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Q&A With ALS Experts

Learn from other healthcare professionals about their clinical experiences with RADICAVA® (edaravone).

Peers Share Their Experiences and Perspectives

Hear from neurologists on their clinical experiences and opinions in treating patients with ALS, as well as their experiences with RADICAVA®.

A headshot of Dr. Joshua Alpers

Joshua Alpers, MD

Erlanger Neuroscience Institute
Chattanooga, TN

A headshot of Dr. Raghav Govindarajan

Raghav Govindarajan, MD

University Physicians Neurology Clinic
Columbia, MO

A headshot of Dr. Raghav Govindarajan

Tomas Holmlund, MD

DENT Institute
Amherst, NY

The Q&A Series is sponsored by Mitsubishi Tanabe Pharma America, Inc. The ALS experts who provided answers to these questions have received compensation from MTPA. The content presented here is the professional opinion of the ALS expert and is not a substitute for independent clinical assessment or judgment. Individual results may vary.

Patient Selection for RADICAVA®

How does ALSFRS-R score and time from symptom onset factor into your decision to start RADICAVA®?
In my practice, the decision to start treatment doesn’t depend on a particular ALSFRS-R score or time since ALS diagnosis. I talk through the role that treatments like RADICAVA® can play in the care of patients with ALS.

—Dr. Joshua Alpers

The clinical trials were conducted in patients with certain ALSFRS-R scores, but, in my opinion, if the patient is interested regardless of the score, a patient deserves a chance to be on RADICAVA® after a full discussion of the safety and efficacy information from the clinical trial. ALSFRS-R is one type of measure that we use and while it is the best tool we have for clinical trials, in my experience, it is not always the best tool we have for real-life care of our patients. Instead, we need to take a holistic approach to care and treatment of ALS patients.

—Dr. Raghav Govindarajan

How do you discuss RADICAVA® when offering it to a patient with an ALSFRS-R score <25?
I present RADICAVA® as an option for almost every patient diagnosed with ALS, regardless of ALSFRS-R score or time since diagnosis. I talk about how RADICAVA® was shown to slow the loss of physical function by about one-third in patients who participated in the clinical trial. In my experience, it is very important to address expectations for treatment. RADICAVA® has been shown to slow the loss of physical function, but does not reverse symptoms.

—Dr. Joshua Alpers

We understand that insurance varies by patient and is a consideration when discussing treatment options. How do you discuss site of care locations when talking about RADICAVA®?
If patients do well with the initial 14 days of consecutive infusions, the next step in my practice is usually port placement for maintenance infusions. At that point, I discuss site of care preferences with patients—some enjoy the interaction they experience by going to infusion centers, while others prefer home infusion.

—Dr. Joshua Alpers

Questions regarding coverage for administration should always be directed to the patient’s insurance provider.

How do you discuss RADICAVA® with a patient who is interested in clinical trials?
In my experience, participation in a clinical trial is a patient-by-patient decision. Those who ask about clinical trials usually have a particular trial in mind, and I help them understand the inclusion and exclusion criteria to determine if their RADICAVA® treatment is allowed.

—Dr. Joshua Alpers

I do discuss clinical trials with my patients, and that discussion typically begins with an overview of the 'three Rs,' riluzole, RADICAVA®, and research.

—Dr. Raghav Govindarajan

In my view, it is essential that physicians help explain how clinical trials work and set clear expectations. It is important for a patient to understand that he or she will not be informed whether they were taking the active drug or the placebo until the end of the trial, if it is a double-blind randomized trial. However, depending on the study, a common inclusion criterion is that riluzole can be taken, and more frequently now RADICAVA®, while enrolled in the study. Physicians should always verify the study criteria. Depending on the trial criteria, a patient might be permitted to use currently approved ALS medications while in the trial.

—Dr. Thomas Holmlund

What are 3 things that you would tell a physician when they are prescribing RADICAVA® for the first time?
In my view, it is better to be aggressive in establishing a diagnosis of ALS so that RADICAVA® can ideally be started earlier in the disease course. While RADICAVA® will not reverse the course of the disease, it was shown in a clinical trial to slow the loss of physical function, so it is important to set that expectation with patients. Finally, I want to be sure that patients understand the logistical considerations with RADICAVA® – the 14 days of consecutive infusions and then maintenance infusions are often very doable for patients, but it needs to be discussed.

—Dr. Joshua Alpers

Discussing RADICAVA® With Patients

How do you describe RADICAVA® to your patients?
I first tell my patients that, in my experience, RADICAVA® can help to slow the loss of physical function from ALS. I describe the results of the pivotal trial that showed RADICAVA® slowed the loss of physical function by 33%, at 24-weeks of treatment, compared to the patients who took placebo. I also discuss the safety profile and the most common side effects. Although RADICAVA® is not curative, it can make a clinically meaningful difference. While every patient is different, I have seen that patients experience a safety profile consistent with the clinical trial results, with the most common adverse events from RADICAVA® being contusion, gait disturbance, and headache.

—Dr. Thomas Holmlund

What are the top 2 questions patients ask about RADICAVA® infusions?
In my experience, patients want to know what results to expect from treatment. Additionally, patients and their caregivers want to understand the logistical considerations and options surrounding the RADICAVA® infusions.

—Dr. Joshua Alpers

When patients are considering RADICAVA® as a treatment option, in my experience, they are typically interested in understanding safety, the potential impact on their function, and how the treatment may be covered by insurance.

—Dr. Raghav Govindarajan

How do you start the ALS treatment discussion?
When thinking about general discussions with patients around their ALS diagnosis, in my opinion, patients need to be prepared to verbalize short-term goals in their lives so that we can determine the extent to which they want to fight their disease. In my experience, some patients may initially decide that they do not want to treat their disease, and this is a very personal decision. I always encourage patients to revisit their decision about treatment – one thing patients have absolute control over is the ability to change their mind regarding their care. They always have that power.

—Dr. Joshua Alpers

What advice would you give to a patient visiting an ALS center for the first time to discuss treatment options?
In my opinion, patients should be prepared to talk about their considerations regarding treatment options and how treatment will impact their daily routine. We have a finite amount of time; the disease is going to do what it is going to do and the end point is ultimately the same for everyone. It is a question of whether patients want to fight or not.

—Dr. Joshua Alpers

In my experience, when patients are visiting the ALS center for the first time, it is important for them to know that they should prepare for a long day where they will be meeting with multidisciplinary team members. They should prepare to discuss the options available to fight their disease.

—Dr. Raghav Govindarajan

Do your patients track their disease progression, and if so, what scales/parameters do they use?
Within several weeks of a patient’s clinic visit, they receive a summary note that has a table with all of their data so that they can then track it themselves if they desire.

—Dr. Joshua Alpers

In my experience, patients are very aware of what they are experiencing in terms of loss of physical function and look to me to track their disease progression. I familiarize them with the ALSFRS-R scale and explain that it is a questionnaire-based scale that measures and tracks changes in a person's physical function over time. The ALSFRS-R scale covers a broad range of physical functions, such as speech, salivation, and swallowing, to dressing, handwriting, and respiratory challenges. Over time, patients become very familiar with this tool and are regularly assessed using the ALSFRS-R scale when they visit their ALS expert.

—Dr. Thomas Holmlund

How do you describe RADICAVA® infusions to patients?
I explain that during the initial treatment cycle, RADICAVA® is infused for 1-hour per day for 14 consecutive days, followed by a two-week drug-free period. All cycles thereafter are infusions for 10-days of every month. I discuss that they will be monitored during treatment to watch for signs and symptoms of all serious side effects; and tell them to call the office right away or go to the emergency room if they experience symptoms of a hypersensitivity reaction. In my experience, people adapt to the infusion schedule. I have patients who have remained on RADICAVA® treatment for 6 cycles or more and are still content with visiting the infusion center. It is important to consider a patient’s health insurance coverage while discussing treatment options. Treatment experience will be different for every patient, so it is important to talk to the patient on an ongoing basis and assess their experience of the infusions and its schedule.

—Dr. Thomas Holmlund

Questions regarding coverage for administration should always be directed to the patient’s insurance provider.

What would you say to a patient visiting an infusion center for the first time?
Every patient’s situation is different. For those patients who attend a center, I’ve observed that infusion centers can often be a place of camaraderie for ALS patients; a place where ALS patients can meet fellow patients. I have experienced that patients can take comfort within this setting because they are able to talk to the nurses who make them feel very comfortable while receiving RADICAVA®. I enjoy coming to the infusion center to say hello to my patients.

—Dr. Thomas Holmlund

How do you communicate the safety and efficacy of RADICAVA® in a way in which patients can relate?
After a full discussion of the safety and efficacy information from the clinical trial, I tell patients that while RADICAVA® is not a cure for ALS, it can help to potentially slow the loss of physical function.

—Dr. Raghav Govindarajan

ALS Tips and Patient Characteristics

What advice would you give to physicians unfamiliar with the need for appropriate and timely diagnosis and treatment of ALS?
When it comes to diagnosis of ALS, my experience is that an aggressive approach is best so that treatment can be started as early as possible if that is the patient’s wish. ALS is a unique situation – I want to be wrong and I encourage patients to seek second opinions regarding the diagnosis. Because on the one hand, patients may get confirmation of their diagnosis, and on the other hand, something may be discovered that leads to a different diagnosis. ALS is a criteria-driven diagnosis—there are no lab tests. I tell my patients, 'You meet the criteria for ALS and I can’t find anything else, so I am going to diagnose this as ALS.' But it is important to keep in mind that our understanding of ALS changes over time, and we as physicians need to be open to taking a step back to consider all the evidence.

—Dr. Joshua Alpers

ALS is a progressive disease where patients lose function over time. Once diagnosed, our job as physicians is to tell the patient what treatments are available, honestly and openly, and set expectations with patients who are being treated for ALS. I describe the results of the pivotal trial that showed RADICAVA® slowed the physical loss of function by 33%, at 24-weeks of treatment, compared to the patients who took placebo. I also discuss the safety profile and the most common side effects. I think it is worth explaining that although RADICAVA® is not curative, it can make a clinically meaningful difference.

—Dr. Thomas Holmund

Describe your experience generally with patients who have been on RADICAVA® for at least 6 cycles.
In my experience, patients with ports tend to stay on RADICAVA® longer. Patients also tend to stay on treatment longer if they develop established routines such that the infusions are a minimal, or even positive, disruption to life. Of course, treatment experience will be different for every patient, so it is important to talk to the patient on an ongoing basis.

—Dr. Joshua Alpers

Of course, every patient is different, but in my experience when I think about typical characteristics of patients who remain on RADICAVA® for at least 6 cycles, they include those who are still fairly ambulatory, are able to perform some activities of daily living, have a port in place, have a strong support system, and importantly still want to fight their disease. Of course, treatment experience will be different for every patient, so it is important to talk to the patient on an ongoing basis.

—Dr. Raghav Govindarajan

What are some important points general neurologists need to know about ALS?
In my opinion, physicians should consider the diagnosis of ALS early. When you have a patient who presents with painless or progressive weakness, or a patient in whom electrodiagnostic findings are consistent with ALS, consider expanding your workup to look for other symptoms suggestive with motor neuron disease, and then send the patient to an ALS center for confirmation of the diagnosis. This is important because, if ALS is diagnosed early, treatment can also be started early to potentially slow the loss of physical function.

—Dr. Joshua Alpers

If a general neurologist suspects the patient has ALS, I believe it is important to seek the opinion of an ALS specialist to confirm the diagnosis of ALS. Once a diagnosis is confirmed, general neurologists can manage patients’ ongoing care, including symptomatic treatments. I would advise general neurologists that RADICAVA® was shown in a clinical trial to slow the loss of physical function. It was studied in a patient population that had earlier disease, but in my experience, while every patient is different, there may be a chance it will benefit patients at later stages of the disease. RADICAVA® gives patients a fighting chance to slow the progression of their disease.

—Dr. Raghav Govindarajan

In my experience, it takes 1 year to diagnose a patient with ALS, and unfortunately this delay in diagnosis has not changed for 30 years. So, there is a need for physicians to consider the diagnosis of ALS earlier in the patient's evaluation.

—Dr. Thomas Holmund

Assessing Patients After Starting RADICAVA® Therapy

How do you monitor patients once they start RADICAVA®?
I look at a variety of factors related to disease progression including ALSFRS-R and FVC. I also consistently monitor side effects. In my personal experience, I have not had to discontinue RADICAVA® due to side effects of RADICAVA®. Some patients may have mild side effects, but in my practice have not chosen to discontinue treatment.

—Dr. Raghav Govindarajan

Do your patients track their disease progression, and if so, what scales/parameters do they use?
I have observed that, while sometimes patients will want to know if the trajectory of their disease has changed, some patients are not interested in numbers. Overall, it is important to remember that this is a 'human story'; and not necessarily a 'data story'.

—Dr. Raghav Govindarajan

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Important Safety Information

Hypersensitivity Reactions

Radicava® (edaravone) is contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients in Radicava®. Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) have been reported. Patients should be monitored carefully for hypersensitivity reactions, and if they occur, discontinue Radicava®, treat per standard of care, and monitor until the condition resolves.

Sulfite Allergic Reactions

Radicava® contains sodium bisulfite, and may cause allergic type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown, but occurs more frequently in asthmatic people.

Most Common Adverse Reactions

Most common adverse reactions (at least 10% and greater than placebo) are contusion, gait disturbance, and headache.

Pregnancy

Based on animal data, Radicava® may cause fetal harm.

Geriatric Use

No overall differences in safety or effectiveness were observed between patients 65 years of age and older and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

To report suspected adverse reactions or product complaints, contact Mitsubishi Tanabe Pharma America, Inc., at 1-888-292-0058. You may also report suspected adverse reactions to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Indication

Radicava® is indicated for the treatment of amyotrophic lateral sclerosis (ALS).

Please see full Prescribing Information.

For more information about RADICAVA®, call 1-888-292-0058.