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Honoring Five Years of Progress
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in Dravet Syndrome Care
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As we commemorate Dravet syndrome (DS) Awareness Month, we also celebrate a key milestone: five years since FINTEPLA® (fenfluramine) was approved to reduce seizures in patients with DS and its use in over 10,000 patients with DS and Lennox-Gastaut syndrome (LGS) worldwide.
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At UCB, we are proud to reflect on the progress made and grateful for your central role in it.
Since launch, FINTEPLA has transformed care for patients with DS. That transformation was only possible
because of your dedication and willingness to embrace innovation, educate peers, and advocate for
patients and families.
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This milestone is a tribute to:
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- The patients and caregivers who placed their trust in new therapies,
- The clinicians who reimagined what is possible for those living with DS, and
- The ongoing collaboration that continues to move the developmental and epileptic encephalopathy (DEE) community forward.
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You will start to see this information shared in other UCB communications outside of the organization and
wanted you to be aware. On behalf of all of us at UCB, we extend our heartfelt appreciation for your
contributions, leadership, and ongoing partnership. We are honored to continue this important work
together and inspired by the progress made and the promise that lies ahead.
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Thank you for being a part of this journey, and for the profound impact you have made, and continue to
make, on the lives of those living with Dravet syndrome.
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Best regards,
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Allison Sackett
FINTEPLA Peer-to-Peer Marketing Lead
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CONFIDENTIAL. DO NOT FORWARD.
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Your expertise matters.
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If there is a case study that stands out in your practice,
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now is a meaningful time to share it.
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Please submit to EXCEL_UCB@calciumco.com
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INDICATIONS AND USAGE
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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.
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IMPORTANT SAFETY INFORMATION
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BOXED WARNING: VALVULAR HEART DISEASE and PULMONARY ARTERIAL HYPERTENSION
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FINTEPLA can cause valvular heart disease and pulmonary arterial hypertension.
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Echocardiogram assessments are required before, during, and after treatment with FINTEPLA.
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FINTEPLA is available only through a restricted program called the FINTEPLA REMS.
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CONTRAINDICATIONS
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FINTEPLA is contraindicated in patients with hypersensitivity to fenfluramine or any of the
excipients in FINTEPLA and with concomitant use, or within 14 days of the administration, of monoamine oxidase
inhibitors because of an increased risk of serotonin syndrome.
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WARNINGS AND PRECAUTIONS
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Valvular Heart Disease and Pulmonary Arterial Hypertension (see Boxed Warning):
FINTEPLA can cause valvular heart disease (VHD) and pulmonary arterial hypertension (PAH). Although no patients
receiving FINTEPLA developed VHD or PAH in clinical trials for DS and LGS of up to 3 years in duration,
cases of VHD and PAH have been reported during use of FINTEPLA in the postmarketing setting.
Because of this risk, cardiac monitoring is required prior to starting treatment, during treatment, and after
treatment with FINTEPLA concludes. Cardiac monitoring via echocardiogram can identify evidence of
VHD and PAH prior to a patient becoming symptomatic, aiding in early detection of these conditions.
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Monitoring: Prior to starting treatment, patients must undergo an echocardiogram to evaluate for
VHD and PAH. Echocardiograms should be repeated every 6 months, and once 3-6 months post treatment
with FINTEPLA.
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The prescriber must consider the benefits versus the risks of initiating or continuing treatment
with FINTEPLA if any of the following signs are observed via echocardiogram: valvular abnormality or
new abnormality; VHD indicated by mild or greater aortic regurgitation or moderate or greater mitral
regurgitation, with additional characteristics of VHD (e.g., valve thickening or restrictive valve
motion); PAH indicated by elevated right heart/pulmonary artery pressure (PASP >35 mm Hg).
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FINTEPLA REMS Program (see Boxed Warning): FINTEPLA is available only through a
restricted distribution program called the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS). Prescribers must be
certified by enrolling in the FINTEPLA REMS. Prescribers must counsel patients receiving FINTEPLA about the risk of VHD and PAH,
how to recognize signs and symptoms of VHD and PAH, the need for baseline (pretreatment) and periodic cardiac monitoring via
echocardiogram during FINTEPLA treatment, and cardiac monitoring after FINTEPLA treatment.
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Decreased Appetite and Decreased Weight: FINTEPLA can cause decreases in
appetite and weight. Decreases in weight appear to be dose related. Weight should be monitored regularly during
treatment with FINTEPLA, and dose modifications should be considered if a decrease in weight is observed.
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Somnolence, Sedation, and Lethargy: FINTEPLA can cause somnolence, sedation,
and lethargy. Other central nervous system depressants, including alcohol, could potentiate these effects of FINTEPLA.
Prescribers should monitor patients for somnolence and sedation and should advise patients not to drive or operate
machinery until they have gained sufficient experience on FINTEPLA to gauge whether it adversely affects their
ability to drive or operate machinery.
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Suicidal Behavior and Ideation: Antiepileptic drugs (AEDs), including
FINTEPLA, increase the risk of suicidal thoughts or behaviors in patients taking these drugs for any indication.
Patients treated with an AED for any indication should be monitored for the emergence or worsening of depression,
suicidal thoughts or behaviors, or any unusual changes in mood or behavior.
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Withdrawal of Antiepileptic Drugs: As with most AEDs, FINTEPLA should generally be
withdrawn gradually because of the risk of increased seizure frequency and status epilepticus. If withdrawal is
needed because of a serious adverse reaction, rapid discontinuation can be considered.
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Serotonin Syndrome: Serotonin syndrome, a potentially life-threatening condition, may
occur with FINTEPLA, particularly during concomitant administration of FINTEPLA with other serotonergic drugs,
including, but not limited to, selective serotonin-norepinephrine reuptake inhibitors (SNRIs), selective serotonin reuptake
inhibitors (SSRIs), tricyclic antidepressants (TCAs), bupropion, triptans, dietary supplements (e.g., St. John’s Wort, tryptophan),
drugs that impair metabolism of serotonin (including monoamine oxidase inhibitors [MAOIs], which are contraindicated with FINTEPLA),
dextromethorphan, lithium, tramadol, and antipsychotics with serotonergic agonist activity. Patients should be monitored for the
emergence of signs and symptoms of serotonin syndrome, which include mental status changes, autonomic instability, neuromuscular
signs, and/or gastrointestinal symptoms. If serotonin syndrome is suspected, treatment with FINTEPLA should be stopped immediately
and symptomatic treatment should be started.
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Increase in Blood Pressure: FINTEPLA can cause an increase
in blood pressure. Rare cases of significant elevation in blood pressure, including hypertensive
crisis, have been reported in adult patients treated with fenfluramine, including patients without
a history of hypertension. In clinical trials for DS and LGS of up to 3 years in duration, no
pediatric or adult patient receiving FINTEPLA developed hypertensive crisis. Monitor blood
pressure in patients treated with FINTEPLA.
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Glaucoma: Fenfluramine can cause mydriasis and can
precipitate angle closure glaucoma. Consider discontinuing treatment with FINTEPLA in patients
with acute decreases in visual acuity or ocular pain.
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ADVERSE REACTIONS
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The most common adverse reactions observed in DS studies (incidence at least 10% and greater than
placebo) were decreased appetite; somnolence, sedation, lethargy; diarrhea; constipation; abnormal
echocardiogram; fatigue, malaise, asthenia; ataxia, balance disorder, gait disturbance; blood pressure
increased; drooling, salivary hypersecretion; pyrexia; upper respiratory tract infection; vomiting;
decreased weight; fall; status epilepticus.
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The most common adverse reactions observed in the LGS study (incidence at least 10% and
greater than placebo) were diarrhea; decreased appetite; fatigue; somnolence; vomiting.
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To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at 1-844-599-2273 or FDA at 1-800-FDA-1088
or
www.fda.gov/medwatch.
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Please see full
Prescribing Information, including Boxed Warning, for additional Important Safety Information.
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| Reference: FINTEPLA (fenfluramine) oral solution: U.S. prescribing information. Smyrna, GA: UCB, Inc. |
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FINTEPLA® is a registered trademark of the UCB Group of Companies.
©2025 UCB, Inc., 1950 Lake Park Drive, Smyrna, GA 30080. All rights reserved.
US-FA-2500483
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