Fintepla (Generic Fenfluramine)
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Serious heart and lung issues could result from fenfluramine use. If you have or have previously had heart or lung disease, let your doctor know. Before you begin taking fenfluramine, every 6 months while you are receiving therapy, and once 3 to 6 months after your last dosage of fenfluramine, your doctor will conduct an echocardiography (test that utilizes sound waves to examine your heart’s capacity to pump blood). If you experience any of the following during treatment, contact your doctor right away: shortness of breath, chest pain, fatigue or weakness, rapid or pounding heartbeat, especially with increased activity, lightheadedness, fainting, irregular pulse, swollen ankles or feet, or bluish skin and lips.
Fenfluramine is only accessible via a unique restricted distribution program due to the hazards associated with this medicine. Fintepla Risk Evaluation and Mitigation Strategies Program (REMS). Before receiving the Fintepla REMS program, you, your doctor, and your pharmacist must sign up for it.
Keep all of your appointments with your physician and the lab. To determine how well your body is responding to fenfluramine, your doctor will prescribe a few tests. During your fenfluramine medication, your doctor will likely keep an eye on your blood pressure.
Whenever you refill your prescription for fenfluramine, your doctor or pharmacist will provide you the manufacturer’s patient information leaflet (Medication Guide). If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website.
Why is this medication prescribed?
Children with Dravet syndrome, which starts in infancy and causes seizures as well as changes in eating, balance, and walking, as well as those with Lennox-Gastaut syndrome (LGS), which also causes seizures and developmental delays, are treated with fenfluramine to control their seizures. The drug fenfluramine belongs to the anticonvulsant drug class. Fenfluramine raises the amount of naturally occurring chemicals in the brain that may lessen seizure activity, while its exact mechanism of action is unknown.
How should this medicine be used?
Fenfluramine is available as a solution (liquid) to be ingested. Typically, it is taken twice daily, with or without food. Fenfluramine should be taken every day at roughly the same time. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Fenfluramine should only be used as prescribed. Never take it in larger or less amounts or more frequently than directed by your doctor.
You’ll likely start taking fenfluramine at a low dose prescribed by your doctor, and they’ll gradually raise it, no more than once every week.
To measure the solution, use the oral syringe that was provided with the medicine. Don’t measure your dose with a regular spoon. You risk receiving too much or too little medication if you estimate your dose with a household teaspoon because they are not precise measuring tools. After each usage, rinse the oral syringe with fresh tap water and let it air dry. Each time you take the medication, use a dry oral syringe.
Your doctor or pharmacist will explain how to prepare fenfluramine for administration if you have a nasogastric (NG) or gastric tube.
Although it does not treat seizures, fenfluramine aids in their control. Fenfluramine should still be taken even if you feel fine. Without consulting your doctor, do not stop taking fenfluramine. You can develop withdrawal symptoms, such as new or severe seizures, if you stop taking fenfluramine abruptly. Your dose will likely be gradually reduced by your doctor.
Other uses for this medicine
Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.
What special precautions should I follow?
Before taking fenfluramine,
- If you have an allergy to fenfluramine, any other drugs, or any of the ingredients in fenfluramine oral solution, let your doctor and pharmacist know right away. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
- Fenfluramine and some drugs shouldn’t be taken together. Before starting fenfluramine, make sure your doctor and pharmacist are aware of any medications you are taking or intend to take. Please consult your doctor or pharmacist before beginning, stopping, or changing any medications while using fenfluramine. While taking fenfluramine, some drugs may need their dosage changed or extra monitoring.
- Dextromethorphan (found in cough syrups), St. John’s Wort, and tryptophan are a few nonprescription or herbal drugs that may interact with fenfluramine. Before beginning to take fenfluramine, be careful to inform your doctor and pharmacist that you are taking these medications. While taking fenfluramine, avoid starting any of these drugs without first consulting your doctor.
- Inform your doctor if you have high blood pressure or glaucoma, which is an elevated pressure in the eye that can result in visual loss. Tell your doctor if you have or have ever had renal or liver disease, suicidal thoughts or actions, depression, mental disorders, or mood swings.
- If you are breastfeeding a child or intend to become pregnant, let your doctor know. Call your doctor if you become pregnant while taking fenfluramine.
- You should be aware that fenfluramine may cause you to feel sleepy and make it challenging for you to accomplish tasks that call for attentiveness or fine motor coordination. Prior to understanding how this drug affects you, avoid using machinery or driving a car.
- While taking fenfluramine, consult your doctor regarding the safe consumption of alcoholic beverages and drugs (such as liquid Nyquil and other cough and cold remedies) that include alcohol. The drowsiness brought on by this drug may be increased by alcohol.
- You should be aware that while taking fenfluramine, your mental health may alter in unexpected ways and you can experience suicidal thoughts or behavior (planning to injure or kill oneself or having thoughts of doing so). One in 500 adults and children aged 5 and older who were treated with anticonvulsants like fenfluramine in clinical studies for a variety of disorders developed suicidal thoughts while on the medication. One week after they began taking the medicine, several of these folks started exhibiting suicidal thoughts and actions. Whether the hazards of using an anticonvulsant drug outweigh the dangers of not using it will be decided by you and your doctor. Any of the following symptoms should prompt you, your family, or your caregiver to call your doctor immediately away: mania (frenzied, abnormally excited mood); panic attacks; agitation or restlessness; new or worsening irritability, anxiety, or depression; acting on risky impulses; trouble falling or staying asleep; aggressive, angry, or violent behavior; any other unusual changes in behavior or mood. Make sure your family or caregiver is aware of any symptoms that could be significant so they can contact the doctor on your behalf if you are unable to call for help.
What special dietary instructions should I follow?
Keep eating normally unless your doctor instructs you otherwise.
What should I do if I forget a dose?
If you miss a dosage, take it as soon as you recall. If the next dose is soon due, skip the missed one and carry on with your regular dosing plan. To make up for a missing dose, do not take a second one.
What side effects can this medication cause?
There may be negative effects from fenfluramine. If any of these symptoms are severe or do not go away, let your doctor know right once:
- Instability or difficulty walking
- Salivation in excess or drooling
- Having trouble falling or staying asleep
- Fever, cough, or other infection-related symptoms
Some adverse effects can be very harmful. Call your doctor right away or seek emergency medical attention if you experience any of the following symptoms or any of those in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections:
- Anxiety, confusion, hallucinations, perspiration, fever, chills, twitching or rigid muscles, lack of coordination, nausea, vomiting, or diarrhea.
- Vision alterations or blurriness, such as seeing colored dots or halos (blurred outlines around objects)
Loss of appetite and weight loss are side effects of fenfluramine. Call your doctor if you notice your kid is losing weight. Your doctor will keep a close eye on your child’s weight and progress. If you are worried about your child’s weight gain or growth while taking this medicine, discuss it with your doctor.
Other negative effects of fenfluramine are possible. If you experience any strange issues while taking this medicine, contact your doctor right away.
You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online at http://www.fda.gov/Safety/MedWatch or by phone at 1-800-332-1088 if you have a serious side event.
What should I know about storage and disposal of this medication?
Keep this medication tightly closed in the original container and out of the reach of children. The oral solution should be kept at normal temperature, away from sources of extreme heat, and dry (not in the bathroom). Don’t freeze or chill the solution. If the “discard after” date on the label or three months have passed since the bottle was first opened, whichever comes first, then discard any unused oral solution.
As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning.http://www.upandaway.org
To make sure that pets, kids, and other people cannot take leftover pharmaceuticals, they should be disposed of in a specific manner. You shouldn’t flush this medication down the toilet, though. The best option to get rid of your medication is instead through a medication take-back program. To find out about take-back initiatives in your neighborhood, speak with your pharmacist or get in touch with your city’s waste/recycling department. If you do not have access to a take-back program, you can find more information at the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p).
In case of emergency/overdose
Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.
Overdose symptoms could include:
- Dilated eyes
- An arched back
- Rapid or erratic heartbeat
- Coma (loss of consciousness for a period of time)
What other information should I know?
No one else should take your medication. The drug fenfluramine is under strict monitoring. Only a limited amount of refills are permitted for prescriptions; if you have any doubts, speak with your pharmacist.
You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.