Medically reviewed by Drugs.com. Last updated on Aug 23, 2021.
Generic name: FENFLURAMINE 2.2mg in 1mL
Dosage form: oral solution
Assessments Prior to Initiating FINTEPLA
Prior to starting treatment with FINTEPLA, obtain an echocardiogram assessment to evaluate for valvular heart disease and pulmonary arterial hypertension [see Dosage and Administration (2.4) and Warnings and Precautions (5.1, 5.2)].
- FINTEPLA is to be administered orally and may be taken with or without food.
- The initial starting and maintenance dosage is 0.1 mg/kg twice daily, which can be increased weekly based on efficacy and tolerability. Table 1 provides the recommended titration schedule, if needed.
- Patients not on concomitant stiripentol who are tolerating FINTEPLA at 0.1 mg/kg twice daily and require further reduction of seizures may benefit from a dosage increase up to a maximum recommended maintenance dosage of 0.35 mg/kg twice daily (maximum daily dosage of 26 mg).
- Patients taking concomitant stiripentol and clobazam who are tolerating FINTEPLA at 0.1 mg/kg twice daily and require further reduction of seizures may benefit from a dosage increase up to a maximum recommended maintenance dosage of 0.2 mg/kg twice daily (maximum daily dosage of 17 mg) [see Drug Interactions (7.1)].
|*For patients not on concomitant stiripentol in whom a more rapid titration is warranted, the dose may be increased every 4 days|
|Without concomitant stiripentol*||With concomitant stiripentol and clobazam|
|Weight-based Dosage||Maximum Total Daily Dosage||Weight-based Dosage||Maximum Total Daily Dosage|
|0.1 mg/kg twice daily||26 mg||0.1 mg/kg twice daily||17 mg|
|Day 7||0.2 mg/kg twice daily||26 mg||0.15 mg/kg twice daily||17 mg|
|Day 14||0.35 mg/kg twice daily||26 mg||0.2 mg/kg twice daily||17 mg|
Assessments During and After Administration of FINTEPLA
To evaluate for valvular heart disease and pulmonary arterial hypertension, obtain an echocardiogram assessment every 6 months during treatment with FINTEPLA, and 3 to 6 months after the final dose of FINTEPLA [see Warnings and Precautions (5.1, 5.2)].
A calibrated measuring device (either a 3 mL or 6 mL oral syringe) will be provided by the pharmacy and is recommended to measure and administer the prescribed dose accurately [see How Supplied/Storage and Handling (16.1)]. A household teaspoon or tablespoon is not an adequate measuring device and should not be used.
Discard any unused FINTEPLA oral solution remaining after 3 months of first opening the bottle or the “Discard After” date on the bottle, whichever is sooner.
FINTEPLA is compatible with commercially available gastric and nasogastric feeding tubes.
Discontinuation of FINTEPLA
When discontinuing FINTEPLA, the dose should be decreased gradually. As with all antiepileptic drugs, abrupt discontinuation should be avoided when possible to minimize the risk of increased seizure frequency and status epilepticus [see Warnings and Precautions (5.7)].
Frequently asked questions
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More about Fintepla (fenfluramine)
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- During Pregnancy
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- Drug class: CNS stimulants
- FDA Approval History
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