Brand Name
Fintepla
Generic Name
Fenfluramine
View Brand Information FDA approval date: July 15, 2020
Form: Solution
What is Fintepla (Fenfluramine)?
FINTEPLA is indicated for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome 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.
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Brand Information
Fintepla (fenfluramine)
WARNING: VALVULAR HEART DISEASE and PULMONARY ARTERIAL HYPERTENSION
FINTEPLA can cause valvular heart disease and pulmonary arterial hypertension
Echocardiogram assessments are required before, during, and after treatment with FINTEPLA. The benefits versus the risks of initiating or continuing FINTEPLA must be considered, based on echocardiogram findings
Because of the risks of valvular heart disease and pulmonary arterial hypertension, FINTEPLA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the FINTEPLA REMS
1INDICATIONS 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.
2DOSAGE FORMS AND STRENGTHS
Oral solution: 2.2 mg/mL fenfluramine as a clear, colorless, cherry flavored liquid.
3CONTRAINDICATIONS
FINTEPLA is contraindicated in patients with:
- Hypersensitivity to fenfluramine or any of the excipients in FINTEPLA
- Concomitant use, or within 14 days of the administration, of monoamine oxidase inhibitors because of an increased risk of serotonin syndrome
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in labeling:
- Valvular Heart Disease and Pulmonary Arterial Hypertension
- Decreased Appetite and Decreased Weight
- Somnolence, Sedation, and Lethargy
- Suicidal Behavior and Ideation
- Withdrawal of Antiepileptic Drugs
- Serotonin Syndrome
- Increase in Blood Pressure
- Glaucoma
4.1Clinical 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 practice.
In controlled and uncontrolled trials in patients with Dravet syndrome (DS), 341 patients were treated with FINTEPLA, including 312 patients treated for more than 6 months, 284 patients treated for more than 1 year, and 138 patients treated for more than 2 years.
In controlled and uncontrolled trials in patients with Lennox-Gastaut syndrome (LGS), 262 patients were treated with FINTEPLA, including 219 patients treated for more than 6 months, 172 patients treated for more than 1 year, and 127 patients treated for more than 2 years.
4.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of FINTEPLA. 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.
Psychiatric disorders: aggression
5OVERDOSAGE
Overdose has not been observed in the FINTEPLA clinical trial program. However, overdose of fenfluramine, the active ingredient in FINTEPLA, has been reported at higher doses than those included in the clinical trial program. Some of the cases were fatal. Events reported after overdose include mydriasis, tachycardia, flushing, tremors/twitching/muscle spasms,agitation/restlessness/anxiety, increased muscle tone/rigor/opisthotonos, respiratory distress or failure, and seizure. Seizure, coma, and cardiorespiratory arrest were reported in most of the fatal overdoses.
There is no available specific antidote to the overdose reactions of FINTEPLA. In the event of overdose, standard medical practice for the management of drug overdosage should be used. An adequate airway, oxygenation, and ventilation should be ensured; monitoring of cardiac rhythm and vital sign measurement is recommended. A certified poison control center should be contacted for updated information on the management of overdose with FINTEPLA.
6DESCRIPTION
FINTEPLA oral solution contains 2.2 mg/mL fenfluramine, equivalent to 2.5 mg/mL of the hydrochloride salt.
The active ingredient, fenfluramine hydrochloride, is designated chemically as N-ethyl-α- methyl-3-(trifluoromethyl)phenethylamine hydrochloride.
The structural formula is:
Fenfluramine hydrochloride is a white to off-white crystalline solid. The pKa of fenfluramine is 10.2.
FINTEPLA is a clear, colorless solution, pH 5.
FINTEPLA contains the following inactive ingredients: cherry flavor, citric acid, ethylparaben hydroxyethylcellulose, methylparaben, potassium citrate, sucralose, and water.
FINTEPLA contains no ingredient made from gluten-containing grain (wheat, barley, or rye), and contains not more than 0.1% of carbohydrates, which is solely derived from the cherry flavor.
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
8INSTRUCTIONS FOR USE FINTEPLA ®(fin-TEP-la) (fenfluramine) oral solution 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
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
- 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.
Oral syringes provided with FINTEPLA by the pharmacy.
With FINTEPLA you will receive 2 reusable oral syringes.
Call the pharmacist at 1-844-288-5007 if you have any questions about the syringes provided with FINTEPLA.
How should I store FINTEPLA?
- Store FINTEPLA at room temperature between 68°F to 77°F (20°C to 25°C).
- Do not refrigerate or freeze.
- Keep the cap tightly closed and the bottle upright.
- Store the FINTEPLA bottle and syringe together in a clean area.
- Throw away (discard) any unused FINTEPLA 3 months after first opening the bottle
- Keep FINTEPLA and all medicines out of the reach of children.
Manufactured for: UCB, Inc., Smyrna, GA 30080
FINTEPLA
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
9PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label - NDC 3376-322-30
NDC 43376-322-30
Fintepla
Rx only
Contents 30 mL
10PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - NDC 3376-322-30
NDC 43376-322-30
Fintepla
For oral use only
Attention Pharmacist:
Contents:
Rx only
11PRINCIPAL DISPLAY PANEL - 360 mL Bottle Label - NDC 43376-322-36
NDC 43376-322-36
Fintepla
For oral use only
Rx only
Contents 360 mL
12PRINCIPAL DISPLAY PANEL - 360 mL Bottle Carton - NDC 43376-322-36
Fintepla
For oral use only
Attention Pharmacist:
Contents:
Rx only
