Perampanel

How to take:

Take perampanel exactly as your health care provider prescribes it. Do not change your dose without talking to your provider first. Stopping a seizure medicine suddenly can cause seizures that will not stop (status epilepticus). 

• Check the number of tablets and strength of the pills from the pharmacy. If your provider changes your dose, the strength of the pills may be different.
• Perampanel can be taken once a day in the evening.
• Tablets can be swallowed whole, chewed, or crushed and added to food or liquid. 
• The oral suspension can be used for people who are unable to use tablets.
  • Always check the bottle for the amount of suspension to take and the strength. The strength is written as mg per ml. Fycompa suspension is given as 0.5 mg per 1 ml. Check with your provider on exactly how much to take. 
  • Shake the bottle well before measuring a dose.
  • Always use an accurate measuring spoon or syringe to make sure the amount is correct. Do not use a regular teaspoon. 
  • If you take an extra dose, call your provider for advice. If you take a larger number of pills or overdose, call the poison controll center (800-222-1222) or call your hospital emergency room. 

How to store:

• Store the medication at room temperature between 68 to 77°F or 20 to 25° C.
• Keep the medicine away from heat, moisture, and light. 
• Keep all medicines out of reach of children.
• Use the oral suspension within 3 months of opening the bottle. 

Taking the right amount of medicine on time every day is the most important way to control seizures. Try these steps to help you remember when to take seizure medicine. 

• If you miss a dose, take it as soon as you remember it. If it is almost time for your next dose, skip the missed dose and go back to your usual schedule.
• Avoid taking 2 doses at the same time or taking extra doses.
• If you are not sure what to do, call your health care provider's office for advice. Do your best to follow their directions.
• To avoid missed doses, use a pillbox or set an alarm on your watch or phone.
• Have reminders sent to you using an online seizure diary.
• Or ask your pharmacy for pre-filled blisterpaks of medicine.
• Write down any missed doses in your seizure calendar. Share this with your health care provider at each visit. 

Fycompa is the first drug from a new type of medicines approved by the FDA to treat seizures. The exact way that perampanel works in the brain to stop seizures is not fully known. 

• Glutamate is a key substance (called neurotransmitter) that acts to excite nerve cells in the brain. It’s thought to be important in many conditions, including epilepsy.
• Perampanel works is thought to work by affecting or blocking these glutamate receptors in the brain, known as AMPA receptors. 

How the body absorbs, digests, and gets rid of a medicine or food is called metabolism. This metabolism can affect how often a medicine should be taken and if it will interact with other medicines or food. Some medical conditions such as liver or kidney problems can also affect a drug's metabolism. 

• Perampanel is easily absorbed after being swallowed.
• When this medicine is taken with food, it takes  a little longer to reach its highest amount (also called peak concentration). 
• The drug has a half-life of over 4 days, which means it will take 2 to 3 weeks for the medicine to reach a stable level in the body once it has begun or the dose has been changed.
• The drug is metabolized or broken down in the liver in a specific way. This may affect how Fycompa affects other medicines. Ask your provider about possible drug interactions and what to look for when this medicine is started or changed. 

The most common side effects include:

• Anxiety
• Dizziness
• Falls
• Headache
• Irritability
• Problems with coordination
• Sleepiness or tired
• Stomach upset, nausea, vomiting
• Unsteady walking or problems with balance
• Vertigo
• Weight gain

Dizziness, gait problems, sleepiness and fatigue: These side effects have been noted more often when the dose of perampanel has been increased. They also occurred more often in older people starting Fycompa.

Psychiatric and behavioral problems: In clinical trials, psychiatric and behavioral problems were seen more often in people taking Fycompa than in people taking a placebo.

• The symptoms began usually in the early weeks of starting the medication and when higher doses were used.
• These problems were seen in people with and without a prior history of psychiatric or behavioral problems.

These reactions are described in the Boxed WARNING bolded below and the Important Safety Information from the package insert.

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 (5.1)

Suicidal thoughts or behavior:  In 2008, the FDA reviewed data from drug studies that showed a possible relationship between many seizure medicines and suicidal thoughts and behavior. Together, these thoughts and behaviors are called suicidality. According to the FDA's alert, among the patients with epilepsy in these drug studies, more had symptoms of suicidality than people taking a placebo or inactive substance - 3.5 of 1,000 people taking a seizure medicine had suicidality as compared to 1 of 1,000 people taking a placebo. The FDA has provided the following information for patients, family members, and caregivers at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm.

• Taking seizure medicines may increase the risk of having suicidal thoughts or actions.
• Do not make any changes to the medicines without first talking to the prescribing health care provider.
• Pay close attention to any day-to-day changes in mood, behavior and actions. These changes can happen very quickly so it is important to be mindful of any sudden differences.
• Be aware of common warning signs that might be a signal for risk of suicide. Some of these are:
  • Talking or thinking about wanting to hurt yourself or end your life
  • Withdrawing from friends and family
  • Becoming depressed or having your depression get worse
  • Becoming preoccupied with death and dying
  • Giving away prized possessions
• Contact your health care provider before stopping any seizure medicine. This could possibly lead to worsening of seizure and mood. 

The effect of perampanel on bone health is unknown. Thinning of bones (osteopenia) and bone loss (osteoporosis) has been seen in people taking other seizure medicines. It's important to talk to your provider about your bone health.

• Vitamin D and calcium may be recommended.
• Blood tests and a test to check the strength of your bones may be needed 

Often medicines may be used for more than one purpose. It is legal to prescribe medicines for "off-label uses", even though the FDA has not formally approved such use. 

• Perampanel is being studied for possible use in other neurological conditions, such as Multiple Sclerosis, Parkinson's disease, and neuropathic pain. 

People should not take perampanel if:

• Have a history of a severe allergic reaction to perampanel or any of its inactive ingredients
• Have severe liver or kidney problems
• Are on hemodialysis for kidney problems
• Taking medications such as Rifampin or St. John's Wort. 

Sometimes one kind of medicine changes the way another kind of medicine works in the body. This can happen with prescription and over-the-counter medicines, herbal products, vitamins, and some foods. Tell your health care team any time a new medicine is given to you or if you take other substances or products. 

Perampanel may affect other medicines:

• Decrease the effectiveness of hormonal birth control. 
• Decrease levels of carbamazepine (Tegretol), clobazam (Onfi), lamotrigine (Lamictal), midazolam, valproic acid/valproate (Depakene/Depakote)
• Increase level of oxcarbazepine (Trileptal)

Perampanel may be affected by other medicines:

• Decreased levels may be caused by carbamazepine (Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenytoin (Dilantin), topiramate (Topamax), rifampin
• Increased levels may be caused by ketoconazole

Perampanel, when used with alcohol and other nervous system depressants, may increase the effects of alcohol. This may cause problems with change in alertness, confusion, or mood.

Effect of seizure medicines during pregnancy: In the United States, the FDA assigns each medication to a Pregnancy Category according to whether it has been proven to be harmful in pregnancy. Perampanel is listed in Pregnancy Category C. This means that caution is advised, but the benefits of the medicine may outweigh the potential risks.

• Talk to your health care providers if you are pregnant or plan to become pregnant.
• The risk of birth defects is generally higher in children of women who:
  • Take more than one seizure medicine at the same time 
  • Have a family history of birth defects

All women who are capable of becoming pregnant should take at least 0.4 mg (400 mcg) each day of the vitamin called folic acid (also called folate). This vitamin is thought to help prevent birth defects affecting the brain and spinal cord, called neural tube defects. The most common of these is known as spina bifida.  

• Women at high risk of having a child with a birth defect (such as those with a birth defect in a previous pregnancy or taking certain seizure medicines) may be asked to take 4 mg (4000 mcg) daily before and during pregnancy. 
• Talk to your health care provider about using folic acid and how much to take.
• Start taking this vitamin before you become pregnant. 

If you were taking perampanel while pregnant, consider enrolling in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334 (www.aedpregnancyregistry.org).

Seizures during pregnancy: Some women may have more seizures during pregnancy, because of hormone changes and how seizure medicine is handled by your body. 

• Talk to your health care provider before pregnancy about seizures and if medicine changes may be needed.
• Know when to check blood levels of medicine during and after pregnancy.
• The dose of seizure medicine may need to be adjusted during and after pregnancy. 

Breastfeeding: Perampanel has been found in breastmilk in animal studies. It is not known if the drug is found in human breastmilk.  

• Women who wish to breastfeed should talk to their doctor about the best medicine to use during pregnancy and when breastfeeding. 
• If you choose to breastfeed, check the baby for drowsiness and keep track of their weight gain and development, especially if you are taking more than one seizure medicine. 
• Talk to your health care team about any concerns that arise and if you have any problems with breastfeeding. 

• Fycompa has not been studied in enough older adults (age 65 and over) to determine its’ safety and effectiveness.
• Some side effects tended to occur more often in older people. The use of this drug in older people should be carefully monitored.
• Lower doses of perampanel may be needed in older adults. The drug may be started slower and increaesd no sooner than every 2 weeks. 

• The "best dose" of any seizure medicine is the amount that completely controls seizures without causing troublesome side effects. It depends on many factors and will be different for each person.
• The recommended amount may change according to other seizure medications that a person takes.
• Age and other medical conditions may also affect how much is taken. 
• Do not stop taking perampanel or change the dose without talking to your doctor first. stopping any seizure medicine all at once can cause seizure emergencies that can be life-threatening. 

In the United States, companies that manufacture medicines are required to publish certain kinds of information about each product. This document is commonly known as a “package insert” because it is usually included with each package of the medicine.

You can also read these documents (also called "prescribing information") online. The U.S. package insert for Fycompa (perampanel) is found at:

• https://www.fycompa.com/documents/Fycompa_Prescribing_Information.pdf

Some of the information may differ in other countries.

To learn how to read and understand a package insert, see How to read a package insert.