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Cobenfy Cast

PERSPECTIVES IN PRACTICE

Prescribers sit down to share their experiences and what starting patients on COBENFYTM can look like in real-world practice.

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.

Host: Justin Ray, MSN, PMHNP-BC

Guest: Sean Bayer, PMHNP-BC

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

Both Sides of the Desk

She's not just a psychiatric nurse practitioner— she's the loving mother of a daughter with schizophrenia. Hear Dr. Craig Chepke talk with Fines Shaw about her unique perspective and her approach to care.

Host: Craig Chepke, MD, DFAPA

Guest: Fines Shaw, DNP, PMHNP-BC, FNP-C

Fines Shaw: Whether as a mom or as a clinician, I think it’s important to gain a clear understanding of what a patient is concerned about.

Dr. Craig Chepke: I’m Dr. Craig Chepke and today’s conversation is one I’ve genuinely been looking forward to. A reminder that COBENFY is indicated for adults with schizophrenia.

My guest today is Fines, a psychiatric nurse practitioner who brings something to this conversation that most of us can’t. She has sat across from patients and families living with schizophrenia for years. She’s had every hard conversation we’ve had. She’s also been on the other side of the desk as a care partner, as a mom.

Today we’re going to talk about what that dual perspective taught her and what it can teach all of us. Fines, welcome. Before we get started with the clinical piece, I’d like you to introduce us to Chanel.

Fines Shaw: Chanel is my daughter, and I’m going to talk about Chanel’s lived experience with schizophrenia. Living with schizophrenia was really hard on her, but it was hard on us as well.

Dr. Craig Chepke: I can’t even imagine. You’re living as a clinician and as a mom.

Fines Shaw: That’s the hard part. For me, it meant being on edge all the time. It’s hard when your child is suffering and you can’t fix it. It’s a helpless feeling. I didn’t want to go anywhere because I felt like I needed to be there for my daughter at all times. It was isolating for both of us, and I was always on guard.

I didn’t want her judged. I didn’t want her embarrassed. Walking on that road with her is what led me deeper into this field. I actually became a psychiatric nurse practitioner to help her and others like her.

Dr. Craig Chepke: Yeah. So, tell us more about Chanel and what those years were like for you.

Fines Shaw: Honestly, they were very dark. More so than anything. You know, it’s really hard to see your, your kid, who you’re supposed to protect, and you can’t. You know, she was feeling people grab at her, you know, she was seeing things. She was scared all the time. That is really hard. So finding a medication that worked for her was the best thing that could happen as a mom.

Dr. Craig Chepke: And you’re watching this not just as a mom, but as a clinician, so you know exactly what you’re seeing, right?

Fines Shaw: And that’s the thing. I knew the diagnosis. I knew the literature. And still, as her mom, I felt like I couldn’t fix it. That tension between what I knew clinically and what I was living at home—that stayed with me. It changed the way I practice. As a clinician, you get a snapshot,

you get 20 minutes, the patient’s in front of you. Being a care partner, it gave me more of the overall full picture—what home looks like, what school looks like, what it does to a family. And that completely changed the questions I asked. Now, I’m not only asking whether someone hears or sees things that other people don’t. I’m asking whether they feel uncomfortable around people, whether it’s hard to get words out, whether they can stay focused on basic daily stuff, what they actually want for themselves.

Dr. Craig Chepke: Yeah. And what you describe, that’s really what the total PANSS score is capturing—the positive symptoms, the negative symptoms, symptoms of general psychopathology. It’s a whole clinical picture and not just one piece.

Fines Shaw: Exactly. Watching Chanel deal with the stigma on top of everything else, I make sure my patients know that they don’t have to be embarrassed when they’re here in my office. They can say anything. And when I tell them that I get it, I do actually get it. That’s not something I just say.

Dr. Craig Chepke: Yeah. That kind of empathy is real. And you can’t learn that in the classroom.

Fines Shaw: And I think it’s what makes me a better nurse practitioner, not because I have all the answers. I didn’t then, I still don’t now. But I do understand, you know, why a family sitting across from me is scared. I’ve been that family.

Dr. Craig Chepke: Absolutely. But let’s talk about COBENFY. How did it first come into your practice? And then after that, when did it become part of Chanel’s story?

Fines Shaw: As a provider, actually. Not as a mom. A patient I was seeing asked about it. She had been reading about it on her own. She had seen it online, and she was doing her own research. Then, before I’d even had a chance to look into it, another patient asked me about it. I thought, okay, well, there’s something here.

Dr. Craig Chepke: What was it that caught your attention when you read about it?

Fines Shaw: Definitely the mechanism. It’s different. COBENFY is a combination of xanomeline, which is an M1 and M4 muscarinic agonist, and trospium chloride, which is a muscarinic antagonist. And Craig, as you know, COBENFY doesn’t bind to D2 receptors, unlike the D2 treatments that we’re used to. That was genuinely intriguing to me.

Dr. Craig Chepke: So, what did you see when you started prescribing it to patients?

Fines Shaw: Well, I saw what the study suggested: overall symptom improvement. It was seen in the EMERGENT-2 & -3 trials, and I saw improvement in overall symptoms in many of my own patients. My experience with Chanel showed me how much overall symptom improvement can mean to a person and to their loved ones. And I carry this into my room for every patient.

Dr. Craig Chepke: Yeah. So, there were two trials, both of which were five weeks long, and both of them showed statistically significant improvement in total PANSS versus placebo at Week five. And that’s an important evidence base. So you’ve had the conversation of what to expect from both points of view. How do you navigate it given your experience as a care partner in addition to being a nurse practitioner?

Fines Shaw: This is where the two roles really collide. Because I wasn’t just the provider reviewing the plan, I was in the room receiving it as a mom. Whether as a mom or as a clinician, I think it’s important to gain a clear understanding of what a patient is concerned about, including the potential side effects of any new medication they’re starting.

Some of the side effects might be new to them. I think it’s important to take the time to explain what they could potentially expect. Some of the most common side effects include nausea, dyspepsia, constipation, vomiting, and hypertension.

Dr. Craig Chepke: What else do you talk about with your patients?

Fines Shaw: Well, as I review with the patient, we discuss what might be different from what they are used to or explain why some may occur. We also talk about how to effectively manage those side effects if they do occur. Ultimately, the conversation always comes back to the same question: Do the potential benefits outweigh the risk?

While this conversation may differ from patient to patient, for Chanel, the answer was yes. I guide my patients the same way now.

Dr. Craig Chepke: What about dosing? Anything that you would flag for your peers?

Fines Shaw: It’s honestly very a simple message. The 50 over 20 dose is just a starting dose, not a therapeutic dose. The therapeutic doses are 100 over 20 and the 125 over 30. And these are the doses that overall symptom improvement was observed at the clinical trials. You may not see what was observed in the trials if you haven’t reached 100 over 20 or the 125 over 30 mg doses.

Dr. Craig Chepke: So, you’ve got a really unique position that most of us don’t understand. Being the mother of someone living with schizophrenia in addition to being a clinician. Both sides of the desk, so to speak. How does that shape how you practice now?

Fines Shaw: Being a mom, it gave me a fuller view of how schizophrenia can affect a person’s life—socially, at school, at home, even. And because of my experience as a care partner, I dig deeper with my patients as a clinician. I assess the full clinical picture across all symptom types, not just for my daughter, but for all my patients.

Dr. Craig Chepke: And as her mother, what do you want for Chanel?

Fines Shaw: I mean, she loves to draw. She loves to create. You know, she’s, she is a lover of animals and elderly people, you know?

Dr. Craig Chepke: Do you think it’s possible we could hear from her on the cast?

Fines Shaw: You will. In another episode, Chanel tells her own story in her own words. And as her mom, that’s the part that I’m proudest of. Not that I can tell it, but that she can.

Dr. Craig Chepke: So, Fines, to a peer that wants what’s best for their patient, but isn’t sure where to start, what would you say to them?

Fines Shaw: What I’d say to any peer? You need curiosity. Look at the evidence. Understand the safety profile and ask whether this can be right for your patient. Each patient experience will be different, but starting together can be the difference for the patient. And that’s what matters.

Dr. Craig Chepke: Next time, we’ll hear from Chanel in her own words. Thank you so much, Fines. Check out all the episodes in this series. Please see Full Prescribing Information at COBENFYhcp.com.

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 affects 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

These promotional videos are sponsored by Bristol Myers Squibb. The speakers are not employees of BMS but are being paid to speak on their behalf.

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