Iloperidonedosage

Administer FANAPT orally twice daily without regard to meals. Titrate the dosage of FANAPT to avoid orthostatic hypotension. See Full Prescribing Information for titration schedule.

Recommended Dosage: Indication Starting Dosage Recommended Dosage Schizophrenia 1 mg twice daily 6 mg to 12 mg twice daily Bipolar Mania 1 mg twice daily 12 mg twice daily CYP2D6 Poor Metabolizers: See Full Prescribing Information for titration schedule and recommended dosage.

2.1 Recommended

Dosage Titrate FANAPT to avoid orthostatic hypotension. Administer FANAPT orally with or without food. Table 1 includes dosage recommendations for FANAPT for the treatment of schizophrenia and the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.

Table 1: Dosage Recommendations for FANAPT in Adults for the Treatment of Schizophrenia or Acute Treatment of Manic or Mixed Episodes Associated with Bipolar I Disorder Indication and Population Titration schedule Recommended Dosage Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Schizophrenia Titration Pack A 1mg twice daily 2 mg twice daily 4 mg twice daily 6 mg twice daily 8 mg twice daily 10 mg twice daily 12 mg twice daily 6 mg to 12 mg twice daily Bipolar I Disorder Manic or Mixed Episodes Titration Pack B 1 mg twice daily 3 mg twice daily 6 mg twice daily 9 mg twice daily 12 mg twice daily Titration complete 12 mg twice daily

2.2 Dosage Recommendations for

Use in Patients Who Are Known CYP2D6 Poor Metabolizers Reduce the dose of FANAPT by one-half for CYP2D6 poor metabolizers. Table 2 includes dosage recommendations for FANAPT in adults who are CYP2D6 poor metabolizers.

Table 2: Dosage Recommendations for FANAPT in Adults with Schizophrenia or Bipolar I Disorder Who are CYP2D6 Poor Metabolizers Indication and Population Titration schedule Recommended Dosage Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Schizophrenia Titration Pack A 1mg twice daily 2 mg twice daily 4 mg twice daily 6 mg twice daily Titration complete 3 mg to 6 mg twice daily Bipolar I Disorder Manic or Mixed Episodes Titration Pack C 1 mg twice daily 3 mg twice daily 6 mg twice daily Titration complete 6 mg twice daily

2.3 Dosage Recommendations in

Patients with Hepatic Impairment No dose adjustment for FANAPT is needed in patients with mild hepatic impairment. Patients with moderate hepatic impairment may require dose reduction, if clinically indicated. FANAPT is not recommended for patients with severe hepatic impairment.

2.4 Dosage Modifications for

Concomitant Use with Strong CYP2D6 Inhibitors and Strong CYP3A4 Inhibitors Coadministration with Strong CYP2D6 Inhibitors Reduce the dose of FANAPT one-half when administered concomitantly with strong CYP2D6 inhibitors such as fluoxetine or paroxetine. When the CYP2D6 inhibitor is withdrawn from the combination therapy, increase the dose of FANAPT to where it was before. Coadministration with Strong CYP3A4 Inhibitors Reduce the dose of FANAPT by one-half when administered concomitantly with strong CYP3A4 inhibitors such as ketoconazole or clarithromycin. When the CYP3A4 inhibitor is withdrawn from the combination therapy, increase the dose of FANAPT to where it was before. Coadministration with Strong CYP2D6 and Strong CYP3A4 Inhibitors Reduce the dose of FANAPT by about one-half if administered concomitantly with inhibitors of CYP2D6 and CYP3A4. When both CYP2D6 and CYP3A4 inhibitors are withdrawn from the combination therapy, increase the dose of FANAPT to where it was before.

2.5 Reinitiation of

Treatment in Patients Previously Discontinued Although there are no data to specifically address reinitiation of treatment, it is recommended that the initiation titration schedule be followed whenever patients have had an interval off FANAPT of more than 3 days.