FYCOMPA- perampanel tablet FYCOMPA- perampanel suspension

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

PERAMPANEL (UNII: H821664NPK) (PERAMPANEL - UNII:H821664NPK)

Verfügbar ab:

Catalyst Pharmaceuticals, Inc.

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

FYCOMPA is indicated for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older. FYCOMPA is indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older. None. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as FYCOMPA, during pregnancy. Encourage women who are taking FYCOMPA during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org. Risk Summary There are no adequate data on the developmental risk associated with use in pregnant women.  In animal studies, perampanel induced developmental toxicity in pregnant rat and rabbit at clinically relevant doses [see Data] . In the U.S. general population the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data Oral administration of perampanel (1, 3, or 10 mg/kg/day) to pregnant rats throughout organogenesis resulted in an increase in visceral abnormalities (diverticulum of the intestine) at all doses tested; maternal toxicity was observed at the mid and high doses. In a dose-ranging study at higher oral doses (10, 30, or 60 mg/kg/day), embryo lethality and reduced fetal body weight were observed at the mid and high doses tested. The lowest dose tested (1 mg/kg/day) is similar to a human dose of 8 mg/day based on body surface area (mg/m2 ). Upon oral administration of perampanel (1, 3, or 10 mg/kg/day) to pregnant rabbits throughout organogenesis, embryo lethality and maternal toxicity were observed at the mid and high doses tested; the no-effect dose for embryo-fetal developmental toxicity in rabbit (1 mg/kg/day) is approximately 2 times a human dose of 8 mg/day based on body surface area (mg/m2 ). Oral administration of perampanel (1, 3, or 10 mg/kg/day) to rats throughout gestation and lactation resulted in fetal and pup deaths at the mid and high doses (associated with maternal toxicity) and delayed sexual maturation in males and females at the highest dose tested. No effects were observed on measures of neurobehavioral or reproductive function in the offspring. The no-effect dose for pre- and postnatal developmental toxicity in rat (1 mg/kg/day) is similar to a human dose of 8 mg/day based on body surface area (mg/m2 ). Risk Summary There are no data on the presence of perampanel in human milk, the effects on the breastfed child, or the effects of the drug on milk production.  Perampanel and/or its metabolites are present in rat milk, and are detected at concentrations higher than that in maternal plasma. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for FYCOMPA and any potential adverse effects on the breastfed child from FYCOMPA or from the underlying maternal condition. Contraception Use of FYCOMPA may reduce the efficacy of hormonal contraceptives containing levonorgestrel. Advise women taking FYCOMPA who are using a levonorgestrel-containing contraceptive to use an additional non-hormonal form of contraception while using FYCOMPA and for a month after discontinuation [see Drug Interactions (7.1), Clinical Pharmacology (12.3)]. Safety and effectiveness of FYCOMPA for the treatment of partial-onset seizures have been established in pediatric patients 4 years of age and older. The safety and effectiveness of FYCOMPA in patients 12 years of age and older was established by three randomized double-blind, placebo-controlled, multicenter studies, which included 72 pediatric patients between 12 and 16 years of age exposed to FYCOMPA [see Clinical Pharmacology (12.3) and Clinical Studies (14.1)] .  Use of FYCOMPA for the treatment of partial-onset seizures in pediatric patients 4 years to less than 12 years of age is supported by evidence from adequate and well-controlled studies of FYCOMPA in patients 12 years of age and older with partial onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data in 225 pediatric patients 4 years to less than 12 years of age treated with FYCOMPA [see Adverse Reactions (6.1) and Clinical Pharmacology (12.3)] . The safety and efficacy of FYCOMPA for the adjunctive therapy of primary generalized tonic-clonic seizures in pediatric patients 12 years of age and older was established in a single randomized double-blind, placebo-controlled, multicenter trial (n=164), which included 11 pediatric patients 12 to 16 years of age exposed to FYCOMPA; an additional 6 patients were treated with FYCOMPA in the open-label extension of the study [see Clinical Studies (14.2)] . The safety and effectiveness of FYCOMPA for the treatment of partial-onset seizures in pediatric patients less than 4 years of age or for the treatment of primary generalized tonic-clonic seizures in pediatric patients less than 12 years of age have not been established. Juvenile Animal Data Oral administration of perampanel (1, 3, 3/10/30 mg/kg/day; high dose increased on postnatal days [PND] 28 and 56) to young rats for 12 weeks starting on PND 7 resulted in reduced body weight, reduced growth, neurobehavioral impairment (water maze performance and auditory startle habituation) at the mid and high doses, and delayed sexual maturation at the high doses. CNS signs (reduced activity, incoordination, excessive grooming/scratching), pup death, decreased hindlimb splay, and decreased hindlimb grip strength were observed at all doses. Effects on pup body weight, pup growth, hindlimb splay, impairment in the water maze performance, and auditory startle persisted after dosing was stopped. A no-effect dose for postnatal developmental toxicity was not identified in this study. Oral administration of perampanel (1, 5, 5/10 mg/kg/day; high dose increased on PND 56) to juvenile dogs for 33 weeks, starting on PND 42, resulted in CNS signs (incoordination, excessive grooming/licking/scratching, spatial disorientation, and/or ataxic gait) at all doses tested. Clinical studies of FYCOMPA did not include sufficient numbers of patients aged 65 and over to determine the safety and efficacy of FYCOMPA in the elderly population. Because of increased likelihood for adverse reactions in the elderly, dosing titration should proceed slowly in patients aged 65 years and older [see Dosage and Administration (2.5)] . Use of FYCOMPA in patients with severe hepatic impairment is not recommended, and dosage adjustments are recommended in patients with mild or moderate hepatic impairment [see Dosage and Administration (2.4), Clinical Pharmacology (12.3)] . Dose adjustment is not required in patients with mild renal impairment. FYCOMPA should be used with caution in patients with moderate renal impairment, and slower titration may be considered. Use in patients with severe renal impairment or patients undergoing hemodialysis is not recommended [see  Dosage and Administration (2.5), Clinical Pharmacology (12.3)] . FYCOMPA contains perampanel and is listed as a Schedule III controlled substance. Prescription drug abuse is the intentional non-therapeutic use of a drug, even once, for its rewarding psychological or physiological effects. Drug addiction, which develops after repeated drug abuse, is characterized by a strong desire to take a drug despite harmful consequences, difficulty in controlling its use, giving a higher priority to drug use than to obligations, increased tolerance, and sometimes physical withdrawal. Drug abuse and drug addiction are separate and distinct from physical dependence (for example, abuse may not be accompanied by physical dependence) [see Drug Abuse and Dependence (9.3)] . Studies of human abuse potential were performed to evaluate the abuse potential of FYCOMPA (8 mg, 24 mg, and 36 mg) as compared to alprazolam C-IV (1.5 mg and 3 mg), and oral ketamine C-III (100 mg) in recreational polydrug users. Supra-therapeutic doses of FYCOMPA 24 and 36 mg produced responses for “Euphoria” that were similar to ketamine 100 mg and alprazolam 3 mg. For “High,” FYCOMPA 24 mg and 36 mg produced responses comparable to ketamine 100 mg and significantly higher than both doses of alprazolam on a visual analog scale (VAS). “Drug Liking,” “Overall Drug Liking,” and “Take Drug Again” for FYCOMPA were each statistically lower than ketamine 100 mg. In addition, for “Bad Drug Effects,” FYCOMPA 24 mg and 36 mg produced responses significantly higher than ketamine 100 mg.  For “Sedation,” FYCOMPA 24 and 36 mg produced responses similar to alprazolam 3 mg and higher than ketamine 100 mg.  Additionally, on VAS measures related to dissociative phenomena such as “Floating,” “Spaced Out,” and “Detached,” FYCOMPA at supratherapeutic doses produced responses similar to ketamine 100 mg and greater than both doses of alprazolam tested. Of note, due to somnolence a number of subjects had missing data around Tmax of FYCOMPA. The above described data might represent an underestimate of FYCOMPA’s effects. The duration of effects of higher doses of FYCOMPA on the majority of measures was much greater than alprazolam 3 mg and ketamine 100 mg. In this study, the incidence of euphoria following FYCOMPA administration 8 mg, 24 mg, and 36 mg was 37%, 46%, 46%, respectively, which was higher than alprazolam 3 mg (13%) but lower than ketamine 100 mg (89%). Physical dependence is characterized by withdrawal symptoms after abrupt discontinuation or a significant dose reduction of a drug.  A nonclinical dependence study in rats demonstrated withdrawal symptoms, including hyperreactivity to handling, muscle rigidity, and decreases in food consumption and body weights. FYCOMPA may cause dependence and withdrawal symptoms that may include anxiety, nervousness, irritability, fatigue, lethargy, asthenia, mood swings, and insomnia.    Instructions for Use FYCOMPA® (fī-COM-puh) (perampanel) Oral Suspension Read this Instructions for Use before you start using FYCOMPA Oral Suspension and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment. Prepare the FYCOMPA Oral Suspension dose You will need the following supplies: See Figure A • FYCOMPA Oral Suspension bottle • Bottle adapter • Dosing syringe (2 dosing syringes are included in the FYCOMPA Oral Suspension box) Figure A Step 1. Remove the FYCOMPA Oral Suspension bottle, bottle adapter, and 2 syringes from the box. See Figure A Step 2. Shake the bottle well before each use. See Figure B Figure B  Step 3. Uncap the bottle and insert the bottle adapter into the bottle by pressing downward. See Figure C and Figure D Figure C  Figure D After the bottle adapter is in place, it cannot be removed. Step 4. Check the dose in milliliters (mL) as prescribed by your healthcare provider. Find this number on the syringe. See  Figure E Figure E  Step 5.  Push the plunger of the syringe all the way down then insert the syringe into the upright bottle through the opening in the bottle adapter. See Figure F Figure F  Step 6. With the syringe in place, turn the bottle upside down. Pull the plunger to withdraw the dose prescribed by your healthcare provider (the amount of liquid medicine in Step 4).  If you see air bubbles in the oral syringe, fully push in the plunger so that the oral solution flows back into the bottle. Then, withdraw the prescribed dose of oral suspension. See  Figure G  Figure G  Measure the mLs of medicine from the end of the plunger. Step 7. If the dose is more than 20 mL, you can use: • 2 syringes or • 1 syringe, taking 2 steps to draw up the medicine in that same syringe For example: If the dose is 24 mL, draw up 20 mL in the first syringe and the remaining 4 mL in the second syringe. or If the dose is 24 mL, draw up 20 mL in the single syringe and squirt the medicine into the mouth, then draw up the remaining 4 mL in that same syringe. If the dose is more than 20 mL, repeat Steps 4 through 6 when drawing up the remaining dose of medicine. Step 8. Turn the bottle right-side up and remove the syringe from the bottle adapter. See Figure H Figure H  Step 9. Slowly squirt the FYCOMPA oral suspension directly into the corner of the mouth until all of the liquid medicine is given. If you need 2 syringes for the dose, slowly squirt the medicine from the first syringe into the mouth, then slowly squirt the medicine from the second syringe into the mouth. See Figure I Figure I  Step 10. Rinse the syringe (or syringes) with tap water after each use. See Figure J • Fill a cup with water • Pull back on the plunger and draw the water from the cup into the syringe • Push down on the plunger to release the water into the sink Figure J  Step 11. Cap the bottle tightly. The cap will fit over the bottle adapter. See Figure K Figure K  How should I store FYCOMPA Oral Suspension? - Store FYCOMPA oral suspension below 86°F (30°C).  Do not freeze. - Replace the cap tightly after opening.  - Use FYCOMPA oral suspension within 90 days after the bottle is first opened. - After 90 days safely throw away any FYCOMPA Oral Suspension that has not been used. This Instructions for Use has been approved by the U.S. Food and Drug Administration. FYCOMPA® is a registered trademark owned by Catalyst Pharmaceuticals, Inc. Marketed by Catalyst Pharmaceuticals, Inc., Coral Gables, FL 33134 ©2023 Catalyst Pharmaceuticals, Inc. Revised: 06/2023

Produktbesonderheiten:

FYCOMPA Tablets             Bottles of 30    NDC 69616-272-30             Bottles of 90    NDC 69616-272-90             Bottles of 30    NDC 69616-274-30             Bottles of 90    NDC 69616-274-90             Bottles of 30    NDC 69616-276-30             Bottles of 90    NDC 69616-276-90             Bottles of 30    NDC 69616-278-30             Bottles of 90    NDC 69616-278-90             Bottles of 30    NDC 69616-280-30             Bottles of 90    NDC 69616-280-90             Bottles of 30    NDC 69616-282-30             Bottles of 90    NDC 69616-282-90 FYCOMPA Oral Suspension Tablets: store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).  [See USP Controlled Room Temperature] Oral Suspension: Do not store above 30°C (86°F).  Do not freeze.  Use within 90 days after the first opening of the bottle.

Berechtigungsstatus:

New Drug Application

Gebrauchsinformation

FYCOMPA- PERAMPANEL SUSPENSION
Catalyst Pharmaceuticals, Inc.
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MEDICATION GUIDE
FYCOMPA® (fī-COM-puh) FYCOMPA® (fī-
COM-puh)
(perampanel) (perampanel)
tablets, for oral use, CIII oral suspension,
CIII
What is the most important information I should know about FYCOMPA?
1. FYCOMPA may cause mental (psychiatric) problems, including:
● new or worse aggressive behavior (including homicidal behavior),
hostility, anger, anxiety, or
irritability
● being suspicious or distrustful (believing things that are not
true)
● seeing objects or hearing things that are not there
● confusion
● difficulty with memory
● other unusual or extreme changes in behavior or mood
Tell your healthcare provider right away if you have any new or
worsening mental problems while
taking FYCOMPA.
2. Like other antiepileptic drugs, FYCOMPA may cause suicidal thoughts
or actions in a very small
number of
people, about 1 in 500.
Call a healthcare provider right away if you have any of these
symptoms, especially if they are new,
worse,
or worry you:
● thoughts about suicide or dying ● attempt to commit suicide
● new or worse depression ● new or worse anxiety
● feeling agitated or restless ● panic attacks
● trouble sleeping (insomnia) ● new or worse irritability
● acting aggressive, being angry, or violent ● acting on dangerous
impulses
● an extreme increase in activity and talking (mania) ● other
unusual changes in behavior
or mood
Suicidal thoughts or actions can be caused by things other than
medicines. If you have suicidal thoughts
or actions, your
healthcare provider may check for other causes.
How can I watch for early symptoms of suicidal thoughts and actions?
● Pay attention to any changes, especially sudden changes, in mood,
behaviors, thoughts, or
feelings.
● Keep all follow-up visits with your healthcare provider as
scheduled.
Call your healthcare provider between visits as needed, especially if
you are worried about symptoms.
Do not stop FYCOMPA without first talking with a healthcare prov

Fachinformation

FYCOMPA- PERAMPANEL TABLET
FYCOMPA- PERAMPANEL SUSPENSION
CATALYST PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FYCOMPA
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FYCOMPA .
FYCOMPA (PERAMPANEL) TABLETS, FOR ORAL USE, CIII
FYCOMPA (PERAMPANEL) ORAL SUSPENSION, CIII
INITIAL U.S. APPROVAL: 2012
WARNING: SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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 (5.1)
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 (5.1)
FYCOMPA SHOULD BE REDUCED IF THESE SYMPTOMS OCCUR AND SHOULD BE
DISCONTINUED
IMMEDIATELY IF SYMPTOMS ARE SEVERE OR ARE WORSENING (5.1)
INDICATIONS AND USAGE
FYCOMPA, a non-competitive AMPA glutamate receptor antagonist, is
indicated for:
Treatment of partial-onset seizures with or without secondarily
generalized seizures in patients with
epilepsy 4 years of age and older (1.1)
Adjunctive therapy in the treatment of primary generalized
tonic-clonic seizures in patients with
epilepsy 12 years of age and older (1.2)
DOSAGE AND ADMINISTRATION
Dosing in the absence of moderate or strong CYP3A4 inducers
Starting dose: 2 mg once daily orally at bedtime (2.1, 2.2)
May increase dose based on clinical response and tolerability by
increments of 2 mg once daily no
more frequently than at weekly intervals (2.1, 2.2)
Recommended maintenance dose in monotherapy or adjunctive therapy for
partial-onset seizures: 8
mg to 12 mg once daily at bedtime (2.1)
Recommended maintenance dose in adjunctive therapy for primary
generalized tonic-clonic seizures: 8
mg once daily at bedtime (2.2)
Measure oral suspension using pro