Hello, my name is Christina Patterson and I am a physician's assistant practicing at Cancer Care Associates of York in York, PA. Welcome to the VENCLEXTA patient initiation video, for patients with previously untreated or relapsed, refractory chronic lymphocytic leukemia, or CLL. Each year, I work with around 40 patients with CLL in our community oncology practice who are being treated with VENCLEXTA. My goal is to share our experiences with VENCLEXTA, and in particular, the preparations and planning that we do when initiating treatment.

It is important to note that VENCLEXTA is a BCL-2 inhibitor that is indicated for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. ¹  In my experience, I find that the best way to be successful with VENCLEXTA is to educate your team and your patients, and to have a plan in place before treatment even begins.

The dosing schedules shown here were specifically designed to initiate treatment with VENCLEXTA to help reduce tumor burden in the debulking phase and decrease the risk of TLS. ¹ Regardless of the line of treatment in CLL, VENCLEXTA dosing ramps up over a period of 5 weeks. ¹ In the first week of treatment, the patients will receive 20 mg per day of VENCLEXTA orally. The dose will increase weekly to 50, 100, 200, and eventually 400 mg per day. ¹ We explain to our patients that because of how VENCLEXTA works, we need to gradually ramp-up dosing, and apply prophylaxis and appropriate monitoring. Upon completion of the 5-week ramp-up, we’ll continue dosing at 400 mg per day until the end of the prescribed treatment regimen, unless VENCLEXTA delay, decrease, or discontinuation is required. ¹

When your patient has been prescribed VENCLEXTA, you should ensure that the VENCLEXTA Starting Pack is ordered. The starter pack was designed to facilitate dosing according to the ramp-up schedule for Weeks 1 through 4 with weekly, color-coded, wallet blister packs. The dosing for Week 5 onwards is provided to the patient in a bottle. To order, please contact your specialty distributor. A list can be found on www.venclextahcp.com.

Let's take a closer look at how we should initiate treatment. To that end, there are 3 key steps to this process. It starts with assessing tumor burden. Then, preparing for the first dose of VENCLEXTA. And finally, initiating VENCLEXTA treatment with the dose ramp-up protocol. I’d like to emphasize that these steps are the same, regardless of whether your patients are receiving VENCLEXTA with an anti-CD20 monoclonal antibody or as monotherapy. In order to prepare our team prior to treatment with VENCLEXTA, I sit down with our nurses and schedulers and, based on a patient’s tumor burden and other clinical characteristics, we will adjust their monitoring and labs to ensure that we are giving our patients the tailored care that they need. In the past we have reached out to our patient advocates at our center for help on various challenges. Planning the treatment out doesn’t end with the logistics however, as it requires that both our staff and our patients know and understand every part of the treatment process—essentially why we are doing what we are doing.

Note that, depending on the assessed tumor burden, I may be administering the initial 20 mg and 50 mg doses of VENCLEXTA in the outpatient or the hospital setting, with the related lab monitoring. From our experience, some patients will need to be in the hospital initially. To put this into perspective, in the CLL14 study in the first-line setting, 22% of patients were characterized as having a high risk of TLS, which would have necessitated an in-hospital start with VENCLEXTA. The majority of patients in CLL14, were characterized as having a low or medium risk of TLS, and thus this majority could start VENCLEXTA and be managed in an outpatient setting unless other factors, such as comorbidities, suggest the patient should initiate VENCLEXTA in the hospital setting. Starting in the hospital requires a slightly different focus for patients and nurses than when it is done in the outpatient setting. One way we have improved the logistics of the onboarding is that we have worked with our Electronic Medical Records to design VENCLEXTA order sets based on the Prescribing Information and our experience.

We stress to them the importance of hydration, particularly during the dose ramp-up period.  I would say this is a really important thing that patients have control over in making treatment initiation a success. We give each patient a specific outline for the dates to begin taking allopurinol and start the hydration protocol. We will also specify the dates and times of each dose, as well as the dates and times for their lab work and related follow-up appointments. By having the days of the week and appointments filled in ahead of time, patients can actually be marking off when things have been completed and track their progress through ramp-up. This can help make things as simple as possible for our patients. Please see the full Prescribing Information for complete preparation recommendations.

Our schedulers need to understand the timing behind when we need our patients to get labs and how this will impact their appointment time. We will also take the time to educate patients, that while a side effect like tumor lysis syndrome, or TLS, can occur, in the phase 3 clinical trials with VENCLEXTA there was 0% incidence of clinical TLS after the implementation of the 5-week dose ramp up, prophylaxis, and monitoring. Up to 3% of overall TLS was observed.

In the event that it does occur, refer to the Prescribing Information for recommendations on dose interruptions or modifications. Thus, patients and their providers understand that while it may seem like there is a lot of up-front monitoring and labs during VENCLEXTA initiation, that it is simply part of the process. It is important to plan ahead for labs to make sure patients are appropriately monitored. A few ways to get stat labs are: To get them in your own outpatient clinic, which is what we do. Another option might be to get stat labs in a local or affiliated outpatient hospital. Another common option could be to get them at a local or national reference lab. What’s important is that the lab understands why you need a response quickly.

Ultimately, the treatment initiation for the VENCLEXTA regimen requires some planning for you and your patient. My biggest piece of advice with VENCLEXTA is to educate your team, educate your patients, and simply be prepared. In my opinion, both academic centers and community practices should be able to successfully initiate VENCLEXTA. Thank you for taking the time to walk with me through the initiation of treatment with VENCLEXTA for patients with previously untreated or relapsed, refractory CLL.