August 29, 2015
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Fycompa

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About 1 out of 10 people has had a seizure. That means seizures are common, and one day you might need to help s"...

Fycompa




Fycompa Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 7/7/2015

Fycompa (perampanel) is a non-competitive AMPA receptor antagonist, which belongs to a new class of drugs to treat drug-resistant partial-onset seizures, used to treat partial onset seizures in patients with epilepsy ages 12 years and older. Side effects of Fycompa include dizziness, sleepiness, drowsiness, tiredness, fatigue, irritability, nausea, weight gain, joint pain, back pain, and problems maintaining balance. Contact your doctor if you experience serious psychiatric and behavioral side effects of Fycompa including aggression, hostility, irritability, anger, and homicidal ideation and threats. Patients should be monitored for such reactions, as well as changes in mood, behaviors,

Starting dose of Fycompa is 2 mg taken once daily at bedtime. Patients taking anti-eleptic drugs (AEDs) should start on 4 mg of Fycompa. Dosage may be increased based on how well patients tolerate Fycompa. The maximum recommended dose is 12 mg taken once daily. Fycompa is not recommended for patients with decreased liver or kidney function, or patients on dialysis. Fycompa may decrease the effectiveness of hormonal contraceptives. Tegretol (carbamazepine), Carbatrol (carbamazepine), Equetro (carbamazepine), Trileptal (oxcarbazepine), Oxtellar XR (oxcarbazepine), Phenobarbital, and Mysoline (primidone), enzyme-inducing AEDs (phenobarbital and primidone), Rifadin (rifampin), Rifamate (rifampin and isoniazid), Rifater (rifampin, isoniazid and pyrazinamide), and St. John's Wort may interact with Fycompa. Fycompa is not recommended for use during pregnancy. It may cause fetal harm. It is not known if Fycompa passes into breast milk. Nursing mothers and their doctors should decide if the patient will take Fycompa or breastfeed. Patients should not do both. If a patient withdraws from Fycompa, there may be an increase in the frequency of seizures.

Our Fycompa (perampanel) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Fycompa in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using perampanel and call your doctor at once if you have a side effect such as:

  • changes in mood, behavior, or personality;
  • anger, aggression, anxiety, trouble sleeping, feeling hostile or irritable;
  • talking more than usual;
  • unusual thoughts, paranoid behavior, panic attacks;
  • thoughts about suicide, or thoughts about hurting someone else;
  • trouble walking, loss of balance or coordination;
  • an accidental fall; or
  • severe dizziness, spinning sensation, feeling like you might pass out.

Common side effects may include:

  • mild dizziness;
  • drowsiness, tiredness;
  • nausea;
  • weight gain; or
  • headache, joint pain, back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Fycompa (Perampanel Tablets, for Oral Use)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Fycompa FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions are described below and elsewhere in the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Partial-Onset Seizures

A total of 1,038 patients receiving FYCOMPA (2, 4, 8, or 12 mg once daily) constituted the safety population in the pooled analysis of the placebo-controlled trials (Studies 1, 2, and 3) in patients with partial-onset seizures. Approximately 51% of patients were female, and the mean age was 35 years.

Adverse Reactions Leading to Discontinuation

In controlled clinical trials (Studies 1, 2, and 3), the rate of discontinuation as a result of an adverse reaction was 3%, 8%, and 19% in patients randomized to receive FYCOMPA at the recommended doses of 4 mg, 8 mg, and 12 mg per day, respectively, and 5% in patients randomized to receive placebo [see Clinical Studies]. The adverse reactions most commonly leading to discontinuation ( ≥ 1% in the 8 mg or 12 mg FYCOMPA group and greater than placebo) were dizziness, somnolence, vertigo, aggression, anger, ataxia, blurred vision, irritability, and dysarthria [see WARNINGS AND PRECAUTIONS].

Most Common Adverse Reactions

Table 2 gives the incidence in the controlled clinical trials (Studies 1, 2, and 3) of the adverse reactions that occurred in ≥ 2% of patients with partial-onset seizures in the FYCOMPA 12 mg dose group and more frequent than placebo (in order of decreasing frequency for the 12 mg dose group).

The most common dose-related adverse reactions in patients receiving FYCOMPA at doses of 8 mg or 12 mg ( ≥ 4% and occurring at least 1% higher than the placebo group) included dizziness (36%), somnolence (16%), fatigue (10%), irritability (9%), falls (7%), nausea (7%), ataxia (5%), balance disorder (4%), gait disturbance (4%), vertigo (4%), and weight gain (4%). For almost every adverse reaction, rates were higher on 12 mg and more often led to dose reduction or discontinuation.

Table 2: Adverse Reactions in Pooled Placebo-Controlled Trials in Patients with Partial-Onset Seizures (Studies 1, 2, and 3) (Reactions ≥ 2% of Patients in Highest FYCOMPA Dose (12 mg) Group and More Frequent than Placebo)

  Placebo
n=442 %
FYCOMPA
4 mg
n=172 %
8 mg
n=431 %
12 mg
n=255 %
Dizziness 9 16 32 43
Somnolence 7 9 16 18
Headache 11 11 11 13
Irritability 3 4 7 12
Fatigue 5 8 8 12
Falls 3 2 5 10
Ataxia 0 1 3 8
Nausea 5 3 6 8
Vertigo 1 4 3 5
Back pain 2 2 2 5
Dysarthria 0 1 3 4
Anxiety 1 2 3 4
Blurred vision 1 1 3 4
Gait disturbance 1 1 4 4
Weight gain 1 4 4 4
Cough 3 1 1 4
Upper respiratory tract infection 3 3 3 4
Vomiting 3 2 3 4
Hypersomnia 0 1 2 3
Anger < 1 0 1 3
Aggression 1 1 2 3
Balance disorder 1 0 5 3
Diplopia 1 1 1 3
Head injury 1 1 1 3
Hypoaesthesia 1 0 0 3
Pain in extremity 1 0 2 3
Constipation 2 2 2 3
Myalgia 2 1 1 3
Coordination abnormal 0 1 < 1 2
Euphoric mood 0 0 < 1 2
Confusional state < 1 1 1 2
Hyponatremia < 1 0 0 2
Limb injury < 1 1 1 2
Mood altered < 1 1 < 1 2
Arthralgia 1 0 3 2
Asthenia 1 1 2 2
Contusion 1 0 2 2
Memory impairment 1 0 1 2
Musculoskeletal pain 1 1 1 2
Oropharyngeal pain 1 2 2 2
Paraesthesia 1 0 1 2
Peripheral edema 1 1 1 2
Skin laceration 1 0 2 2

Primary Generalized Tonic-Clonic Seizures

A total of 81 patients receiving FYCOMPA 8 mg once daily constituted the safety population in the placebo-controlled trial in patients with primary generalized tonic-clonic seizures (Study 4). Approximately 57% of patients were female, and the mean age was 27 years.

In the controlled primary generalized tonic-clonic seizure clinical trial (Study 4), the adverse reaction profile was similar to that noted for the controlled partial-onset seizure clinical trials (Studies 1, 2, and 3).

Table 3 gives the incidence of adverse reactions in patients receiving FYCOMPA 8 mg ( ≥ 4% and higher than in the placebo group) in Study 4. The most common adverse reactions in patients receiving FYCOMPA ( ≥ 10% and greater than placebo) were dizziness (32%), fatigue (15%), headache (12%), somnolence (11%), and irritability (11%).

The adverse reactions most commonly leading to discontinuation in patients receiving FYCOMPA 8 mg ( ≥ 2% and greater than placebo) were vomiting (2%) and dizziness (2%).

Table 3: Adverse Reactions in a Placebo-Controlled Trial in Patients with Primary Generalized Tonic-Clonic Seizures (Study 4) (Reactions ≥ 4% of Patients in FYCOMPA Group and More Frequent than Placebo)

  Placebo
n=82 %
FYCOMPA 8 mg
n=81 %
Dizziness 6 32
Fatigue 6 15
Headache 10 12
Somnolence 4 11
Irritability 2 11
Vertigo 2 9
Vomiting 2 9
Weight gain 4 7
Contusion 4 6
Nausea 5 6
Abdominal pain 1 5
Anxiety 4 5
Urinary tract infection 1 4
Ligament sprain 0 4
Balance disorder 1 4
Rash 1 4

Weight Gain

Weight gain has occurred with FYCOMPA.

In controlled partial-onset seizure clinical trials, FYCOMPA-treated adults gained an average of 1.1 kg (2.5 lbs) compared to an average of 0.3 kg (0.7 lbs) in placebo-treated adults with a median exposure of 19 weeks. The percentages of adults who gained at least 7% and 15% of their baseline body weight in FYCOMPA-treated patients were 9.1% and 0.9%, respectively, as compared to 4.5% and 0.2% of placebo-treated patients, respectively. Clinical monitoring of weight is recommended.

Similar increases in weight were also observed in adult and pediatric patients treated with FYCOMPA in the primary generalized tonic-clonic seizure clinical trial.

Elevated triglycerides

Increases in triglycerides have occurred with FYCOMPA use.

Comparison of Sex and Race

No significant sex differences were noted in the incidence of adverse reactions.

Although there were few non-Caucasian patients, no differences in the incidence of adverse reactions compared to Caucasian patients were observed.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of FYCOMPA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Dermatologic: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).

Read the entire FDA prescribing information for Fycompa (Perampanel Tablets, for Oral Use)

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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