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Iloperidone

Also known as: Fanapt

Atypical Antipsychotic

Route: Oral

3 interactions on record⛔ Black Box Warning

Iloperidone has 3 known drug interactions based on U.S. FDA drug labeling data. Notable interactions include combinations with Fluoxetine, Ketoconazole, Paroxetine. Patients taking Iloperidone should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 3
Moderate: 3

Moderate (3)

Iloperidone + Fluoxetine— Strong CYP2D6 inhibitor that increased iloperidone AUC 2-3 fold and metabolite P88 levels, decreased P95 metabolite. Dos…
Iloperidone + Ketoconazole— Strong CYP3A4 inhibitor that increased iloperidone AUC by 57%, metabolite P88 by 55%, and P95 by 35%. Dose reduction req…
Iloperidone + Paroxetine— Strong CYP2D6 inhibitor that increased iloperidone and P88 metabolite peak concentrations ~1.6 fold, decreased P95 by ha…

Iloperidone + Fluoxetine🟡Moderate

Strong CYP2D6 inhibitor that increased iloperidone AUC 2-3 fold and metabolite P88 levels, decreased P95 metabolite. Dose reduction required.

Iloperidone + Ketoconazole🟡Moderate

Strong CYP3A4 inhibitor that increased iloperidone AUC by 57%, metabolite P88 by 55%, and P95 by 35%. Dose reduction required.

Iloperidone + Paroxetine🟡Moderate

Strong CYP2D6 inhibitor that increased iloperidone and P88 metabolite peak concentrations ~1.6 fold, decreased P95 by half. Dose reduction required.

⛔ FDA Black Box Warning

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. FANAPT is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1) ] . WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. FANAPT is not approved for use in patients with dementia-related psychosis. ( 5.1 )

Contraindications

4 CONTRAINDICATIONS FANAPT is contraindicated in individuals with a known hypersensitivity reaction to the product. Anaphylaxis, angioedema, and other hypersensitivity reactions have been reported [see Adverse Reactions (6.2) ] . Known hypersensitivity to FANAPT or to any components in the formulation. ( 4 , 6.2 )

Pregnancy & Breastfeeding

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to FANAPT during pregnancy. For more information contact the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/ . Risk Summary Neonates whose mothers are exposed to antipsychotic drugs, including FANAPT, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery [see Clinical Considerations ] . The limited available data with FANAPT in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. Iloperidone was not teratogenic when administered orally to pregnant rats during organogenesis at doses up to 26 times the maximum recommended human dose of 24 mg/day on mg/m 2 basis. However, it prolonged the duration of pregnancy and parturition, increased still births, early intrauterine deaths, increased incidence of developmental delays, and decreased post-partum pup survival. Iloperidone was not teratogenic when administered orally to pregnant rabbits during organogenesis at doses up to 20-times the MRHD on mg/m 2 basis. However, it increased early intrauterine deaths and decreased fetal viability at term at the highest dose which was also a maternally toxic dose [see Data] . The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder have been reported in neonates whose mothers were exposed to antipsychotic dru

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine. For informational purposes only. Always consult your pharmacist or physician.