The Start
Based on their own experience, Justin Ray and Sean Bayer break down how they approach their patients' starts. Learn how this framework guides their discussions around starting patients on COBENFY.
Sean Bayer: You set the why right at the start.
Justin Ray: Welcome to COBENFYcast. I’m Justin Ray, and today’s conversation is all about mastering the start. Joining me is psych nurse practitioner, Sean Bayer, who will share his firsthand experience starting his patients on COBENFY and how his approach has evolved since his first patient.
Quick reminder, COBENFY is indicated for adults with schizophrenia. Welcome, Sean. Glad for you to be here.
Sean Bayer: Thanks, Justin. Happy to be here. I still very much remember my first COBENFY patient. I think, like many providers, I had a lot of
questions, reservations that very first time that I recommended COBENFY and subsequently started them on it.
So I’m here today just to share a little bit about my insight—where I started with COBENFY, what I’ve learned, and where I stand now.
Justin Ray: So, so take me through that. Do you have a system in place that you use or is it just instinct?
Sean Bayer: Actually, I use a systematic approach with the phrase MASTER.
Justin Ray: Take me through them one at a time.
Sean Bayer: M is for match. For me, one of the most important pieces is identifying an appropriate patient and looking at where COBENFY fits into
their day-to-day life and needs.
Justin Ray: So when somebody is sitting in front of you, right, and you’re trying to evaluate them, what kind of things are you looking for?
Sean Bayer: I’m thinking about the patient who’s experiencing symptoms overall and is in need of treatment. I’m thinking about clinical goals as well as the steps they are taking toward their goals. I’m thinking about their home life. Loved ones.
Justin Ray: Right. So you’re starting with their goals, meeting them where they are.
Sean Bayer: 100%. It’s asking the questions that lets us get below the surface. When you start to ask those right questions, you start to see those various symptoms. Not only what you notice when they first enter the room, but also how these symptoms have touched nearly every aspect of their day-to-day life.
Justin Ray: So what’s A?
Sean Bayer: So A is align on expectations. And be willing to educate the patient about what to expect in their treatment journey. I start by asking the patient about where they stand right now, how their overall symptoms are aeecting them. Then we move on to what symptom improvement looks like for them and how we reach those goals together. This ensures everyone is on the same page.
Justin Ray: You know, this conversation sets the stage of kind of what’s to come.
Sean Bayer: Oh, absolutely. I’m a big advocate of being proactive rather than reactive. This helps build their confidence, tells them what to possibly expect, how to navigate it, and when a potential issue or concern arises, how to interact with the treatment team, my stae, myself, and that way we can handle it together.
Justin Ray: What are we basing those expectations on?
Sean Bayer: Everything comes from the COBENFY clinical trials. In these trials, statistically significant improvement was seen in PANSS total score among those taking COBENFY versus placebo at week five. That’s the evidence that I’m drawing on when I set those expectations with my patient.
Justin Ray: Okay, but what about safety? What are some of the things that you need to talk to your patients about?
Sean Bayer: There are some things we definitely talk about. Common adverse events seen in the studies included nausea, dyspepsia, constipation, vomiting, hypertension. And I’d rather the patient hear it from me first. Just a clearly laid-out plan that we’ve both agreed on together.
Justin Ray: Okay. So to drill down a little bit further, what exactly do you tell your patients when it comes to nausea and vomiting?
Sean Bayer: So I explained to them what was seen in the trials and I helped them correlate that data. The initial onset of nausea and vomiting cases was mild to moderate, and most patients do not discontinue because of these.
I’ll also mention that I’m going to write a prescription for an antiemetic at the same time. This may be useful for patients to have on hand if nausea and vomiting occur. Remember I, again, my preference is proactivity not reactivity.
And my patients have really appreciated thinking through this together ahead of time in advance.
Justin Ray: Next one. S, what exactly is S?
Sean Bayer: So S is set the administration plan. Basically, it’s how it’s taken. It’s one capsule, twice daily, empty stomach, at least an hour before eating and two hours after.
Justin Ray: Interesting. So COBENFY on empty. Yeah, and it’s not just a preference. Why is this important?
Sean Bayer: It’s because taking it too close to food can increase the chance of certain side effects. And one more thing to mention before we move on. There is recommended clinical testing before initiation, so make sure to look at the Prescribing Information and be familiar with those details.
Justin Ray: Yeah, plan and the prep at one time, I like that. So T, what’s that one.
Sean Bayer: So T is titrate. My biggest piece of advice to other providers and practitioners to adopt the “Don’t wait, titrate” approach very early on. Be open and understanding to the ability to move to that therapeutic dose by the third day.
Justin Ray: Okay.
Sean Bayer: The starting dose isn’t the therapeutic dose. So we don’t want to linger on it. So we start at the 50/20 mg twice daily. Then we step up to the 100/20 mg after at least two days. That’s our therapeutic dose. From there, after at least five days, you can go to 125/30 mg based on tolerability and responsiveness to the medication.
Both the 100/20 mg and the 125/30 mg are the therapeutic doses. For geriatric patients, though, I do consider slower titration and only going up to a maximum of the 100/20 mg dose.
Justin Ray: Okay, so don’t wait, titrate. That’s the headline today.
Sean Bayer: Absolutely.
Justin Ray: Okay. What dosage did most end up on in the trial?
Sean Bayer: Nine out of the ten patients who completed these five-week EMERGENT trials were on the 125/30 mg dose. And those numbers are absolutely consistent with what I find in practice, my own experience.
Justin Ray: And E. What is E?
Sean Bayer: So E is enroll your patients in COBENFY Cares. So COBENFY Cares is a 24/7 live support. COBENFY Cares oeers free, real time, one-on-one support from a Champion. A real person who can answer questions about COBENFY. The patient also gets personalized tools and tips to help them build into that routine and connections to free local resources.
Think things, for example, like social support groups and housing and transportation. COBENFY Cares Champions are available to provide support to patients who have been prescribed COBENFY and their care partners. Champions don’t provide medical advice or care, and it’s a service provided by Bristol Myers Squibb.
Available 24/7, 365 days a year. English and Spanish. You can check out COBENFYCares.com for more information.
Justin Ray: Yeah. That’s awesome. I think it’s available to family members too, like family members have questions or concerns. Are they’re able to call as well.
Sean Bayer: Yeah.
Justin Ray: Okay. That’s awesome. Can you enroll with even a sample?
Sean Bayer: Absolutely. Yes. Enrolling in COBENFY Cares is easy, and 90% of the patients self-report staying on therapy through that first month when enrolled. So in my practice, we have the patient actually sign the form. Stae faxes it in.
COBENFY Cares is especially valuable because of the sheer number of available resources, not just for the patients, but for their families and loved ones as well.
It really reinforces for the patient that they are not alone and they’re not.
Justin Ray: The last one is R, right. So what is R?
Sean Bayer: So R, hands down, is my favorite. Remember the why. Not because it’s least important or last for that matter. But because it’s the final piece that holds everything together. The questions both the patient and I had and should be able to answer by this point is, are we moving toward those goals together?
Justin Ray: The goals that you set at the start become the measure for everything else in the process.
Sean Bayer: Exactly. You set the why right at the start, and then every single step of the way, you make sure that you’re still working toward that goal together.
Justin Ray: Alright Sean, so, MASTER, right? Match, align, set the plan, titrate, enroll, remember the why. Six steps. And really, it’s about being prepared.
Sean Bayer: Oh, absolutely.
Justin Ray: As we kind of come to the end of our discussion, if you could tell a clinician one important thing about how you start COBENFY, what would it be?
Sean Bayer: Do the prep we just talked about, align with your patient, follow the titration, enroll them in COBENFY Cares.
Justin Ray: Hundred percent, hundred percent. Yeah, well listen, I appreciate you coming by. Appreciate you sharing your knowledge with everybody.
Sean Bayer: Oh, Justin, thank you for having me on. Being such a welcoming host and allowing me to share my experience with others. It’s been an absolute privilege and a pleasure. Thank you.
Justin Ray: And for everyone else listening, thanks for tuning in. Check out all the episodes in this series. Please see the full Prescribing Information at COBENFYhcp.com and see you next time.
INDICATION
COBENFY™ (xanomeline and trospium chloride) is indicated for the treatment of schizophrenia in adults.
IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS
COBENFY is contraindicated in patients with:
- urinary retention
- moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment
- gastric retention
- history of hypersensitivity to COBENFY or trospium chloride. Angioedema has been reported with COBENFY and trospium chloride.
- untreated narrow-angle glaucoma
WARNINGS AND PRECAUTIONS
Risk of Urinary Retention: COBENFY can cause urinary retention. Geriatric patients and patients with clinically significant bladder outlet obstruction and incomplete bladder emptying (e.g., patients with benign prostatic hyperplasia (BPH), diabetic cystopathy) may be at increased risk of urinary retention.
COBENFY is contraindicated in patients with pre-existing urinary retention and is not recommended in patients with moderate or severe renal impairment.
In patients taking COBENFY, monitor for symptoms of urinary retention, including urinary hesitancy, weak stream, incomplete bladder emptying, and dysuria. Instruct patients to be aware of the risk and promptly report symptoms of urinary retention to their healthcare provider. Urinary retention is a known risk factor for urinary tract infections. In patients with symptoms of urinary retention, consider reducing the dose of COBENFY, discontinuing COBENFY, or referring patients for urologic evaluation as clinically indicated.
Risk of Use in Patients with Hepatic Impairment: Patients with hepatic impairment have higher systemic exposures of xanomeline, a component of COBENFY, compared to patients with normal hepatic function, which may result in increased incidence of COBENFY-related adverse reactions.
COBENFY is contraindicated in patients with moderate or severe hepatic impairment. COBENFY is not recommended in patients with mild hepatic impairment.
Assess liver enzymes prior to initiating COBENFY and as clinically indicated during treatment.
Risk of Use in Patients with Biliary Disease: In clinical studies with COBENFY, transient increases in liver enzymes with rapid decline occurred, consistent with transient biliary obstruction due to biliary contraction and possible gallstone passage.
COBENFY is not recommended for patients with active biliary disease such as symptomatic gallstones. Assess liver enzymes and bilirubin prior to initiating COBENFY and as clinically indicated during treatment. The occurrence of symptoms such as dyspepsia, nausea, vomiting, or upper abdominal pain should prompt assessment for gallbladder disorders, biliary disorders, and pancreatitis, as clinically indicated.
Discontinue COBENFY in the presence of signs or symptoms of substantial liver injury such as jaundice, pruritus, or alanine aminotransferase levels more than five times the upper limit of normal or five times baseline values.
Decreased Gastrointestinal Motility: COBENFY contains trospium chloride. Trospium chloride, like other antimuscarinic agents, may decrease gastrointestinal motility. Administer COBENFY with caution in patients with gastrointestinal obstructive disorders because of the risk of gastric retention. Use COBENFY with caution in patients with conditions such as ulcerative colitis, intestinal atony, and myasthenia gravis.
Risk of Angioedema: Angioedema of the face, lips, tongue, and/or larynx has been reported with COBENFY and trospium chloride, a component of COBENFY. In one case, angioedema occurred after the first dose of trospium chloride. Angioedema associated with upper airway swelling may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, discontinue COBENFY and initiate appropriate therapy and/or measures necessary to ensure a patent airway. COBENFY is contraindicated in patients with a history of hypersensitivity to trospium chloride.
Risk of Use in Patients with Narrow-angle Glaucoma: Pupillary dilation may occur due to the anticholinergic effects of COBENFY. This may trigger an acute angle closure attack in patients with anatomically narrow angles. In patients known to have anatomically narrow angles, COBENFY should only be used if the potential benefits outweigh the risks and with careful monitoring.
Increases in Heart Rate: COBENFY can increase heart rate. Assess heart rate at baseline and as clinically indicated during treatment with COBENFY.
Anticholinergic Adverse Reactions in Patients with Renal Impairment: Trospium chloride, a component of COBENFY, is substantially excreted by the kidney. COBENFY is not recommended in patients with moderate or severe renal impairment (estimated glomerular filtration rate (eGFR) <60 mL/min). Systemic exposure of trospium chloride is higher in patients with moderate and severe renal impairment.
Therefore, anticholinergic adverse reactions (including dry mouth, constipation, dyspepsia, urinary tract infection, and urinary retention) are expected to be greater in patients with moderate and severe renal impairment.
Central Nervous System Effects: Trospium chloride, a component of COBENFY, is associated with anticholinergic central nervous system (CNS) effects. A variety of CNS anticholinergic effects have been reported with trospium chloride, including dizziness, confusion, hallucinations, and somnolence. Monitor patients for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing the dose. Advise patients not to drive or operate heavy machinery until they know how COBENFY aeects them. If a patient experiences anticholinergic CNS effects, consider dose reduction or drug discontinuation.
Most Common Adverse Reactions (≥5% and at least twice placebo): nausea, dyspepsia, constipation, vomiting, hypertension, abdominal pain, diarrhea, tachycardia, dizziness, and gastroesophageal reflux disease.
Use in Specific Populations:
- Moderate or Severe Renal Impairment: Not recommended
- Mild Hepatic Impairment: Not recommended
Pregnancy and Lactation: There is a pregnancy exposure registry that monitors outcomes in women exposed to psychiatric medications, including COBENFY, during pregnancy. Healthcare providers are encouraged to advise patients to register by calling 1-866-961-2388 or visiting
There are no available data on COBENFY use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Additionally, there are no data on the presence of xanomeline or trospium in human milk, the effects on the breastfed infant, or the effects on milk production. However, xanomeline and trospium are present in animal milk, suggesting they may also be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for COBENFY and any potential adverse effects on the breastfed infant from COBENFY or the underlying maternal condition.
COBENFY (xanomeline and trospium chloride) is available in 50mg/20mg, 100mg/20mg, and 125mg/30mg capsules.
Please see U.S. Full Prescribing Information, including Patient Information at
