Key opinion leaders in neurology discuss the safety and efficacy of apomorphine hydrochloride and provide insights into the advantages and disadvantages of its subcutaneous formulation.
Laxman Bahroo, DO: With recent approvals in the data, we’re going to jump in and look at each treatment option. We’re going to discuss different options and medication options for managing OFF episodes. We’re going to start with the first medication approved for OFF episodes, which is apomorphine hydrochloride subcutaneous injection, also known as Apokyn. Apokyn is unique in that it is a subcutaneous injection, and its efficacy is based on several studies, all of which looked at how quickly the medication took effect and how robust of a response it provided. We know from the data that it is responsible for terminating 95% of OFF episodes. The medication takes effect in as early as 10 minutes and provides a robust on by 20 minutes. But it is subcutaneously administered, which may be a barrier. We’ll talk about that in more detail. Dr Bixby, what are the advantages or disadvantages you see in this formulation?
Mindy K. Bixby, DO: The advantages are that it kicks in so quickly and it’s reliable. This formulation has been around for a long time. It has been extremely effective and ultimately helping an OFF period. I have patients who use it when they first wake up so they can go on and start their day. Before this was available, a lot of patients would take their medication and then go back to sleep until they started feeling on, and then they would be able to start their day. As such, that’s the beauty of this medication: It’s reliable, it kicks in within 10 minutes, and it gives you about an hour and a half to feel on before the other medication kicks in. Sometimes it’s nice because that’s variable, regarding the pill form that goes with that. That’s the second thing that’s wonderful about this medication—it doesn’t go to the gut. Specifically, it surpasses the gut, so if a patient has gastric creases or slowness with the gut wall, it’s nice to have something that will give them an on quickly. Some people use this 5 times a day just to get them to a nice bridge. Regarding disadvantages, it is a subcutaneous injection, so that is concerning for some patients who do not like needles. If those patients are having a difficult time of fine motor movements and they don’t have somebody else there to help them administer injection, they’re sometimes at a disadvantage.
Laxman Bahroo, DO: I completely agree with you. The robustness is very much the best feature of the medication. Plus, the reliability of it, the fact that it terminates 95% of OFF episodes, and it provides you a response. In studies, they’ve shown it gives you the response that levodopa does but much quicker. I agree, the main disadvantage is the delivery system, which is subcutaneous. If a population wants to avoid an injection, this is the 1 medication they will hedge against at any cost until they can’t hedge anymore. From a safety point of view, a couple of points that we should be concerned about with regard to safety include skin reactions, which might occur from an injectable. Though in a placebo control trial, that did not show up. Patients who have never been exposed to any other subcutaneous injection might complain of redness or itchiness at the site. Orthostasis is important to be aware of because that’s something that happens in Parkinson. But because this is such a powerful D1-D2 dopamine agonist [DA], it may cause some orthostasis to people who are prone to it, so we prefer to prescreen our folks with this. Nausea is something that is also a well-known adverse effect. It’s important for us to be aware of it. Individuals have been pretreated. It’s recommended with trimethobenzamide. However, the availability of trimethobenzamide has been an issue, so that may put a wrinkle into this. But overall, I agree. The medication’s efficacy is its best feature in many ways. What has been your personal experience with this?
Mindy K. Bixby, DO: I’ve been using this for some time. What happens is that once patients feel they can get effectiveness with this medication, they use it long term. I have patients who have been using, with this medication, the same dose throughout whole chronic use of Parkinson disease. What happens is that this medication is used at the same dose throughout their lifetime, which is nice because they don’t have to reiterate and have a circle-of-care nurse come in as their disease gets worse. I’m grateful for that because it’s helped a lot of patients. Over time, patients will use it maybe once or twice, but they may use it more as a disease becomes more chronic and more difficult for them to manage with just medication. It’s nice to be able to have that medication and understand what it does for the patients. A lot of patients understand that this is something you can use on a regular basis. Or you can have it in your pocket, and maybe you won’t use it for several months, but it’s there to keep you in a good space. Often, the fear of going OFF is much less, so they’re able to do the things they love to do because they have that just in case.
Laxman Bahroo, DO: I agree with you completely. Regarding the unpredictability aspect, having a portable medication like this in your pocket, I have folks who will carry in purses and spouses who will carry for their husbands in their purses, especially if they’re going out and being active or going somewhere where the medication may be a little more strenuous. That way, the OFF episode doesn’t become an impact in the way that it would if it was untreated.
My personal experience is parallel with yours. Once individuals find the right dose, that’s the dose for them whether that’s 0.02, which is the starting dose, or 0.6—I have folks who have used that. Over time, they’ve meandered from using twice a day to 3 times a day. They’re either having more OFF episodes or becoming more comfortable treating them. Many times, people will start this at once a day or twice a day. Most noticeably, my individuals start it first thing in the morning, because the a.m. OFF episodes are so powerful for them and create such a big interference in their day that they want to do anything to be able to mitigate them. For the individuals who get up and have to crawl to the bathroom, or just wait for their medications, it’s very interesting that they are more than willing to start the medication when we discuss it with them. The impact study showed how robust of a response you can get. Well, a large population of patients are prone to dose failures first thing in the morning.
Mindy K. Bixby, DO: Absolutely.
Laxman Bahroo, DO: The circle-of-care program is a hub, or concierge service, that manages this. It has several aspects to it. It’s an interesting thing because we’re in an era where most of our medications are specialty pharmacies. This has been around for quite some time, and the circle-of-care program has a 3-pronged approach. It has the portion that runs your benefits and discusses co-pay assistance. There’s the portion that sets up delivery of the drug, and the distribution portion that providers liaise with much more, which is the nursing services. Specifically, the nurse goes to their house, communicates with them regularly before the initiation and then while they’re on the medication. As you mentioned, there have been individuals on this medication for years who have continued to stay on it. The nursing service is always available. What has been your experience with the circle-of-care program?
Mindy K. Bixby, DO: It has really affected me as a practitioner and the patients because way before the new brand took over—a long time ago—it was much harder for you to initiate these patients on this drug because you would do it in the office. Now you can do it at home; the nurse is there 24-7, which is fantastic. If patients have questions, or if they need to have medication titrated at home, they can do that. There’s always 1 of these questions, “How much does this drug cost? Can I afford it?” They’re not sure. It allows us to have the circle of care and help us through this with both. The burden is in making sure the patient gets what they need. It’s a great drug, but it also allows them to know what they’re in for and understand that process, making sure they get this drug…regardless of home-care nurses, which is amazing, and then move forward. From there, it gives us opportunities to understand what happened during the visit, which is wonderful.
Laxman Bahroo, DO: That sounds great. Thank you for that information.
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Transcript Edited for Clarity