Module 3- Lupron PI Flashcards
In prostate cancer patients, when does GnRH analogue treatment usually begin?
As soon as they’re diagnosed with advanced prostate cancer.
Why are HCP’s warned not to use fractional doses, or combine smaller doses of Lupron?
Fifferent formulations have different release characteristics.
What are the 4 doses of Lupron Depot for the palliative treatment of advanced prostate cancer?
7.5mg, 22.5mg, 30mg and 45mg
Because Lupron Depot doesn’t contain preservatives, HCP’s should inject it immedicately, or discard it if not used within?
2 hours
Before injecting Lupron Depot, HCP’s should visually inspect the powder for?
Clumping, or caking
What areas should be used for injection of Lupron Depot?
Deltoid, anterior thigh, or gluteal area.
Lupron Depot can be administered over which treatment periods?
4 weeks, 12 weeks, 16 weeks, or 24 weeks
Lupron Depot is supplied as a kit with?
Alcohol swab, single syringe with dual chamber system
Which of the following are possible risks for men receiving treatment with GnRH agonists and/or leuprolide therapy?
Increased risk of hyperglycemia and developing diabetes, MI, sudden cardiac death, stroke, increased risk of convulsions.
Do increases in serum levels of testosterone go to approximately 50% above baseline during the first weeks of treatment with any GnRH agonist?
Yes
In patients taking leuprolide acetate therapy, post marketing experience has shown that convulsions may occur in which patients?
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.
In clinical studies of Lupron Depot, what was the most common AE?
Hot flashes/sweats
In study 012 of Lupron Depot 30mg for 4 week administration, which was most common adverse event for orchiectomized patients?
Injection site reaction
In clinical trials of all Lupron Depot formulations, which lab abnormalities were noted in the majority of trials?
Increased cholesterol (hyperlipidemia)
Decreased hemoglobin
During clinical trials of Lupron Depot 45mg for 24 week administration, which of the following AE’s led to discontinuation?
Fatigue, hot flush, second primary neoplasm, Asthenia, Coronary artery disease, constipation, Hyperkalemmia, sleep disorder.
Lupron depot is not indicted for use in which populations?
Pregnant women and nursing mothers
Lupron Depot may cause _______ _____ to pregnant women.
Fetal harm
Due to suppression of the pituitary adrenal system, how long may lab tests and pituitary donadotropic and gonadal functions be affected?
For up to 3 months after discontinuation.
Administration of leuprolide acetate has resulted in which of the following?
Initial and transient increase in circulating concentrations of LH and FSH.
Atrophy of reproductive organs.
Inhibition of the growth of certain hormone dependent tumors.
Upon treatment with Lupron Depot, decreases in testosterone and/or estrogen occur within what period?
2 to 4 weeks after initiating treatment.
For the absorption of each formulation of Lupron Depot following a single injections, fill in the mean concentration.
7.5mg=.36, 22.4mg=.67, 30mg=.30 and 45mg=.07
Terminal elimination of half life of Lupron Depot was approximately ____ _____ based on a two compartment model.
3 hours
What were the number of participants in and length of each study for Lupron Depot?
7.5mg=56 and 24 weeks, 22.5=92 and 24 weeks, 30mg=49 and 32 weeks and 45mg=151 and 48 weeks.
In the Lupron Depot clinical studies, by when was the serum testosterone suppressed to castrate range for the majority of patients?
30 days, or 4 weeks after initial injection.
Which Lupron Depot clinical study had an initial treatment period and a long term treatment phase?
30mg
At what temperature should Lupron Depot be stored?
25 degrees celsius- with excusrions permitted to 15-30 degrees celsius.
What are the gauge needle for each respective dose of Lupron?
23 gauge
What is the length of the saftey needle for each dose of Lupron?
1.5”
What is the total volume per dose of Lupron Depot?
7.5mg= 1mL
22.5mg= 1.5Ml
30mg=1.5mL
45mg=1.5mL
