WorksheetsPsych Inductive Exam2
Total questions: 25
Worksheet time: 1hrs 15mins
(a) is 9-OH-risperidone the active component of risperidone.
Activity of paliperidone:
–Blockades the ____________ and _________________ receptors
–Also blockades _____________ and _______________
–No affinity for _________________ receptors
(a)
For Sustenna treatment initiation, give injections on Day __ and Day __; no oral supplementation required.
(a)
What is the maintenance dosing for Sustenna?
Once monthly injection
Once Weekly injection
Bi-monthly injection
Bi-weekly injection
How is Sustenna administered?
Deltoid
Gluteal IM
Deltoid and gluteal IM
No correct answer
How should Sustenna be given to patients?
Reconstitution required
Reconstitution required; all dosage strengths are 2 mL
No reconstitution required;
prefilled syringes
No reconstitution required; each dose must be drawn up into a syringe; multi-dose vials available
Refrigeration is required for Sustenna.
True
False
The SmPC recommended administration is an injection of Sustenna® ____eq. into the deltoid muscle on Day 1, followed by a deltoid injection of ____eq. on Day 8.
(a)
Subsequent doses can be administered into either the deltoid or gluteal muscle, with a recommended monthly maintenance dose of (a) eq.; some patients may benefit from lower or higher doses within the recommended range of 25−150 mg eq. based on individual patient tolerability and/or efficacy.
Following a single IM dose, the plasma concentrations of paliperidone gradually rise to reach a maximum at a median Tmax of (a) days for gluteal injections.
Following a single IM dose, the plasma concentrations of paliperidone gradually rise to reach a maximum at a median Tmax of (a) days for deltoid injections.
The mean steady-state peak:trough ratio for a Sustenna® dose of 100 mg eq. was ____ hours following gluteal administration and ____ hours following deltoid administration
(a)
Steady state is achieved within (a) after 2 doses of initiation regimen (15 days).
Paliperidone is predominantly excreted by the ____.
Liver
Kidney
Bladder
No correct answer
If the patient misses an injection during the monthly maintenance phase of treatment (from treatment Day 36 onwards), the dose can be administered within (a) days of the missed scheduled injection without affecting the treatment schedule of the following monthly injections.
When switching from depot antipsychotics to Sustenna, there is no requirement for a washout period before switching treatment.
True
False
This study was performed to assess the efficacy and tolerability of 150 mg eq. Sustenna® but also assess the lower 25 and 100 mg eq. doses.
PALM-PSY-3001
PALM-PSY-3007
PALM-PSY-3010
PALM-PSY-3017
Primary efficacy endpoint was the __________ from baseline to the end of the double-blind treatment period
change in PSP total score
change in CGI total score
change in PANSS total score
All choices are correct
In PALM-PSY- 3007, Change in PANSS score was statistically significant from Day (a) onwards for Sustenna® 25 mg eq. and Sustenna® 150 mg eq. dose compared with placebo.
In PALM-PSY-3007, Sustenna® 100 mg eq. was statistically significant from Day (a) .
_______ was a double-blind, randomized study designed to evaluate the efficacy and safety of Sustenna® in delaying time to relapse.
PALM-PSY-3001
PALM-PSY-3007
PALM-PSY-3010
PALM-PSY-3017
What is the primary endpoint of PALM-PSY-3001?
time-to-recovery during the double-blind phase
time-to-first relapse during the maintenance phase
time-to-first relapse during the wash out phase
time-to-first relapse during the double-blind phase
How was relapse defined in PAL-PSY-3001? (4)
It is a multi center, randomized, prospective, active controlled, open label, rater blinded, 24 month study in recently diagnosed ( within 1-5 years ) patients with Schizophrenia.
PALM-PSY 3001
PALM-PSY-3007
PROSIPAL STUDY
No correct answer
The primary efficacy endpoint of PROSIPAL study was change from baseline to endpoint based on the LOCF approach in the (a) total score.
