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
What gauge of needle is used for Zoladex
16 gauge for 3.6mg
14 gauge for 10.8mg
What area should be used for the injection of Zoladex?
Abdomen
Extra care should be taken when administering Zoladex to what types of patients?
Low BMI
Those on a full dose of anticoagulent
In Zoladex clinical trials, what was the most common AE?
hot flashes
In 2 controlled clinical trials comparing Zoladex 10.8mg vs Zoladex 3.6mg, what was the ONLY AE reported by more than 5% of patients?
hot flashes
In the clinical study of Zoladex 3.6mg for stage B2-C prostate carcinoma, what 2 treatment arms were compared?
Zoladex 3.6mg + flutamide + radiation compared to radiation alone.
In the clinical study of Zoladex 3.6mg for prostate carcinoma, what two treatment arms were compared?
Zoladex 3.6mg to Orchiectomy
In clinical studies on Zoladex 10.8mg for prostatic carcinoma what 2 treatment arms were compared?
Zoladex 3.6mg to Zoladex 10.8mg
What type of drug is Firmagon?
GnRH antagonist
What area should be used for injection with Firmagon?
abdomen
Firmagon must be administered within what period of time after the addition of sterile water?
1 hour
What is the injection volume of each dose of Firmagon?
loading dose is 2 3mL doses equalling 6mL.
maintenance dose is 4mL.
In clinical trials, what was the most common AE?
Injection site reaction
In the Firmagon active controlled study, to what drug was Firmagon compared?
Leuprolide
In the Firmagon active controlled study, on what day of treatment did more than 90% of patients achieve medical castration range?
Day 3
In the Firmagon clinical study, what % of patients mainained medical castration rates from day 28 to day 364?
98.3% of patients treated with 240/160
97.2% of patients treated with 240/80
How often must Firmagon be dosed for maintenance?
Monthly
