- Zogenix, a global biopharmaceutical company developing rare disease therapies, today launched the FINTEPLA Photo Diary, a community sharing, charitable campaign and contest.
| EMERYVILLE, Calif., May 19, 2021 /PRNewswire/ -- Zogenix, Inc., a global biopharmaceutical company developing rare disease therapies, today launched the FINTEPLA Photo Diary, a community sharing, charitable campaign and contest. To participate in the charitable campaign and contest, Zogenix is asking the Dravet syndrome community to share photos of their everyday moments in life with fewer seizures on FINTEPLA® (fenfluramine) from now through June 9, 2021. From June 21 – July 19, 2021, each time a member of the public “Likes” or shares a featured photo in the FINTEPLA Photo Diary hosted on the FINTEPLA Facebook page, Zogenix will proudly donate $25 to support advocacy organizations that serve the Dravet syndrome community in the United States (US). Up to $50,000 will be donated and equally divided between the Dravet Syndrome Foundation and the Epilepsy Foundation, in support of the work they do for those impacted by Dravet.
The FINTEPLA Photo Diary campaign and contest is powered by FINTEPLA families and aims to celebrate everyday moments in life with fewer seizures, as well as the Dravet syndrome community. These moments are meaningful, because Dravet syndrome is a rare, catastrophic form of epilepsy in which a person may have multiple seizures per day coupled with significant developmental, motor, and behavioral impairments that severely impact patients, families, and caregivers. FINTEPLA is a prescription medicine approved by the US Food and Drug Administration (FDA) in 2020 to treat the seizures associated with Dravet syndrome in patients 2 years of age and older. In a clinical study, when added to other antiepileptic medicines, FINTEPLA was shown to reduce monthly seizures by 79% on average in patients taking 0.7 mg/kg/day of FINTEPLA, compared to a 16% reduction in patients taking other antiepileptic medicines and placebo. Due to the risk of heart valve problems and pulmonary arterial hypertension, FINTEPLA is available only through the FINTEPLA REMS Program in the US. Please read Important Safety Information, including Boxed Warning below. “We are constantly inspired by the Dravet community and members’ support for one another. These families have taught us the importance of capturing everyday moments that can occur when seizures do not. We feel these moments are worth recognizing,” said Ashish Sagrolikar, Chief Commercial Officer at Zogenix, Inc. “At Zogenix, we are committed to working alongside the Dravet syndrome and the larger epilepsy community to celebrate more everyday moments, and we hope that the FINTEPLA Photo Diary will inspire others to do the same.” In addition to making charitable contributions to advocacy organizations, three families with the highest total number of “Likes” and shares will also win prizes. The FINTEPLA family whose featured photo receives the most “Likes” and shares from the public will earn an outdoor photo shoot with a local, professional photographer. Two runner-up submissions will receive an iPad to capture even more everyday moments between seizures. “With my daughter’s seizures more controlled, we’re capturing even more moments as a family,” said Bethany Goering, a caregiver whose 12-year-old daughter has Dravet syndrome. “The FINTEPLA Photo Diary campaign and contest is an opportunity for us to share the hope that we have in between seizures. We’re excited that our participation will support advocacy groups helping others with Dravet syndrome.” The FINTEPLA Photo Diary Charitable Campaign and Contest is open only to residents of the US. Campaign details can be found on the FINTEPLA Facebook page and at DravetPhotoDiary.com. Through June 9, 2021: Call for Photo Entries
June 21 – July 19, 2021: Sharing and “Liking” to Support Advocacy Groups
INDICATION
IMPORTANT SAFETY INFORMATION 1. 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 fenfluramine, the active ingredient in 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:
Because of the risk of heart valve problems and 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. 2. Decreased appetite and decreased weight. Decreased appetite and decreased weight are both serious and common side effects.
3. Sleepiness, sedation, and lack of energy (lethargy). These are both serious and common side effects of FINTEPLA. 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. 4. 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:
How can I watch for early symptoms of suicidal thoughts and actions?
5. Do not stop taking FINTEPLA without first talking to your healthcare provider. Call your healthcare provider between visits as needed, especially if you are worried about symptoms. Do not take FINTEPLA if you:
Before taking FINTEPLA, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine. How should I take FINTEPLA?
What should I avoid while taking FINTEPLA?
What are the possible side effects of FINTEPLA? FINTEPLA may cause serious side effects, including:
If you have any of these symptoms, call your healthcare provider right away.
These are not all the possible side effects of FINTEPLA. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1–800–FDA–1088. Keep FINTEPLA and all medicines out of the reach of children. General information about the safe and effective use of FINTEPLA. What are the ingredients in FINTEPLA? Active ingredient: fenfluramine hydrochloride FINTEPLA contains no ingredient made from gluten-containing grain (wheat, barley, or rye). Please see Medication Guide and full Prescribing Information, including Boxed Warning, for additional information about FINTEPLA.
SOURCE Zogenix |
View original content to download multimedia:
