Fintepla

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Fenfluramine can cause serious side effects on your heart and lungs. Call your doctor right away if you have:

• chest pain, pounding heartbeats or fluttering in your chest;
• shortness or breath;
• blue colored skin or lips;
• swelling in your lower legs; or
• unusual tiredness or weakness, feeling like you might pass out.

Also call your doctor at once if you have:

• loss of appetite and weight loss;
• worsening seizures;
• blurred vision, tunnel vision, eye pain or redness, or seeing halos around lights;
• nausea or vomiting; or
• increased blood pressure--severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Fenfluramine can affect weight or growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common side effects may include:

• loss of appetite, vomiting, diarrhea, constipation;
• seizures that do not stop;
• feeling weak or tired;
• fever, infections;
• abnormal heart function tests;
• problems with balance, walking, or muscle movement;
• drooling; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Fintepla (FenfluramineOral Solution)

 

Fintepla Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in labeling:

• Valvular Heart Disease [see WARNINGS AND PRECAUTIONS]
• Pulmonary Arterial Hypertension [see WARNINGS AND PRECAUTIONS]
• Decreased Appetite and Decreased Weight [see WARNINGS AND PRECAUTIONS]
• Somnolence, Sedation, and Lethargy [see WARNINGS AND PRECAUTIONS]
• Suicidal Behavior and Ideation [see WARNINGS AND PRECAUTIONS]
• Withdrawal of Antiepileptic Drugs [see WARNINGS AND PRECAUTIONS]
• Serotonin Syndrome [see WARNINGS AND PRECAUTIONS]
• Increase in Blood Pressure [see WARNINGS AND PRECAUTIONS]
• Glaucoma [see WARNINGS AND PRECAUTIONS]

Clinical 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, 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 placebo-controlled trials of patients with Dravet syndrome, 122 patients were treated with FINTEPLA [see Clinical Studies]. The duration of treatment in these trials was 16 weeks (Study 1) or 17 weeks (Study 2). In Study 1 and Study 2, the mean age was 9 years (range 2 to 19 years) and approximately 46% of patients were female and 74% were White. All patients were receiving at least one other AED.

In Study 1 and Study 2, the rates of discontinuation as a result of any adverse reaction were 13%, 0%, and 7% for patients treated with FINTEPLA 0.7 mg/kg/day, 0.2 mg/kg/day, and 0.4 mg/kg/day in combination with stiripentol, respectively, compared to 6% for patients on placebo. The most frequent adverse reaction leading to discontinuation in the patients treated with any dose of FINTEPLA was somnolence (n=3, 3%).

The most common adverse reactions that occurred in patients treated with FINTEPLA (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.

Table 3 lists the adverse reactions that were reported in 5% or more of patients treated with FINTEPLA and at a rate greater than those on placebo during the titration and maintenance phases of Study 1 and Study 2.

Table 3: Adverse Reactions in 5% or More of Patients Treated with FINTEPLA and Greater Than Placebo in Placebo-Controlled Trials

	FINTEPLA Dose Group			Combined Placebo Group(2)
	Study 1		Study 2
	0.2 mg/kg/day	0.7 mg/kg/day	0.4 mg/kg/day(1)
	N=39 %	N=40 %	N=43 %	N=84 %
Decreased appetite	23	38	49	8
Somnolence, sedation, lethargy	26	25	23	11
Abnormal echocardiogram(3)	18	23	9	6
Diarrhea	31	15	23	6
Constipation	3	10	7	0
Fatigue, malaise, asthenia	15	10	30	5
Ataxia, balance disorder, gait disturbance	10	10	7	1
Abnormal behavior	0	8	9	0
Blood pressure increased	13	8	0	5
Drooling, salivary hypersecretion	13	8	2	0
Hypotonia	0	8	0	0
Rash	8	8	5	4
Blood prolactin increased	0	5	0	0
Chills	0	5	2	0
Decreased activity	0	5	0	1
Dehydration	0	5	0	0
Insomnia	0	5	5	2
Pyrexia	15	5	21	14
Stereotypy	0	5	0	0
Upper respiratory tract infection	21	5	7	10
Vomiting	10	5	5	8
Weight decreased	13	5	7	1
Croup	5	3	0	1
Ear infection	8	3	9	5
Gastroenteritis	8	3	2	0
Increased heart rate	5	3	0	2
Irritability	0	3	9	2
Rhinitis	8	3	7	2
Tremor	3	3	9	0
Urinary incontinence	5	3	0	0
Decreased blood glucose	0	0	9	1
Bronchitis	3	0	9	1
Contusion	5	0	0	0
Eczema	0	0	5	0
Enuresis	5	0	0	0
Fall	10	0	0	4
Headache	8	0	0	2
Laryngitis	0	0	5	0
Negativism	5	0	0	0
Status epilepticus	3	0	12	2
Urinary tract infection	5	0	5	0
Viral infection	0	0	5	1
(1) 0.4 mg/kg/day was not an intermediate dose. Patients on the 0.4 mg/kg/day dose were also taking concomitant stiripentol plus clobazam, which increases exposure of FINTEPLA. (2) Patients in placebo groups from Studies 1 and 2 were pooled. (3) Consisted of trace and mild mitral regurgitation, and trace aortic regurgitation, which are considered physiologic.

Echocardiographic Safety Assessments Of Valvular Heart Disease And Pulmonary Arterial Hypertension

Valvular heart disease and pulmonary arterial hypertension were evaluated in the placebocontrolled and open-label extension studies via echocardiography for up to 3 years in duration [see WARNINGS AND PRECAUTIONS].

No patient developed echocardiographic findings consistent with either valvular heart disease or pulmonary arterial hypertension in the placebo-controlled studies or during the open-label extension study of up to 3 years in duration. In Study 1 and Study 2, 16% of patients taking FINTEPLA compared to 6% of patients taking placebo were reported to have trace mitral regurgitation, and 3% of patients taking FINTEPLA and no patients taking placebo were found to have trace aortic regurgitation. During the open-label extension study, trace mitral regurgitation and trace aortic regurgitation were reported in 14% and 0.4%, respectively, of patients taking FINTEPLA. Trace and mild mitral regurgitation, and trace aortic regurgitation are considered physiologic in the absence of structural valve abnormalities.

Read the entire FDA prescribing information for Fintepla (FenfluramineOral Solution)

&Copy; Fintepla Patient Information is supplied by Cerner Multum, Inc. and Fintepla Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.