Module 4: Trelstar, Zoladex and Firmagon PI Flashcards
What type of drug is Trelstar?
A GnRH agonist
What areas should be used for the injection of Trelstar?
Either buttock.
Why should the Trelstar suspension be administered immediately after reconstitution?
Because the suspension can separate.
What gauge of needle is used for all doeses of Trelstar?
21 gauge
Trelstar is administered via a ____ injetion with an injection volume of ____.
IM, 2 mL
In clinical trials of Trelstar, which was the most common AE?
Hot flush
During Trelstar clinical trials, what was the impact on mean testosterone levels?
Initial transient increase above baseline during the 1st week following the initial injection.
Declined to baseline, or below by the end of the 2nd week of treatment.
For both the 11.25mg and 22.5mg doses o Trelstar, which lab value abnormalities were not present at baseline, but were observed in < 10% of patients>
Increased glucose, decreased hemoglobin
In the Trelstar clinical studies, what was the castration rate (%) on day 29 for the 3 doses?
3.75=91.2
11.25=97.7
22.5=97.5
In the Trelstar clinical study, on the 22.5mg dose, what was the rate on castration maintenance (%) from days 5-337?
93.3%
How many caucasian patients made up each treatment group?
3.75mg=59.9
11.25mg=48
22.5mg=64
How many black patients made up each treatment group?
3.75mg=39.3
11.25=38
22.5=23
How many unidentified race patients made up each treatment group?
3.75mg=.8
11.25mg=15
22.5mg=13
Which are the approved doses and administration times for Zoladex?
3.6mg every 28 days
10.8mg every 12 weeks
What type of drug delivery system does Zoladex use?
Implant
