotonin and norepinephrine in the brain, which may provide relief for certain types of chronic pain conditions such as fibromyalgia or neuropathic pain.
• Social Anxiety Disorder: In some cases, Fetzima may be used off-label to manage symptoms of social anxiety disorder.

What special precautions should I follow?

As for special precautions to follow when taking Fetzima, here are some important considerations:

• Suicidal Thoughts and Behaviorv Like other antidepressants, Fetzima may increase the risk of suicidal thoughts and behavior, particularly in children, adolescents, and young adults. Close monitoring by healthcare providers is essential, especially during the early stages of treatment and dosage adjustments.
• Serotonin Syndrome: Fetzima can increase serotonin levels in the brain, potentially leading to serotonin syndrome. Symptoms of serotonin syndrome include agitation, hallucinations, rapid heart rate, high blood pressure, fever, excessive sweating, shivering or shaking, blurred vision, muscle spasm or stiffness, tremor, incoordination, stomach cramp, nausea, vomiting, and diarrhea. Seek immediate medical attention if you experience these symptoms.
• Blood Pressure and Heart Rate: Fetzima may increase blood pressure and heart rate, so it should be used with caution in individuals with pre-existing cardiovascular conditions.
• Liver Function: Regular monitoring of liver function tests may be necessary during treatment with Fetzima, as it has been associated with liver damage in some cases.
• Hyponatremia: Fetzima can cause low sodium levels in the blood (hyponatremia), which may lead to symptoms such as headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness. Contact your healthcare provider if you experience these symptoms.
• Pregnancy and Breastfeeding: The safety of Fetzima during pregnancy and breastfeeding has not been established. If you are pregnant, planning to become pregnant, or breastfeeding, discuss the risks and benefits of Fetzima with your healthcare provider.
• Drug Interactions: Fetzima may interact with other medications, including other antidepressants, monoamine oxidase inhibitors (MAOIs), linezolid, tramadol, and certain migraine medications. Inform your healthcare provider about all medications you are taking, including prescription, over-the-counter, and herbal supplements.
• Alcohol: Avoid alcohol while taking Fetzima, as it may increase the risk of side effects such as drowsiness and dizziness.

Always follow your healthcare provider’s instructions and advice when taking Fetzima, and contact them if you have any questions or concerns about its use.

What special dietary instructions should I follow?

• There are no specific dietary restrictions associated with taking Fetzima. However, maintaining a healthy and balanced diet is important for overall well-being, which can complement your treatment for depression.
• Some individuals may experience changes in appetite or weight while taking Fetzima. If you notice any significant changes, discuss them with your healthcare provider.

What should I do if I forget a dose?

• If you forget to take a dose of Fetzima, take it as soon as you remember, unless it is close to the time for your next scheduled dose. In that case, skip the missed dose and continue with your regular dosing schedule.
• Do not take a double dose to make up for a missed one.
• If you are unsure about what to do, or if you have missed several doses, contact your healthcare provider or pharmacist for guidance.

What side effects can this medication cause?

Fetzima (levomilnacipran) can cause various side effects, ranging from mild to severe. It’s important to note that not all individuals will experience these side effects, and some may experience none at all. Common side effects of Fetzima include:

• Nausea: Feeling nauseous or experiencing an upset stomach is a common side effect of Fetzima.
• Headache: Some individuals may experience headaches while taking Fetzima.
• Dry Mouth: Fetzima can cause a decrease in saliva production, leading to a dry mouth sensation.
• Sweating: Increased sweating, particularly during sleep, can occur as a side effect of Fetzima.
• Constipation: Fetzima may cause constipation in some individuals.
• Decreased Appetite: Some people may experience a decrease in appetite while taking Fetzima.
• Insomnia: Difficulty falling asleep or staying asleep can occur as a side effect of Fetzima.
• Increased Heart Rate: Fetzima may cause an increase in heart rate (tachycardia) in some individuals.
• Dizziness or Lightheadedness: Feeling dizzy or lightheaded is a possible side effect of Fetzima.
• Fatigue: Some individuals may experience fatigue or tiredness while taking Fetzima.
• Sexual Dysfunction: Fetzima can sometimes cause sexual side effects such as decreased libido, erectile dysfunction, or difficulty achieving orgasm.
• Blurred Vision: Blurred vision or changes in vision clarity may occur as a side effect of Fetzima.
• Urinary Retention: Difficulty emptying the bladder fully or experiencing urinary hesitancy can occur with Fetzima use.
• Hyponatremia: Fetzima may cause low sodium levels in the blood (hyponatremia), leading to symptoms such as headache, confusion, weakness, and unsteadiness.
• Withdrawal Symptoms: Abrupt discontinuation of Fetzima can lead to withdrawal symptoms such as dizziness, headache, nausea, vomiting, irritability, and sweating.

It’s essential to discuss any concerning side effects with your healthcare provider. They can provide guidance on managing side effects or adjusting your treatment plan if necessary. Additionally, seek medical attention if you experience severe or persistent side effects while taking Fetzima.

What should I know about storage and disposal of this medication?

Storage and Disposal:

• Store Fetzima at room temperature away from moisture and heat.
• Keep Fetzima out of reach of children and pets.
• Do not flush Fetzima down the toilet or pour it into a drain unless instructed to do so.
• Dispose of any unused or expired Fetzima properly according to local regulations or guidelines. You can consult your pharmacist or healthcare provider for information on how to dispose of medications safely.

In case of emergency/overdose

• If you suspect an overdose of Fetzima, seek immediate medical attention or contact a poison control center right away.
• Symptoms of Fetzima overdose may include extreme drowsiness, confusion, hallucinations, rapid heart rate, high blood pressure, seizures, fainting, and difficulty breathing.
• It is important to take the medication bottle with you to the hospital or provide information about the medication ingested.

What other information should I know?

• Inform all healthcare providers involved in your care that you are taking Fetzima, including dentists and pharmacists, as it may interact with other medications or treatments.
• Avoid alcohol while taking Fetzima, as it may increase the risk of side effects such as drowsiness and dizziness.
• Do not stop taking Fetzima suddenly without consulting your healthcare provider, as this can lead to withdrawal symptoms.
• Attend all scheduled follow-up appointments with your healthcare provider for monitoring and adjustment of your treatment plan.
• Be aware that Fetzima may cause dizziness or lightheadedness, especially when standing up from a sitting or lying position. Take caution when engaging in activities that require mental alertness or coordination.
• Inform your healthcare provider if you experience any new or worsening symptoms while taking Fetzima.
• Keep a list of all medications you are taking, including prescription, over-the-counter, and herbal supplements, and share it with your healthcare provider to avoid potential drug interactions.

By following these guidelines and staying informed about your medication, you can help ensure safe and effective use of Fetzima as part of your treatment plan for depression.