Fintepla

Approved Uses

Fintepla is specifically indicated for the treatment of seizures associated with two rare and severe forms of epilepsy:

• Dravet syndrome: A rare, lifelong genetic condition that typically begins in infancy. It is characterized by frequent or prolonged seizures that are often difficult to control.
• Lennox-Gastaut syndrome: A severe form of epilepsy that usually appears in early childhood. It involves multiple types of seizures and often requires several medications for management.

This medication is approved for use in patients who are at least 2 years of age. It is typically prescribed when other anti-seizure treatments have not provided adequate relief or control of seizure activity.

Mechanism of Action

Fintepla belongs to a class of medications known as anticonvulsants. While the exact way it works to control seizures is not fully understood, researchers believe it primarily affects chemical signaling in the brain.

Serotonin Regulation

One of the main ways Fintepla is thought to work is by increasing the levels and activity of serotonin. Serotonin is a natural substance, or neurotransmitter, that helps brain cells communicate. Fintepla acts as a serotonin receptor agonist, which means it stimulates specific receptors in the brain that respond to serotonin. This increased activity is believed to help regulate the electrical signals that can lead to seizures.

Sigma-1 Receptors

In addition to its effects on serotonin, Fintepla may also interact with sigma-1 receptors. These receptors play a role in how nerve cells function and communicate with one another. By acting on these pathways, the medication helps stabilize brain activity.

By influencing these different chemical systems, Fintepla helps to decrease the frequency of seizures in people with certain types of epilepsy, such as Dravet syndrome and Lennox-Gastaut syndrome.

Common Side Effects

• Decreased appetite and weight loss
• Drowsiness or extreme tiredness
• Diarrhea, constipation, or vomiting
• Fever
• Drooling
• Upper respiratory tract infections
• Increased risk of falls

Serious Side Effects

Contact a healthcare provider immediately if you experience any of the following serious side effects:

• Heart valve problems: Signs may include shortness of breath, swelling in the legs or ankles, or a fast or irregular heartbeat.
• Pulmonary arterial hypertension: High blood pressure in the lungs, which can cause difficulty breathing or tiredness.
• Serotonin syndrome: A dangerous reaction that may cause agitation, hallucinations, rapid heart rate, sweating, muscle stiffness, or tremors.
• Suicidal thoughts: New or worsening depression, anxiety, or thoughts of hurting yourself.
• Vision changes: Eye pain, redness, or blurred vision, which may indicate increased pressure in the eye (glaucoma).

Heart and Lung Risks

Fintepla is associated with risks of valvular heart disease and pulmonary arterial hypertension (PAH). Due to these risks, the medication is only available through a restricted distribution program called the Fintepla REMS. Patients must undergo echocardiograms to monitor heart and lung health before starting treatment, every six months during treatment, and three to six months after the final dose.

Drug Interactions and Contraindications

This medication should not be used by anyone with a known hypersensitivity to fenfluramine. It is also contraindicated for use with or within 14 days of taking monoamine oxidase inhibitors (MAOIs), as this combination increases the risk of serotonin syndrome.

Mental Health and Neurological Warnings

• Suicidal Behavior: Anti-seizure medications, including Fintepla, may increase the risk of suicidal thoughts or actions.
• Serotonin Syndrome: This is a potentially life-threatening condition characterized by mental status changes, fast heart rate, and muscle coordination issues, particularly when used with other serotonergic drugs.
• Somnolence: Fintepla can cause significant sleepiness and sedation.

Additional Precautions

• Weight Loss: Decreased appetite and weight loss are common. Healthcare providers typically monitor weight during treatment.
• Glaucoma: The medication may cause increased pressure in the eyes.
• Seizure Frequency: Stopping Fintepla abruptly can lead to an increase in seizure frequency. Withdrawal should be managed gradually under medical supervision.

Pregnancy

The safety of Fintepla during pregnancy has not been established. While animal studies have suggested potential risks to a developing fetus, there is currently no adequate data on its effects in pregnant humans. Individuals who are pregnant or planning to become pregnant should consult their healthcare provider to weigh the potential benefits against the risks.

There is a pregnancy registry for people who take Fintepla during pregnancy. This registry monitors outcomes to help healthcare professionals understand the drug's impact on pregnancy and infant health.

Breastfeeding

It is unknown if Fintepla passes into breast milk or if it could affect a breastfeeding child. If you are breastfeeding or planning to breastfeed, discuss your options with your doctor to determine the safest approach for you and your baby.

Dosage Forms

Fintepla is supplied in the following form:

• Oral solution: This is a liquid form of the medication that is swallowed.

The oral solution is a clear, colorless liquid. It is typically administered using a specialized oral syringe to ensure the dose is measured correctly. It is important to use the measuring device provided with the medication rather than a household spoon.

FDA Approval and Indications

Fintepla (fenfluramine) was first approved by the FDA in June 2020 for the treatment of seizures associated with Dravet syndrome. In March 2022, the FDA expanded its approved use to include the treatment of seizures associated with Lennox-Gastaut syndrome. It is indicated for use in pediatric and adult patients 2 years of age and older.

Boxed Warning and Safety Risks

The FDA has issued a Boxed Warning for Fintepla because of the risk of serious cardiovascular complications, specifically valvular heart disease and pulmonary arterial hypertension. Because of these risks, patients must undergo regular cardiac monitoring, including echocardiograms before starting treatment, every six months during treatment, and once six months after treatment has stopped.

REMS Program

Due to the risk of heart and lung complications, Fintepla is only available through a restricted distribution program called the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS). Under this program:

• Prescribers and pharmacies must be certified with the REMS program to prescribe or dispense the medication.
• Patients must be enrolled in the program and comply with the required cardiac monitoring schedule.

Controlled Substance Status

Fintepla is classified as a Schedule IV controlled substance under the Controlled Substances Act. This classification is due to its potential for abuse and dependence, requiring healthcare providers to monitor patients for signs of misuse.

Brand-Name Status

Fintepla is a brand-name medication, and there is currently no generic version available. Brand-name drugs typically cost more than generics because they are protected by patents that prevent other companies from making the same medication for a set period.

Insurance Coverage

Most insurance plans, including private insurance and government programs like Medicare or Medicaid, may cover Fintepla. However, the out-of-pocket cost will vary based on your specific plan's formulary, your deductible, and your copayment or coinsurance requirements. Some insurance companies may require prior authorization before they agree to cover the medication.

Specialty Pharmacy and REMS

Fintepla is not available at most local retail pharmacies. It must be obtained through a restricted distribution program called the Fintepla REMS program. This means the drug is dispensed by authorized specialty pharmacies, which may have different billing processes than standard pharmacies.

Financial Assistance

The manufacturer of Fintepla offers support programs to help patients manage the cost of the drug. These may include:

• Copay Savings Cards: These cards can help reduce out-of-pocket costs for patients with commercial (private) insurance.
• Patient Assistance Programs: These programs may provide the medication at a lower cost or for free to individuals who are uninsured or underinsured and meet certain income requirements.