Fycompa: Uses, Side Effects and Dosage

What is FYCOMPA used for?

FYCOMPA is used with other medicines to manage:

• a type of seizure called partial-onset seizures in children 7 years of age and older and adults.

• a type of seizure called tonic-clonic (grand mal) seizures in children 12 years of age and older and adults who have epilepsy.

FYCOMPA should only be used in patients whose seizures are not controlled with standard treatment.

Serious Warnings and Precautions

• aggression
• hostility
• irritability
• anger
• thoughts of harming or threatening others
• unusual changes in mood, personality, or behaviour

How does FYCOMPA work?

FYCOMPA belongs to a group of medicines called antiepileptic medicines. The exact mechanism of action is not entirely understood.

What are the ingredients in FYCOMPA?

Medicinal ingredient: Perampanel

Non-medicinal ingredients: hypromellose, lactose monohydrate, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide.

The tablets also contain the following non-medicinal ingredients:

2 mg tablets: yellow ferric oxide, red ferric oxide

4 mg tablets: red ferric oxide

6 mg tablets: red ferric oxide

8 mg tablets: black ferric oxide, red ferric oxide

10 mg tablets: FD&C Blue #2 indigo carmine aluminum lake, yellow ferric oxide

12 mg tablets: FD&C Blue #2 indigo carmine aluminum lake

FYCOMPA comes in the following dosage forms:

Tablets: 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, 12 mg

Do not use FYCOMPA if:

• you/your child are allergic to perampanel or any of the other ingredients in FYCOMPA.

To help avoid side effects and ensure proper use, talk to you/your child’s healthcare professional before you/your child take FYCOMPA. Talk about any health conditions or problems you/your child may have, including if you/your child:

• Have or have had depression, mood problems, or suicidal thoughts or behaviour.
• Have mild or moderate liver problems.
• Have moderate or severe kidney problems or are undergoing hemodialysis.

• Have or ever had a problem with:

  • substance use, including prescribed or illegal drugs, or

  • alcohol

• Are taking birth control, especially birth control containing levonorgestrel. FYCOMPA may decrease the efficacy of birth control that contains levonorgestrel.
• Are pregnant or plan to become pregnant.
• Are breastfeeding or plan to breastfeed.
• Are taking other antiepileptic medicines such as carbamazepine, oxcarbazepine, and phenytoin

• Are lactose intolerant or have one of the following rare hereditary disease:

  • galactose intolerance
  • Lapp lactase deficiency
  • glucose-galactose malabsorption
• Regularly or occasionally drink alcohol.
• Are 65 years of age or older.

Other warnings you should know about:

Do not stop your/your child’s treatment with FYCOMPA without first checking with your/your child’s healthcare professional. This could lead to a sudden worsening of your/your child’s seizures or make them happen more often.

Severe skin reactions: Serious allergic reactions, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), can be caused by anti-seizure medicines, often involving a skin reaction. These may occur shortly after starting treatment, or several months later. Get help right away if you/your child develop a skin rash, regardless of its severity, either alone or with a combination of the following symptoms:

• any other serious skin reaction such as blistering or peeling of the mouth, nose, eyes or genitals,
• fever,
• swollen glands,
• flu-like feeling,
• swelling of the face and/or legs,
• problems related to the liver, kidneys, heart, lungs or other organs

Driving and Using Machines: FYCOMPA may make you/your child feel dizzy, drowsy and affect your/their coordination. These effects may be worse if you/your child drink alcohol. Do not drive, use machinery, or do activities that require you/your child to be alert until you/they know how FYCOMPA affects you/them.

Falls and Injuries: FYCOMPA may cause you/your child to feel sleepy, dizzy and affect your/your child’s balance and coordination. This increases the risks of falling, which can cause fractures or other fall-related injuries, especially when there is a change in your/your child’s dose, or you are elderly.

Suicidal thoughts and behaviour: FYCOMPA may cause you/your child to have suicidal thoughts and behaviours or to become more depressed. If you/your child have thoughts of harming or killing yourself/themselves or others at any time, tell your/their healthcare professional or go to a hospital right away. You/your child may find it helpful to tell a relative or close friend you/your child are taking FYCOMPA. Ask them to read this leaflet. You might ask them to tell you if they:

• think your/your child’s depression is getting worse, or
• are worried about changes in your/your child’s behaviour.

Pregnancy and breastfeeding:

• It is not known if FYCOMPA can harm your/your child’s unborn baby. Tell your/your child’s

  • healthcare professional right away if you/your child become pregnant or think you/your child might be pregnant while taking FYCOMPA. You and your/your child’s healthcare professional will decide if you/your child should take FYCOMPA while you/your child are pregnant.
• Pregnancy registry: If you/your child become pregnant while taking FYCOMPA, talk to your/your child’s healthcare professional about registering with the North American Antiepileptic Drug Pregnancy Registry. You/your child can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic medicines during pregnancy. Information about the registry can also be found at the website: http://www.aedpregnancyregistry.org/.
• It is not known whether FYCOMPA can pass into breast milk. You must discuss with your/your child’s healthcare professional whether to breastfeed or take FYCOMPA.

Vision Problems: FYCOMPA may cause you/your child to see two of the same image (diplopia) or blurred vision. If you/your child experience problems with your/their vision while taking FYCOMPA, talk to your/your child’s healthcare professional.

Tell your/your child’s healthcare professional about all the medicines you/your child take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with FYCOMPA:

• other antiepileptic drugs such as carbamazepine, phenytoin, oxcarbazepine, phenobarbital, lamotrigine, topiramate, clobazam, and valproic acid
• alcohol
• birth control containing levonorgestrel
• medicines used to treat HIV
• medicines used to treat bacterial infections such as rifampin and clarithromycin
• St. John’s Wort, a herbal remedy
• medicines used to treat fungal infections such as ketoconazole
• midazolam, used before surgery and other medical procedures to cause drowsiness and decrease anxiety
• central nervous system depressants including benzodiazepines, narcotics, barbituates and sedating antihistamines
• levodopa, used to treat symptoms of Parkinson’s disease

How to take FYCOMPA:

• Take/give FYCOMPA exactly as your/your child’s healthcare professionals tell you to. They will decide on the dose that is right for you/your child. Never increase or decrease your/your child’s dose without talking to your/their healthcare professional.
• Do not stop taking/giving FYCOMPA without talking to your/your child’s healthcare professional. Stopping FYCOMPA suddenly can cause your/your child’s seizures to be worse or make them happen more often. Your/your child’s healthcare professional will tell you if and when you/your child can stop taking this medicine.
• Take/give your/your child’s dose once a day at bedtime.

Usual dose:

Usual starting dose: Your/your child’s healthcare professional will determine the starting dose that is right for you/your child. This may be 2 mg or 4 mg once a day. Your/their dose will depend on:

• if you/they have liver or kidney problems
• other antiepileptic medicines you/your child may be taking

Depending on your/your child’s response and tolerability to FYCOMPA, your/your child’s healthcare professional may increase your/your child’s dose.

Maximum daily dose: 12 mg a day

Overdose:

Signs of an overdose may include:

• changes to mental status
• agitation
• aggressive behaviour
• dizziness

Missed Dose:

If you/your child miss a dose of this medication, do not make up the missed dose. Skip the missed dose and continue with your/their next scheduled dose. Do not take or give two doses at the same time to make up for the missed dose.

Talk to your/your child’s healthcare professional if you/your child miss more than one dose.

What are possible side effects from using FYCOMPA?

These are not all the possible side effects you/your child may have when taking FYCOMPA. If you/your child experience any side effects not listed here, tell your/their healthcare professional.

Side effects may include:

• dizziness
• sleepiness
• tiredness
• problems with muscle coordination
• problems with walking normally (gait disturbance)
• vertigo (sense of spinning)
• weight gain
• nausea
• diarrhea
• vomiting
• joint pain
• muscle aches and pain
• feeling weak or lacking of energy
• cough, runny nose, fever, sore throat
• constipation
• headache

Serious side effects and what to do about them

Serious side effects and what to do about them

If you/your child have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your/your child’s daily activities, tell your/their healthcare professional.

Reporting Side Effects

Storage:

Store at room temperature (15ºC to 30 ºC).

Keep out of the reach and sight of children.

If you want more information about FYCOMPA:

• Talk to your/your child’s healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website Eisai.ca, or by calling 1-877-873-4724.

FYCOMPA^® is a registered trademark owned by Eisai R&D Management Co., Ltd.

Last revised: Nov 16, 2023