Generic Name and Formulations:
Iloperidone 1mg, 2mg, 4mg, 6mg, 8mg, 10mg, 12mg; tabs.
Vanda Pharmaceuticals, Inc.
Indications for FANAPT:
Titrate slowly. ≥18yrs: Initially 1mg twice daily, then 2mg, 4mg, 6mg, 8mg, 10mg, and 12mg twice daily on Days 2, 3, 4, 5, 6, and 7 respectively, to reach the 12mg/day to 24mg/day dose range. Reduce dose by ½ with concomitant strong CYP2D6/CYP3A4 inhibitors, or poor metabolizers of CYP2D6. Retitrate if therapy suspended >3 days.
<18yrs: not established.
Increased mortality in elderly patients with dementia-related psychosis (not approved use). Bradycardia, hypokalemia, hypomagnesemia, congenital QT prolongation, recent MI, uncompensated heart failure, arrhythmias: avoid (risk of torsades de pointes/ sudden death). Cardio- or cerebrovascular disease. Monitor electrolytes esp. K+, Mg++. Moderate hepatic impairment. Severe hepatic impairment: not recommended. Diabetes or risk factors (obtain baseline fasting blood sugar). Monitor for hyperglycemia, weight changes. History of breast cancer or seizures. Orthostatic hypotension. Preexisting low WBC count or history of leukopenia/neutropenia: monitor CBC during 1st few months of therapy; discontinue if WBCs decline. If neutropenia develops, monitor for fever, signs/symptoms of infection; discontinue if severe neutropenia (absolute neutrophil count <1000/mm3) occurs. Exposure to extreme heat. Aspiration pneumonia risk. Dehydration. Perform fall risk assessments when initiating and recurrently on long-term therapy. Suicidal tendencies. Write ℞ for the smallest practical amount. Monitor for neuroleptic malignant syndrome. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Reevaluate periodically. Pregnancy. Nursing mothers: not recommended.
Avoid other drugs that cause QT prolongation (eg, quinidine, procainamide, amiodarone, sotalol, chlorpromazine, thioridazine, gatifloxacin, moxifloxacin, pentamidine, levomethadyl acetate, methadone). May potentiate antihypertensives. Caution with alcohol, CNS depressants. Potentiated by inhibitors of CYP2D6 (eg, fluoxetine, paroxetine) or CYP3A4 (eg, clarithromycin, ketoconazole).
Dizziness, dry mouth, fatigue, nasal congestion, orthostatic hypotension, somnolence, tachycardia, increased weight; QT prolongation (discontinue if QTc >500msec persists), priapism, neuroleptic malignant syndrome, tardive dyskinesia, hyperglycemia, dyslipidemia, dysphagia, hyperprolactinemia, hypersensitivity reactions.
Tabs—60; Titration pack—8 (2 x 1mg, 2 x 2mg, 2 x 4mg, 2 x 6mg)