Module 2: Eligard PI Flashcards
Eligard is a lutenizing hormone releasing hormone agonist that?
Both reduced the amount of testosterone in the body and reduced the testicles’ production of testosterone.
Which are the 4 approved doses of Eligard?
7.5mg, 22.5mg, 30mg and 45mg
What time should Eligard be administered?
When it has come to room temperature (generally 30 minutes.)
Eligard should be stored between __ and __ degrees Celcius?
2 and 8
If brought to room temperature, Eligard can be stored for how long before needing to be discarded?
8 weeks
Name the gauge size of the needles associated with each dose?
7.5mg=20, 22.5mg=20, 30mg=20 and 45mg=18.
What is the length of the safety needle in the Eligard product line?
5/8”
When injecting Eligard, what areas should be avoided?
areas with brawny tissue, areas with fibrous subcutaneous tissue, or areas that could be rubbed, or compressed.
Eligard can be administered over which treatment periods?
1,3,4 and 6 months
What are the common colors of each dose of a thoroughly mixed Eligard suspension?
7.5mg= light tan to tan, 22.5mg= clear to pale yellow, 30mg= clear to pale yellow and 45mg= clear to pale yellow.
Which of the following risks have been reported in men receiving treatment with GnRH agonists like Eligard?
Hyperglycemia, developing diabetes, MI, sudden cardiac death, stroke, possible prolonged QT/QTc interval.
What are results of all doses of Eligard?
Transient increase in serum concentrations of testosterone above baseline during first week of treatment.
A decline in serum concentration of testosteroneto baseline, or below by the end of the second, or third week of treatment.
Bone pain, bladde routlet obstruction, neuropathy and spinal cord compression are all possible side effect from what?
The transient increase in serum testosterone levels that come with initial dose of Eligard.
Possibly, or probably related systemic AE’s reported by less than 2% of patients can be reported on which table in the PI?
4
What is a side effect that men who have undergone orchiectomy, or who have taken ADT for long periods of time experience?
Bone density loss
According to table 4, what was the most frequently reported systemic AE? (>2%)
Hot flashes/sweats
According to table 3, what was the most frequently reported injection site AE?
Transient burning and stinging
How is Eligard supplied and administered?
Eligard is supplied in two syringes, which are joined to form a single dose product which is mixed until homogenous.
Eligard is administered subcutaneously, where is forms a solid drug delivery depot.
Eligard is supplied in two syringes: one containing an in-situ polymeric gel delivery system and one containting leuprolide acetate.
When first injected, what can be expected from Eligard?
Initial increase in the circulating levels of LH.
What are the dosage volumes for each of the Eligard doses?
7.5mg=.25 mL, 22.5mg=.375mL, 30mg=.50mL and 45mg=.375mL
Eligard is indicated for which populations?
Men and Elderly Men
Eligard is contraindicated in which populations?
Pregnant women
Continued administration of Eligard results in?
Decreased levels of FH and LSH
Testosterone reduction to below the castrate threshold
What is the castrate threshold as listed in the PI?
<50 ng/dL
How long does it take Eligard to achieve castrate levels of Testosterone?
2 to 4 weeks
Long term studies show that continued therapy with Eligard maintains testosterone to below castrate levels for up to?
7 years
With Eligard 22.5mg how many patients in the trials experienced a breakthrough?
1
What was the effect on serum PSA in clinical trial patients whose baseline values were elevated above the normal limit at the beginning of the trial?
100% decreased
Across all clinical trials which Jewett stage were the majority of patients?
C
How many patients started & finished each dose in the clinical studies?
7.5mg- 120 started- 117 finished
22.5mg- 117 started, 111 finished
30mg- 90 started, 82 finished
45mg-111 started, 103 finished
