Fintepla

What is Fintepla?

Fintepla is a prescribed medicine for treating seizures that can be caused by Dravet syndrome and Lennox-Gastaut syndrome in patients who are 2 years old or older.

Fintepla is a federally controlled substance (C-IV) because it is a drug that contains the chemical fenfluramine. Make sure to keep this medication in a safe location to prevent abuse and misuse and also to guard the medicine from theft. Do not distribute your Fintepla to any other person, as it could cause harm to the person receiving it. The sale or distribution of Fintepla is against the law. Contact your physician if you've been using or becoming dependent on prescription drugs, alcohol, or street drugs.

It isn't known whether this medicine has been proven safe or effective for children younger than 2 years old.

Warnings

Do not use Fintepla if you:

• Are allergic to fenfluramine as well as any other active ingredients in Fintepla.

• You are currently taking or, within the last 14 days, stopped taking monoamine oxidase inhibitors (MAOI), serotonin antagonists, and serotonin reuptake inhibitors. When you take these medications together with Fintepla, it could cause a serious or life-threatening issue known as serotonin syndrome.

Valvular heart diseases and hypertension of the pulmonary artery

Issues with the valves of the heart (valvular heart disease) and high blood pressure in the lungs' arteries (pulmonary arterial hypertension) have been linked to the drug fenfluramine.

Your doctor will perform an ultrasoundcardiogram test to test your heart and detect excessive blood pressure within the arteries that supply the lungs before you begin treatment. You should have it every six months throughout treatment and once every 3 to 6 months following the time you have taken your last dose.

Contact your doctor immediately if you experience any of these signs or signs of lung or heart problems while you are receiving Fintepla:

• Lips with a pinkish hue and your skin (cyanosis)

• Chest pain

• A pulse that is irregular

• A fainting or lightheadedness

• Feelings of a fast heartbeat that is fluttering (palpitations)

• Breathing shortness

• Foot swelling or ankles

• Apathy or fatigue is especially evident with the increase in physical activity.

The blood pressure rises.

Your blood pressure needs constant monitoring throughout your treatment with Fintepla.

Weight loss and decreased appetite

Fintepla could cause a reduction in appetite and may cause weight loss. The weight of your body should be monitored often, and your dosage might have to be reduced when your weight falls. In certain instances, the treatment might need to be halted.

Glaucoma

Consult your physician when you notice an abrupt decrease in your vision or eye discomfort.

Sleepiness, Insomnia, and a lack of energy (lethargy)

Fintepla could cause you to become tired or sleepy. Avoid driving, operating large machinery, or engaging in other risky actions until you are aware of the extent to which Fintepla affects your body.

The use of Fintepla in conjunction with alcohol, depressants, and even Fintepla could cause sleepiness.

Suicidal thoughts and behaviour

As with other antiepileptic medications, Fintepla can trigger suicidal ideas or actions in a small percentage of individuals (about 1 out of 500).

Contact your doctor immediately if you notice any of the above symptoms, in particular when they're new or get worse, if you have any unusual changes in your behaviour or mood, or if you are thinking about suicide or death.

Refrain from treatment.

Do not discontinue using Fintepla without first speaking to your physician. When it is time to stop taking the medication, it is important to do so gradually because stopping medication for seizures in a hurry can result in seizures occurring more frequently or seizures that don't cease (status epilepticus).

Before you take drugs.

Before you take Fintepla, inform your doctor about your medical conditions, especially those that:

• Are you suffering from heart issues?

• Have you or someone else experienced a loss of weight?

• Have you experienced depression or mood issues? suicidal thoughts, depression, or a pattern of behaviours

• Have you had liver problems?

• Are you suffering from kidney issues?

• Are expecting, planning to become pregnant, or nursing.

Talk to your healthcare professional about every medication you are taking, such as prescription and over-the-counter supplements as well as vitamins and herbal supplements.

Be aware of the medications you are taking. Keep a list to show your doctor or pharmacist when you receive new medication.

Pregnancy

There isn't any data available on the efficacy of Fintepla for pregnant women. Inform your doctor right away if you're planning to become pregnant.

If you accidentally develop a pregnancy during your treatment with Fintepla and you are pregnant, speak to your physician about joining the North American Antiepileptic Pregnancy Registry. You can enrol in this registry by calling 1-888-233-2334 or visiting www.aedpregnancyregistry.org. The goal of this registry is to gather details about how safe antiepileptic medicines are during pregnancy.

Lactation

Consult your physician if you are nursing or plan to breastfeed. It isn't known how Fintepla gets into your breast milk.

What is Fintepla?

Fintepla is a medicine that can be taken with or without meals.

• Make sure you measure your dosage with the dosing syringe offered to you by your pharmacy. Do not use a standard teaspoon or a tablespoon. Fintepla is available via nasogastric or gastric feeding tubes.

• Due to the potential for heart valve issues as well as pulmonary arterial hypertension, Fenfluramine is available only through a restricted programme known as the Risk Evaluation for Fintepla and Mitigation (REMS) ogram. When either you or your child is given Fintepla, your doctor or pharmacist will ensure that you are aware of how to use the medication safely. If you have any questions, ask your healthcare provider, visit www.FinteplaREMS.com, or call 1-877-964-3649.

• Check out the Instructions on Use brochure included with the prescription. Follow the exact instructions your physician gives you on how to take the medication.

• The recommended dosage for starting is 0.1 mg/kg twice a day. This can be increased each week depending on the level of tolerability as well as the effectiveness of kidney disease and other medicines.

Side Effects of Fintepla:

The most frequent Fintepla side effects include:

• Abnormal echocardiogram

• Constipation

• A decrease in appetite

• Diarrhoea

• Falls

• Fever

• High blood pressure

• Drooling has increased.

• Infection

• Energy inefficient

• Troubles with balance, movement, and walking

• Infections of the respiratory tract

• Tiredness

• Vomiting

• Weakness.

May cause drowsiness. Don't drive, operate heavy machinery, or engage in other hazardous activities until you understand how Fintepla can affect you.

Adverse effects

Serotonin syndrome may be caused by Fintepla. Contact your doctor immediately if you notice any of the symptoms listed below:

• Changes in mental status, like being able to see things that aren't visible (hallucinations), agitation, or the coma

• Variations in blood pressure

• Muscles that are tight

• Fast heartbeat

• Nausea, vomiting, and diarrhoea

• High body temperature

• Trouble walking.

Fintepla can also increase pressure inside your eye (glaucoma). Glaucoma symptoms could include:

• Eyes red

• Halos or glowing colours in the vicinity of lights

• Nausea or vomiting

• Vision loss

• Eye discomfort or pain

• Blurred vision.

If you are experiencing one of the symptoms listed above, you should contact your doctor immediately. You may report any adverse reactions to the FDA at 1-800-FDA-1088.

What happens if I miss the dose?

Don't miss the dose you missed; take the next dose at your regular time. Don't take two doses at the same time.

What happens  if I overdose?

For medical emergencies, seek emergency medical attention or contact the Poison Help line toll-free at 1-800-222-1222.

Interactions with other drugs

A wide range of medications can cause Fintepla. This includes prescription as well as over-the-counter supplements, vitamins, and herbal supplements. The interactions of all medications are not mentioned in this article. Inform your doctor of your current medications and any medications you begin or stop taking.

Common medications that could interfere with Fintepla include:

• Antidepressant medicines are referred to as SSRIs. SNRIs, TCAs, and MAOIs

• Antipsychotics

• Clobazam

• Cyproheptadine

• Dextromethorphan

• Lithium

• St. John's Wort

• Stiripentol

• Tramadol

• Tryptophan.

Storage

Keep Fintepla at room temperature, between 68°F and 77°F (20°C between 25°C and 20°C).

• Do not freeze or refrigerate.

• Place the bottle and syringe together in a dry place.

• Discard (discard) any unopened Fintepla 3 months following the first opening of the bottle, or there is a discard. After time, either the bottle or package has expired. Whatever comes first

• Make sure that all medications are out of reach of pets and children.

Ingredients

Active ingredient: fenfluramine hydrochloride

Inactive ingredients: cherry flavour, citric acid, ethylparaben, hydroxyethylcellulose, methylparaben, potassium citrate, sucralose, and water. Fintepla is free of any ingredient that comes from gluten-containing grains (wheat, barley, wheat, or rye).