Pronunciation:

per-AM-pa-nel

Brand Names:

• Fycompa

Dosage Forms:

• Tablet
• Suspension

Warnings:

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. Monitor patients for these reactions as well as for changes in mood, behavior, or personality that are not typical for the patient, 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 .

Classifications:

Therapeutic—

Anticonvulsant

Uses of This Medicine:

Perampanel is used alone or together with other medicines to treat certain types of epilepsy, such as partial onset seizures and generalized tonic-clonic seizures. It works in the brain to prevent seizures. Perampanel will not cure epilepsy and will only control the seizures as long as you continue to take it.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of perampanel to treat partial onset seizures in children younger than 4 years of age or to treat generalized tonic-clonic seizures in children younger than 12 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of perampanel in the elderly. However, elderly patients are more likely to have unwanted effects, which may require an adjustment in the dose for patients receiving perampanel.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Alfentanil
• Alprazolam
• Benzhydrocodone
• Bosentan
• Bromazepam
• Buprenorphine
• Butorphanol
• Calcifediol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbamazepine
• Ceritinib
• Cetirizine
• Clarithromycin
• Clobazam
• Clonazepam
• Codeine
• Daridorexant
• Dexmedetomidine
• Dihydrocodeine
• Doxylamine
• Efavirenz
• Enzalutamide
• Esketamine
• Eslicarbazepine Acetate
• Etravirine
• Fedratinib
• Fentanyl
• Fexinidazole
• Flibanserin
• Fosphenytoin
• Gabapentin
• Gabapentin Enacarbil
• Hydrocodone
• Hydromorphone
• Itraconazole
• Ketamine
• Lacosamide
• Lemborexant
• Levocetirizine
• Levorphanol
• Lofexidine
• Lorlatinib
• Loxapine
• Lumacaftor
• Magnesium Oxybate
• Mavacamten
• Meperidine
• Methadone
• Metoclopramide
• Midazolam
• Mitotane
• Modafinil
• Morphine
• Morphine Sulfate Liposome
• Nafcillin
• Nalbuphine
• Olanzapine
• Omaveloxolone
• Orlistat
• Oxcarbazepine
• Oxycodone
• Oxymorphone
• Pentazocine
• Periciazine
• Phenobarbital
• Phenytoin
• Potassium Oxybate
• Pregabalin
• Primidone
• Remifentanil
• Remimazolam
• Rifampin
• Ropeginterferon Alfa-2b-njft
• Scopolamine
• Sodium Oxybate
• St John's Wort
• Sufentanil
• Tapentadol
• Topiramate
• Tramadol
• Trazodone
• Zuranolone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Levonorgestrel

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Behavior or mood changes (eg, aggression, anger) or
• Coordination problems (eg, walking, balance) or
• Depression or
• Dizziness—Use with caution. May make these conditions worse.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Kidney disease, severe or
• Liver disease, severe or
• Patients receiving hemodialysis—Use is not recommended in patients with these conditions.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Measure the oral liquid with the bottle adapter and oral syringe provided. Shake the bottle well before each use.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (suspension or tablets):
  • For generalized tonic-clonic seizures:
    • Adults and children 12 years of age and older—At first, 2 milligrams (mg) once a day, taken at bedtime. Your doctor may increase your dose as needed and tolerated. However, the dose is usually not more than 12 mg per day.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.
  • For partial-onset seizures:
    • Adults and children 4 years of age and older—At first, 2 milligrams (mg) once a day, taken at bedtime. Your doctor may increase your dose as needed and tolerated. However, the dose is usually not more than 12 mg per day.
    • Children younger than 4 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Call your doctor if you miss more than one dose of this medicine.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away any unused oral liquid 90 days after the bottle is opened for the first time.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Also tell your doctor if you or your child have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you, your child, or your caregiver notice any of these side effects, tell your doctor right away.

This medicine may cause some people to become dizzy, drowsy, clumsy, faint, unsteady, or less alert than they are normally. It may also cause trouble with controlling body movements, which may lead to falls, fractures, or other injuries. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Check with your doctor right away if you have a fever, chills, cough, sore throat, swollen, painful, or tender lymph glands in the neck, armpit, or groin, or yellow skin or eyes while using this medicine. These could be symptoms of a serious condition, called drug reaction with eosinophilia and systemic symptoms (DRESS).

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Do not stop taking this medicine without checking first with your doctor. Stopping the medicine suddenly may cause your seizures to return or to occur more often. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely.

Birth control pills containing levonorgestrel may not work as well while you are using this medicine. Use another form of birth control together with your pills during treatment and for at least 1 month after the last dose to avoid getting pregnant. Talk to your doctor if you have questions.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines, medicines for hay fever, allergies or colds, sedatives, tranquilizers, or sleeping medicines, prescription pain medicines or narcotics, and other medicines for seizures. Check with your doctor before taking any of these medicines together with perampanel.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Aggression or anger

anxiety

clumsiness or unsteadiness

deep or fast breathing with dizziness

dry mouth

irregular heartbeat

irritability

numbness of the feet, hands, and around the mouth

restlessness

shakiness

sleepiness or unusual drowsiness

trouble sleeping

unsteadiness, trembling, or other problems with muscle control or coordination

unsteady walk

unusual tiredness or weakness

Less common

Abnormal or decreased touch sensation

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

Incidence not known

Changes in behavior

depression

thoughts of killing oneself

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Dizziness or lightheadedness

feeling of constant movement of self or surroundings

headache

nausea

sensation of spinning

stomach pain

Less common

Back pain

bloating or swelling of the face, arms, hands, lower legs, or feet

blurred vision

body aches or pain

bone pain

changes in speech patterns

chills

confusion

cough

decreased urine output

difficulty having a bowel movement

difficulty with moving

double vision

ear congestion

fast or irregular heartbeat

fever

increased thirst

lack or loss of strength

loss of voice

muscle pain, cramps, or stiffness

nasal congestion

pain in the arms, joints, or legs

runny nose

slurred speech

sneezing

sore throat

trouble remembering

trouble with speaking

unusual weight gain or loss

unusually deep sleep

vomiting

Incidence not known

Unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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