Fycompa

Fycompa is a prescription medication used to treat certain types of seizures in people with epilepsy. Fycompa belongs to a group of drugs called anti-epileptic medicines, which decrease abnormal brain activity.

This medication is available as a tablet and an oral suspension and is taken once a day before bedtime.

Common side effects include dizziness, sleepiness, and tiredness. Do not drive or operate heavy machinery until you know how Fycompa affects you.

Fycompa is a prescription medicine that is:

• used to treat partial-onset seizures with or without secondarily generalized seizures in people with epilepsy who are 12 years of age and older
• given with other medications to treat primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

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Fycompa may cause serious side effects. See "Drug Precautions" section.

The most common side effects include:

• dizziness
• sleepiness
• tiredness
• irritability
• falls
• nausea
• problems with muscle coordination
• problems walking normally
• vertigo (sense of spinning)
• weight gain

Tell your healthcare provider about any side effect that bothers you or does not go away.

These are not all of the possible side effects of Fycompa. For more information ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Taking Fycompa with certain other medicines can cause side effects or reduce either drug's benefit. Especially tell your healthcare provider if you take:

• oral contraceptives (birth control pills). Fycompa may lower your oral contraceptive's ability to prevent pregnancy if your oral contraceptive contains levonorgestrel.
• carbamazepine (Carbatrol, Tegretol, Tegretol XR, Equetro)
• phenytoin (Dilantin, Phenytek) 
• oxcarbazepine (Trileptal)
• rifampin (Rifadin, Rimactane)
• St. John's Wort

Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist each time you get a new medicine.

Fycompa may cause serious side effects including:

1. Fycompa may cause mental (psychiatric) problems. Tell your healthcare provider right away if you have any new or worsening mental problems including:
   • new or worse aggressive behavior (including homicidal behavior), hostility, anger, anxiety, or irritability
   • being suspicious or distrustful (believing things that are not true)
   • other unusual or extreme changes in behavior or mood
2. Like other antiepileptic drugs, Fycompa may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you. Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.
   • thoughts about suicide or dying
   • attempt to commit suicide
   • new or worse depression
   • new or worse anxiety
   • feeling agitated or restless
   • panic attacks
   • trouble sleeping (insomnia)
   • new or worse irritability
   • acting aggressive, being angry, or violent
   • acting on dangerous impulses
   • an extreme increase in activity and talking (mania)
   • other unusual changes in behavior or mood

Watch for early symptoms of suicidal thoughts and actions:

• Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
• Keep all follow-up visits with your healthcare provider as scheduled.

3. A serious allergic reaction that may affect your skin or other parts of your body such as your liver, kidneys, heart, or blood cells. This allergic reaction can be life-threatening and can cause death. Call your healthcare provider right away if you have:

• a skin rash, hives
• fever or swollen glands that do not go away
• swelling of your face
• shortness of breath
• swelling of the legs
• yellowing of the skin or whites of the eyes, or dark urine

Fycompa may cause other serious side effects, including:

• Dizziness, vertigo (sense of spinning) and problems walking normally. You may have problems walking normally if you are unsteady because you feel dizzy. These symptoms can increase when your dose of Fycompa is increased. Your risk of feeling dizzy and having problems walking normally may be higher if you are elderly.
• Sleepiness and tiredness.
• Increased risk of falls. Taking Fycompa can increase your chance of falling. These falls can cause serious injuries. Your risk of falling may be higher if you are elderly.

Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop Fycompa without first talking with a healthcare provider. Stopping Fycompa suddenly can cause serious problems. Stopping Fycompa suddenly can cause you to have seizures more often.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Fycompa there are no specific foods that you must exclude from your diet when receiving this medication.
 

Before you take Fycompa, tell your healthcare provider if you:

• have or have had depression, mood problems, aggressive or hostile behavior (for example homicidal behavior), suicidal thoughts or behavior, or other psychiatric problems
• have liver or kidney problems
• drink alcohol
• have abused prescription medicines, street drugs, or alcohol in the past
• have any other medical problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

• If you become pregnant while taking Fycompa, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of Fycompa and other antiepileptic medicine during pregnancy.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if Fycompa passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Fycompa. You and your healthcare provider should decide if you will take Fycompa or breastfeed. You should not do both.

• Take Fycompa exactly as your healthcare provider tells you. Your healthcare provider will tell you how much Fycompa to take and when to take it.
• Fycompa is usually taken 1 time a day at bedtime.
• If you take the oral suspension, make sure to use the provided adaptor and dosing syringe to measure the oral suspension. 
• Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider.
• Talk to your healthcare provider about what to do if you miss 1 or more doses of Fycompa.
• If you take too much Fycompa, call your local Poison Control Center or go to the nearest hospital emergency room right away.

What to avoid while taking Fycompa:

• Do not drive, operate heavy machinery, or do other dangerous activities until you know how Fycompa affects you. Fycompa may make you dizzy, sleepy or tired.
• Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking Fycompa until you talk to your healthcare provider. Fycompa taken with alcohol or medicines that cause sleepiness or dizziness may make your sleepiness or dizziness worse.

The recommended starting dosage of Fycompa is 2 mg once daily taken orally at bedtime. Increase dosage by 2 mg per day increments no more frequently than every week. In elderly patients, dosage increases during titration are recommended no more frequently than every two weeks.

The recommended maintenance dose range for treating partial-onset seizures is 8 mg to 12 mg once daily.

The recommended maintenance dose for treating primary generalized tonic-clonic seizures is 8 mg once daily at bedtime. 

The dose will depend on how you tolerate the medication and how you respond to the medication. 

Your healthcare provider may recommend a different dose if you are taking certain other medications in combination with Fycompa. Dosage adjustments may also be recommended if you have liver or kidney disease.

If you take too much Fycompa, call your local Poison Control Center or go to the nearest hospital emergency room right away.

• Store Fycompa tablets at room temperature between 68°F to 77°F (20°C to 25°C).
• Store Fycompa oral suspension below 86° F (30°C). Do not freeze.
• Replace the cap tightly after opening.
• Use Fycompa oral suspension within 90 days after the bottle is first opened
• Keep Fycompa and all medicines out of the reach of children.

WARNING: SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS

• Serious or life-threatening psychiatric and behavioral adverse reactions including aggression, hostility, irritability, anger, and homicidal ideation and threats have been reported in patients taking Fycompa.
• These reactions occurred in patients with and without prior psychiatric history, prior aggressive behavior, or concomitant use of medications associated with hostility and aggression.
• Advise patients and caregivers to contact a healthcare provider immediately if any of these reactions or changes in mood, behavior, or personality that are not typical for the patient are observed while taking Fycompa or after discontinuing Fycompa.
• Closely monitor patients particularly during the titration period and at higher doses.
• Fycompa should be reduced if these symptoms occur and should be discontinued immediately if symptoms are severe or are worsening.