WARNING

Fintepla (fenfluramine) is a medication primarily used to treat seizures associated with Dravet syndrome, a severe form of epilepsy. While it can be effective in managing seizures, there are potential risks associated with its use:

• Cardiac Risks: Fenfluramine, the active ingredient in Fintepla, has been associated with cardiac valvulopathy, which is a condition affecting the heart valves. This risk led to the withdrawal of fenfluramine-based weight loss drugs in the past.
• Pulmonary Hypertension: Another serious risk is pulmonary arterial hypertension (PAH), a condition characterized by high blood pressure in the arteries of the lungs. This condition can lead to serious complications and may be fatal if not managed properly.
• Psychiatric and Behavioral Changes: Some patients may experience psychiatric and behavioral changes while taking Fintepla, including depression, aggression, and suicidal thoughts. It’s important to monitor patients closely, especially those with a history of psychiatric disorders.
• Serotonin Syndrome: Fintepla can increase serotonin levels in the brain, which may lead to serotonin syndrome, a potentially life-threatening condition characterized by rapid changes in mental status, agitation, muscle rigidity, and seizures.
• Drug Interactions: Fintepla can interact with other medications, particularly those that affect serotonin levels, such as antidepressants and certain migraine medications. These interactions can increase the risk of serotonin syndrome or other adverse effects.
• Other Side Effects: Common side effects of Fintepla include decreased appetite, diarrhea, fatigue, and insomnia. These side effects can vary in severity and may require adjustments to the dosage or discontinuation of the medication.

Due to these risks, Fintepla is typically prescribed under strict supervision by healthcare professionals who are experienced in managing epilepsy and its associated complications. Patients taking Fintepla should be closely monitored for any signs of adverse effects, and the benefits of the medication should be carefully weighed against the potential risks.

Why is this medication prescribed?

Fintepla (fenfluramine) is primarily prescribed for the treatment of seizures associated with Dravet syndrome, a rare and severe form of epilepsy that typically begins in infancy or early childhood. Dravet syndrome is known to be difficult to treat with conventional antiepileptic medications, and Fintepla may offer an additional treatment option for patients who have not responded well to other therapies.

Fenfluramine, the active ingredient in Fintepla, works by increasing the levels of serotonin in the brain, which can help to reduce the frequency and severity of seizures in some patients with Dravet syndrome.

How should this medicine be used?

When using Fintepla, it’s essential to follow the prescribing healthcare provider’s instructions carefully. Generally, the medication is taken orally, usually in the form of a solution. The dosage is typically started low and gradually increased over time to achieve the desired therapeutic effect while minimizing side effects.

Here are some general guidelines for using Fintepla:

• Dosage: The initial dosage and subsequent adjustments should be determined by a healthcare provider based on the patient’s age, weight, and individual response to the medication.
• Administration: Fintepla is typically taken orally, usually as a solution. It can be administered with or without food.
• Monitoring: Patients should be closely monitored by healthcare professionals while taking Fintepla, especially during the titration period when dosage adjustments are being made. This monitoring helps to assess the medication’s effectiveness and detect any potential side effects or adverse reactions.
• Compliance: It’s crucial for patients to take Fintepla exactly as prescribed by their healthcare provider. Missing doses or discontinuing the medication abruptly can increase the risk of breakthrough seizures or other complications.
• Adverse Effects: Patients and caregivers should be aware of potential side effects of Fintepla, such as decreased appetite, fatigue, diarrhea, and insomnia. Any concerning or severe side effects should be reported to a healthcare provider promptly.
• Interactions: Fintepla can interact with other medications, so it’s essential to inform healthcare providers about all medications, supplements, or herbal products being taken concurrently.
• Regular Check-ups: Regular follow-up appointments with healthcare providers are essential for ongoing monitoring of the patient’s response to Fintepla and adjustment of the treatment plan as needed.

Overall, Fintepla should be used as part of a comprehensive treatment approach for Dravet syndrome under the guidance and supervision of experienced healthcare professionals.

Other uses for this medicine

Fintepla is primarily indicated for the treatment of seizures associated with Dravet syndrome. However, it’s always essential to consult with a healthcare professional for any off-label uses of medications.

What special precautions should I follow?

Regarding special precautions for Fintepla, here are some important considerations:

• Cardiac Monitoring: Fintepla can cause valvular heart disease and pulmonary arterial hypertension. Before starting treatment, patients should undergo cardiac evaluation, including echocardiogram and cardiology consultation, to assess baseline cardiac status. Regular cardiac monitoring is essential during treatment.
• Pregnancy: Fintepla may cause fetal harm if used during pregnancy. It’s important for women of childbearing potential to use effective contraception during treatment and for at least one month after discontinuing Fintepla.
• Serotonin Syndrome: Fintepla increases serotonin levels and may lead to serotonin syndrome when used with other serotonergic drugs. Caution should be exercised when combining Fintepla with other medications that affect serotonin levels.
• Hypotension and Bradycardia: Fintepla can cause hypotension and bradycardia. Blood pressure and heart rate should be monitored during treatment, especially in patients with cardiac abnormalities or on medications affecting blood pressure or heart rate.
• Withdrawal Symptoms: Abrupt discontinuation of Fintepla can lead to withdrawal symptoms. Dosage should be tapered off gradually under medical supervision when discontinuing treatment.
• Psychiatric Effects: Fintepla may cause psychiatric adverse reactions, including aggression, anxiety, irritability, and depression. Patients should be monitored for these effects, especially at the initiation of treatment and during dosage adjustments.
• Sedation and Cognitive Impairment: Fintepla may cause sedation and cognitive impairment, which can affect the ability to operate machinery or drive. Patients should be advised to avoid activities requiring mental alertness until they know how Fintepla affects them.

As with any medication, it’s crucial to discuss potential risks and benefits with a healthcare provider before starting treatment with Fintepla. They can provide personalized guidance based on individual health factors and medical history.

What special dietary instructions should I follow?

There are no specific dietary instructions associated with Fintepla. However, it’s always important to maintain a balanced diet and follow any dietary recommendations provided by a healthcare provider. Some individuals may experience changes in appetite or weight while taking Fintepla, so monitoring food intake and weight regularly may be beneficial.

What should I do if I forget a dose?

If a dose of Fintepla is missed, it should be taken as soon as remembered, unless it is almost time for the next scheduled dose. In that case, the missed dose should be skipped, and the regular dosing schedule should be resumed. Patients should not take a double dose to make up for a missed one. If unsure about what to do, it’s advisable to consult a healthcare provider or pharmacist for guidance.

What side effects can this medication cause?

Fintepla (fenfluramine) can cause a range of side effects, some of which may be serious and require medical attention. It’s important to note that not all individuals will experience these side effects, and the severity and frequency can vary. Common side effects of Fintepla may include:

• Decreased appetite: Many patients experience a decrease in appetite while taking Fintepla.
• Fatigue: Feeling tired or fatigued is a common side effect.
• Somnolence: Some individuals may experience drowsiness or excessive sleepiness.
• Diarrhea: Diarrhea is reported as a common side effect.
• Pyrexia (fever): Fever can occur in some patients.
• Upper respiratory tract infection: This includes symptoms such as cough, nasal congestion, and sore throat.
• Vomiting: Nausea and vomiting are potential side effects.
• Bradycardia: A slower than normal heart rate can occur.
• Decreased weight: Weight loss is commonly reported.
• Lethargy: A feeling of sluggishness or lack of energy may occur.
• Fall: Some individuals may experience falls.
• Decreased blood pressure: Hypotension, or low blood pressure, can occur.
• Pneumonia: Infections such as pneumonia have been reported.
• Nausea: Some patients may experience nausea as a side effect.
• Decreased heart rate: Fintepla can cause a decrease in heart rate.
• Dizziness: Feeling lightheaded or dizzy is reported in some patients.
• Insomnia: Difficulty falling or staying asleep may occur.
• Aggression: Some patients may experience increased aggression or irritability.
• Constipation: Difficulty passing stools can occur.
• Rash: Skin rash or itching may occur.

It’s important for patients to report any side effects they experience to their healthcare provider. Additionally, some side effects of Fintepla may be serious and require immediate medical attention, including signs of valvular heart disease, pulmonary arterial hypertension, serotonin syndrome, and psychiatric effects such as new or worsening depression, anxiety, or aggression. Any unusual symptoms or concerns should be discussed with a healthcare provider promptly.

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

Storage and Disposal:

Storage:

• Store Fintepla at room temperature between 20 to 25 degrees Celsius (68 to 77 degrees Fahrenheit).
• Keep Fintepla in its original container, tightly closed, and out of reach of children.
• Protect the medication from light and moisture.
• Do not freeze Fintepla.

Disposal:

• Dispose of unused or expired Fintepla properly.
• Follow any specific disposal instructions provided by your healthcare provider or pharmacist.
• Do not flush Fintepla down the toilet or pour it down the drain unless instructed to do so.
• Contact your local waste disposal facility for guidance on how to properly dispose of Fintepla.

In case of emergency/overdose

In case of emergency or overdose of Fintepla:

• In case of an overdose or emergency situation, call your local emergency services or go to the nearest emergency room immediately.
• Symptoms of overdose may include severe drowsiness, confusion, difficulty breathing, seizures, and loss of consciousness.
• It’s important to bring the medication container or information about the medication to the emergency room if possible.

What other information should I know?

• Follow all dosage instructions provided by your healthcare provider carefully. Do not adjust your dose without consulting your healthcare provider.
• Keep all appointments for follow-up and monitoring, including cardiac evaluations if recommended by your healthcare provider.
• Inform your healthcare provider about all medications, supplements, and herbal products you are taking before starting Fintepla, as it may interact with certain medications.
• Avoid consuming alcohol while taking Fintepla, as it may increase the risk of side effects.
• Do not stop taking Fintepla abruptly without consulting your healthcare provider, as it may lead to withdrawal symptoms.
• Report any new or worsening symptoms to your healthcare provider promptly, including mood changes, aggression, or unusual behavior.

Always consult your healthcare provider or pharmacist if you have any questions or concerns about Fintepla or its use. They can provide personalized guidance based on your individual medical history and needs.