If you have had a seizure, there are many medicines that can help lower your risk of having more seizures. The right choice for you depends on several factors, including the cause and the type of seizures you have. Fintepla is a medicine used to treat seizures related to Lennox-Gastaut syndrome (LGS) or Dravet syndrome.
How Does Fintepla Work for Seizures?
Seizures are caused by sudden electrical activity changes in the brain. These changes are temporary but result in changes in movement, behavior, sensation, or awareness.
The exact way that Fintepla works to reduce the number of seizures you have is not known. Fintepla may alter electrical signals in the brain to help reduce your seizures.
How Do I Take Fintepla?
Fintepla is an oral liquid that you take twice daily. Your health care provider will decide the proper dose based on your body weight.
The Fintepla bottle is supplied with a bottle adapter to help you measure the exact dose of Fintepla. This adapter should stay on the bottle. The child-resistant cap can be placed over the bottle adapter.
Your Fintepla oral solution is supplied with two syringe sizes, and you should select the size that best matches your dose.
- If your dose is 3 mL or less, use the 3 mL syringe.
- If your dose is more than 3 mL, use the 6 mL syringe.
To withdraw your dose of Fintepla, insert the appropriate size syringe into the bottle adapter with the plunger all the way down. Flip the bottle upside down and slowly pull back the plunger of the syringe to withdraw the dose you need. Once you have collected the right dose, turn the bottle right side up and pull the oral syringe out of the bottle adapter.
Fintepla should be slowly administered from the syringe to the inside of the cheek. Do not forcefully push the plunger or administer to the back of the throat, as this may cause choking.
The bottle of Fintepla can be used for up to three months. After that, you should discard any Fintepla that has not been used.
Follow your health care provider’s directions and read the full Instructions for Use that comes with your medicine.
How Was Fintepla Studied for Seizures?
Fintepla was studied in separate clinical trials for people with Lennox-Gastaut syndrome and Dravet syndrome.
Lennox-Gastaut syndrome (LGS)
One study tested whether Fintepla could reduce seizures in people with LGS. People aged 2-35 years continued their usual seizure medicines and were given either Fintepla or a placebo that did not contain medicine for 14 weeks. Most people were taking one to four medicines for their seizures when they started the study. The median (middle) number of seizure medicines at the time of study entry was three. The most common seizure medicines were valproate, clobazam, lamotrigine, levetiracetam, and rufinamide.
The study included 263 patients. The average participant age was 13 years. More than half (56%) were men, and 44% were women. Most were White (79%), 5% were Black or African American, 3% were Asian, and the rest identified as other races, unknown, or did not report their race.
Even though they were already taking other seizure medicines, all of the people in the study had two or more drop seizures per week during the four weeks before the study started. A drop seizure is a type of seizure where your muscles go limp, causing you to drop objects or fall.
The main goal of the study was to look at whether adding Fintepla to the participants’ ongoing treatment lowered the number of drop seizures compared to placebo after 14 weeks of treatment. People taking Fintepla had a median drop seizure reduction of 26.5%, while people taking a placebo had a 7.6% seizure reduction.
Out of the study participants who were not missing data, Fintepla reduced monthly seizures that resulted in a fall or injury by 23.7% during the study, compared with an 8.7% reduction in the placebo group.
Your results may differ from what was seen in clinical studies.
Dravet syndrome (DS)
Two studies tested whether Fintepla could reduce seizures in people with DS who had seizures that were not controlled with at least one seizure medicine. Both studies included people aged 2-18 years (average age, 9 years). In one study (study 1), people were not taking stiripentol (another medicine for seizures), while in the other study (study 2), all people were taking stiripentol.
Study 1 involved 119 people who were treated with either a lower dose of Fintepla, a higher dose of Fintepla, or a placebo for 14 weeks. People in the study were taking one to four medicines for their seizures when they started the study. The average number of seizure medicines at the time of study entry was 2.4. The most common seizure medicines taken with the study medicine were clobazam, valproate, levetiracetam, and topiramate.
Even though they were already taking other seizure medicines, all of the people in this study had six or more seizures during the six weeks before the study started. The study looked at whether adding Fintepla to their treatment lowered the number of convulsive seizures per month compared to placebo. A convulsive seizure is a type of seizure where your body shakes uncontrollably, or your muscles stiffen or jerk.
Results. People taking a higher dose of Fintepla had 62.3% fewer seizures each month compared to placebo, and people taking a lower dose of Fintepla had 32.4% fewer seizures each month compared to placebo.
In study 2, a total of 87 people received either Fintepla or a placebo for 15 weeks. People in the study had to take stiripentol plus either clobazam or valproic acid, and they were taking up to four seizure medicines when the study started. Even though they were already taking other seizure medicines, including stiripentol, all of the people in this study had six or more seizures during the six weeks before the study started. The study looked at whether adding Fintepla decreased the number of convulsive seizures per month compared to placebo. People taking Fintepla had 54% fewer convulsive seizures each month compared to placebo.
Your results may differ from what was seen in clinical studies.
What Are the Serious Safety Concerns With Fintepla?
Fenfluramine, the active ingredient in Fintepla, has been linked to serious problems with heart valves (valvular heart disease) and pulmonary arterial hypertension (high blood pressure in the arteries of your lungs). Although no serious safety concerns were reported during clinical trials, Fintepla is only available through a special program, from certain pharmacies, and to certain people because of the risk of safety concerns.
Before you start treatment with Fintepla, your health care provider will do a test called an echocardiogram. The echocardiogram checks your heart and can identify high blood pressure in the arteries of your lungs. You will receive an echocardiogram every six months while you take Fintepla and a final echocardiogram three to six months after you stop Fintepla.
You should contact your health care provider if you develop any signs or symptoms of heart or lung problems:
- Trouble breathing
- Tiredness or weakness
- Dizziness or fainting
- Swelling or fluid in your ankles or feet
- Chest pain
- Fast or abnormal heartbeat
- Bluish skin or lips
Other serious side effects of Fintepla may include weight loss or a decrease in appetite, tiredness, and thoughts of suicide. You should contact your health care provider or seek help right away if you have thoughts of suicide, new or worsening depression, or other changes in mood or feelings.
How Do I Manage Common Side Effects of Fintepla?
In studies, the most common Fintepla side effects were reduced appetite and diarrhea. Decreased appetite affected up to 49% of people with Dravet syndrome and up to 36% of people with Lennox-Gastaut syndrome. Decreased appetite can lead to weight loss, which may be concerning, especially in children. In studies, some children lost a noticeable amount of weight, but many returned to normal weight over time.
During Fintepa treatment, health care providers will regularly check weight and growth and can make changes if needed to support healthy growth. Let your health care provider know if you have decreased appetite, diarrhea, or other side effects while taking Fintepla. They can recommend ways to manage this side effect, such as dose adjustments or diet changes.
How Do I Get Fintepla?
Fintepla is only available through a drug safety program known as the Risk Evaluation and Mitigation Strategy (REMS) due to its safety concerns. Before you can take Fintepla, you need to be enrolled in the REMS program. Once your health care provider has submitted the required forms, you will be enrolled in the ONWARD Support Program, which will contact you with more information regarding your medicine.
What Are Other Unique Considerations to Be Aware Of?
Do not stop taking Fintepla without consulting your health care provider. You should not stop taking Fintepla suddenly because this may cause you to have more seizures and increase your risk of status epilepticus. Your health care provider will help you decrease your dose slowly if you need to stop taking Fintepla.
Your health care provider will monitor your weight during Fintepla treatment. You may require a lower dose of Fintepla if you lose weight during treatment. In some cases, you may have to stop taking Fintepla if your weight decreases.
Your health care provider will monitor your blood pressure during Fintepla treatment. Fintepla may increase your blood pressure even if you have never had high blood pressure before.
Fintepla is compatible with a ketogenic diet. It contains no gluten, and carbohydrates — which come from the cherry flavor — make up no more than 0.1%.
Is There Any Cost Assistance Available?
You may be eligible for assistance with the cost of Fintepla. Find out more by visiting www.fintepla.com/cost-and-copay or calling 833-463-7547.
