Fintepla fenfluramine 2.2 mg/mL Solution — NDC 43376-322-36 (Billing 43376-0322-36)

1 INDICATIONS AND USAGE FINTEPLA is indicated for the treatment of seizures associated with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) in patients 2 years of age and older. FINTEPLA is indicated for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in patients 2 years of age and older. ( 1 )

2 DOSAGE AND ADMINISTRATION FINTEPLA is to be administered orally and may be taken with or without food. ( 2.2 ) Dravet Syndrome The initial starting and maintenance dosage is 0.1 mg/kg twice daily, which can be increased weekly based on efficacy and tolerability. ( 2.2 ) The maximum daily maintenance dosage of FINTEPLA is 0.35 mg/kg twice daily (maximum daily dosage of 26 mg).

( 2.2 ) Lennox-Gastaut Syndrome The initial starting dosage is 0.1 mg/kg twice daily, which should be increased weekly based on tolerability. ( 2.2 ) The recommended maintenance dosage of FINTEPLA is 0.35 mg/kg twice daily (maximum daily dosage of 26 mg). ( 2.2 ) Dravet Syndrome and Lennox-Gastaut Syndrome Dose adjustment is required in patients taking concomitant stiripentol plus clobazam: the maximum daily maintenance dosage of FINTEPLA is 0.2 mg/kg twice daily (maximum daily dosage of 17 mg).

( 2.2 , 2.3 , 2.4 , 7.1 ) Dosage adjustment is recommended in patients: Taking strong CYP1A2 or CYP2D6 inhibitors ( 2.3 , 7.1 ) With severe renal impairment ( 2.4 , 8.6 ) With mild, moderate, and severe hepatic impairment ( 2.5 , 8.7 )

2.1Assessments Prior to Initiating FINTEPLA Prior to starting treatment with FINTEPLA, obtain an echocardiogram assessment to evaluate for valvular heart disease and pulmonary arterial hypertension [see Dosage and Administration (2.6) and Warnings and Precautions (5.1) ] .

2.2Dosing Information FINTEPLA is to be administered orally and may be taken with or without food. Dravet Syndrome The initial starting and maintenance dosage for patients with Dravet syndrome is 0.1 mg/kg twice daily, which can be increased weekly based on efficacy and tolerability. Table 1 provides the recommended titration schedule, if needed.

Patients with Dravet syndrome not on concomitant stiripentol who are tolerating FINTEPLA at 0.1 mg/kg twice daily and require further reduction of seizures may benefit from a dosage increase up to a maximum recommended maintenance dosage of 0.35 mg/kg twice daily (maximum daily dosage of 26 mg). Patients with Dravet syndrome taking concomitant stiripentol plus clobazam who are tolerating FINTEPLA at 0.1 mg/kg twice daily and require further reduction of seizures may benefit from a dosage increase up to a maximum recommended maintenance dosage of 0.2 mg/kg twice daily (maximum daily dosage of 17 mg) [see Drug Interactions (7.1) ].

Lennox-Gastaut Syndrome The initial starting dosage for patients with Lennox-Gastaut syndrome is 0.1 mg/kg twice daily, which should be increased weekly based on tolerability. Table 1 provides the recommended titration schedule. Patients with Lennox-Gastaut syndrome not on concomitant stiripentol who are tolerating FINTEPLA should be titrated to the recommended maintenance dosage of 0.35 mg/kg twice daily (maximum daily dosage of 26 mg).

Patients with Lennox-Gastaut syndrome taking concomitant stiripentol plus clobazam who are tolerating FINTEPLA should be titrated to the recommended maintenance dosage of 0.2 mg/kg twice daily (maximum daily dosage of 17 mg) [see Drug Interactions (7.1) ]. Table 1: FINTEPLA Recommended Titration Schedule For patients not on concomitant stiripentol in whom a more rapid titration is warranted, the dose may be increased every 4 days. Without concomitant stiripentol With concomitant stiripentol plus clobazam Weight-based Dosage To calculate the dose volume: Weight (kg) × Weight-based dosage (mg/kg) ÷ 2.2 mg/mL = mL dose to be taken twice daily Maximum Total Daily Dosage For maximum dosage with concomitant use of strong CYP1A2 or CYP2D6 inhibitors, in patients with severe renal impairment, or in patients with hepatic impairment see Dosage and Administration 2.3, 2.4, 2.5.

Weight-based Dosage Maximum Total Daily Dosage Initial Dosage For patients with Dravet syndrome, dosage may be increased based on clinical response to the maximum recommended dosage, as needed. 0.1 mg/kg twice daily 26 mg 0.1 mg/kg twice daily 17 mg Day 7 0.2 mg/kg twice daily 26 mg 0.15 mg/kg tw… [Excerpted — this section continues on DailyMed.]

3 DOSAGE FORMS AND STRENGTHS Oral solution: 2.2 mg/mL fenfluramine as a clear, colorless, cherry flavored liquid. Oral solution: 2.2 mg/mL fenfluramine ( 3 )

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Administration Information Advise patients who are prescribed FINTEPLA to use the oral dosing syringes provided by the pharmacy [see Dosage and Administration (2.7) and Instructions for Use ] . Instruct patients to discard any unused FINTEPLA 3 months after first opening the bottle or if the "discard after" date on the dispensing bottle has passed, whichever is sooner [see How Supplied/Storage and Handling (16.1) , (16.2) ].

Valvular Heart Disease and Pulmonary Arterial Hypertension Advise patients that cardiac monitoring must be performed using echocardiography to monitor for serious heart valve changes or high blood pressure in the arteries of the lungs [see Warnings and Precautions (5.1) ]. FINTEPLA REMS Program FINTEPLA is available only through a restricted program called the FINTEPLA REMS program [see Warnings and Precautions (5.2) ] . Inform the patient of the following notable requirements: Patients must enroll in the program and comply with ongoing echocardiogram monitoring requirements [see Warnings and Precautions (5.1) ].

FINTEPLA is only prescribed by certified health care providers and only dispensed from certified pharmacies participating in the program. Therefore, provide patients with the telephone number and website for information on how to obtain the product [see Warnings and Precautions (5.2) ]. Decreased Appetite and Decreased Weight Advise patients that decreased appetite is frequent during treatment with FINTEPLA, which can cause decrease in weight [see Warnings and Precautions (5.3) ] .

Somnolence, Sedation, and Lethargy Inform patients that FINTEPLA can cause somnolence, sedation, and lethargy. Caution patients about operating hazardous machinery, including motor vehicles, until they are reasonably certain that FINTEPLA does not affect them adversely (e.g., impair judgment, thinking, or motor skills) [see Warnings and Precautions (5.4) ] . Suicidal Thinking and Behavior Counsel patients, their caregivers, and their families that antiepileptic drugs may increase the risk of suicidal thoughts and behavior and advise them 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 of self-harm.

Instruct patients, caregivers, and families to report behaviors of concern immediately to healthcare providers [see Warnings and Precautions (5.5) ] . Withdrawal of Antiepileptic Drugs (AEDs) Advise patients not to discontinue use of FINTEPLA without consulting with their healthcare provider. FINTEPLA should normally be gradually withdrawn to reduce the potential for increased seizure frequency and status epilepticus [see Dosage and Administration (2.8) , Warnings and Precautions (5.6) ] .

Serotonin Syndrome Inform patients about the risk of serotonin syndrome, which can be life-threatening. Advise patients on the signs and symptoms of serotonin syndrome and that certain over-the-counter medications and herbal supplements can increase this risk [see Warnings and Precautions (5.7) ]. Increase in Blood Pressure Inform patients that FINTEPLA can cause an increase in blood pressure [see Warnings and Precautions (5.8) ].

Glaucoma Inform patients that FINTEPLA can cause mydriasis and can precipitate angle closure glaucoma. Instruct patients to contact their healthcare provider if they have any acute decreases in visual acuity or ocular pain [see Warnings and Precautions (5.9) ]. Pregnancy Registry Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during FINTEPLA therapy.

Encourage women who are taking FINTEPLA to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy [see Use in… [Excerpted — this section continues on DailyMed.]

MEDICATION GUIDE FINTEPLA ® (fin-TEP-la) (fenfluramine) oral solution This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 4/2025 Read this Medication Guide before you start taking FINTEPLA and each time you get a refill.

There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. What is the most important information I should know about FINTEPLA?

FINTEPLA can cause serious side effects, including: Problems with the valves in the heart (valvular heart disease) and high blood pressure in the arteries of the lungs (pulmonary arterial hypertension) have been associated with FINTEPLA. Your healthcare provider will do a test called an echocardiogram to check your heart and for high blood pressure in the arteries of the lungs before you start taking FINTEPLA, again every 6 months during treatment, and one time 3 to 6 months after you take your last dose of FINTEPLA.

Call your healthcare provider right away if you develop any of these signs and symptoms of heart or lung problems during treatment with FINTEPLA: shortness of breath tiredness or weakness, especially with increased activity lightheadedness or fainting swollen ankles or feet chest pain sensations of a rapid, fluttering heartbeat (palpitations) irregular pulse bluish color to your lips and skin (cyanosis) Because of the risk of heart valve problems (valvular heart disease) and high blood pressure in arteries of lungs (pulmonary arterial hypertension) FINTEPLA is only available through a restricted program called the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) Program.

Before you or your child receives FINTEPLA, your healthcare provider or pharmacist will make sure you understand how to take FINTEPLA safely. If you have any questions about FINTEPLA, ask your healthcare provider, visit www.FinteplaREMS.com, or call 1-877-964-3649. Decreased appetite and decreased weight.

Decreased appetite and decreased weight are both serious and common side effects of FINTEPLA in people with Dravet syndrome (DS) or Lennox-Gastaut syndrome (LGS). Your weight should be checked regularly during your treatment with FINTEPLA. Your healthcare provider may need to make changes to your FINTEPLA dose if your weight decreases.

In some cases, FINTEPLA may need to be stopped. Sleepiness, sedation, and lack of energy (lethargy). These are both serious and common side effects of FINTEPLA in people with Dravet syndrome (DS) or Lennox-Gastaut syndrome (LGS).

Taking FINTEPLA with central nervous system (CNS) depressants including alcohol may increase sleepiness. Do not drive, operate heavy machinery, or do other dangerous activities until you know how FINTEPLA affects you. Like all other antiepileptic drugs, FINTEPLA may cause suicidal thoughts or actions in a very small number of people (about 1 in 500).

Call your 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 trouble sleeping (insomnia) attempts to commit suicide new or worse irritability new or worse depression acting aggressive, being angry, or violent new or worse anxiety acting on dangerous impulses feeling agitated or restless an extreme increase in activity and talking (mania) panic attacks other unusual changes in behavior or mood 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. 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. Do not stop taking FINTEPLA without first talking to your healthcare provider . Stopping a seizure medicine such as FINTEPLA suddenly can cause you to have seizures more often or… [Excerpted — this section continues on DailyMed.]

INSTRUCTIONS FOR USE FINTEPLA ® (fin-TEP-la) (fenfluramine) oral solution 2.2 mg/mL Be sure that you read, understand, and follow these instructions before you start using FINTEPLA oral solution and each time you get a refill. There may be new information. This Instructions for Use contains information on how to take FINTEPLA.

This information does not take the place of talking to your healthcare provider about your medical condition or treatment. What is included with FINTEPLA? The following items are included to prepare and give an oral dose of FINTEPLA: 1 bottle of FINTEPLA oral solution (2.2 mg/mL) 2 reusable oral syringes 1 Bottle of FINTEPLA Oral Solution (2.2 mg/mL) 2 Oral Syringes Call the pharmacist at 1-844-288-5007 if you did not receive the items listed above, or if you need help using them.

Important information about FINTEPLA FINTEPLA is an oral medicine (taken by mouth) and is given 2 times each day . Follow your healthcare provider's instructions for taking or giving doses of FINTEPLA. If you have questions about how to prepare or give FINTEPLA, contact your healthcare provider or call your pharmacist.

Always use the oral syringes provided with FINTEPLA to make sure the right dose is given. If you need a new syringe contact your pharmacist. Do not use a household teaspoon or tablespoon.

Oral syringes provided with FINTEPLA by the pharmacy. With FINTEPLA you will receive 2 reusable oral syringes. 2 oral syringes that can measure up to 3 mL OR 2 oral syringes that can measure up to 6 mL or Call the pharmacist at 1-844-288-5007 if you have any questions about the syringes provided with FINTEPLA.

Parts of the Oral Syringe Preparing a Dose Step 1. Make sure you have: The bottle of FINTEPLA oral solution, and A clean, dry reusable oral syringe that was provided with FINTEPLA. Step 2.

Check the "Discard After" date (MM/DD/YYYY). Do not use the medicine if the "Throw Away" (Discard) date has passed. If the date is near, contact your pharmacy or healthcare provider to get a refill or new prescription.

If the date has passed, dispose of any unused FINTEPLA. Step 3. Press down and turn the childproof cap to the left (counterclockwise) and remove it from the bottle.

Set the cap aside (do not throw away). Step 4. Make sure the adapter is on the bottle.

If the bottle does not have an adapter, contact the pharmacist. Always leave the adapter in place in the bottle of medicine. Step 5.

Remove an oral syringe from its packaging, if needed. Only use the oral syringes provided with FINTEPLA. If an oral syringe is damaged, or you cannot read the dose markings : Use the other oral syringe provided, or Contact the pharmacist to get a new one.

Step 6. Make sure the plunger is pushed all the way into the oral syringe. Step 7.

Hold the bottle of medicine firmly on a hard, flat surface. Step 8. Push the tip of the oral syringe into the opening of the adapter until it cannot be pushed further.

Step 9. Hold the oral syringe and bottle together and turn upside down. Step 10.

Slowly pull the plunger of the oral syringe to withdraw the prescribed dose. Step 11. Line up the end of the plunger with the mark for the prescribed dose on the oral syringe.

Tips to Getting the Correct Dose If you draw out too much medicine: Leave the oral syringe in the adapter. Push the plunger slowly back into the syringe until you reach the prescribed dose. If you see air bubbles in the medicine: Leave the oral syringe in the adapter.

Pull the plunger further down. Allow the bubbles to rise to the tip of the syringe. Push the plunger in all the way.

Slowly pull the plunger out to the prescribed dose. Note: Very small bubbles in the liquid are normal. Step 12.

Hold the oral syringe and bottle together and then turn the bottle right side up. Step 13. Holding the bottle firmly, gently pull the oral syringe out of the bottle adapter.

Step 14. Make sure the dose in the oral syringe still matches the prescribed dose. If the dose does not match: Put the syringe back int… [Excerpted — this section continues on DailyMed.]