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IMPORTANT SAFETY INFORMATION

Important Facts
About COBENFY™

(xanomeline and trospium chloride)

This is a summary of important information that you need to know about COBENFY. Your healthcare team can work with you to help answer any questions you may have. Keep this information in a safe place so you can refer to it before you start taking it and during your treatment.

Look out for the following icons as you read:

 

Talk to your healthcare team
 

Call a healthcare provider right away
 

Helpful information to remember

What is COBENFY?

COBENFY is an oral prescription medicine used to treat adults with schizophrenia.
It is not known if COBENFY is safe and effective in children.

 

Do not take COBENFY if you have:
  • trouble emptying your bladder completely or at all (urinary retention problems)
  • moderate or severe liver problems (impairment)
  • gastric retention problems (your stomach empties slower than it should)
  • an allergy to COBENFY, xanomeline, trospium chloride, or any of the ingredients in COBENFY
  • an eye problem called untreated narrow-angle glaucoma (fluid build-up in your eye)
 

Talk to your healthcare team before taking COBENFY if you have any of these conditions, or don't know if you have any of these conditions.

Before taking COBENFY, what should I discuss with my healthcare provider?

 

Talk to your healthcare team about all of your medical conditions, including if you have:
  • an enlarged prostate, problems passing urine, or a blockage in your bladder
  • liver problems
  • a history of gallstones or problems with your bile ducts or pancreas
  • problems with your stomach or intestines, which may include:
    • constipation
    • an inflammatory bowel disease called ulcerative colitis
    • your stomach emptying slowly
    • a chronic autoimmune disease called myasthenia gravis
  • narrow-angle glaucoma (fluid build-up in your eye)
  • kidney problems
 

Talk to your healthcare team about all the medicines you are taking, including:
  • prescription medicines
  • over-the-counter medicines
  • vitamins
  • herbal supplements

Know the medicines you take. Taking COBENFY with certain other medicines may increase your risk of side effects from COBENFY or the other medicines and affect how COBENFY or your other medicines work. Keep a list of the medicines you take to show your healthcare provider and pharmacist when you start taking COBENFY or any other medicine.

 

Talk to your healthcare team about anything you might be unsure of before starting treatment. The topics in this document are not all of the topics you should discuss with your healthcare team.

Before taking COBENFY, what should I discuss with my healthcare provider about pregnancy and breastfeeding?

 

Tell your healthcare provider if:
   

You are pregnant or plan to become pregnant: It is not known if COBENFY may harm your unborn baby.
   

You are breastfeeding or plan to breastfeed: It is not known if COBENFY passes into your breast milk or if it can harm your baby.
 

Tell your healthcare provider if you become pregnant during treatment with COBENFY. There is a program called a “pregnancy exposure registry” for people who take COBENFY during their pregnancy. It is a program designed to gather information about the health of people exposed to COBENFY and their baby. If you become pregnant while taking COBENFY, your healthcare provider will register you by calling 1-866-961-2388 or online at https://womensmentalhealth.org/research/pregnancyregistry/atypicalantipsychotic/

What should I avoid while taking COBENFY?

 

Do not drive, operate heavy machinery, or do any other activity that could be dangerous until you know how COBENFY affects you. COBENFY may cause:
  • dizziness
  • confusion
  • seeing or hearing things that are not real (hallucinations)
  • sleepiness

What are the serious side effects of COBENFY?

COBENFY may cause serious side effects. A serious side effect is a side effect that can sometimes become life-threatening and can lead to hospitalization or death. The serious side effects of COBENFY may include:

Problems with emptying your bladder (urinary retention). COBENFY may cause your bladder to not empty completely or at all. Problems with emptying your bladder may increase your chance of getting a UTI (urinary tract infection). Do not take COBENFY if you have trouble emptying your bladder.

You are at a higher chance of developing urinary retention if you:

  • are elderly (65 years or older)
  • have a blockage in your bladder
  • have a prostate that is bigger than it should be (benign prostatic hyperplasia)
  • have problems emptying your bladder because of diabetes
  • are taking a higher dose of COBENFY
 

Call a healthcare provider or get emergency help right away if you have any of these signs or symptoms:
  • trouble urinating
  • urinating in weak streams or drips
  • urinating frequently
  • full bladder and difficulty emptying your bladder
  • pain when you urinate

Increased chance of side effects in people with liver problems (impairment). It is not recommended that people with mild liver problems take COBENFY. Your healthcare provider will test the liver enzyme levels in your blood before starting treatment and as needed during treatment with COBENFY. Do not take COBENFY if you have moderate or severe liver problems (impairment).

 

Call a healthcare provider if you have any of these signs or symptoms:
  • yellowing of your skin or the white part of your eyes
  • dark urine
  • pain and swelling in the upper right part of your stomach (abdomen)
  • stomach pain that spreads to your back or to below your right shoulder
  • itching
  • nausea or vomiting
  • loss of appetite
  • fever
  • chills
  • light colored stools
  • feeling tired

Blockage in your bile ducts in people with bile duct and gallbladder problems (biliary disease). COBENFY may cause blockage in your bile ducts that could lead to gallstones, pancreatitis, and increases in your liver enzymes. Your healthcare provider will check your liver enzyme and bilirubin levels in your blood before starting treatment and as needed during treatment with COBENFY.

 

Call a healthcare provider if you have any of these signs or symptoms:
  • upset stomach or a burning feeling in your stomach (dyspepsia)
  • nausea
  • vomiting
  • pain in the upper right part of your stomach (abdomen)

Slow emptying of your stomach (decreased gastrointestinal motility). Do not take COBENFY if you have gastric retention problems that cause your stomach to empty slowly. You are at a higher chance of developing decreased gastrointestinal motility if you:

  • have an inflammatory bowel disease called ulcerative colitis
  • already have problems with slow stomach emptying
  • have an autoimmune disorder called myasthenia gravis
 

Call a healthcare provider if you have any of these signs or symptoms:
  • constipation
  • vomiting
  • nausea
  • stomach (abdominal) bloating
  • stomach (abdominal) pain
  • a feeling of fullness after eating just a few bites
  • acid reflux

Serious allergic reactions (angioedema). COBENFY may cause life-threatening allergic reactions.

 

Stop taking COBENFY and call your healthcare provider or get emergency help right away if you have any of these signs or symptoms:
  • hives
  • swelling of your face, lips, mouth, or tongue
  • swelling of your throat
  • hoarseness or difficulty speaking
  • trouble breathing

An eye problem called narrow-angle glaucoma. People can develop or be born with "narrow angles" in their eyes, which is when the angle between two parts of the eye (iris and pupil) is smaller than usual. If you have narrow angles in your eyes, COBENFY may cause a sudden attack (acute angle closure) of glaucoma. Do not take COBENFY if you have an eye problem called untreated narrow-angle glaucoma.

 

Call a healthcare provider if you have any of these signs or symptoms:
  • red eyes
  • blurred vision
  • seeing halos or bright colors around lights
  • eye pain or discomfort
  • nausea or vomiting
  • severe headache

Higher heart rate (pulse) than usual. COBENFY may increase your heart rate. Your healthcare provider should check your heart rate before you start treatment and during treatment as needed.

 

Call a healthcare provider if you experience a racing or pounding feeling in your chest when taking COBENFY.

Increased chance of side effects in people with kidney problems. If you are taking COBENFY and you have kidney problems, you have a higher chance of developing:

  • dry mouth
  • constipation
  • stomach upset or burning
  • UTIs (urinary tract infection)
  • trouble emptying your bladder (urinary retention)

Problems with the brain and spinal cord (central nervous system).

 

Do not drive, operate heavy machinery, or do any other activity that could be dangerous until you know how COBENFY affects you. COBENFY may cause:
  • dizziness
  • confusion
  • seeing or hearing things that are not real (hallucinations)
  • sleepiness

What are the most common side effects of COBENFY?

The most common side effects of COBENFY include:

  • nausea
  • stomach upset or a burning feeling in your stomach (dyspepsia)
  • constipation
  • vomiting
  • high blood pressure (hypertension)
  • pain in the stomach (abdomen)
  • diarrhea
  • faster heartbeat
  • feeling dizzy
  • heartburn (gastrointestinal reflux disease)

The common and serious side effects mentioned in this document are not all the possible side effects of COBENFY.
Your healthcare provider may lower your dose or stop treatment with COBENFY if you get certain side effects.

 

Talk to your healthcare provider for more information or advice about side effects. You are encouraged to report side effects to the FDA at www.fda.gov/medwatch or by calling 1-800-FDA-1088. 

How should I take COBENFY?

Take COBENFY exactly as your healthcare provider tells you. COBENFY should be taken twice daily on an empty stomach. Do not change the dose or stop taking COBENFY without first talking to your healthcare provider.

 

Do take COBENFY by mouth (orally)
 

Do take COBENFY at least 1 hour before meals or at least 2 hours after a meal
 

Do not open capsules

What if I take too much COBENFY?

 

Call a healthcare provider or Poison Health Line (at 1-800-222-1222), or go to the nearest hospital emergency room right away.

Starting COBENFY: You will begin taking COBENFY in smaller doses and gradually increase your dosage. You will start with:

  • at least 2 days of taking one light brownish yellow 50mg/20mg capsule twice daily followed by
  • at least 5 days of taking one brown 100mg/20mg capsule twice daily

Continuing COBENFY: Your healthcare provider will determine the correct dose. You may be prescribed either

  • one brown 100mg/20mg capsule twice daily, OR
  • one dark orange 125mg/30mg capsule twice daily
 

Setting an alarm clock or a calendar notification is a great way to remember to take medication.

COBENFY is available in three different capsules with different dosage strengths. Each capsule is a different color and marked with "Karuna" and its dosage strength (50mg/20mg, 100mg/20mg, or 125mg/30mg) printed in black ink.

Icon capsule

50mg/20mg
Light brownish yellow

OR

Icon capsule

100mg/20mg
Brown

OR

Icon capsule

125mg/30mg
Dark orange

Note: Images do not represent actual capsule sizes

Ingredients:

  • Active: xanomeline, trospium chloride
  • Inactive: ascorbic acid, lactose monohydrate, microcrystalline cellulose, and talc.
    Capsule shell: hypromellose, red iron oxide, titanium dioxide, black iron oxide (only in 100mg/20mg capsule), and yellow iron oxide (only in 50mg/20mg and 100mg/20mg capsules)

How should I store COBENFY?

Store capsules at room temperature between 68°F to 77°F (20°C to 25°C).
Keep COBENFY and all medicines out of reach of children.

What else should I know about COBENFY?

Do not use COBENFY for any condition other than what your healthcare provider has prescribed it for. Healthcare providers may sometimes prescribe COBENFY for purposes other than those mentioned in this document.

Do not give COBENFY to other people, even if they have the same symptoms as you. It may harm them.

Ask your healthcare team for the information about COBENFY that is written for healthcare providers if you would like.

 

For more information, please see the accompanying U.S. Full Prescribing Information and Patient Information for COBENFY. Talk to your healthcare provider for more information about this medication.
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Cobenfy, Cobenfy Cares, and the Cobenfy logo are trademarks of Karuna Therapeutics, Inc., a Bristol Myers Squibb company.
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