Module 4: Trelstar, Zoladex and Firmagon PI

Question 1

What type of drug is Trelstar?

Answer 1

A GnRH agonist

Question 2

What areas should be used for the injection of Trelstar?

Answer 2

Either buttock.

Question 3

Why should the Trelstar suspension be administered immediately after reconstitution?

Answer 3

Because the suspension can separate.

Question 4

What gauge of needle is used for all doeses of Trelstar?

Answer 4

21 gauge

Question 5

Trelstar is administered via a ____ injetion with an injection volume of ____.

Answer 5

IM, 2 mL

Question 6

In clinical trials of Trelstar, which was the most common AE?

Answer 6

Hot flush

Question 7

During Trelstar clinical trials, what was the impact on mean testosterone levels?

Answer 7

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.

Question 8

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>

Answer 8

Increased glucose, decreased hemoglobin

Question 9

In the Trelstar clinical studies, what was the castration rate (%) on day 29 for the 3 doses?

Answer 9

3.75=91.2
11.25=97.7
22.5=97.5

Question 10

In the Trelstar clinical study, on the 22.5mg dose, what was the rate on castration maintenance (%) from days 5-337?

Answer 10

93.3%

Question 11

How many caucasian patients made up each treatment group?

Answer 11

3.75mg=59.9
11.25mg=48
22.5mg=64

Question 12

How many black patients made up each treatment group?

Answer 12

3.75mg=39.3
11.25=38
22.5=23

Question 13

How many unidentified race patients made up each treatment group?

Answer 13

3.75mg=.8
11.25mg=15
22.5mg=13

Question 14

Which are the approved doses and administration times for Zoladex?

Answer 14

3.6mg every 28 days
10.8mg every 12 weeks

Question 15

What type of drug delivery system does Zoladex use?

Answer 15

Implant

Question 16

What gauge of needle is used for Zoladex

Answer 16

16 gauge for 3.6mg
14 gauge for 10.8mg

Question 17

What area should be used for the injection of Zoladex?

Answer 17

Abdomen

Question 18

Extra care should be taken when administering Zoladex to what types of patients?

Answer 18

Low BMI

Those on a full dose of anticoagulent

Question 19

In Zoladex clinical trials, what was the most common AE?

Answer 19

hot flashes

Question 20

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?

Answer 20

hot flashes

Question 21

In the clinical study of Zoladex 3.6mg for stage B2-C prostate carcinoma, what 2 treatment arms were compared?

Answer 21

Zoladex 3.6mg + flutamide + radiation compared to radiation alone.

Question 22

In the clinical study of Zoladex 3.6mg for prostate carcinoma, what two treatment arms were compared?

Answer 22

Zoladex 3.6mg to Orchiectomy

Question 23

In clinical studies on Zoladex 10.8mg for prostatic carcinoma what 2 treatment arms were compared?

Answer 23

Zoladex 3.6mg to Zoladex 10.8mg

Question 24

What type of drug is Firmagon?

Answer 24

GnRH antagonist

Question 25

What area should be used for injection with Firmagon?

Answer 25

abdomen

Question 26

Firmagon must be administered within what period of time after the addition of sterile water?

Answer 26

1 hour

Question 27

What is the injection volume of each dose of Firmagon?

Answer 27

loading dose is 2 3mL doses equalling 6mL.

maintenance dose is 4mL.

Question 28

In clinical trials, what was the most common AE?

Answer 28

Injection site reaction

Question 29

In the Firmagon active controlled study, to what drug was Firmagon compared?

Answer 29

Leuprolide

Question 30

In the Firmagon active controlled study, on what day of treatment did more than 90% of patients achieve medical castration range?

Answer 30

Day 3

Question 31

In the Firmagon clinical study, what % of patients mainained medical castration rates from day 28 to day 364?

Answer 31

98.3% of patients treated with 240/160
97.2% of patients treated with 240/80

Question 32

How often must Firmagon be dosed for maintenance?

Answer 32

Monthly