Dosing
The lowest dose of Fanapt
1mg BID
Indications for Fanapt
Treatment of schizophrenia in adults.
Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.
Name 5 of the commonly observed adverse reactions (incidence ≥5% and 2-fold greater than placebo) in Bi-Polar 1
tachycardia, dizziness, dry mouth, hepatic enzymes increased, nasal congestion, weight increased, hypotension, and somnolence
This is the percentage of patients with worsened Barnes Akathisia Rating Scale global scores from Baseline- Fanapt and Placebo
Fanapt 24mg/day - 2.8%
Placebo - 3.8%
Fanapt is an agonist, Antagonist, or partial agonist of neurotransmitters
Antagonist
The highest dose of Fanapt
12mg BID
This is the Primary Endpoint and correlating Result in the Bi-Polar 1 study
Efficacy was measured by decrease in YMRS score at day 28
Result was that Fanapt was superior to placebo with a 14-point drop from baseline to endpoint at day
Name 5 of the commonly observed adverse reactions (incidence ≥5% and 2-fold greater than placebo) in Schizophrenia
dizziness, dry mouth, fatigue, nasal congestion, orthostatic hypotension, somnolence, tachycardia, and weight increased.
This was the adjusted mean change on YMRS total score from baseline and the timeframe
Fanapt -14 points at day 28
This is the dose adjustments with Fanapt for patients who are poor metabolizers of CYP2D6
Cut the dose in half
Minimum number of days to reach an effective dose of Fanapt
4 days
This is the name of the study to evaluate the safety and effectiveness of Fanapt for the prevention of relapse in adult schizophrenia patients
Reprieve
Percentage of Akathisia Compared to Placebo in 4- or 6-week Schizophrenia Trials
Placebo- 2.7%
Fanapt 10-16 mg- 1.7%
Fanapt 20-24mg- 2.3%
Fill in the blank. Mean changes from baseline to endpoint___________ for Fanapt and placebo treated patients
were similar
This is the Black Box Warning for Fanapt
Increased Mortality in elderly patients with dementia-related psychosis
This is the recommended starting and recommended dose for Schizophrenia
1 mg twice daily: 6 mg to 12 mg twice daily
The efficacy of FANAPT in the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults was supported by.....
one multicenter, randomized, double-blind, placebo-controlled study that enrolled patients who met the DSM-5 criteria for bipolar I disorder, manic or mixed type
Percentage of Akathesia Compared to Placebo in a 4-week Bipolar Mania Trial
Placebo- 0%
Fanapt 24mg- 4.4%
Fill in the blank. In clinical trials, more than _____% of patients taking Fanapt did not experience significant_________.
65%
weight gain
This is the number of days off Fanapt therapy that a patient should follow the titration process
3 Days
This is the recommended starting and recommended dose for Bi-Polar 1 with mixed and manic episodes
1 mg twice daily; 12 mg twice daily
The efficacy of FANAPT in the treatment of schizophrenia was supported by....
2 placebo- and active-controlled short-term (4- and 6-week) trials and one long-term placebo-controlled randomized withdrawal trial.
This is the weight gain in kg for the 2 short term studies in Schizophrenia and the 1 Bi-Polar study
Schizophrenia: FANAPT 10-16mg/day - 2kg
FANAPT 20-24 mg/day - 2.7kg
Bi-Polar - FANAPT 24mg/day 4.6 kg
This is the MOA of Fanapt
The mechanism of action of iloperidone in schizophrenia and bipolar I disorder is unknown. However, the efficacy of iloperidone could be mediated through a combination of dopamine type 2 (D2) and serotonin type 2 (5-HT2) antagonism.
This is the information is included in the FANAPT PI regarding QT prolongation
Fanapt is associate with a 9 msec QTc prolongation at a dose of 12mg BID
Fanapt is associated with a 19 msec QTc prolongation for patients on potent CTP2D6 and CYP3A4 inhibitors at a dose of 12mg BID