Brenda Heath, RN

The Effect of Leuprolide Formulations on Organizational Management Practices in Metastatic Prostate Cancer

In this companion article, Brenda Heath, RN, discusses key challenges related to the use of leuprolide acetate and leuprolide mesylate from an organizational management perspective.

Expert Perspectives on Advanced/Metastatic Prostate Cancer

,” thought leaders in the management of hormone-sensitive or castration-resistant prostate cancer reflect on advancements in the treatment landscape, including key considerations in the use of different formulations of leuprolide. Considering challenges in the use of leuprolide formulations from an organizational management perspective, Brenda Heath, RN, discusses key points related to nurse training, inventory management practices, and patient assistance programs in the companion interview ahead.

Do nursing staff require special training on how to prepare and administer leuprolide?

We always have a training method set up for … our new nurses, and they're following experienced nurses who have injected this medication multiple times. Usually, the training is incorporated with the experienced nurse training the new nurse, observing at first and then getting their hands on it. Most of the nurses … [have] experience [and] know how to administer subcutaneous injections. Most training comes from just being able to mix the different leuprolide acetate medications appropriately and [knowing] how to administer [them]. However,… there is available training with each of the sponsors to assist , [if needed], and nurse educators [can] come … and help with that.

 Are there any challenges to managing leuprolide or other prostate cancer therapy inventory?

There have definitely been more challenges [related to] trying to keep inventory for any health care supplies now… since the COVID-19 (coronavirus disease–2019) [pandemic] hit. But for the most part, I don't think that we've had any limitations with keeping it on-hand or keeping track. We have a system in place [in which] we make sure that we are signing out all of our medications whenever an injection is removed so that we keep track of our inventory, and we reorder and resupply when that is getting low.

 Can you talk more in-depth about the programs and materials that are available from the leuprolide manufacturers to help you address administration and/or inventory challenges, such as product-specific training materials and instructions or inventory management programs?

 Most of the leuprolide injectables have inventory programs that can assist in scanning and making sure that the inventory at the location is up to date, and they can automatically work with resupplying the site with the product. That can come in handy. There are also great resources on each of the websites for the different medications that show how to mix and administer each of the injectables. That can [be] helpful, as well. We also know that we have, of course, the representatives that come on-site and are readily available with their information to support us if we have any questions. There [are] support programs for most of these injectables that can work to help patients who … have any financial issues. I have experienced and worked with some of the support programs to assist our patients who just can’t afford the medications.

Videos

In this companion article, Brenda Heath, RN, discusses key challenges related to the use of leuprolide acetate and leuprolide mesylate from an organizational management perspective. 

EP. 4B: The Effect of Leuprolide Formulations on Organizational Management Practices in Metastatic Prostate Cancer

Most of the leuprolide injectables have inventory programs that can assist in scanning and making sure that the inventory at the location is up to date, and they can automatically work with resupplying the site with the product. That can come in handy. There are also great resources on each of the websites for the different medications that show how to mix and administer each of the injectables. That can [be] helpful, as well. We also know that we have, of course, the representatives that come on-site and are readily available with their information to support us if we have any questions. There [are] support programs for most of these injectables that can work to help patients who … have any financial issues. I have experienced and worked with some of the support programs to assist our patients who just can’t afford the medications.

In the fourth interview of the series, Brenda Heath, RN, shares expert insights into key factors related to nurse training on leuprolide administration, inventory management of the drug, and patient support programs.  

EP. 4A: Organizational Perspectives on the Use of Leuprolide in Prostate Cancer

,” key opinion leaders in the management of hormone-sensitive or castration-resistant prostate cancer reflect on the evolving treatment landscape, including key considerations about the using leuprolide-containing therapeutic combinations. Given the availability of multiple leuprolide formulations, it is essential that clinicians consider key benefits and challenges associated with each option. In the following interview, Brenda Heath, RN, builds a lively discussion concerning practical considerations in using different leuprolide acetate and leuprolide mesylate formulations in patients with prostate cancer.

 What are the available leuprolide formulations and their recommending dosing strategies and routes of administration? Can you start by describing leuprolide acetate and its associated benefits and challenges?

Leuprolide acetate is dosed in different increments. There [are] 1-month, 3-month,4-month, and 6-month doses. [It is available as] a subcutaneous (SC) version and an intramuscular (IM) version. Having the different dose ranges is very helpful [for] coordinating appointments with patients and [ensuring that they come] in for [injections] at appropriate times. Leuprolide acetate [has 2 components] that have to be mixed [to form] the product that is administered to the patient. One version does not need to be refrigerated, [but] the other version [needs refrigeration]. The [refrigerated] version has 2 separate vials [with contents] that need to be mixed … it is important to make sure that we remove [them from refrigeration] 30 minutes before [mixing]. It makes it much easier to mix together, and it's best practice for the patient [to] decrease any stinging or pain. The leuprolide acetate [that needs no refrigeration] is stored at room temperature. The mixing is a little bit different—it's filled in 1 syringe, and you just have to push the plunger up to mix the liquid and the powder together and[then] twirl [it] while it's sitting upright. They are a little bit different, for sure.

Leuprolide mesylate is new to the market here, and we're very excited about this medication. [It requires only] 1 dose, which could be a limiting factor in [using] it; however, it is already prefilled [and] premixed. It [must be] refrigerated, so it [needs] to be removed from the refrigerator 30 minutes ahead of [administration]. However, [it’s] very convenient when [we're] running an advanced prostate cancer clinic day, and [we] have a whole list of patients coming in. [It’s] convenient for the nurses to be able to pull that and already have it premixed.

 What other challenges do the pharmacy and nursing teams encounter with the various leuprolide formulations?

Refrigeration is probably one of the biggest ones. Making sure [that] the appropriate leuprolide acetate and leuprolide mesylate are removed from the [refrigerator] 30 minutes ahead of time can be difficult and challenging to complete with a full schedule. However, [we] are also factoring in the mixing and the premixed injectables and different doses that can come into play. Having [those] 1-, 3-, 4-, [and] 6-month doses can be important as opposed to just the 6-month dose, especially when we have patients who are going to Florida—we may want to meet up with them [in the summer] and give them a 4-month [dose] so that we can give them a 6-month [dose] in November. By the time they return, they are appropriately due for their next injection.

 Can you speak to the clinical data for each of the leuprolide formulations? Did they differ at sustaining suppressed serum testosterone levels? Are they the same or different?

They're pretty similar at sustaining the testosterone levels. They are all agonists, so they all have that potential tumor flare in the beginning. However, they all seem to work comparably at maintaining the testosterone at castrate levels. As long as that testosterone is castrate, their PSA (prostate-specific antigen) suppression is usually pretty good, but, as we know in this day and age, depending on the disease space and the disease that the patient has, we are typically mixing this with another oral oncolytic to keep that PSA [level] down. We are rarely utilizing just leuprolide acetate or leuprolide mesylate as a monotherapy unless it is [given as adjuvant therapy] with radiation.

 How do the adverse event (AE) profiles compare across the different formulations of leuprolide?

I'd definitely say the [AEs] are pretty similar, the top 2 being hot flashes and fatigue. However, they can differ in how they're administered. [For] the leuprolide acetate that's administered IM … I have patients who don't really complain about the IM injections. [This drug and administration route] don't [cause] any site irritation [or] lump. [In comparison], the leuprolide acetate or the leuprolide mesylate that is administered via SC [injection] to the abdomen can cause a little discomfort [and] some stinging. There can be a bump at the site of administration. Those are the differences that … account for the different medications.

 What clinical and nonclinical factors inform your choice of leuprolide formulation? Do you feel that some formulations of leuprolide are easier to use than are others?

Clinically, it depends on the dosing. Some physicians like to start out with a lower dose of leuprolide … and make sure that the [patient isn’t] going to have any AEs and [that] they're going to tolerate it well. Obviously, the most important thing … is making sure that the patient is at a castrate level, so testosterone castration and suppression of the PSA [are] the highest and most important [priorities] that we're looking for with these medications. Clinically, we're looking for testosterone castration and appropriate dosing for a patient [who] is going to be going out of town or [whose] physician wants to start at a lower dose and then increase to a higher dose.

Having the prefilled syringe [of leuprolide mesylate] is definitely much more convenient for the flow of the schedule. That is huge—just being able to pull that medication out ahead of time and administer it when it's already premixed. However, once again, the refrigeration can come into play, [so we should] make sure [that we remove] it from [the refrigerator] 30 minutes ahead of time, especially if [we need to give] multiple injections that day. That can come into play, as well. The main considerations are [whether the formulation is] premixed [and] refrigerated [or needs] mixing and [is] nonrefrigerated.

In this companion article, Brenda Heath, RN, reflects on practical considerations in the preparation and administration of formulations of leuprolide acetate and leuprolide mesylate. 

EP. 2B: Clinical Perspectives on the Use of Leuprolide Acetate and Leuprolide Mesylate

They are all agonists, so they all have that potential tumor flare in the beginning. However, they all seem to work comparably at maintaining the testosterone at castrate levels. As long as that testosterone is castrate, their PSA (prostate-specific antigen) suppression is usually pretty good, but, as we know in this day and age, depending on the disease space and the disease that the patient has, we are typically mixing this with another oral oncolytic to keep that PSA [level] down. We are rarely utilizing just leuprolide acetate or leuprolide mesylate as a monotherapy unless it is [given as adjuvant therapy] with radiation.

The [AEs] are pretty similar, the top 2 being hot flashes and fatigue. However, they can differ in how they're administered. [For] the leuprolide acetate that's administered IM … I have patients who don't really complain about the IM injections. [This drug and administration route] don't [cause] any site irritation [or] lump. [In comparison], the leuprolide acetate or the leuprolide mesylate that is administered via SC [injection] to the abdomen can cause a little discomfort [and] some stinging. There can be a bump at the site of administration. Those are the differences that … account for the different medications.

Some physicians like to start out with a lower dose of leuprolide … and make sure that the [patient isn’t] going to have any AEs and [that] they're going to tolerate it well. Obviously, the most important thing … is making sure that the patient is at a castrate level, so testosterone castration and suppression of the PSA [are] the highest and most important [priorities] that we're looking for with these medications.

In the second interview of the series, Brenda Heath, RN, examines special considerations in the preparation and administration of formulations of leuprolide acetate and leuprolide mesylate. 

Brenda Heath, RN

Articles

EP. 4B: The Effect of Leuprolide Formulations on Organizational Management Practices in Metastatic Prostate Cancer

EP. 4A: Organizational Perspectives on the Use of Leuprolide in Prostate Cancer

EP. 2B: Clinical Perspectives on the Use of Leuprolide Acetate and Leuprolide Mesylate

EP. 2A: Key Challenges in the Preparation and Administration of Leuprolide for Prostate Cancer