Fanapt Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Fanapt Indications
Indications
Acute treatment of manic or mixed episodes associated with bipolar I disorder.
Fanapt Dosage and Administration
Adult
Titrate slowly. ≥18yrs: Initially 1mg twice daily, then 3mg, 6mg, 9mg, and 12mg twice daily on Days 2, 3, 4, and 5 respectively, to reach 24mg/day dose. Reduce dose by ½ with concomitant strong CYP2D6/CYP3A4 inhibitors, or poor metabolizers of CYP2D6. Retitrate if therapy suspended >3 days.
Children
Fanapt Contraindications
Not Applicable
Fanapt Boxed Warnings
Boxed Warning
Fanapt Warnings/Precautions
Warnings/Precautions
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). Discontinue if persistent QTc measurements >500msec occur. Cardio- or cerebrovascular disease. Monitor electrolytes esp. K+, Mg++. Monitor for neuroleptic malignant syndrome (NMS); discontinue if suspected and treat appropriately. Consider discontinuing if tardive dyskinesia occurs; assess periodically the need for continued treatment. Moderate hepatic impairment. Severe hepatic impairment: not recommended. Diabetes or risk factors (obtain baseline fasting blood sugar). Dyslipidemia (obtain baseline fasting lipid profile). Monitor for blood glucose, lipid profile, 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. Risk of intraoperative floppy iris syndrome (IFIS) during cataract or glaucoma surgery: not recommended. Write ℞ for the smallest practical amount. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Reevaluate periodically. Pregnancy. Nursing mothers: not recommended.
Fanapt Pharmacokinetics
Absorption
Time to peak plasma concentrations: within 2 to 4 hours. Relative bioavailability: 96%.
Distribution
Apparent volume of distribution: 1340 to 2800 L. 95% serum protein bound.
Elimination
Renal (58.2% for extensive metabolizers; 45.1% for poor metabolizers), fecal (19.9% for extensive metabolizers; 22.1% for poor metabolizers). Half-life: 18 hours (extensive metabolizers); 33 hours (poor metabolizers).
Fanapt Interactions
Interactions
Fanapt Adverse Reactions
Adverse Reactions
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, intraoperative floppy iris syndrome (IFIS).
Fanapt Clinical Trials
See Literature
Fanapt Note
Not Applicable
Fanapt Patient Counseling
See Literature
Fanapt Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Fanapt Indications
Indications
Fanapt Dosage and Administration
Adult
Children
Fanapt Contraindications
Not Applicable
Fanapt Boxed Warnings
Boxed Warning
Fanapt Warnings/Precautions
Warnings/Precautions
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). Discontinue if persistent QTc measurements >500msec occur. Cardio- or cerebrovascular disease. Monitor electrolytes esp. K+, Mg++. Monitor for neuroleptic malignant syndrome (NMS); discontinue if suspected and treat appropriately. Consider discontinuing if tardive dyskinesia occurs; assess periodically the need for continued treatment. Moderate hepatic impairment. Severe hepatic impairment: not recommended. Diabetes or risk factors (obtain baseline fasting blood sugar). Dyslipidemia (obtain baseline fasting lipid profile). Monitor for blood glucose, lipid profile, 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. Risk of intraoperative floppy iris syndrome (IFIS) during cataract or glaucoma surgery: not recommended. Write ℞ for the smallest practical amount. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Reevaluate periodically. Pregnancy. Nursing mothers: not recommended.
Fanapt Pharmacokinetics
Absorption
Time to peak plasma concentrations: within 2 to 4 hours. Relative bioavailability: 96%.
Distribution
Apparent volume of distribution: 1340 to 2800 L. 95% serum protein bound.
Elimination
Renal (58.2% for extensive metabolizers; 45.1% for poor metabolizers), fecal (19.9% for extensive metabolizers; 22.1% for poor metabolizers). Half-life: 18 hours (extensive metabolizers); 33 hours (poor metabolizers).
Fanapt Interactions
Interactions
Fanapt Adverse Reactions
Adverse Reactions
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, intraoperative floppy iris syndrome (IFIS).
Fanapt Clinical Trials
See Literature
Fanapt Note
Not Applicable
Fanapt Patient Counseling
See Literature
Images
