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Fintepla
fenfluramine
Black Box Warnings .
Appropriate Use
avail. only through restricted program (Fintepla REMS) due to risk of valvular heart disease and pulmonary arterial HTN; prescribers, patients, and pharmacies must enroll at 1-877-964-3649 or www.FinteplaREMS.com
Valvular Heart Disease and Pulmonary Arterial HTN
can cause valvular heart disease and pulmonary arterial HTN; echocardiogram required before, during, and after tx; weigh risk vs. benefit of initiating or continuing tx based on echocardiogram
Adult Dosing .
Dosage forms: SOL: 2.2 mg per mL
Restricted Distribution in US
- [1-877-964-3649 or www.FinteplaREMS.com for more info]
seizures, Dravet syndrome
- [w/o stiripentol]
- Dose: 0.1-0.35 mg/kg/dose PO bid; Start: 0.1 mg/kg/dose PO bid x6 days, then may incr. to 0.2 mg/kg/dose PO bid x7 days, then may incr. to 0.35 mg/kg/dose PO bid; Max: 0.35 mg/kg/dose, 26 mg/day; Info: may incr. dose q4 days if more rapid titration needed; taper dose gradually to D/C
- [w/ stiripentol and clobazam]
- Dose: 0.1-0.2 mg/kg/dose PO bid; Start: 0.1 mg/kg/dose PO bid x6 days, then may incr. to 0.15 mg/kg/dose PO bid x7 days, then may incr. to 0.2 mg/kg/dose PO bid; Max: 0.2 mg/kg/dose, 17 mg/day; Info: taper dose gradually to D/C
seizures, Lennox-Gastaut syndrome
- [w/o stiripentol]
- Dose: 0.35 mg/kg/dose PO bid; Start: 0.1 mg/kg/dose PO bid x6 days, then incr. to 0.2 mg/kg/dose PO bid x7 days, then incr. to 0.35 mg/kg/dose PO bid; Max: 26 mg/day; Info: may incr. dose q4 days if more rapid titration needed; taper dose gradually to D/C
- [w/ stiripentol and clobazam]
- Dose: 0.2 mg/kg/dose PO bid; Start: 0.1 mg/kg/dose PO bid x6 days, then incr. to 0.15 mg/kg/dose PO bid x7 days, then incr. to 0.2 mg/kg/dose PO bid; Max: 17 mg/day; Info: taper dose gradually to D/C
renal dosing
- [w/o stiripentol]
- eGFR 15-29: max 20 mg/day; eGFR <15: not defined
- HD/PD: not defined
- [w/ stiripentol and clobazam]
- eGFR 15-29: max 17 mg/day; eGFR <15: not defined
- HD/PD: not defined
hepatic dosing
- [w/o stiripentol]
- Child-Pugh Class A or B: max 20 mg/day; Child-Pugh Class C: max 17 mg/day
- [w/ stiripentol and clobazam]
- Child-Pugh Class A: max 13 mg/day; Child-Pugh Class B or C: avoid use
Peds Dosing .
- Dosage forms: SOL: 2.2 mg per mL
Restricted Distribution in US
- [1-877-964-3649 or www.FinteplaREMS.com for more info]
seizures, Dravet syndrome
- [w/o stiripentol, 2 yo and older]
- Dose: 0.1-0.35 mg/kg/dose PO bid; Start: 0.1 mg/kg/dose PO bid x6 days, then may incr. to 0.2 mg/kg/dose PO bid x7 days, then may incr. to 0.35 mg/kg/dose PO bid; Max: 0.35 mg/kg/dose, 26 mg/day; Info: may incr. dose q4 days if more rapid titration needed; taper dose gradually to D/C
- [w/ stiripentol and clobazam, 2 yo and older]
- Dose: 0.1-0.2 mg/kg/dose PO bid; Start: 0.1 mg/kg/dose PO bid x6 days, then may incr. to 0.15 mg/kg/dose PO bid x7 days, then may incr. to 0.2 mg/kg/dose PO bid; Max: 0.2 mg/kg/dose, 17 mg/day; Info: taper dose gradually to D/C
seizures, Lennox-Gastaut syndrome
- [w/o stiripentol, 2 yo and older]
- Dose: 0.35 mg/kg/dose PO bid; Start: 0.1 mg/kg/dose PO bid x6 days, then incr. to 0.2 mg/kg/dose PO bid x7 days, then incr. to 0.35 mg/kg/dose PO bid; Max: 26 mg/day; Info: may incr. dose q4 days if more rapid titration needed; taper dose gradually to D/C
- [w/ stiripentol and clobazam, 2 yo and older]
- Dose: 0.2 mg/kg/dose PO bid; Start: 0.1 mg/kg/dose PO bid x6 days, then incr. to 0.15 mg/kg/dose PO bid x7 days, then incr. to 0.2 mg/kg/dose PO bid; Max: 17 mg/day; Info: taper dose gradually to D/C
renal dosing
- [w/o stiripentol]
- eGFR 15-29: max 20 mg/day; eGFR <15: not defined
- HD/PD: not defined
- [w/ stiripentol and clobazam]
- eGFR 15-29: max 17 mg/day; eGFR <15: not defined
- HD/PD: not defined
hepatic dosing
- [w/o stiripentol]
- Child-Pugh Class A or B: max 20 mg/day; Child-Pugh Class C: max 17 mg/day
- [w/ stiripentol and clobazam]
- Child-Pugh Class A: max 13 mg/day; Child-Pugh Class B or C: avoid use
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- MAO inhibitor use w/in 14 days
- abrupt withdrawal
- hepatic impairment, Child-Pugh Class B-C (patients on concurrent stiripentol and clobazam)
- caution: hepatic impairment, Child-Pugh Class A
- caution: hepatic impairment, Child-Pugh Class B-C (patients not on concurrent stiripentol)
- caution: eGFR <30
- caution: valvular heart disease
- caution: pulmonary arterial HTN
- caution: HTN
- caution: CNS depressant use, concurrent
- caution: alcohol use, concurrent
- caution: suicide risk
- caution: smoking habit change
Drug Interactions .
Overview
fenfluramine
5-HT2B agonist
- CYP1A2 substrate
- CYP2B6 substrate
- CYP2D6 substrate
- CYP3A4 substrate
- affected by altered fat absorption
- antiepileptic agent
- CNS depression
- hypertensive effects
- serotonergic effects
- add MAO inhibitor to Interaction Check if recent (14 days) use
Contraindicated
- amifampridine
- bupropion
- dalfampridine
- isocarboxazid
- phenelzine
- selegiline transdermal
- tranylcypromine
Avoid/Use Alternative
- alfentanil
- amphetamine
- apalutamide
- buprenorphine
- butalbital
- butorphanol
- carbamazepine
- citalopram
- clobazam
- clomipramine
- clonidine
- codeine
- cyclobenzaprine
- desipramine
- desvenlafaxine
- dextroamphetamine
- dihydrocodeine
- doxylamine
- duloxetine
- encorafenib
- enzalutamide
- epinephrine inhaled
- escitalopram
- ethanol
- fentanyl
- fluoxetine
- fluvoxamine
- fosphenytoin
- furosemide
- gepirone
- ginkgo
- granisetron
- hydrocodone
- hydromorphone
- isoniazid
- ivosidenib
- kava
- kratom
- landiolol
- levomilnacipran
- levorphanol
- linezolid
- lisdexamfetamine
- lithium
- lumacaftor/ivacaftor
- meperidine
- metaxalone
- methadone
- methamphetamine
- methylene blue oral
- metoclopramide
- midazolam
- midodrine
- milnacipran
- mirtazapine
- mitotane
- morphine
- nalbuphine
- nortriptyline
- oliceridine
- ondansetron
- opium
- oxybate
- oxycodone
- oxymorphone
- paroxetine
- pentazocine
- pentobarbital
- phenobarbital
- phenytoin
- primidone
- procarbazine
- promethazine
- rasagiline
- remifentanil
- rifabutin
- rifampin
- ropeginterferon alfa-2b
- safinamide
- selegiline
- sertraline
- St. John's wort
- stiripentol
- sufentanil
- tapentadol
- thalidomide
- tramadol
- trimethobenzamide
- trimipramine
- venlafaxine
- vilazodone
- vortioxetine
- yohimbe
- ziprasidone
- zuranolone
Monitor/Modify Tx
- 5-HTP
- abiraterone acetate
- acebutolol
- albuterol
- albuterol inhaled
- aldesleukin
- aliskiren
- almotriptan
- alprazolam
- amiloride
- amitriptyline
- amlodipine
- amoxapine
- angiotensin II
- aprocitentan
- arformoterol inhaled
- armodafinil
- asciminib
- atenolol
- atogepant
- atomoxetine
- atropine ophthalmic
- axitinib
- azilsartan medoxomil
- baclofen intrathecal
- benazepril
- benzphetamine
- betamethasone
- betaxolol
- bevacizumab
- bismuth subsalicylate
- bisoprolol
- black cohosh
- brigatinib
- bromocriptine
- budesonide
- bumetanide
- buspirone
- cabozantinib
- caffeine
- caffeine citrate
- candesartan cilexetil
- cannabis
- captopril
- carfilzomib
- carvedilol
- celecoxib
- chlordiazepoxide
- chlorothiazide
- chlorpromazine
- chlorthalidone
- ciprofloxacin
- clevidipine
- clonazepam
- clorazepate
- cocaine
- copanlisib
- corticotropin
- cortisone
- cyclosporine
- dacomitinib
- danazol
- darbepoetin alfa
- daridorexant
- deflazacort
- desflurane
- desmopressin
- dexamethasone
- dexmedetomidine
- dexmedetomidine injection
- dexmethylphenidate
- dextromethorphan
- diazepam
- diclofenac
- diclofenac topical
- diethylpropion
- diflunisal
- dihydroergotamine
- diltiazem
- dobutamine
- dopamine
- doxapram
- doxazosin
- doxepin
- doxepin topical
- dronabinol
- droperidol
- droxidopa
- eletriptan
- enalapril
- enalaprilat
- enasidenib
- ephedra
- ephedrine injection
- ephedrine oral
- epinephrine
- eplerenone
- epoetin alfa
- eptinezumab
- erenumab
- ergotamine
- esketamine
- esmolol
- estazolam
- estetrol (contraceptive)
- estradiol (contraceptive)
- eszopiclone
- ethacrynic acid
- ethanol (in some formulations)
- ethinyl estradiol (contraceptive)
- etodolac
- etomidate
- etrasimod
- felodipine
- fenoldopam
- fenoprofen
- fingolimod
- fludrocortisone
- fluphenazine
- flurazepam
- flurbiprofen
- formoterol inhaled
- fosinopril
- fostamatinib
- fremanezumab
- frovatriptan
- fruquintinib
- gabapentin
- gabapentin enacarbil
- galcanezumab
- guanfacine
- hoodia
- hydralazine
- hydrochlorothiazide
- hydrocortisone
- hydroxocobalamin IV
- hydroxyzine
- ibrutinib
- ibuprofen
- ifosfamide
- imipramine
- indapamide
- indomethacin
- irbesartan
- isoflurane
- isradipine
- ketamine
- ketoprofen
- ketorolac
- labetalol
- lanreotide
- lasmiditan
- leflunomide
- lemborexant
- lenvatinib
- levalbuterol inhaled
- levothyroxine
- licorice
- liothyronine
- lisinopril
- lorazepam
- lorlatinib
- losartan
- luspatercept
- magnesium salicylate
- mavorixafor
- meclofenamate
- mefenamic acid
- meloxicam
- methohexital
- methoxy polyethylene glycol-epoetin beta
- methyldopa
- methylene blue injection
- methylergonovine
- methylphenidate
- methylprednisolone
- methyltestosterone
- metolazone
- metoprolol
- minoxidil
- mirabegron
- modafinil
- moexipril
- nabumetone
- nadolol
- naproxen
- naratriptan
- naxitamab
- nebivolol
- nefazodone
- nelarabine
- nicardipine
- nifedipine
- nimodipine
- niraparib
- nisoldipine
- norepinephrine
- obinutuzumab
- olanzapine
- olmesartan medoxomil
- olodaterol inhaled
- opicapone
- osilodrostat
- oxaprozin
- oxazepam
- oxybutynin
- oxymetazoline nasal
- oxytocin
- ozanimod
- palonosetron
- pazopanib
- perindopril
- perphenazine
- pexidartinib
- phendimetrazine
- phenoxybenzamine
- phentermine
- phentolamine
- phenylephrine
- phenylephrine injection
- phenylephrine nasal
- phenylephrine ophthalmic
- phenylephrine rectal
- pindolol
- piroxicam
- ponatinib
- ponesimod
- pralsetinib
- prazosin
- prednisolone
- prednisone
- pregabalin
- propofol
- propranolol
- protriptyline
- pseudoephedrine
- quazepam
- quetiapine
- quinapril
- quinidine (antiarrhythmic)
- quinidine (CYP2D6 inhibitor)
- ramipril
- ramucirumab
- regorafenib
- remimazolam
- rimegepant
- ripretinib
- rizatriptan
- ropinirole
- rotigotine transdermal
- salmeterol inhaled
- salsalate
- SAMe
- selpercatinib
- sevoflurane
- siponimod
- solriamfetol
- sorafenib
- spironolactone
- sulindac
- sumatriptan
- sunitinib
- suvorexant
- tacrolimus
- tagraxofusp
- telmisartan
- temazepam
- terazosin
- terbinafine
- terbutaline
- teriflunomide
- testosterone
- thioridazine
- thiothixene
- thyroid
- timolol
- tivozanib
- tolmetin
- torsemide
- trametinib
- trandolapril
- trazodone
- triamcinolone
- triamterene
- triazolam
- ubrogepant
- vadadustat
- valsartan
- vamorolone
- vandetanib
- vasopressin
- verapamil
- vilanterol inhaled
- viloxazine
- voclosporin
- zaleplon
- zavegepant
- ziconotide
- ziv-aflibercept
- zolmitriptan
- zolpidem
Caution Advised
- acyclovir
- allopurinol
- amantadine
- aminophylline
- amoxicillin
- ampicillin
- apomorphine
- apraclonidine ophthalmic
- aripiprazole bimonthly injection
- aripiprazole lauroxil
- aripiprazole monthly injection
- aripiprazole oral
- asenapine
- axicabtagene ciloleucel
- baclofen
- bosentan
- brexpiprazole
- brexucabtagene autoleucel
- brimonidine ophthalmic
- brimonidine topical
- brivaracetam
- brompheniramine
- busulfan
- cannabidiol
- carbinoxamine
- cariprazine
- carisoprodol
- cefazolin
- cefepime
- cefiderocol
- ceftaroline
- ceftazidime
- ceftobiprole
- cenobamate
- cetirizine
- chamomile, German
- chlophedianol
- chlorambucil
- chloroquine
- chlorpheniramine
- chlorzoxazone
- ciltacabtagene autoleucel
- cisatracurium
- clemastine
- clozapine
- cycloserine
- cyproheptadine
- dabrafenib
- dantrolene
- darifenacin
- darolutamide
- delafloxacin
- deutetrabenazine
- dexbrompheniramine
- dexchlorpheniramine
- dichlorphenamide
- dicloxacillin
- difelikefalin
- difenoxin
- dimenhydrinate
- diphenhydramine
- diphenoxylate
- domperidone
- donepezil
- efavirenz
- elivaldogene autotemcel
- entacapone
- entrectinib
- ertapenem
- eslicarbazepine acetate
- ethosuximide
- etravirine
- felbamate
- fesoterodine
- fexinidazole
- flibanserin
- foscarnet
- foslevodopa
- galantamine
- ganaxolone
- ganciclovir
- glofitamab
- glycopyrrolate
- goserelin
- haloperidol
- histrelin
- hydroxychloroquine
- hyoscyamine
- idecabtagene vicleucel
- iloperidone
- imipenem
- interferon beta 1a
- interferon beta 1b
- iohexol
- iopamidol
- lacosamide
- lamotrigine
- leuprolide
- levetiracetam
- levocarnitine
- levocetirizine
- levodopa
- levofloxacin
- lidocaine
- lidocaine topical
- linvoseltamab
- lisocabtagene maraleucel
- lofexidine
- lopinavir/ritonavir
- loxapine
- lumateperone
- lurasidone
- magnesium citrate
- mavacamten
- meclizine
- mefloquine
- melatonin
- meprobamate
- meropenem
- methocarbamol
- methotrexate
- methsuximide
- metronidazole
- metyrapone
- metyrosine
- mexiletine
- mitapivat
- molindone
- mosunetuzumab
- moxifloxacin
- mycophenolate mofetil
- nafarelin nasal
- nafcillin
- naltrexone
- obecabtagene autoleucel
- ofloxacin
- orphenadrine
- oxacillin
- oxcarbazepine
- pacritinib
- paliperidone
- passion flower
- peginterferon beta 1a
- penicillin G
- penicillin V
- perampanel
- pheniramine
- pimozide
- piperacillin
- polyethylene glycol
- polyethylene glycol/electrolytes
- pramipexole
- prochlorperazine
- pyridostigmine
- pyrilamine
- pyrimethamine
- quinine
- ramelteon
- regadenoson
- repotrectinib
- rifapentine
- risperidone
- ritonavir
- rivastigmine
- rufinamide
- scopolamine
- selinexor
- sodium picosulfate
- solifenacin
- sotorasib
- sulfate bowel prep
- tasimelteon
- teclistamab
- tetrabenazine
- theophylline
- thiotepa
- tiagabine
- tinidazole
- tisagenlecleucel
- tizanidine
- tolcapone
- tolterodine
- topiramate
- tranexamic acid
- treosulfan
- trifluoperazine
- trihexyphenidyl
- triprolidine
- triptorelin
- trospium
- valacyclovir
- valbenazine
- valerian
- valganciclovir
- valproic acid
- varenicline
- vigabatrin
- zonisamide
Adverse Reactions .
Serious Reactions
- valvular heart disease
- pulmonary arterial HTN
- serotonin syndrome
- suicidality
- HTN
- glaucoma, angle-closure
- withdrawal seizures if abrupt D/C
Common Reactions
- anorexia
- diarrhea
- fatigue
- somnolence
- echocardiogram abnormal
- URI
- fever
- vomiting
- sialorrhea
- weight loss
- BP incr.
- constipation
- ataxia
- behavioral disturbance
- tremor
- glucose decr.
- bronchitis
- irritability
- ear infection
- hypotonia
- gastroenteritis
- rhinitis
- headache
- rash
Safety/Monitoring .
Monitoring Parameters
eGFR at baseline; echocardiogram at baseline, q6mo during tx, then 3-6mo after D/C; BP; weight; signs/symptoms of depression, behavior changes, suicidality
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; possible risk of fetal harm, incl. embryo-fetal death, malformations, and decr. fetal wt, based on animal data
Pregnancy Registry
encourage patients to enroll in North American Antiepileptic Drug Pregnancy Registry at 1-888-233-2334; additional info at www.aedpregnancyregistry.org
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: liver primarily; CYP450: 1A2, 2B6, 2C9, 2C19, 2D6, 3A4/5; Info: active metobolite
Excretion: urine >90%, feces <5%; Half-life: 20h
Subclass: Seizure Disorders
Mechanism of Action
exact mechanism of action unknown; interacts w/ serotonin transporter proteins to incr. extracellular serotonin (5-HT2 receptor agonist)
Formulary .
No Formulary Selected
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