Seizures can affect your daily life and well-being. Certain medicines can help lower the risk of having seizures, which can help manage your condition. Fycompa is a medicine used to manage partial-onset seizures (also known as focal seizures) in children and adults.
How Does It Work for Partial-Onset Seizures?
A seizure happens when neurons in the brain, which are responsible for communicating chemical and electrical signals, suddenly fire too much. Neurons control how you move, think, and speak. When there is too much electrical signaling in the brain caused by the neurons, this can cause your body to do things that you cannot control.
Seizures can be triggered by many things, such as:
- Certain medicines or missing doses of medicines
- Infections
- Using recreational drugs such as cocaine or ecstasy
- Flashing lights
- Drinking too much alcohol
- Lack of sleep
- Stress
A partial-onset seizure, also known as a focal seizure, starts in one part of the brain. This type of seizure can cause symptoms such as:
- Seeing, feeling, or hearing things that are not there
- Twitching in your arms, legs, or fingers
- Strange tastes or smells
- Gagging, smacking your lips, crying, or laughing suddenly
- Seeing flashes of light
- Uncontrolled muscle contractions
Fycompa is a medicine that contains the drug perampanel, which is used to treat and prevent seizures. Although the exact way that Fycompa works to decrease the amount of seizures is not known, it is thought to be related to its effects on glutamate receptors in the brain. Fycompa blocks these receptors, which decreases the firing of nerve cells, leading to fewer seizures.
How Do I Use It?
Fycompa comes as a tablet or oral liquid that is taken once a day at bedtime.
When you first start Fycompa, your health care provider will likely start you on the lowest dose of Fycompa and increase your dose by a small amount each week until you reach a dose that controls your seizures. This slow increase in your dose is called titration. A maintenance dose is the dose that you stay on and take every day to help manage your symptoms. Your health care provider will determine the right dose for you based on your other medical conditions, how well Fycompa is working to control your seizures, and whether you are having any side effects.
How Was Fycompa Studied?
Three clinical studies were done to see if Fycompa was safe and effective for controlling partial-onset seizures. People in the studies were 12 years of age or older and were still having seizures despite already taking other seizure medicines. Across the studies, more than 85% of people were receiving two to three seizure medicines. The most common seizure medicines taken were carbamazepine, lamotrigine, levetiracetam, and valproic acid (also known as divalproex). Even though they were already taking other seizure medicines, all of the people in these studies had five or more seizures during the six weeks before the study started.
People in the three studies had an epilepsy diagnosis for an average of 21 years, and had a median (middle) seizure frequency of nine to 14 seizures per 28 days at the start of the studies. People across the studies were, on average, 35 years old, and approximately 75% were White, 2% Black or African American, 12% Asian, 7% Chinese, and 3% classified as "Other. "
The studies looked at whether adding Fycompa to their treatment decreased the number of seizures. People received Fycompa or a placebo pill that did not contain medicine for 19 weeks during the studies. People did not know if they were taking Fycompa or a placebo.
What Benefits Were Seen in the Studies?
During the three studies, Fycompa reduced the amount of seizures over the dose range of 4 to 12 mg daily. Although Fycompa did not reduce the number of seizures by 50% compared to a placebo in all of the studies, Fycompa was still shown to be better at reducing the number of seizures compared to a placebo.
In the first two studies, Fycompa reduced the number of seizures over 28 days at doses of 8 mg and 12 mg daily when compared to placebo medicine. When taking Fycompa with other medicines for seizures, the median (middle) number of partial-onset seizures over 28 days was reduced by 18% to 34% in people taking 12 mg daily, by 26%-31% in people taking 8 mg daily, and by 10%-21% in people taking a placebo.
In the third study, Fycompa reduced the number of seizures over 28 days at doses of 4 mg and 8 mg daily when compared to placebo medicine. When taking Fycompa with other medicines for seizures, the median (middle) number of partial-onset seizures over 28 days was reduced by 31% in people taking 8 mg daily, by 23% in people taking 4 mg daily, and by 11% in people taking a placebo.
Your results may differ from what was seen in the clinical studies.
How Strong Is the Evidence for It?
Guidelines for treatment-resistant epilepsy state that Fycompa helps as an additional seizure medicine in certain people who still have partial-onset seizures even though they are taking other seizure medicines.
How Can I Tell if It Is Working?
Fycompa works to lower your risk of having a seizure by stopping the nerve cells in your brain from over-firing. Your health care provider has to slowly increase your dose of Fycompa weekly when you first start taking the medicine, which means you may not see the full effects of the medicine right away.
If Fycompa is working for you, you will have fewer seizures than you did before you started taking the medicine. If you have already increased your dose of Fycompa and are still having the same number of seizures as before, or are having more seizures than before, speak with your health care provider about your treatment options. Your health care provider may increase the dose of Fycompa if you are not already on the highest dose, add on another medicine, or change you to a different medicine. Do not stop taking Fycompa without speaking to your health care provider first, even if it does not seem to be working for you. Stopping Fycompa suddenly can cause you to have more seizures. It can also cause other serious adverse effects.
What Are Common Side Effects and How Can I Manage Them?
Some common side effects seen with Fycompa are dizziness, sleepiness, and tiredness. Fycompa has also caused serious psychiatric and behavioral problems in some people.
Because Fycompa can make you dizzy, sleepy, or tired, it is important to not drive, operate heavy machinery, or do other dangerous activities until you know how Fycompa affects you. Dizziness, sleepiness, or tiredness with Fycompa can also increase your risk of falls and injuries. Be careful walking, climbing stairs, and doing other physical activities while taking Fycompa.
Because Fycompa has caused serious mental and behavioral problems in some people, you should pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. Your family and caregivers should also help you watch for these changes. Mental (psychiatric) and behavioral problems to watch for include suicidal thoughts and actions, anger, aggressive behavior, hostility, seeing or hearing things that others do not see or hear (hallucinations), delusional thoughts, confusion, unusual changes in mood, personality, or behavior, and other behavioral problems. Tell your health care provider right away if you have any of those symptoms, or if you have been told by others that you have those symptoms.
If you are having headaches because of Fycompa, taking over-the-counter medicines such as acetaminophen or ibuprofen can help. Talk to your health care provider if your headaches do not go away or if they are getting worse.
These are not all the possible side effects of Fycompa. Contact your health care provider for medical advice about side effects if you are having symptoms that bother you. You can also report side effects to the FDA at 800-FDA-1088 (800-332-1088).
What Type of Drug Interactions Can Happen?
Taking certain medicines for seizures, some of which include carbamazepine (Tegretol, Carbatrol), oxcarbazepine (Trileptal), and phenytoin (Dilantin, Phenytek), with Fycompa can cause Fycompa to not work as well. Your health care provider may increase your dose of Fycompa when you are taking any of these medicines. And if you stop taking any of these medicines while taking Fycompa, you should let your health care provider know, since they may need to lower your dose of Fycompa.
Taking Fycompa with birth control that contains levonorgestrel can cause the birth control to not work as well. A backup method of birth control (condoms, diaphragm, spermicide) should be used when taking Fycompa and for one month after stopping Fycompa.
Fycompa may cause you to feel drowsy or dizzy. Taking Fycompa with alcohol or other medicines that make you feel drowsy can worsen this. Taking Fycompa with alcohol can also worsen your mood and increase anger, confusion, and depression. Do not drink alcohol or take other medicines while taking Fycompa without first talking to your health care provider. Do not drive or do activities that require alertness or coordination if you feel drowsy.
This is not a complete list of interactions. Tell your pharmacist or other health care provider about all the prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, or other supplements you take or have recently taken. This will help them know if there are any interactions with Fycompa, or if you need to change your dose.
What Are Other Unique Considerations to Be Aware Of?
Fycompa is classified as a Schedule III controlled medicine, which means it has a high risk of abuse and misuse. Taking the medicine can lead to physical dependence, which means your body starts to rely on the medicine. Suddenly stopping the medicine or significantly decreasing your dose can cause anxiety, nervousness, crankiness, fatigue, lack of energy, weakness in the body, mood swings, and insomnia. Keep Fycompa in a safe place. Selling or giving Fycompa to other people can cause harm and is illegal.
Is There Any Cost Assistance Available?
There is a savings card program available for people with insurance that can reduce your prescription cost to as little as $5 per month. You can find out more by visiting www.fycompa.com/savings-card-program/ or by calling 888-392-6674.
