Join leading dermatology experts as they review the SILIQ Risk Evaluation and Mitigation Strategy (REMS) Program!See Full Prescribing Information for SILIQ, including BOXED WARNING about suicidal ideation and behavior, <a target="_blank" rel="noopener noreferrer" href="https://pi.bauschhealth.com/globalassets/BHC/PI/Siliq-pi.pdf">here</a>.

The SILIQ REMS Process: A Worthwhile and Uncomplicated Conversation

MSN, A/GNP-C

An Obligation to Our Patients

The following are opinions of Melodie Young, MSN A/GNP-C, and are not intended to replace the informed consent process between the provider and patient, nor is it intended to serve as medical and or legal advice. This video is not intended to replace all of the REMS requirements. More information will be discussed later in this video. Hello. I am Melodie Young and I am a nurse practitioner at Mindful Dermatology and modern research associates located in Texas. I have more than 30 years of experience in dermatology and even served as one of the investigators for the SILIQ clinical trials. I am a certified SILIQ prescriber. I'm here today to talk to you about an important conversation you should have about suicidal ideation and behavior with patients you're considering prescribing SILIQ for, and to take the mystery out of that worthwhile and simple conversation. SILIQ is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. I position SILIQ as second line therapy for psoriasis and we use it in our most difficult cases. In my experience, SILIQ is very much predictably effective. Many of my patients were able to attain 100% clearance or have very little evidence of disease while taking SILIQ. Before any patient can start SILIQ, though, they need to enroll in the SILIQ Risk Evaluation and Mitigation Strategy or REMS program. So it is important to review the boxed warning for suicidal ideation and behavior in the full prescribing information with them. The REMS program is not something that's foreign to dermatology and this program is in place for public safety and to protect providers. There is a precedent with other products where we have to discuss rims. So you already have your rhythm. My REMS conversation lasts less than a minute. I start off by telling my patients, hey, I've got a drug with a different mechanism of action and that we use in our most difficult cases. I think it's a good option for you. Here's how you inject it and we talk about setting expectations about what they are likely to see and when benefits are going to start to show. I will then discuss the safety piece of it. I tell my patients there are potential side effects with SILIQ and we talk about what to expect in terms of safety. I will then say the one thing that I will be watching for on this drug is I'm going to ask you, how are you doing physically and emotionally? Every time I then go over the information on the rims enrollment form and the concern about suicidal ideation and discuss it with them. I will often say it's a possible event, but not a probable event based on statistics. That's why I'm going to ask you that question. I will then tell them. The form says that I have warned you that there are reports in the trials of patients experiencing depression. Depression can show up as sleepiness, loss of interest in activities, change in appetite, wanting to drink more, wanting to take more over the counter pain meds, a change in relationships, and not wanting to go to work. It can be all that, but it can also be a lot of other things. If you don't feel good and several days pass or a couple weeks pass and you're worried, just call us if you can't get in touch with me. We're going to give you this card and the phone number for the National Suicide Prevention hotline. I want you to call this number and seek immediate attention if you have any suicidal thoughts or changes in behavior while taking this drug. I will then show the patient this form and tell them. And by us signing this form, we are confirming that we've talked about it and that you know that I'm the person you're going to contact if you have problems. If you're having some kind of side effect with this medication, we'll decide together whether to keep you on it or not. I'm going to hold your hand through it, but I'm going to be strict. It only takes one extra minute to sign the paper and go through the entire conversation. There is even an electronic form which makes it easier to get onto the chart, less paperwork. It's just a simple assessment to register as a SILIQ provider. I can see a new psoriasis patient decide on a therapy, do the coaching for the therapy, and have the paperwork signed in under two minutes. Most of my patients want to be on SILIQ. Even with the REMS program information I have, people panic at the thought of not being able to get SILIQ because they have tried one or two other biologics before that didn't work. They've all been through some trauma, physical or emotional, when they had bad psoriatic disease, and they depend on me to help them find alternative therapies that may work for them. They want something that works, and for most of my patients, SILIQ clinically makes sense. SILIQ has helped so many of my patients and having these brief rims conversations saves a lot of time in the long run. Now, before we close, I want to be sure you get a chance to hear some additional information about the SILIQ REMS program and important safety information for SILIQ. The SILIQ REMS program physicians must register for the SILIQ REMS program at siliqrems.com. Discontinuation or transfer of care must be reported to the SILIQ REMS program. This video is not intended to replace all of the REMS requirements. Complete details about the SILIQ REMS are available at siliqrems.com. Indication SILIQ injection is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. Important safety information warning suicidal ideation and behavior suicidal ideation and behavior, including completed suicides, have occurred in patients treated with SILIQ prior to prescribing SILIQ. Weigh the potential risks and benefits in patients with a history of depression and or suicidal ideation or behavior. Patients with new or worsening suicidal ideation and behavior should be referred to a mental health professional as appropriate. Advise patients and caregivers to seek medical attention for manifestations of suicidal ideation or behavior, new onset or worsening depression, anxiety, or other mood changes. See warnings and precautions in the full prescribing information. Because of the observed suicidal behavior in subjects treated with Salik, Salik is available only through a restricted program under a risk evaluation and mitigation strategy rems called the Salik REMS program. See warnings and precautions in the full prescribing information. Crohn's disease Salik is contraindicated in patients with Crohn's disease. In clinical trials, which excluded Crohn's patients, one Salik patient was withdrawn after developing Crohn's disease. Discontinue SILIQ if a patient develops Crohn's disease. SILIQ Risk Evaluation and Mitigation Strategy REMS program SILIQ is available only through a restricted program called the SILIQ REMS because of observed suicidal ideation and behavior in patients treated with SILIQ. Before prescribing SILIQ, prescribers must be certified with the program. Have each patient sign a patient prescriber agreement form and provide the patient a wallet card describing symptoms requiring immediate medical evaluation. Pharmacies must be certified and only dispense to patients authorized to receive SILIQ. More information is available at siliqrems.com or by calling the SILIQ REMS program call center at 855-511-6135 infections SILIQ may increase the risk of infections serious infections and fungal infections were observed at a higher rate in patients treated with SILIQ than placebo treated patients in clinical trials, including one case of cryptococcal meningitis that led to discontinuation of therapy. Consider risks and benefits prior to prescribing SILIQ in patients with a chronic infection or history of recurrent infection. Instruct patients to seek treatment if signs or symptoms of a chronic or acute infection occur. Risk for latent tuberculosis TB reactivation evaluate patients for tb prior to initiating treatment with SILIQ and do not treat patients with active TB. Initiate treatment for latent TB prior to starting SILIQ and consider antitb therapy prior to initiation in patients with history of latent TB. If adequate treatment cannot be confirmed, monitor closely for symptoms of active TB during and after treatment immunizations avoid use of live vaccines in patients treated with SILIQ. Adverse reactions the most commonly reported adverse reactions in clinical trials were arthralgia, headache, fatigue, diarrhea, oropharyngeal pain, nausea, myalgia, injection site reactions, influenza, neutropenia, and tinia infections. To report suspected adverse reactions, contact Bausch Health at 1803 214576 or the FDA at 1800 FDA 1088 or visit FDA gov Medwatch. Please see full prescribing information, including boxed warning about suicidal ideation and behavior at siliq.com.

Melodie Young - An Obligation to Our Patients

In this video, Melodie Young, MSN,A/GNP-C, describes how she structures a consultation with new adult patients who have moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies.Melodie shares examples of conversations she has with her patients who have difficult to treat psoriasis including the serious and important topic of the risk of suicidal behavior. She walks through the SILIQ® (brodalumab) injection Risk Evaluation and Mitigation Strategy (REMS) Program, what to expect in follow-up visits, and what to do if patients begin experiencing changes in mood or thoughts of suicide while being treated for plaque psoriasis.See the Full Prescribing Information, including BOXED WARNING about suicidal ideation and behavior, <a target="_blank" rel="noopener noreferrer" href="https://pi.bauschhealth.com/globalassets/BHC/PI/Siliq-pi.pdf">here</a>.