Fycompa Special Precautions

Suicidal ideation: Suicidal ideation and behaviour have been reported in patients treated with antiepileptic medicinal products in several indications. A meta-analysis of randomised placebo-controlled trials of antiepileptic medicinal products has also shown a small increased risk of suicidal ideation and behaviour. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for perampanel.
Therefore, patients (children, adolescents, and adults) should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
Severe cutaneous adverse reactions (SCARs): Severe cutaneous adverse reactions (SCARs) including drug reaction with eosinophilia and systemic symptoms (DRESS) and Stevens-Johnson Syndrome (SJS), which can be life-threatening or fatal, have been reported (frequency unknown; see Adverse Reactions) in association with perampanel treatment.
At the time of prescription, patients should be advised of the signs and symptoms and monitored closely for skin reactions.
Symptoms of DRESS include typically, although not exclusively, fever, rash associated with other organ system involvement, lymphadenopathy, liver function tests abnormalities and eosinophilia. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident.
Symptoms of SJS include typically, although not exclusively, skin detachment (epidermal necrosis/blister) <10%, erythematous skin (confluent), rapid progression, painful atypical target-like lesions and/or purpuric macules in wide dissemination or large erythema (confluent), bullous/erosive involvement of more than 2 mucous membranes.
If signs and symptoms suggestive of these reactions appear, perampanel should be withdrawn immediately and an alternative treatment considered (as appropriate).
If the patient has developed a serious reaction such as SJS or DRESS with the use of perampanel, treatment with perampanel must not be restarted in this patient at any time.
Absence and myoclonic seizures: Absence and myoclonic seizures are two common generalised seizure types that frequently occur in IGE patients. Other AEDs are known to induce or aggravate these seizure types. Patients with myoclonic seizures and absence seizures should be monitored while on Fycompa.
Nervous system disorders: Perampanel may cause dizziness and somnolence and therefore may influence the ability to drive or use machines (see Effects on ability to drive and use machines as follows).
Hormonal contraceptives: At doses of 12 mg/day, Fycompa may decrease the effectiveness of progestative-containing hormonal contraceptives; in this circumstance, additional non-hormonal forms of contraception are recommended when using Fycompa (see Interactions and Use in Pregnancy & Lactation).
Falls: There appears to be an increased risk of falls, particularly in the elderly; the underlying reason is unclear.
Aggression: Aggressive and hostile behaviour has been reported in patients receiving perampanel therapy. In perampanel-treated patients in clinical trials, aggression, anger and irritability were reported more frequently at higher doses. Most of the reported events were either mild or moderate and patients recovered either spontaneously or with dose adjustment. However, thoughts of harming others, physical assault or threatening behaviour were observed in some patients (<1% in perampanel clinical studies). Homicidal ideation has been reported in patients. Patients and caregivers should be counselled to alert a healthcare professional immediately if significant changes in mood or patterns of behaviour are noted. The dosage of perampanel should be reduced if such symptoms occur and should be discontinued immediately if symptoms are severe.
Abuse potential: Caution should be exercised in patients with a history of substance abuse and the patient should be monitored for symptoms of perampanel abuse.
Concomitant CYP3A-inducing antiepileptic medicinal products: Response rates after addition of perampanel at fixed doses were less when patients received concomitant CYP3A enzyme-inducing antiepileptic medicinal products (carbamazepine, phenytoin, oxcarbazepine) as compared to response rates in patient who received concomitant non-enzyme-inducing antiepileptic medicinal products. Patients' response should be monitored when they are switching from concomitant non-inducer antiepileptic medicinal products to enzyme-inducing medicinal products and vice versa. Depending upon individual clinical response and tolerability, the dose may be increased or decreased 2 mg at a time (see Dosage & Administration).
Other concomitant (non-antiepileptic) cytochrome P450-inducing or -inhibiting medicinal products: Patients should be closely monitored for tolerability and clinical response when adding or removing cytochrome P450 inducers or inhibitors, since perampanel plasma levels can be decreased or increased; the dose of perampanel may need to be adjusted accordingly.
Hepatotoxicity: Cases of hepatotoxicity (mainly hepatic enzyme increased) with perampanel in combination with other antiepileptic drugs have been reported. If hepatic enzyme elevation is observed, monitoring of liver function should be considered.
Excipients: Film-coated tablet: Lactose intolerance: Fycompa tablets contain lactose, therefore patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Oral suspension: Fructose intolerance: Fycompa contains sorbitol (E420); therefore, patients with rare hereditary problems of fructose intolerance should not take this medicinal product.
Caution should be exercised when combining Fycompa oral suspension with other antiepileptic medications containing sorbitol, since a combined intake of over 1 gram of sorbitol may affect absorption of some drugs.
Effects on ability to drive and use machines: Fycompa has moderate influence on the ability to drive and use machines.
Perampanel may cause dizziness and somnolence and, therefore, may influence the ability to drive or use machines. Patients are advised not to drive a vehicle, operate complex machinery or engage in other potentially hazardous activities until it is known whether perampanel affects their ability to perform these tasks (see Nervous system disorders as previously mentioned and Interactions).