Fintepla

Fenfluramine

Add-on therapy to other anti-epileptic medicines for the treatment of seizures associated w/ Dravet syndrome & Lennox-Gastaut syndrome in patients ≥2 yr.

Adult, & childn ≥2 yr Dose may be increased every 4 days for patients requiring more rapid titration. Dravet syndrome (w/o stiripentol) Starting dose (1st wk): 0.1 mg/kg bd (0.2 mg/kg/day). Day 7 (2nd wk): 0.2 mg/kg bd (0.4 mg/kg/day). Day 14 (further titration as applicable): 0.35 mg/kg bd (0.7 mg/kg/day). Max dose: 26 mg (13 mg bd). Dravet syndrome (w/ stiripentol) Starting dose (1st wk): 0.1 mg/kg bd (0.2 mg/kg/day). Day 7 (2nd wk): 0.2 mg/kg bd (0.4 mg/kg/day). Max dose: 17 mg (8.6 mg bd). Lennox-Gastaut syndrome Starting dose (1st wk): 0.1 mg/kg bd (0.2 mg/kg/day). Day 7 (2nd wk): 0.2 mg/kg bd (0.4 mg/kg/day). Maintenance dose (day 14): 0.35 mg/kg bd (0.7 mg/kg/day). Max dose: 26 mg (13 mg bd). Patient w/ severe hepatic impairment (Child-Pugh C) not receiving concomitant stiripentol Max dose: 0.2 mg/kg bd. Max total daily dose: 17 mg.

May be taken with or without food: Compatible w/ commercially available gastric & nasogastric feeding tubes. Compatible w/ ketogenic diet.

Hypersensitivity. Aortic or mitral valvular heart disease. Pulmonary arterial HTN. W/in 14 days of MAOI administration.

Prescribed & dispensed according to the controlled access programme. Avoid abrupt discontinuation to minimize risk of increased seizure frequency & status epilepticus. Risk of valvular heart disease & pulmonary arterial HTN. Conduct echocardiogram to establish baseline prior to initiating treatment & exclude any pre-existing valvular heart disease or pulmonary HTN. Monitor echocardiogram every 6 mth for the 1st 2 yr & annually thereafter. Evaluate benefit versus risk of continuing treatment if pathological abnormalities are observed on the echocardiogram. Conduct final echocardiogram 3-6 mth after the last dose of treatment. Risk of decreased appetite & wt loss. Monitor patient's wt. Evaluate benefit versus risk prior to commencing treatment in patients w/ history of anorexia nervosa or bulimia nervosa. Risk of somnolence; suicidal behaviour & ideation; serotonin syndrome; increased seizure frequency. Can cause mydriasis & precipitate angle closure glaucoma. Discontinue therapy in patients w/ acute decreases in visual acuity. Decreased efficacy w/ cyproheptadine, & strong CYP1A2 or CYP2B6 inducers. Co-administration w/ strong CYP1A2 or CYP2D6 inhibitors may result in adverse events. Contains Na ethyl para-hydroxybenzoate (E 215) & Na methyl para-hydroxybenzoate (E 219), which may cause allergic reactions (possibly delayed). Contains sulfur dioxide (E 220), which may rarely cause severe hypersensitivity reactions & bronchospasm. Contains glucose, which may be harmful to the teeth. Should not be taken by patients w/ rare glucose-galactose malabsorption. Moderate influence on ability to drive & use machines. Has not been studied in patients w/ ESRD. Limited clinical data on use w/ stiripentol in patients w/ mild hepatic impairment. Not recommended for use in patients w/ renal impairment or moderate & severe hepatic impairment treated w/ stiripentol. Avoid use during pregnancy. Discontinue breast-feeding or discontinue/abstain from therapy. Safety & efficacy in childn <2 yr have not yet been established. No data on use in elderly patients.

Decreased appetite; somnolence; diarrhoea; fatigue. Bronchitis; aggression; lethargy, seizure, status epilepticus, tremor; constipation, salivary hypersecretion; rash; decreased wt, increased blood prolactin. Dravet syndrome: Pyrexia; decreased blood glucose, abnormal echocardiogram. Abnormal behaviour, agitation, insomnia, mood swings; ataxia, hypotonia. Lennox-Gastaut syndrome: Vomiting. Flu, pneumonia.

Increased risk of aggravated CNS depression w/ other CNS depressants eg, other serotonergic agents (including SSRIs, SNRIs, TCAs, or triptans), agents that impair serotonin metabolism (eg, MAOIs), or antipsychotics that may affect the serotonergic neurotransmitter systems. Increased plasma conc of CYP2D6 & MATE1 substrates. Decreased plasma conc of CYP2B6 & CYP3A4 substrates. Co-administration w/ stiripentol plus clobazam &/or valproate increased fenfluramine AUC_0-24 & decreased norfenfluramine AUC_0-24. Co-administration w/ cannabidiol increased fenfluramine AUC_0-INF & C_max, & decreased norfenfluramine AUC_0-INF & C_max. Co-administration w/ rifampicin (strong CYP3A & 2C19 inducer, & moderate CYP1A2, 2B6, 2C8 & 2C9 inducer) decreased fenfluramine AUC_0-t & C_max, decreased norfenfluramine AUC_0-t, & increased norfenfluramine C_max. Co-administration w/ fluvoxamine (strong CYP1A2 inhibitor) or paroxetine (strong CYP2D6 inhibitor) increased fenfluramine AUC_0-t & C_max, & decreased norfenfluramine AUC_0-t & C_max.

Anticonvulsants

N03AX26 - fenfluramine ; Belongs to the class of other antiepileptics.

P₁S₁S₃