Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: Valvular Heart Disease and Pulmonary Arterial Hypertension [see Warnings and Precautions (5.1) ] Decreased Appetite and Decreased Weight [see Warnings and Precautions (5.3) ] Somnolence, Sedation, and Lethargy [see Warnings and Precautions (5.4) ] Suicidal Behavior and Ideation [see Warnings and Precautions (5.5) ] Withdrawal of Antiepileptic Drugs [see Warnings and Precautions (5.6) ] Serotonin Syndrome [see Warnings and Precautions (5.7) ] Increase in Blood Pressure [see Warnings and Precautions (5.8) ] Glaucoma [see Warnings and Precautions (5.9) ] The most common adverse reactions (incidence at least 10% and greater than placebo) in patients with Dravet syndrome were decreased appetite;
somnolence, sedation, lethargy;
constipation;
abnormal echocardiogram;
fatigue, malaise, asthenia;
ataxia, balance disorder, gait disturbance;
blood pressure increased;
drooling, salivary hypersecretion;
upper respiratory tract infection;
decreased weight;
5 WARNINGS AND PRECAUTIONS Decreased Appetite and Decreased Weight: Advise patients that FINTEPLA can cause decreased appetite and decreased weight.
( 5.3 ) Somnolence, Sedation, and Lethargy: Monitor for somnolence and sedation.
Advise patients not to drive or operate machinery until they have gained sufficient experience on FINTEPLA.
( 5.4 ) Suicidal Behavior and Ideation: Monitor patients for suicidal behavior and thoughts.
( 5.5 ) Withdrawal of Antiepileptic Drugs: FINTEPLA should be gradually withdrawn to minimize the risk of increased seizure frequency and status epilepticus.
Like all medications, Fintepla can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: