Module 3- Lupron PI

Question 1

In prostate cancer patients, when does GnRH analogue treatment usually begin?

Answer 1

As soon as they’re diagnosed with advanced prostate cancer.

Question 2

Why are HCP’s warned not to use fractional doses, or combine smaller doses of Lupron?

Answer 2

Fifferent formulations have different release characteristics.

Question 3

What are the 4 doses of Lupron Depot for the palliative treatment of advanced prostate cancer?

Answer 3

7.5mg, 22.5mg, 30mg and 45mg

Question 4

Because Lupron Depot doesn’t contain preservatives, HCP’s should inject it immedicately, or discard it if not used within?

Answer 4

2 hours

Question 5

Before injecting Lupron Depot, HCP’s should visually inspect the powder for?

Answer 5

Clumping, or caking

Question 6

What areas should be used for injection of Lupron Depot?

Answer 6

Deltoid, anterior thigh, or gluteal area.

Question 7

Lupron Depot can be administered over which treatment periods?

Answer 7

4 weeks, 12 weeks, 16 weeks, or 24 weeks

Question 8

Lupron Depot is supplied as a kit with?

Answer 8

Alcohol swab, single syringe with dual chamber system

Question 9

Which of the following are possible risks for men receiving treatment with GnRH agonists and/or leuprolide therapy?

Answer 9

Increased risk of hyperglycemia and developing diabetes, MI, sudden cardiac death, stroke, increased risk of convulsions.

Question 10

Do increases in serum levels of testosterone go to approximately 50% above baseline during the first weeks of treatment with any GnRH agonist?

Answer 10

Yes

Question 11

In patients taking leuprolide acetate therapy, post marketing experience has shown that convulsions may occur in which patients?

Answer 11

1)patients who take medications where convulsions are a risk (buproprion and SSRI’s
2)patients with a pre-existing seizure disorder
3)patiients who has NO history of seizures.

Question 12

In clinical studies of Lupron Depot, what was the most common AE?

Answer 12

Hot flashes/sweats

Question 13

In study 012 of Lupron Depot 30mg for 4 week administration, which was most common adverse event for orchiectomized patients?

Answer 13

Injection site reaction

Question 14

In clinical trials of all Lupron Depot formulations, which lab abnormalities were noted in the majority of trials?

Answer 14

Increased cholesterol (hyperlipidemia)
Decreased hemoglobin

Question 15

During clinical trials of Lupron Depot 45mg for 24 week administration, which of the following AE’s led to discontinuation?

Answer 15

Fatigue, hot flush, second primary neoplasm, Asthenia, Coronary artery disease, constipation, Hyperkalemmia, sleep disorder.

Question 16

Lupron depot is not indicted for use in which populations?

Answer 16

Pregnant women and nursing mothers

Question 17

Lupron Depot may cause _______ _____ to pregnant women.

Answer 17

Fetal harm

Question 18

Due to suppression of the pituitary adrenal system, how long may lab tests and pituitary donadotropic and gonadal functions be affected?

Answer 18

For up to 3 months after discontinuation.

Question 19

Administration of leuprolide acetate has resulted in which of the following?

Answer 19

Initial and transient increase in circulating concentrations of LH and FSH.

Atrophy of reproductive organs.

Inhibition of the growth of certain hormone dependent tumors.

Question 20

Upon treatment with Lupron Depot, decreases in testosterone and/or estrogen occur within what period?

Answer 20

2 to 4 weeks after initiating treatment.

Question 21

For the absorption of each formulation of Lupron Depot following a single injections, fill in the mean concentration.

Answer 21

7.5mg=.36, 22.4mg=.67, 30mg=.30 and 45mg=.07

Question 22

Terminal elimination of half life of Lupron Depot was approximately ____ _____ based on a two compartment model.

Answer 22

3 hours

Question 23

What were the number of participants in and length of each study for Lupron Depot?

Answer 23

7.5mg=56 and 24 weeks, 22.5=92 and 24 weeks, 30mg=49 and 32 weeks and 45mg=151 and 48 weeks.

Question 24

In the Lupron Depot clinical studies, by when was the serum testosterone suppressed to castrate range for the majority of patients?

Answer 24

30 days, or 4 weeks after initial injection.

Question 25

Which Lupron Depot clinical study had an initial treatment period and a long term treatment phase?

Answer 25

30mg

Question 26

At what temperature should Lupron Depot be stored?

Answer 26

25 degrees celsius- with excusrions permitted to 15-30 degrees celsius.

Question 27

What are the gauge needle for each respective dose of Lupron?

Answer 27

23 gauge

Question 28

What is the length of the saftey needle for each dose of Lupron?

Answer 28

1.5”

Question 29

What is the total volume per dose of Lupron Depot?

Answer 29

7.5mg= 1mL
22.5mg= 1.5Ml
30mg=1.5mL
45mg=1.5mL