Fycompa perampanel 8 mg Tablet, 90-count — NDC 69616-278-90 (Billing 69616-0278-90)

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 )

1.1Partial-Onset Seizures 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.

1.2Primary Generalized Tonic-Clonic Seizures 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.

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 provided adaptor and dosing syringe ( 2.7 ) Dosing in the presence of concomitant moderate or strong CYP3A4 inducers : see section

2.3Specific Populations Mild and Moderate Hepatic Impairment: Maximum recommended daily dose is 6 mg (mild) and 4 mg (moderate) once daily at bedtime ( 2.4 ) Severe Hepatic Impairment: Not recommended ( 2.4 ) Severe Renal Impairment or on Hemodialysis: Not recommended ( 2.5 ) Elderly: Increase dose no more frequently than every 2 weeks ( 2.6 )

2.1Dosage for Partial-Onset Seizures Monotherapy or Adjunctive Therapy The recommended starting dosage of FYCOMPA in adults and pediatric patients 4 years of age and older is 2 mg once daily taken orally at bedtime. Increase dosage no more frequently than at weekly intervals by increments of 2 mg once daily based on individual clinical response and tolerability. The recommended maintenance dose range is 8 mg to 12 mg once daily, although some patients may respond to a dose of 4 mg daily.

A dose of 12 mg once daily resulted in somewhat greater reductions in seizure rates than the dose of 8 mg once daily, but with a substantial increase in adverse reactions. Dosage adjustment is recommended with concomitant use of moderate or strong CYP3A4 enzyme inducing drugs, which include certain antiepileptic drugs (AEDs) [see Dosage and Administration (2.3) ].

2.2Dosage for Primary Generalized Tonic-Clonic Seizures Adjunctive Therapy The recommended starting dosage of FYCOMPA in adults and pediatric patients 12 years of age and older is 2 mg once daily taken orally at bedtime. Increase dosage no more frequently than at weekly intervals by increments of 2 mg once daily based on individual clinical response and tolerability. The recommended maintenance dose is 8 mg once daily taken at bedtime.

Patients who are tolerating FYCOMPA at 8 mg once daily and require further reduction of seizures may benefit from a dose increase up to 12 mg once daily if tolerated. Dosage adjustment is recommended with concomitant use of moderate or strong CYP3A4 enzyme inducing drugs, which include certain AEDs [see Dosage and Administration (2.3) ].

2.3Dosage Modifications with Concomitant Use of Moderate or Strong CYP3A4 Enzyme Inducers Moderate and strong CYP3A4 inducers, including enzyme-inducing AEDs such as phenytoin, carbamazepine, and oxcarbazepine, cause a reduction in FYCOMPA plasma levels [see Drug Interactions (7.2) , Clinical Pharmacology (12.3) ] . Therefore, in adults and pediatric patients 4 years of age and older receiving these concomitant enzyme-inducing drugs, the recommended starting dosage of FYCOMPA is 4 mg once daily taken orally at bedtime.

Increase dosage by increments of 2 mg once daily based on individual clinical response and tolerability, no more frequently than at weekly intervals. A maintenance dose has not been established in clinical trials. The highest dose studied in patients on concomitant enzyme-inducing AEDs was 12 mg once daily.

When moderate or strong CYP3A4 inducers are introduced or withdrawn from a patient’s treatment regimen, the patient should be closely monitored for clinical response and tolerability. Dose adjustment of FYCOMPA may be necessary.

2.4Dosage Adjustment in Patients with Hepatic Impairment In patients with mild and moderate hepatic impairment, the starting dose of FYCOMPA is 2 mg once daily. Increase dosage by increments of 2 mg once daily… [Excerpted — this section continues on DailyMed.]

3 DOSAGE FORMS AND STRENGTHS Tablets 2 mg tablets: orange, round, debossed with “2” on one side and “Є 275” on the other. 4 mg tablets: red, round, debossed with “4” on one side and “Є 277” on the other. 6 mg tablets: pink, round, debossed with “6” on one side and “Є 294” on the other.

8 mg tablets: purple, round, debossed with “8” on one side and “Є 295” on the other. 10 mg tablets: green, round, debossed with “10” on one side and “Є 296” on the other. 12 mg tablets: blue, round, debossed with “12” on one side and “Є 297” on the other.

Oral Suspension 0.5 mg/mL white to off-white opaque liquid suspension for oral administration. Tablets: 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg ( 3 ) Oral Suspension: 0.5 mg/mL ( 3 )

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use ). Administration of Oral Suspension Advise patients who are prescribed the oral suspension to shake the bottle well before every administration and to use the adaptor and oral dosing syringe provided. Advise patients that a household teaspoon or tablespoon is not an adequate measuring device.

Instruct patients to discard any unused FYCOMPA oral suspension remaining 90 days after first opening the bottle [see Dosage and Administration (2.7) ] . Serious Psychiatric and Behavioral Reactions Counsel patients, families, and caregivers of patients of the need to monitor for the emergence of anger, aggression, hostility, hallucinations, delusions, confusion, unusual changes in mood, personality, or behavior, and other behavioral symptoms. Advise them to report any such symptoms immediately to their healthcare providers [see Warnings and Precautions (5.1) ] .

Suicidal Thinking and Behavior Counsel patients, their caregivers, and families that AEDs, including FYCOMPA, may increase the risk of suicidal thinking and behavior and advise them of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Instruct patients, caregivers, and families to report behaviors of concern immediately to healthcare providers [see Warnings and Precautions (5.2) ] .

Neurologic Effects: Dizziness, Gait Disturbance, Somnolence, and Fatigue Counsel patients that FYCOMPA may cause dizziness, gait disturbance, somnolence, and fatigue. Advise patients taking FYCOMPA not to drive, operate complex machinery, or engage in other hazardous activities until they have become accustomed to any such effects associated with FYCOMPA [see Warnings and Precautions (5.3) ] . Falls Counsel patients that FYCOMPA may cause falls and injuries [see Warnings and Precautions (5.4) ] .

DRESS/Multi-organ Hypersensitivity Instruct patients that a fever associated with signs of other organ system involvement (e.g., rash, lymphadenopathy, hepatic dysfunction) may be drug-related and should be reported to their healthcare provider immediately [see Warnings and Precautions (5.5) ]. Withdrawal of Antiepileptic Drugs Counsel patients that abrupt discontinuation of FYCOMPA may increase seizure frequency [see Warnings and Precautions (5.6) ] . Contraceptives Counsel females of reproductive potential that FYCOMPA may decrease efficacy of contraceptives containing levonorgestrel, and advise them to use an additional non-hormonal form of contraception while using FYCOMPA and for a month after discontinuation [see Drug Interactions (7.1) , Use in Specific Populations (8.3) ] .

Alcohol and Other CNS Depressants Counsel patients that FYCOMPA may enhance the impairment effects of alcohol. These effects may also be seen if FYCOMPA is taken with other CNS depressants [see Drug Interactions (7.3) ] . Missed Doses Counsel patients that if they miss a dose, they should resume dosing the following day at their prescribed daily dose.

Instruct patients to contact their physician if more than one day of dosing is missed. Controlled Substance Counsel patients that FYCOMPA is a controlled substance that can be misused and abused [see Drug Abuse and Dependence (9.1) ] . Pregnancy Registry Advise women who are exposed to FYCOMPA during pregnancy that there is a pregnancy exposure registry that monitors pregnancy outcomes.

Encourage these patients to enroll in the NAAED Pregnancy Registry [see Use in Specific Populations (8.1) ] . FYCOMPA ® is a registered trademark owned by Catalyst Pharmaceuticals, Inc. Manufactured by Eisai Inc. for Catalyst Pharmaceuticals, Inc.

Marketed by Catalyst Pharmaceuticals, Inc., Coral Gables, FL 33134 ©2023 Catalyst Pharmaceuticals, Inc.

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 provider. Stopping FYCOMPA suddenly can cause serious problems. Stopping FYCOMPA suddenly can cause you to have seizures more often.

What is FYCOMPA? FYCOMPA is a prescription medicine used: ● to treat partial-onset seizures with or without secondarily generalized seizures in people with epilepsy who are 4 years of age and older ● with other medicines to treat primary generalized tonic-clonic seizures in people with epilepsy who are 12 years of age and older FYCOMPA is a controlled substance (CIII) because it can be abused or lead to drug dependence. Keep your FYCOMPA in a safe place to protect it from theft.

Never give your FYCOMPA to anyone else because it may harm them. Selling or giving away this medicine is against the law. It is not known if FYCOMPA is safe and effective for partial onset seizures in children under 4 years of age or for primary generalized tonic clonic seizures in patients under 12 years of age.

Before taking FYCOMPA, tell your healthcare provider about all of your medical conditions, including if you: ● have or have had depression, mood problems, aggressive or hostile behavior (for example, homicidal behavior), suicidal thoughts or behavior, or other psychiatric problems. ● have liver or kidney problems ● drink alcohol ● have abused prescription medicines, street drugs, or alcohol in the past ● are pregnant or plan to become pregnant. It is not known if FYCOMPA will harm your unborn baby. ○ If you become pregnant while taking FYCOMPA, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry.

You can enroll in this registry by calling 1-888-233-2334 or go to http://www.aedpregnancyregistry.org. The purpose of this registry is to collect information about the safety of FYCOMPA and other antiepileptic medicine during pregnancy. ● are breastfeeding or plan to breastfeed. It is not known if FYCOMPA passes into your breast milk.

Talk to your healthcare provider about the best way to feed your baby if you take FYCOMPA. You and your healthcare provider should decide… [Excerpted — this section continues on DailyMed.]

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 image description image description image description image description image description image description image description image description image description image description image description