Perampanel

Brand Names: Fycompa

Perampanel (per AM pa nel) has been approved by the FDA to treat focal-onset seizures (with or without secondarily generalized seizures) in patients 4 years and older and as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 12 years and older.

Your epilepsy treatment should always be discussed with your healthcare provider before use. Based on their judgment and knowledge, a drug may be prescribed for other epilepsy types not included in the indications. For more information, please see the prescribing information.

How can you take perampanel? (Available formulations)

Perampanel is available as a tablet or oral suspension.

Who should not take perampanel?

Other considerations may influence whether you should take perampanel. Tell your healthcare provider if you:

  • have or have had depression, mood problems, aggressive/hostile behavior, or suicidal thoughts or behavior.
  • have liver problems.
  • have kidney problems.
  • drink alcohol.
  • have abused or been dependent on prescription medicines, street drugs, or alcohol.
  • are pregnant or plan to become pregnant.
  • are breastfeeding or plan to breastfeed.

What is important to know about taking perampanel?

Do not stop taking perampanel suddenly unless directed to do so by your healthcare provider.

As with all antiseizure medications, perampanel should be withdrawn gradually to minimize the risk of causing or worsening seizures or status epilepticus. You should not stop using perampanel suddenly unless your healthcare provider tells you to stop the medicine because of a serious side effect.

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

Taking perampanel with certain other medicines may cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider. Especially tell your healthcare provider if you take: carbamazepine, phenytoin, oxcarbazepine, rifampin, birth control, St. John’s wort.

Boxed Warning

Perampanel is approved by the FDA because it is safe and effective for the majority of people who take it. However, there are risks associated with all medicines. Some side effects caused by perampanel can be very serious, and even life-threatening. It is important to be informed about these serious reactions and to be aware of their symptoms.

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 perampanel.

These reactions occurred in patients with and without prior psychiatric history, prior aggressive behavior, or concomitant use of medications associated with hostility and aggression.

You or caregivers should contact a healthcare provider immediately if any of these reactions or changes in mood, behavior, or personality that are not typical for you are observed while taking perampanel or after discontinuing perampanel.

You should be closely monitored, particularly during the titration period and at higher doses.

Perampanel should be reduced if these symptoms occur and should be discontinued immediately if symptoms are severe or are worsening.

Women or those who are/plan to become pregnant

Use in Pregnancy

At this time, there is not enough evidence regarding developmental risks associated with the use of perampanel in pregnant people. In animal studies, there were instances of developmental issues at clinically relevant doses. However, having a seizure during pregnancy could harm both the pregnant individual and the baby. Tell your healthcare provider right away if you become pregnant. Do not start or stop taking seizure medication during pregnancy without your healthcare provider’s advice.

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

Use during breastfeeding

There are no data on the presence of perampanel in human milk, the effects on the breastfed child, or the effects of the drug on milk production. Talk to your healthcare provider about the risks. Your healthcare provider will consider the developmental and health benefits of breastfeeding along with your need for perampanel and the potential effect on the infant from perampanel or from your epilepsy.

Effect on birth control and fertility

The use of perampanel may reduce the efficacy of hormonal contraceptives containing levonorgestrel. Advise people taking perampanel who are using a levonorgestrel-containing contraceptive to use an additional non-hormonal form of contraception while using perampanel and for a month after discontinuation. To prevent pregnancy while using perampanel, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge.

What are the side effects of perampanel?

Common side effects

The most common side effects that were reported in studies of perampanel are dizziness, drowsiness (somnolence), fatigue, irritability, falls, nausea, weight gain, vertigo (off-balance sensation), problems with movement and balance (ataxia), headache, vomiting, contusion (bruise), abdominal pain, and anxiety.

Rare, but serious side effects

Other serious reactions, including serious blood or liver problems

Rare but life-threatening reactions involving the immune system or multi-organ hypersensitivity, which can cause serious blood or liver problems have been reported with perampanel use. You may or may not have a rash with these types of reactions. Call your healthcare provider right away if you experience fever, frequent infections, severe muscle pain, swelling of your face, eyes, lips, or tongue, swollen lymph glands, unusual bruising or bleeding, weakness, fatigue, yellowing of your skin, or the white part of your eyes, trouble walking or seeing, seizures happening more often, or pain/tenderness in the area toward the top of your stomach (enlarged liver/spleen).

Suicidal thoughts or behaviors

Studies have found that people who take antiseizure medications including perampanel may have suicidal thoughts or behaviors, which occur in approximately 1 in 500 patients. If you experience any thoughts or impulses to hurt yourself, you should contact your healthcare provider immediately.

Neurological reactions

Drowsiness, tiredness, gait disturbance, and dizziness are common with perampanel but can be severe. Perampanel can also cause problems with balance and coordination. Do not drive or operate machinery until you have gained sufficient experience on perampanel to gauge whether it adversely affects your ability to drive or operate machinery. The amount of sleepiness and fatigue you may experience is related to the dose you take. The chance of experiencing these adverse effects is greatest early in treatment but can occur at any time.

Do not drive or operate machinery until you have gained sufficient experience on perampanel to gauge whether it adversely affects your abilities.

Falls

An increased risk of falls, in some cases leading to serious injuries including head injuries and bone fracture, occurred in patients being treated with perampanel (with and without concurrent seizures). Elderly patients had an increased risk of falls compared to younger adults and pediatric patients. Monitor falls and injuries from falls.