5 tips to help your student thrive this year

2024-02-15T07:01:01

(BPT) – Do you remember how challenging school could be? As a parent, it’s easy to forget that studying and homework aren’t always easy. Your child needs your support and guidance to help stay on task with studies and achieve at the highest level.

Don’t know where to start? Check out these top five tips to help support your student’s educational journey so they can thrive academically this year.

1. Get organized

Messy and cluttered school supplies are a recipe for frustration. Encourage your student to keep notes and handouts organized to quickly and easily locate what is needed for any assignment. Encourage your student to pick out notebooks, folders and binders in favorite colors and designs. Let your student label or decorate front covers and assign a subject to each.

Take organization to the next level with a digital tool like the Five Star® Study App. Using the app and Five Star compatible notebooks, folders and academic planners, your student can scan handwritten notes and handouts to access study materials anytime, anywhere!

Once digitized, your student can add, revise and arrange notes as needed, organizing materials into digital folders that correspond with physical notebook colors. The free app provides your child with the best of physical and digital studying and even turns notes and handouts into digital flashcards.

2. Create a consistent study routine

It may sound simple, but establishing a consistent study routine can go a long way to help your student succeed in school. Creating a routine develops time management and prioritization skills for tasks and projects.

Guide your student to set a time each day for homework and studying, for example right after school, before or after dinner or extracurriculars. If a certain time isn’t working, suggest a change to find a time and rhythm that works best.

No matter what time of day they choose, consistency is the most important aspect of a study routine. After a couple of weeks, the study routine will become a habit that provides consistency and stability so your child can focus on tasks with minimal distractions.

3. Set realistic goals

A large project or study packet can be overwhelming and discouraging for anyone, let alone a young scholar. Expecting to finish a large assignment or study for a big test in one sitting can seem daunting and cause undue anxiety.

Help your child avoid panic and stress by helping set realistic and achievable study goals. Demonstrate how to break down big assignments into smaller tasks, and even create a task list to check off as each one is completed.

Using a tool like the Five Star Study App, your child can set reminders for different tasks, tackle them at a steady pace, and meet deadlines, building a sense of accomplishment. More importantly, this practice fosters a growth mindset and builds perseverance.

4. Encourage handwritten notes

Typing notes may be more convenient, but handwritten notes can give your child an academic edge. Many research studies suggest that writing on paper improves recall and allows notetakers to better understand complicated concepts.

You don’t have to sacrifice the power of paper for the convenience of digital. Your student can have the best of both worlds, thanks to the Five Star brand. Students can scan handwritten notes from compatible Five Star school supplies into the study app. To learn more about the Five Star Study App, visit FiveStarBuiltStrong.com.

5. Take regular breaks

Nonstop studying can quickly lead to burnout and less productivity. During study sessions, invite your child to take a break. Take a walk together, do some quick stretches, or simply ask them to step away from the study area and go outside to get some fresh air. When returning to study, your student will feel refreshed and ready to tackle the remaining assignments.

Every child is different, so collaborate with your students to find the best strategies that fit their learning style. However your child decides to study, your support is the most important tool in their arsenal. Using these five tips and fostering a positive attitude toward learning, you can help set up your child for academic success in 2024.

Did you know heart palpitations can tell the story of your heart? Sometimes these flutters can be a sign of changes to your heart health

2024-02-13T14:49:00

(BPT) – Read on to learn the power of heart rhythms to tell your heart health story …

Heart rhythms can tell a story with the power to help change a life.

You may have heard of heart palpitations because they are common[1], accounting for 16% of visits to primary care physicians and are the second leading cause of visits to cardiologists[2]. Often perceived as mere inconveniences, heart palpitations can be important cues from our bodies. While they are sometimes caused by temporary stressors, they may also signify deeper health concerns like arrhythmias that require medical attention.

An arrhythmia is an irregular heartbeat where your heart may beat too quickly, too slowly or irregularly. One study shows that up to 5% of the general population — or 16 million people[3] — experience arrhythmias. Some arrhythmias, if not treated, can damage the heart, brain or other organs.[4] Other arrhythmias may even lead to an increased risk of stroke or death.[5] And for the person experiencing one, arrhythmias can feel scary.

Causes and Risk Factors

How can you do better by your heart? First and foremost, you can reduce risk factors for arrhythmias. Risk factors that may affect an individual’s risk of arrhythmia include heart disease, high blood pressure, high alcohol use, obesity and family history.[6] Arrhythmias and related conditions are more common in those over 60 years of age,[7] and can be particularly dangerous if undetected.

And, for early detection, it is worthwhile talking with your healthcare provider as there are advancements in heart monitoring technologies that offer lightweight, wearable electrocardiogram (ECG) patches that seamlessly integrate into your daily life and record important heart rhythms and help tell your individualized story of cardiac health.

Types of Arrhythmias

In general, heart arrhythmias are grouped by the speed of the heart rate. For example, tachycardia is a fast heartbeat, while bradycardia is a slow heartbeat[8].

Atrial fibrillation, or Afib, is a common arrhythmia, with an irregular and often very rapid heart rhythm (tachycardia). There are 5-8 million people with Afib in the U.S., with up to 1.5 million adults living with Afib who don’t even know they have it.[9] In fact, Afib causes one out of seven strokes[10], and 160,000 deaths per year.[11]

Early Detection is Vital

Being proactive about your heart health is critical. And that includes early detection and treatment of arrhythmias to reduce the burden of cardiac disease.[12]

While arrhythmias are treatable, your path may depend on the specific type of arrhythmia. Evaluating your unique treatment journey requires a diagnosis from a doctor.

A Path Forward

The path to getting a diagnosis and understanding your specific arrhythmia hasn’t always been easy. Not so long ago, finding out if you had an arrhythmia required a hospital or clinic visit to get an ECG. But as arrhythmia symptoms often come and go, and an ECG can capture the exact time your heartbeat is irregular. An in-clinic ECG scan sometimes meant that getting a diagnosis required repeat ECGs or the condition was missed altogether.

Today, while doctors still widely use Holter monitors to detect arrhythmias — wired, clunky devices introduced in the 1960s that are worn for only 24 to 48 hours — clinical studies have shown that longer ECG recording periods are more effective[13] because some people could go days or weeks without an episode. In fact, three out of four patients who use a Holter monitor do not get a diagnosis on the first test.[14]

Nowadays, even a smartwatch can tell you that you might have atrial fibrillation, by tracking your pulse to see if it becomes irregular, though the accuracy is not always perfect. If you have any symptoms or get a smartwatch alert, take heed — but know that you will likely still need an ECG to get a diagnosis from your doctor.

The good news is that modern ECG monitors can be worn at home and continuously record your heart’s electrical signal for longer than 24 to 48 hours if your doctor prescribes it. iRhythm has been creating these types of ECG monitors since 2008 and has recently launched its next generation monitoring device, the Zio monitor. The device is a discreet adhesive patch and a sensor the size of a quarter, weighing less than a pencil[15], with no clunky wires and no need to change batteries during the wear period.

Recordings from these Zio ECG monitoring devices continuously record your heart for up to 14 days — capturing up to 1.5 million heart beats[16] — and can help doctors accurately diagnose heart arrhythmias.

“Palpitations, skipped beats, and other heart-rhythm symptoms can be a nuisance and affect quality of life. However, sometimes they tell a greater story and may signal a more serious condition like atrial fibrillation, which can cause stroke and heart failure,” said Mintu Turakhia, MD, MAS, a cardiologist and the chief medical and scientific officer at iRhythm. “Because these rhythms can be treated and complications prevented, early detection is key. The good news is there are heart monitoring technologies that can help get to a diagnosis quickly — or give you peace of mind.”

In a world where our health is paramount, understanding and responding to our heart’s rhythms is a powerful step toward longevity and well-being. So, listen to your heart, embrace the technological strides in cardiac monitoring, and take proactive steps towards heart health. Your heart’s story is worth knowing, and with the right tools and care, you can help ensure it’s a long and healthy one.


Newer heart monitoring technology is helping in the shift to more preventative and proactive treatment and care, providing an effective way to diagnose arrhythmias and protect your health. If you or your loved one has symptoms of arrhythmias, talk to your physician or care team to learn more if heart monitoring is right for you and the best option for your situation.

[1] Raviele A, Giada F, Bergfeldt L, et al. Management of patients with palpitations: a position paper from the European Heart Rhythm Association. Europace. 2011;13(7):920-934.

[2] Wexler, et al. Palpitations: Evaluation in the Primary Care Setting. Am Fam Physician, 2017.

[3] Desai et al. Arrhythmias. StatPearls [Internet], 2022. https://www.ncbi.nlm.nih.gov/books/NBK558923/ [accessed October 2022]

[4] What is an arrhythmia? National Heart Lung and Blood Institute, 2022. https://www.nhlbi.nih.gov/health/arrhythmias Accessed November 18, 2022

[5] Ataklte et al. Meta-analysis of ventricular premature complexes and their relation to cardiac mortality in general populations. The American Journal of Cardiology, 2013.

Lin et al. Long-Term Outcome of Non-Sustained Ventricular Tachycardia in Structurally Normal Hearts. PLOS ONE, 2016.

Wolf et al. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke, 1991.

[6] Arrhythmias: causes and triggers. National Heart Lung and Blood Institute (NHLBI), 2022

[7] Mirza, M. et al,. Mechanisms of arrhythmias and conduction disorders in older adults. Clin Geriatr Med., 2012

[8] https://www.heart.org/-/media/Files/Health-Topics/Answers-by-Heart/What-is-Arrhythmia.pdf

[9] Turakhia MP, et al., Contemporary prevalence estimates of undiagnosed and diagnosed atrial fibrillation in the United States. Clin Cardiol, 2023.

[10] Heart Rhythm Society. (2019). Complications from Atrial Fibrillation.

[11] Atrial Fibrillation. Centers for Disease Control and Prevention (CDC), 2022. https://www.cdc.gov/heartdisease/atrial_fibrillation.htm [accessed September 2023]

[12] Rilig et al. Early Rhythm Control in Patients With Atrial Fibrillation and High Comorbidity Burden. Circulation, 2022.

[13] Reynolds et al. Comparative effectiveness of ambulatory monitors for arrhythmia diagnosis: A retrospective analysis of Medicare beneficiaries managed with ambulatory cardiac monitors between 2017 and 2019. Accepted for ACC.23 presentation, presented at New Orleans, LA.

[14] Tsang, et al., Benefits of monitoring patients with mobile cardiac telemetry (MCT) compared with the Event or Holter monitors. Medical Devices: Evidence and Research, 2013.

[15] 10g

[16] Data on file. iRhythm Technologies, 2019.

Seventy percent of U.S. drivers don’t know this vital winter driving fact

2024-02-13T09:01:00

(BPT) – Seven in 10 American drivers are unaware of a vital piece of information. All-season tires aren’t built to drive in all four seasons.

It sounds counterintuitive, but it’s true: The tires used by most Americans harden when temps fall below 45 degrees, rendering them less responsive to the road when it’s cold or snowy. In fact, nearly three-fourths of North American all-season tire drivers say they feel unsafe on the road at least a few times each winter.

What’s the solution?

Thankfully, there’s a remedy: all-weather tires.

The name is so similar that only 30% of U.S. drivers are able to distinguish them from all-season tires. But there’s an easy way to think about it: all-weather tires are made for all types of weather, whereas all-season tires are three-season tires in most parts of the United States and Canada.

How can consumers tell the difference? All-weather tires are certified with the three-peak mountain snowflake symbol on their sidewalls. That signifies they’re meant for use in winter conditions.

What sets all-weather tires apart?

All-weather tires remain soft in the wintry months, and their tread patterns are designed to carve through snow and slush. At the same time, they perform well in spring rain and summer heat. While there’s nothing safer in extreme winter than a dedicated winter tire, all-weather tires are a compromise option for drivers who live in areas with moderate or unpredictable winter weather.

If snow, ice and frigid weather stay for a few months, it’s best to swap to a set of winter tires. But for drivers who visit winter or have winter visit them, an all-weather tire is an appealing solution.

All-weather tires have been around for nearly a quarter century; Nokian Tyres introduced the all-weather passenger tire to North America in 1999. The company, which also invented the winter tire in the 1930s, just debuted its sixth-generation all-weather tire this winter — the Nokian Tyres Remedy WRG5.

Like many all-weather tires, the Remedy WRG5 is tested around the globe — in this case, at Nokian Tyres’ Arctic test facility in northern Finland and its new test track in the Spanish desert. The inside of the tire has snow claws that carve into wintry surfaces, while the outside of the tire channels away moisture like an all-season tire.

Who should consider all-weather tires?

Drivers who live in the Sun Belt can usually get away with all-season tires year-round. But anyone who visits winter, or sees winter visit them, should consider an all-weather tire — especially if they don’t plan to swap to dedicated winter tires this time of year.

What drivers don’t know about four-season driving can hurt them. All-weather tires offer an appealing remedy. Learn more about all-weather tires at NokianTires.com/Remedy.

How a new Subaru partnership is providing warmth, confidence and hope to kids this winter

2024-02-13T08:01:00

(BPT) – As cold weather moves across much of this country, winter coats, shoes and socks are a necessity that most of us may take for granted. But with 40 million people living in poverty according to the U.S. Census Bureau, many do not have the means for or access to the essentials they need to make it safely through the season staying warm and dry.

That’s why as part of Subaru Loves to Help® month the automaker is partnering with Operation Warm®, a national nonprofit that produces those necessary items and organizes gifting programs with beneficiary organizations for children in urgent need. In a free shopping experience, volunteers from Subaru retailers and community organizations help kids select brand-new essential clothing in their size and in colors that they love.

This winter wear will keep them cozy, which is a basic need they may be living without. The fact that the items are new and personally selected by the wearer can also have a significant impact on a child’s emotional well-being. According to the U.S. Department of Housing and Urban Development (HUD) 2023 Annual Homeless Assessment Report, roughly 653,100 people were experiencing homelessness during a single night in 2023, a record high since data collection began in 2007 and a 12% increase over the year before. Nearly three of every 10 people (28%) experiencing homelessness did so as part of a family with children.

“For too many children, going without a coat, shoes or even socks can mean the difference between going to school, participating in activities and feeling confident in themselves,” said Alan Bethke, senior vice president of marketing, Subaru of America, Inc. “By pairing our own commitment to be ‘More Than a Car Company,’ with Operation Warm’s mission of being ‘More Than a Coat’ we’re providing children in urgent need with the opportunity to select and own the brand-new necessities they need to thrive.”

In partnership with Operation Warm, more than 600 Subaru retailers around the country have been matched with a local beneficiary organization that serves children in need in their local community. Through gifting and drop-off events, Subaru will help provide more than 150,000 children with brand-new coats, shoes and socks. These special events are tailored to address the unique preferences and essential needs of each child through a variety of coat, shoe and sock options donated by the Subaru retailer.

Picking out something new that is theirs to keep is important for a child’s self-esteem. Choosing a new coat can provide:

  • Improved social interactions and confidence. New winter coats are a fact of life for many kids. For those experiencing homelessness and other urgent need situations, new clothing can provide a sense of normalcy and belonging.
  • A symbol of care and respect. The ability to choose their own winter wear shows a child that their preferences matter. That they matter.
  • Reduced anxiety and stress. There’s no worry that a child won’t have a beautiful new coat to keep them warm on the playground at school, which eases stress on kids and their caregivers.
  • Hope and optimism. Knowing that someone cares is a powerful force in this world.

“Coats, shoes and socks provide so much more than just physical warmth, and programs like this are giving kids in urgent need the relief and confidence to socialize and succeed,” said Grace Sica, executive director of Operation Warm. “Teaming up with Subaru, who clearly shares our values of community connection, allows us to bring warmth and confidence to even more children around the country than ever before.”

That’s why Subaru has signed on to be the largest automotive partner of Operation Warm. It’s part of their Subaru Love Promise vision, in which the automaker commits to be a positive force in the local communities where they live and work, going beyond donations to include actions that set an example for others to follow.

Through this partnership, Subaru and Operation Warm will be addressing the immediate needs of more than 150,000 children by the end of February, but the impact will have much longer-lasting effects. And that can make everyone feel a little warmer.

Addressing Misinformation

2024-02-12T09:01:00

(BPT) – Frequently asked questions about Ozempic (semaglutide)

Novo Nordisk is a healthcare company with a 100­-year history of driving change to improve the lives of people living with serious, chronic diseases. As broader conversations about diabetes medicines are ongoing in both mainstream and social media, we believe it is important to continue to raise awareness and to reinforce our commitment to responsible use of Novo Nordisk medicines. These efforts are intended to support the safety of all people for one of our medicines that is well known in the diabetes community, Ozempic®.

See Medication Guide: bit.ly/OzempicPI & Safety Info: bit.ly/OzempicISI for Ozempic (semaglutide) injection 0.5 mg, 1 mg, or 2 mg.

Heart to Heart With a Leading Cardiologist: What You Need to Know About Coronary Artery Disease

2024-02-12T11:01:00

(BPT) – Did you know that the heart beats about 70 times per minute?1 Despite this muscle only being about the size of your fist, it is responsible for pumping oxygen-rich blood throughout your entire body 24/7 using arteries or blood vessels.1

When there is a narrowing or blockage of the coronary arteries due to a build-up of plaque, it can threaten the supply of oxygen and blood to the heart.1 This can result in a condition known as coronary artery disease (CAD), which is the most common type of heart disease in the United States.1

To help people, especially those over 65, stay heart healthy, Dr. Manesh Patel,* a Cardiologist at the Duke Heart Center in Durham, North Carolina, answers the most common questions about CAD.2

Q&A with Dr. Manesh Patel

Q: What is coronary artery disease – CAD – and how could it impact someone’s life?

A: In simple terms, CAD is the narrowing of blood vessels, also known as coronary arteries, that supply oxygen and blood to the heart.1 This is the most common type of heart disease and its complications are the leading cause of death for males and females in the U.S.1 CAD is very serious because patients with the condition are at a higher risk for health issues caused by blood clots such as stroke, heart attack, and cardiovascular-related death.1,3 That is why it’s so important for people to talk to their doctor or cardiologist about CAD and develop a treatment plan, if necessary.

CAD affects about 20.5 million Americans.4

Q: How does someone know if they have CAD?

A: Many patients come into my office with chest pain or discomfort, weakness, light-headedness, nausea, and shortness of breath, which are common symptoms of CAD.1 Pain or discomfort in the arms, neck, back, or shoulders can also be signs of CAD.1

I also consider other factors such as age, sex (men are generally at a higher risk of CAD), family history, smoking, high blood pressure, high blood cholesterol levels, diabetes, obesity, physical inactivity, stress, and eating an unhealthy diet because they can make someone have a higher risk for CAD.1 It’s always important to discuss any symptoms you have with your doctor or cardiologist because these are only some of the symptoms associated with CAD.1 Sometimes CAD can develop without any risk factors, or if you have multiple risk factors, you may be at even higher risk of developing CAD.5

After I evaluate my patients’ symptoms and discuss their medical history, I typically order lab tests to confirm a diagnosis.1 Other doctors and cardiologists may take a similar approach.

Q: Are there treatments to prevent the effects of CAD?

A: Yes, there are different ways to treat CAD. One medicine approved to prevent blood clots that are associated with CAD and other cardiovascular conditions is rivaroxaban (XARELTO®). When taken with aspirin, it can reduce the risk of major cardiovascular events, which is defined as cardiovascular death, heart attack, and stroke.6 XARELTO® may cause serious side effects including bleeding, which can be serious. It is important to talk to your doctor before beginning or stopping XARELTO®. Please see Important Safety Information below.

When considering the best treatment option for my patients, I often look at the latest clinical practice guidelines issued by reputable cardiology organizations. Guideline updates are important milestones that help keep healthcare providers up to date on the latest medicines and research to provide guidance on how to treat patients.

In July 2023, the American College of Cardiology (ACC) and the American Heart Association (AHA) updated their clinical practice guidelines for the management of chronic coronary disease, including CAD. The updated guidelines state that it is reasonable to use rivaroxaban (XARELTO®) plus an aspirin treatment regimen for patients at high ischemic risk and low bleeding risk to help reduce the risk of major cardiovascular events in patients with chronic coronary disease, otherwise known as CAD.7

XARELTO® (2.5 mg twice daily plus aspirin 75 mg-100 mg once daily) is the only approved direct oral anticoagulant drug in its class for the treatment of CAD.6 That said, it’s important to talk with your doctor or cardiologist to find the most appropriate treatment plan for you, as XARELTO® is not right for everyone.

Q: What should I ask my doctor about treating CAD?

A: If you think you or a loved one may have CAD, are experiencing any of the common signs and symptoms, or have any of the risk factors for the disease, it’s important to talk with your doctor or cardiologist. They will evaluate your symptoms and risk factors, and if you are diagnosed with CAD, develop a treatment plan that could include medication, exercise, and lifestyle changes.

It is important that CAD is diagnosed as soon as possible to help reduce the risk of serious outcomes such as heart attack and stroke.3

Questions to consider asking at your next doctor’s visit:

  • My family has a history of heart disease. Does this increase my risk of CAD?
  • I often feel short of breath. Could this be a sign that I have CAD?
  • I have other health conditions. Might they be linked to CAD?
  • I have CAD, what are my treatment options to help me manage my condition?

Finding the right CAD care is key to your overall heart health. If you or a loved one are experiencing symptoms of the disease, it is important to talk to your doctor. CAD is a serious condition but there is hope for people who may be at risk. You can learn more about CAD and how XARELTO® can help manage your condition by visiting Xarelto.com

Sponsored by Janssen Pharmaceutical companies of Johnson & Johnson

* Manesh Patel, M.D. is a paid consultant for the Janssen Pharmaceutical companies of Johnson & Johnson.

References:

  1. “All About Coronary Artery Disease.” Pacific Heart, Lung & Blood Institute, 2020.
  2. Xia, T. L., Huang, F. Y., Li, Y. M., Chai, H., Huang, B. T., Ou, Y. W., Li, Q., Pu, X. B., Zuo, Z. L., Peng, Y., Chen, M., & Huang, D. J. (2018). The impact of age on the implementation of evidence-based medications in patients with coronary artery disease and its prognostic significance: a retrospective cohort study. BMC public health, 18(1), 150. https://doi.org/10.1186/s12889-018-5049-x.
  3. “Symptoms of Coronary Artery Disease.” VeryWell Health, 2021.
  4. “Heart Disease and Stroke Statistics—2023 Update: A Report From the American Heart Association.” AHA Journals, 2023. Accessed June 24, 2023. https://www.ahajournals.org/doi/10.1161/CIR.0000000000001123#d1e727
  5. “Coronary Artery Disease.” MayoClinic, 2019.
  6. XARELTO® (rivaroxaban) [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.
  7. Virani, S. Salim et al. 2023 AHA/ACC/ACCP/ASPC/NLA/PCNA Guideline for the Management of Patients with Chronic Coronary Disease. Journal of the American College of Cardiology 2023.

Important Safety Information

WHAT IS XARELTO® (rivaroxaban)?

XARELTO® is a prescription medicine used to:

  • reduce the risk of stroke and blood clots in adults who have a medical condition called atrial fibrillation that is not caused by a heart valve problem. With atrial fibrillation, part of the heart does not beat the way it should. This can lead to the formation of blood clots, which can travel to the brain, causing a stroke, or to other parts of the body
  • treat blood clots in the veins of your legs (deep vein thrombosis or DVT) or lungs (pulmonary embolism or PE)
  • reduce the risk of blood clots from happening again in adults who continue to be at risk for DVT or PE after receiving treatment for blood clots for at least 6 months
  • help prevent a blood clot in the legs and lungs of adults who have just had hip or knee replacement surgery
  • help prevent blood clots in certain adults hospitalized for an acute illness and after discharge, who are at risk of getting blood clots because of the loss of or decreased ability to move around (mobility) and other risks for getting blood clots, and who do not have a high risk of bleeding

XARELTO® is used with low dose aspirin to:

  • reduce the risk of serious heart problems, heart attack and stroke in adults with coronary artery disease (a condition where the blood supply to the heart is reduced or blocked)
  • reduce the risk of a sudden decrease in blood flow to the legs, major amputation, serious heart problems or stroke in adults with peripheral artery disease (a condition where the blood flow to the legs is reduced) and includes adults who have recently had a procedure to improve blood flow to the legs

XARELTO® is used in children to:

  • treat blood clots or reduce the risk of blood clots from happening again in children from birth to less than 18 years, after receiving at least 5 days of treatment with injectable or intravenous medicines used to treat blood clots
  • help prevent blood clots in children 2 years and older with congenital heart disease after the Fontan procedure

XARELTO® was not studied and is not recommended in children less than 6 months of age who:

  • were less than 37 weeks of growth (gestation) at birth
  • had less than 10 days of oral feeding, or
  • had a body weight of less than 5.7 pounds (2.6 kg)

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT XARELTO®?

XARELTO® may cause serious side effects, including:

  • Increased risk of blood clots if you stop taking XARELTO®. People with atrial fibrillation (an irregular heart beat) that is not caused by a heart valve problem (nonvalvular) are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body. XARELTO® lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking XARELTO®, you may have increased risk of forming a clot in your blood.

Do not stop taking XARELTO® without talking to the doctor who prescribes it for you. Stopping XARELTO® increases your risk of having a stroke. If you have to stop taking XARELTO®, your doctor may prescribe another blood thinner medicine to prevent a blood clot from forming.

  • Increased risk of bleeding. XARELTO® can cause bleeding which can be serious and may lead to death. This is because XARELTO® is a blood thinner medicine (anticoagulant) that lowers blood clotting. During treatment with XARELTO® you are likely to bruise more easily, and it may take longer for bleeding to stop. You may be at higher risk of bleeding if you take XARELTO® and have certain other medical problems.

You may have a higher risk of bleeding if you take XARELTO® and take other medicines that increase your risk of bleeding, including:

    • Aspirin or aspirin-containing products
    • Long-term (chronic) use of non-steroidal anti-inflammatory drugs (NSAIDs)
    • Warfarin sodium (Coumadin®, Jantoven®)
    • Any medicine that contains heparin
    • Clopidogrel (Plavix®)
    • Selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)
    • Other medicines to prevent or treat blood clots

Tell your doctor if you take any of these medicines. Ask your doctor or pharmacist if you are not sure if your medicine is one listed above.

Call your doctor or get medical help right away if you or your child develop any of these signs or symptoms of bleeding:

    • Unexpected bleeding or bleeding that lasts a long time, such as:
      • Nosebleeds that happen often
      • Unusual bleeding from gums
      • Menstrual bleeding that is heavier than normal, or vaginal bleeding
    • Bleeding that is severe or you cannot control
    • Red, pink, or brown urine
    • Bright red or black stools (looks like tar)
    • Cough up blood or blood clots
    • Vomit blood or your vomit looks like “coffee grounds”
    • Headaches, feeling dizzy or weak
    • Pain, swelling, or new drainage at wound sites
  • Spinal or epidural blood clots (hematoma). People who take a blood thinner medicine (anticoagulant) like XARELTO®, and have medicine injected into their spinal and epidural area, or have a spinal puncture, have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis). Your risk of developing a spinal or epidural blood clot is higher if:
    • A thin tube called an epidural catheter is placed in your back to give you certain medicine
    • You take NSAIDs or a medicine to prevent blood from clotting
    • You have a history of difficult or repeated epidural or spinal punctures
    • You have a history of problems with your spine or have had surgery on your spine

If you take XARELTO® and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symptoms of spinal or epidural blood clots.

Tell your doctor right away if you have:

    • back pain
    • tingling
    • numbness
    • muscle weakness (especially in your legs and feet)
    • or loss of control of the bowels or bladder (incontinence)

XARELTO® is not for use in people with artificial heart valves.

XARELTO® is not for use in people with antiphospholipid syndrome (APS), especially with positive triple antibody testing.

Do not take XARELTO® if you or your child:

  • Currently have certain types of abnormal bleeding. Talk to your doctor before taking XARELTO® if you currently have unusual bleeding.
  • Are allergic to rivaroxaban or any of the ingredients of XARELTO®.

Before taking XARELTO®, tell your doctor about all your medical conditions, including if you or your child:

  • Have ever had bleeding problems
  • Have liver or kidney problems
  • Have antiphospholipid syndrome (APS)
  • Are pregnant or plan to become pregnant. It is not known if XARELTO® will harm your unborn baby.
    • Tell your doctor right away if you become pregnant during treatment with XARELTO®. Taking XARELTO® while you are pregnant may increase the risk of bleeding in you or in your unborn baby.
    • Females who are able to become pregnant: Talk with your doctor about pregnancy planning during treatment with XARELTO®. Talk with your doctor about your risk for severe uterine bleeding if you are treated with blood thinner medicines, including XARELTO®.
    • If you take XARELTO® during pregnancy, tell your doctor right away if you have any signs or symptoms of bleeding or blood loss. See “What is the most important information I should know about XARELTO®?” for signs and symptoms of bleeding.
  • Are breastfeeding or plan to breastfeed. XARELTO® may pass into your breast milk. Talk to your doctor about the best way to feed your baby during treatment with XARELTO®.

Tell all of your doctors and dentists that you or your child are taking XARELTO®. They should talk to the doctor who prescribed XARELTO® for you before you have any surgery, medical or dental procedure.

Tell your doctor about all the medicines you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Some of your other medicines may affect the way XARELTO® works, causing side effects. Certain medicines may increase your risk of bleeding. See “What is the most important information I should know about XARELTO®?”

HOW SHOULD I TAKE XARELTO®?

  • Take XARELTO® exactly as prescribed by your doctor.
  • Do not change your dose or stop taking XARELTO® unless your doctor tells you to. Your doctor may change your dose if needed.
  • Your doctor will decide how long you should take XARELTO®.
  • XARELTO® may need to be stopped for one or more days before any surgery or medical or dental procedure. Your doctor will tell you when to stop taking XARELTO® and when to start taking XARELTO® again after your surgery or procedure.
  • If you need to stop taking XARELTO® for any reason, talk to the doctor who prescribed XARELTO® to you to find out when you should stop taking it. Do not stop taking XARELTO® without first talking to the doctor who prescribes it to you.
  • If you have difficulty swallowing XARELTO® tablets whole, talk to your doctor about other ways to take XARELTO®.
  • Do not run out of XARELTO®. Refill your prescription of XARELTO® before you run out. When leaving the hospital following a hip or knee replacement, be sure that you will have XARELTO® available to avoid missing any doses.
  • If you take too much XARELTO®, go to the nearest hospital emergency room or call your doctor right away.

If you take XARELTO® for:

  • Atrial Fibrillation that is not caused by a heart valve problem:
    • Take XARELTO® 1 time a day with your evening meal.
    • If you miss a dose of XARELTO®, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time.
  • Blood clots in the veins of your legs or lungs:
    • Take XARELTO® 1 or 2 times a day as prescribed by your doctor.
    • For the 10-mg dose, XARELTO® may be taken with or without food.
    • For the 15-mg and 20-mg doses, take XARELTO® with food at the same time each day.
    • If you miss a dose:
      • If you take the 15-mg dose of XARELTO® 2 times a day (a total of 30 mg of XARELTO® in 1 day): Take XARELTO® as soon as you remember on the same day. You may take 2 doses at the same time to make up for the missed dose. Take your next dose at your regularly scheduled time.
      • If you take XARELTO® 1 time a day: Take XARELTO® as soon as you remember on the same day. Take your next dose at your regularly scheduled time.
  • Hip or knee replacement surgery:
    • Take XARELTO® 1 time a day with or without food.
    • If you miss a dose of XARELTO®, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time.
  • Blood clots in people hospitalized for an acute illness:
    • Take XARELTO® 1 time a day, with or without food, while you are in the hospital and after you are discharged as prescribed by your doctor.
    • If you miss a dose of XARELTO®, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time.
  • Reducing the risk of serious heart problems, heart attack and stroke in coronary artery disease:
    • Take XARELTO® 2.5 mg 2 times a day with or without food.
    • If you miss a dose of XARELTO®, take your next dose at your regularly scheduled time.
    • Take aspirin 75 to 100 mg once daily as instructed by your doctor.
  • Reducing the risk of a sudden decrease in blood flow to the legs, major amputation, serious heart problems or stroke in people with peripheral artery disease, including those who have recently had a procedure to improve blood flow to the legs:
    • Take XARELTO® 2.5 mg 2 times a day with or without food.
    • If you miss a dose of XARELTO®, take your next dose at your regularly scheduled time.
    • Take aspirin 75 to 100 mg once daily as instructed by your doctor.

For children who take XARELTO®:

  • The dose of XARELTO® depends on your child’s body weight and will be calculated by your child’s doctor. Your child’s doctor will tell you if XARELTO® can be given to your child with or without food.
  • The adult caregiver should give the dose.
  • If your child is taking the tablet, the tablet should be taken whole and should not be split in an attempt to provide a lower dose of XARELTO®.
  • If your child is taking the oral suspension, use the syringes provided in the original carton. The suspension will be prepared by the pharmacy. See the Instructions for Use included in the carton on how to properly give a dose of XARELTO® oral suspension to your child.
  • Do not switch between the XARELTO® oral suspension or tablet without first talking to your doctor.
  • If your child vomits or spits up:
    • right after or within 30 minutes of taking the oral suspension, give a new full dose.
    • more than 30 minutes after taking the oral suspension, do not give the dose again. Give the next dose at the regularly scheduled time.
    • if vomiting or spitting up persists, contact your child’s doctor right away.
  • If your child misses a dose:
    • If your child is taking XARELTO® 1 time a day, give the dose as soon as you remember on the same day. If this is not possible, skip this dose and give the next dose at the regularly scheduled time.
    • If your child is taking XARELTO® 2 times a day, give the missed morning dose as soon as you remember. You may give the missed morning dose together with the evening dose. However, a missed evening dose can only be taken in the same evening.
    • If your child is taking XARELTO® 3 times a day, skip the missed dose and give the next dose at the regularly scheduled time.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF XARELTO®?

XARELTO® may cause serious side effects:

  • See “What is the most important information I should know about XARELTO®?”

The most common side effect of XARELTO® in adults was bleeding.

The most common side effects of XARELTO® in children include:

  • bleeding
  • vomiting
  • cough
  • inflamed stomach and gut

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Janssen Pharmaceuticals, Inc., at 1-800-JANSSEN (1-800-526-7736).

Please read full Prescribing Information, including Boxed Warnings, and Medication Guide for XARELTO®.

Trademarks are those of their respective owners.

cp-53637v8

cp-400546v1 01/24

Modern Schizophrenia Treatment Plans Should Include Less-Frequent Dosing Options for Adult Patients

2024-02-12T23:01:00

(BPT) – Talking about and acknowledging mental health challenges have evolved, with more acceptance and mainstream conversation in recent years from both patients and their loved ones, as well as healthcare providers (HCPs). Yet with schizophrenia, many patients are not aware of all the different treatment and dosing options that are now available.1 Whether due to low awareness, stigma and outdated stereotypes, or social or geographical issues that make accessing treatment options difficult, there are countless barriers that exist for many adult patients living with schizophrenia.1-4 However, by equipping HCPs with information on the latest treatments and less-frequent dosing options, they can help their patients make more-informed treatment decisions when they are aware of available treatment options.

Understanding Behaviors and Fighting Stigma

Millions of adults in the United States live with schizophrenia, a complex and chronic brain disorder that can impact all aspects of day-to-day life. People with schizophrenia often experience distortions in thinking, perceptions, emotions, language, and behavior that interrupt everything from personal relationships to managing a career.2,5 Without consistent treatment, schizophrenia symptoms can often create challenges for patients that impact even simple tasks in their lives.2,3 There can be many factors for why someone wouldn’t take medicine, from stigma to forgetting, which can happen to anyone, but adults living with schizophrenia are often nonadherent due to the nature of the condition or a lack of social support.2,6,7

Daily oral schizophrenia medications are the most prescribed treatment despite the adherence challenges that might result from patients forgetting to take their medication as prescribed.6-8 Within emergency room and hospital settings, many HCPs must rely on injectable antipsychotics that act quickly to minimize psychosis symptoms with patients in crises and in cases where there is no health history or known diagnosis.9 Understandably, the administration of an injection in a crisis setting can be associated with negative experiences for patients, which can result in a sense of fear and distrust in injectable treatments.10 Yet for day-to-day symptom management in adults diagnosed with schizophrenia, there are other options, known as long-acting injectables (LAIs).

A Different Kind of Injection for Symptom Management

LAIs are not the same injections that patients receive in emergency situations. Instead, LAIs offer less-frequent dosing options that can help patients stay on track with their medication management over time. Additionally, among other benefits, LAIs are professionally administered by a trained HCP, which can help patients avoid medication nonadherence because their HCP will be aware if they miss an injection appointment and can help them get back on track with their treatment.

A recent survey also showed there is a gap between what some patients desire as a treatment option and what HCPs typically prescribe. In the survey, 90% (44 of 49) of adult schizophrenia patients currently on an LAI agree that after knowing what living with schizophrenia is like, they wish they would have started an LAI treatment sooner after diagnosis.4 Additionally, 90% (172 of 192) of adult schizophrenia patients want their HCPs to recommend an LAI if they feel it is the right treatment option, even if the patient is stable on a current treatment.4 Because LAIs are administered by healthcare professionals, treatment teams have greater insight into when a patient has missed a dose and can therefore provide additional support to get that patient back on therapy.

Patrick’s Story of Hope and His Treatment Plan

Take it from patients like Patrick, who initially struggled with finding the right treatment to help address the symptoms he experienced with schizophrenia and challenges he faced with his oral medication. After Patrick’s loved ones helped connect him to a care team that embraced a different treatment approach with LAIs, Patrick was able to experience symptom relief. With his symptoms under control, Patrick was able to regain his sense of stability and independence by managing his condition with fewer schizophrenia medication doses per year.

Johnson & Johnson schizophrenia LAIs (J&J LAIs) are among the latest treatment options for adults living with schizophrenia. They offer a consistent and effective approach to symptom management, with dosing options of 1, 3, or 6 months, the longest dosing interval available.
INVEGA HAFYERA® (paliperidone palmitate 6-month) was approved for the treatment of adults with schizophrenia based on a pivotal, phase 3, randomized, double-blind, global study in which it demonstrated noninferiority to INVEGA TRINZA® (paliperidone palmitate 3-month) in delaying time to relapse.11

A total of 702 stabilized patients were randomized in a 2:1 ratio to receive INVEGA HAFYERA® (paliperidone palmitate 6-month) (n=478) or INVEGA TRINZA® (paliperidone palmitate 3-month) (n=224) over the 12-month, double-blind study.11 178 patients who were relapse-free on INVEGA HAFYERA® (n=121) or INVEGA TRINZA® (n=57) in the double-blind phase chose to continue treatment with INVEGA HAFYERA® in the 2-year, Real-world, Open-label Extension Safety and Tolerability Study.12 This open-label study of INVEGA HAFYERA® found that approximately 96% (171 of 178) of adult patients who chose to enter the study remained relapse-free on INVEGA HAFYERA® and nearly 9 out of 10 (154 of 178) adult patients completed 2 years of treatment with INVEGA HAFYERA®.12 In the pivotal study, the most common side effects of INVEGA HAFYERA® included injection site reactions, weight gain, headache, upper respiratory tract infections, feeling restlessness or difficulty sitting still, slow movements, tremors, stiffness and shuffling walk.13 In the open-label extension study, the most common adverse reactions were headache, blood prolactin increased, hyperprolactinemia, diarrhea, weight increased, and nasopharyngitis.12

For patients like Patrick, who is currently treated with INVEGA HAFYERA®, the ability to receive a long-term treatment that is professionally administered rather than a daily dose of schizophrenia medication frees up time so that he doesn’t have to remember to take it every day. This gives him the freedom to spend more time on the activities he enjoys while his schizophrenia symptoms are controlled.

Advocating for LAIs with Your Treatment Team

“I have seen the benefits of LAIs firsthand while helping Patrick and other adult patients living with schizophrenia,” says Dr. Gus Alva, board-certified psychiatrist and Patrick’s doctor. “As a healthcare provider, I always aim to create holistic treatment plans that factor in the important social, emotional, and physical aspects of a patient’s life. LAIs have been a key tool for me in creating a path forward for patients following diagnosis.”

With his symptoms under control, Patrick has been able to focus on the things that matter most to him, like his education and hobbies. “After some time on my first LAI—and finding music as a means for meditation—alongside support from my psychiatrist, family, and friends, I started to regain a sense of independence and noticed I was spending less time thinking about my next dose,” Patrick says. “I felt that my physical and mental health was improving. And day-by-day, I had a greater sense of stability, which I hadn’t experienced for a while.”

For adult patients who are recently diagnosed with schizophrenia or who have tried various treatments, consider speaking with a psychiatric nurse practitioner or other HCP about J&J LAIs and the pathway to fewer doses per year with INVEGA HAFYERA®. Before starting INVEGA HAFYERA®, patients must first be adequately treated with INVEGA SUSTENNA® (paliperidone palmitate 1-month) for at least 4 months or for one 3-month injection cycle with INVEGA TRINZA®, at an appropriate dose.13 With the support of family and treatment teams, living a full life with schizophrenia is possible. For more information about J&J LAIs, please visit JanssenLAIs.com.

INDICATIONS

INVEGA HAFYERA (6-month paliperidone palmitate) is a prescription medicine given by injection every 6 months by a healthcare professional and used to treat schizophrenia. INVEGA HAFYERA is used in adults who have been treated with either:

  • INVEGA SUSTENNA® (paliperidone palmitate) a 1-time-each-month paliperidone palmitate extended-release injectable suspension for at least 4 months
  • INVEGA TRINZA® (paliperidone palmitate) a 1-time-every-3-months paliperidone palmitate extended-release injectable suspension for at least 3 months

INVEGA TRINZA® is a prescription medicine given by injection every 3 months by a healthcare professional and used to treat schizophrenia. INVEGA TRINZA® is used in people who have been adequately treated with INVEGA SUSTENNA® for at least 4 months.

INVEGA SUSTENNA® is a prescription medicine given by injection by a healthcare professional.
INVEGA SUSTENNA® is used to treat schizophrenia in adults.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about INVEGA HAFYERA™, INVEGA TRINZA® and INVEGA SUSTENNA®?

INVEGA HAFYERA™, INVEGA TRINZA® and INVEGA SUSTENNA® may cause serious side effects, including:

  • Increased risk of death in elderly people with dementia-related psychosis.
    INVEGA HAFYERA™, INVEGA TRINZA® and INVEGA SUSTENNA® increase the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). INVEGA HAFYERA™, INVEGA TRINZA® and INVEGA SUSTENNA® are not for the treatment of people with dementia-related psychosis.

Do not receive INVEGA HAFYERA™, INVEGA TRINZA® or INVEGA SUSTENNA® if you are allergic to paliperidone, paliperidone palmitate, risperidone, or any of the ingredients in INVEGA HAFYERA™, INVEGA TRINZA® or INVEGA SUSTENNA®. See the end of the Patient Information leaflet in the full Prescribing Information for a complete list of INVEGA HAFYERA™, INVEGA TRINZA® and INVEGA SUSTENNA® ingredients.

Before you receive INVEGA HAFYERA™, INVEGA TRINZA® or INVEGA SUSTENNA®, tell your healthcare professional about all your medical conditions, including if you:

  • have had Neuroleptic Malignant Syndrome (NMS)
  • have or have had heart problems, including a heart attack, heart failure, abnormal heart rhythm, or long QT syndrome
  • have or have had low levels of potassium or magnesium in your blood
  • have or have had uncontrolled movements of your tongue, face, mouth, or jaw (tardive dyskinesia)
  • have or have had kidney or liver problems
  • have diabetes or have a family history of diabetes
  • have Parkinson’s disease or a type of dementia called Lewy Body Dementia
  • have had a low white blood cell count
  • have had problems with dizziness or fainting or are being treated for high blood pressure
  • have or have had seizures or epilepsy
  • have any other medical conditions
  • are pregnant or plan to become pregnant. It is not known if INVEGA HAFYERA™, INVEGA TRINZA® or INVEGA SUSTENNA® will harm your unborn baby
    • If you become pregnant while taking INVEGA HAFYERA™, INVEGA TRINZA® or INVEGA SUSTENNA®, talk to your healthcare professional about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry.
    • Infants born to women who are treated with INVEGA HAFYERA™, INVEGA TRINZA® or INVEGA SUSTENNA® may experience symptoms such as tremors, irritability, excessive sleepiness, eye twitching, muscle spasms, decreased appetite, difficulty breathing, or abnormal movement of arms and legs. Let your healthcare professional know if these symptoms occur.
  • are breastfeeding or plan to breastfeed. INVEGA HAFYERA™, INVEGA TRINZA® or INVEGA SUSTENNA® can pass into your breast milk. Talk to your healthcare professional about the best way to feed your baby if you receive INVEGA HAFYERA™, INVEGA TRINZA® or
    INVEGA SUSTENNA®.

Tell your healthcare professional about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. INVEGA HAFYERA™, INVEGA TRINZA® and INVEGA SUSTENNA® may affect the way other medicines work, and other medicines may affect how INVEGA HAFYERA™, INVEGA TRINZA® and INVEGA SUSTENNA® works.

Your healthcare provider can tell you if it is safe to receive INVEGA HAFYERA™, INVEGA TRINZA® or INVEGA SUSTENNA® with your other medicines. Do not start or stop any medicines during treatment with INVEGA HAFYERA™, INVEGA TRINZA® or INVEGA SUSTENNA® without talking to your healthcare provider first. Know the medicines you take. Keep a list of them to show to your healthcare professional or pharmacist when you get a new medicine.

Patients (particularly the elderly) taking antipsychotics with certain health conditions or those on long-term therapy should be evaluated by their healthcare professional for the potential risk of falls.

How will I receive INVEGA HAFYERA™, INVEGA TRINZA® or INVEGA SUSTENNA®?

  • Follow your treatment schedule exactly as your healthcare provider tells you to.
  • Your healthcare provider will tell you how much you will receive and when you will receive it.

What should I avoid while receiving INVEGA HAFYERA™, INVEGA TRINZA® or INVEGA SUSTENNA®?

  • INVEGA HAFYERA™, INVEGA TRINZA® and INVEGA SUSTENNA® may affect your ability to make decisions, think clearly, or react quickly. Do not drive, operate heavy machinery, or do other dangerous activities until you know how INVEGA HAFYERA™, INVEGA TRINZA® or
    INVEGA SUSTENNA® affects you.
  • Avoid getting overheated or dehydrated.

INVEGA HAFYERA™, INVEGA TRINZA® and INVEGA SUSTENNA® may cause serious side effects, including:

  • See “What is the most important information I should know about INVEGA HAFYERA™, INVEGA TRINZA® and
    INVEGA SUSTENNA®?”
  • stroke in elderly people (cerebrovascular problems) that can lead to death
  • Neuroleptic Malignant Syndrome (NMS). NMS is a rare but very serious problem that can happen in people who receive
    INVEGA HAFYERA™, INVEGA TRINZA® or INVEGA SUSTENNA®. NMS can cause death and must be treated in a hospital. Call your healthcare professional right away if you become severely ill and have any of these symptoms: high fever; severe muscle stiffness; confusion; loss of consciousness; changes in your breathing, heartbeat, and blood pressure.
  • problems with your heartbeat. These heart problems can cause death. Call your healthcare professional right away if you have any of these symptoms: passing out or feeling like you will pass out, dizziness, or feeling as if your heart is pounding or missing beats.
  • uncontrolled movements of your tongue, face, mouth, or jaw (tardive dyskinesia)
  • metabolic changes. Metabolic changes may include high blood sugar (hyperglycemia), diabetes mellitus and changes in the fat levels in your blood (dyslipidemia), and weight gain.
  • low blood pressure and fainting
  • changes in your blood cell counts
  • high level of prolactin in your blood (hyperprolactinemia). INVEGA HAFYERA™,
    INVEGA TRINZA® or INVEGA SUSTENNA® may cause a rise in the blood levels of a hormone called prolactin (hyperprolactinemia) that may cause side effects including missed menstrual periods, leakage of milk from the breasts, development of breasts in men, or problems with erection.
  • problems thinking clearly and moving your body
  • seizures
  • difficulty swallowing that can cause food or liquid to get into your lungs
  • prolonged or painful erection lasting more than 4 hours. Call your healthcare professional or go to your nearest emergency room right away if you have an erection that lasts more than 4 hours.
  • problems with control of your body temperature, especially when you exercise a lot or spend time doing things that make you warm. It is important for you to drink water to avoid dehydration.

The most common side effects of INVEGA HAFYERA™ include: injection site reactions, weight gain, headache, upper respiratory tract infections, feeling restlessness or difficulty sitting still, slow movements, tremors, stiffness and shuffling walk.

The most common side effects of INVEGA TRINZA® include: injection site reactions, weight gain, headache, upper respiratory tract infections, feeling restlessness or difficulty sitting still, slow movements, tremors, stiffness and shuffling walk.

The most common side effects of INVEGA SUSTENNA® include: injection site reactions; sleepiness or drowsiness; dizziness; feeling of inner restlessness or needing to be constantly moving; abnormal muscle movements, including tremor (shaking), shuffling, uncontrolled involuntary movements, and abnormal movements of your eyes.

Tell your healthcare professional if you have any side effect that bothers you or does not go away. These are not all the possible side effects of INVEGA HAFYERA™, INVEGA TRINZA® or INVEGA SUSTENNA®. For more information, ask your healthcare professional or pharmacist.

Call your healthcare professional for medical advice about side effects. You may report side effects of prescription drugs to the FDA at 1-800-FDA-1088.

General information about the safe and effective use of INVEGA HAFYERA™, INVEGA TRINZA® or INVEGA SUSTENNA®

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use INVEGA HAFYERA™,
INVEGA TRINZA® or INVEGA SUSTENNA® for a condition for which it was not prescribed. You can ask your pharmacist or healthcare professional for information about INVEGA HAFYERA™, INVEGA TRINZA® or INVEGA SUSTENNA® that is written for healthcare professionals.

For more information, go to www.invegahafyera.com, www.invegatrinza.com or www.invegasustenna.com or call 1-800-526-7736.

Please click to read the full Prescribing Information, including Boxed WARNING, for

INVEGA HAFYERA™, INVEGA TRINZA® and INVEGA SUSTENNA® and discuss any questions you have with your healthcare professional.

References

  1. Cahling L, Berntsson A, Bröms G, Öhrmalm L, BJPsych Bull. 2017 Oct; 41(5): 254–259. doi:10.1192/pb.bp.116.055483
  2. Goldstone LW. Am J Manag Care. 2020;26(3):S48-S54. doi:10.37765/ajmc.2020.43011
  3. Parellada E, Bioque M. CNS Drugs. 2016;30(8):689-701. doi:10.1007/s40263-016-0350-7
  4. Data on file. Janssen Pharmaceuticals, Inc.
  5. Correll CU, Schooler NR. Neuropsychiatr Dis Treat. 2020;16:519-534. doi:10.2147/NDT.S225643
  6. Ostuzzi G, Bertolini F, Tedeschi F, et al. World Psychiatry. 2022;21(2):295-307. doi:10.1002/wps.20972
  7. Acosta FJ, Hernández JL, Pereira J, Herrera J, Rodríguez CJ. World Journal of Psychiatry. 2012;2(5):74-82. doi:10.5498/wjp.v2.i5.74
  8. Data on file. Janssen Pharmaceuticals, Inc.
  9. Furiato AJ, Ruffalo ML. Psychiatr Times. 2021;38(11):42-43.
  10. Bosanac P, Castle DJ. BJPsych Advances. 2015;21(2):98-105. doi:10.1192/apt.bp.114.013565
  11. Najarian D, Sanga P, Wang S, et al. Int J of Neuropsychopharmacol. 2022;25(3):238-251. doi:10.1093/ijnp/pyab071
  12. Najarian D, Turkoz I, Knight R, et al. Int J of Neuropsychopharmacol. 2023;26(8):537-544. doi:10.1093/ijnp/pyad028
  13. INVEGA HAFYERA® [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.

© Janssen Pharmaceuticals, Inc. 2024 01/24 cp-426188v1

Survey Finds Americans Are Helping Neighbors – and Want to Do Even More

2024-02-12T09:07:00

(BPT) – According to results from a national survey1 released by Wells Fargo and Ipsos, Americans helped their neighbors on average six times in the last year without expecting anything in return and 77% did so at least once. Furthermore, 73% of Americans strive to support their communities by shopping local, and on average, shopped at or supported a local small business 11 times in the last year.

The survey showed they want to do more. More than half of Americans would like to volunteer more time (57%) and donate more money (57%) to local organizations; and 53% wish they knew where to go to learn which organizations in their community are looking for volunteers or donations.

“As The Bank of Doing, we have an important responsibility to help strengthen the communities we serve — and we’re glad to see our fellow neighbors are taking action to help others, too,” said Kristy Fercho, Head of Diverse Segments, Representation and Inclusion at Wells Fargo. “Doing goes far beyond the investments we make. It is the sum of the impact we have when we work together to tackle societal challenges.”

Wells Fargo commissioned the online survey of more than 5,000 adults in the U.S. to understand how Americans give back and what they prioritize most in their communities. The survey is part of The Bank of Doing campaign, which reinforces Wells Fargo’s longstanding commitment to putting people and communities first.

How would you spend $1 million to help your community?

In another question, those surveyed were asked how they would spend $1 million if given that amount to improve their communities. Americans answered — on average, they’d allocate the most money toward affordable housing investments.

Overall, they believe their local community needs additional financial investment in the availability of affordable housing (70%), the condition of roads and sidewalks (69%), and support for small businesses (67%).

The good news is Americans also believe progress has already been made in their communities. For example, many indicated they are satisfied that their local communities have made improvements in small business support (60%), internet infrastructure (60%), and job creation (46%).

Since 2019, Wells Fargo has donated $525 million to help address housing affordability, including supporting available and affordable rentals, homeownership, and housing stability.

Additionally, The Bank of Doing has funded $107 million in higher education scholarships and programming for diverse communities and has donated about $420 million to organizations that support small businesses through its Open for Business Fund, a recovery effort created in July 2020. That initiative has impacted a projected 178,000 small businesses to help them create or preserve more than 222,000 jobs.

For more information, visit www.wellsfargo.com/impact.

1 An online survey was conducted among 7,067 total adults age 18+ from the continental U.S., Alaska, and Hawaii by Ipsos on behalf of Wells Fargo from May 31 through June 15, 2023. The sample consisted of 5,077 adults 18+, divided evenly across each state in the U.S., for a minimum of 100 respondents from each state, and 1990 adults 18+, within 14 targeted media markets within the U.S. Weights were applied to national and state data cuts to match the Census on age, gender, region, race/ethnicity, and income. The targeted markets were also weighted to Census data on age, gender, race/ethnicity, and household income.

The precision of Ipsos online non-probability polls is measured using a credibility interval. In this case, the poll has a credibility interval of plus or minus 1.4 percentage points for all respondents, plus or minus 1.7 percentage points for the national sample, and a range of 11.0-12.0 percentage points for the individual states.

How to design your next trip around your travel personality

2024-02-12T08:01:00

(BPT) – When imagining your next vacation, ask yourself: What kind of traveler are you? Recent research and various travel experts have identified popular types of travelers according to their preferences, beliefs, and destination “must-haves.” Recognizing where you may fit in one of these categories can help you discover the perfect destination for your next travel adventure. Read on to learn more about three of the top traveler categories, along with a great location that will fit your unique travel preferences.

Once you’ve found the perfect destination, make your travel experience more enjoyable with a travel credit card so you can take advantage of amazing benefits and earn points toward your next trip. For example, from now until April 3, 2024, new Chase IHG One Rewards Premier Credit Cardmembers can earn 165,000 bonus points after spending $3,000 in the first three months from account opening, and new Chase IHG One Traveler Credit Cardmembers can earn 100,000 bonus points after spending $2,000 in the first three months from account opening.

With these offers, many ways to earn points through everyday purchases on the cards, and other benefits, you’ll be able to get going on your perfect trip even faster, no matter where it is.

Pop Culture Enthusiasts

Are you motivated to visit locales featured in your favorite movies or TV shows? You may just be a pop culture enthusiast. In fact, 86% of travelers surveyed by Skyscanner were inspired by destinations in movies or TV, with 33% of U.S. travelers wanting to “experience Paris” like their favorite TV show character. You may also enjoy following current media trends and major cultural events — and you’re always looking for places that are “Insta-worthy.”

For anyone in this category, a Paris voyage would be high on your list, especially with some major sporting events in 2024 top of mind. The “City of Love” is not only the fashion capital of the world, but its iconic landmarks, romantic river bridges and picturesque architecture also make it a very Instagrammable locale.

You can make your stay even more memorable by booking a luxury central Paris hotel such as IHG Hotels & Resorts®Kimpton St. Honoré or InterContinental Paris – Le Grand. And the Chase IHG One Rewards Premier Credit Card can make international travel simpler; cardmembers can receive a Global Entry, TSA PreCheck® or NEXUS Statement Credit of up to $100 every four years as reimbursement for the application fee charged to the card.

Wellness Wanderers

If your idea of the perfect vacation involves nothing more strenuous than walking from your massage to the pool, you could be a wellness wanderer. These travelers consider trips primarily as opportunities to rejuvenate and refresh. A whopping 94% of travelers want to incorporate self-care into their trips this year, and 29% are interested in traveling for wellness.

These kinds of vacations never feel long enough, but when Chase IHG One Rewards Premier and Traveler Credit Cardmembers redeem IHG One Rewards points for a consecutive four-night IHG hotel stay, they receive the fourth Reward Night free (redeemable at that same hotel during that same stay), making extra time for rest and relaxation easier.

Wellness wanderers want to spend their well-deserved time away at tranquil, remote locations where they can take advantage of natural surroundings to enhance their wellness. For example, the Holiday Inn Express Sedona – Oak Creek is located in a quiet, scenic area with Arizona’s famed red sandstone canyons as its backdrop, offering a pool and proximity to plenty of spas for a relaxing, peaceful getaway.

Sustainable Travelers

Are you concerned about the economic or environmental impacts of traveling? If so, you may be a sustainable traveler. In 2023, 69% actively sought sustainable travel options, and Google searches for “sustainable travel” have increased 226% over the last five years. Sustainable travelers want to explore nature and seek places to stay that provide a sustainable infrastructure and opportunities to give back to local communities.

Did you know Melbourne, Australia, was named the most sustainable city in the world? With over 480 parks, this beautiful city offers tours with sustainability or conservation-focused guides. You could also plan your stay at voco Melbourne Central, which embodies sustainability through beds made of recycled materials as well as bedding made from recycled plastic and biodegradable materials.

No matter what profile you fit or what city you choose, IHG® Hotels and Resorts has just the right stay for you. With a growing portfolio of 19 brands and over 6,000 hotels across the globe, every type of traveler will be able to find a spot that checks off all their must-haves.

And with all of the rewards that help Chase IHG One Rewards Cardmembers get the most out of their travels, you could enjoy your next trip that much more. Visit chase.com/ihgcards to learn more about current offers.

Chase credit cards are issued by JPMorgan Chase Bank, N.A. Member FDIC. Accounts subject to credit approval. Restrictions and limitations apply. Offer subject to change.

How a novel treatment helped a pro skier heal her ACL

2024-02-12T02:01:00

(BPT) – For some, skiing isn’t just a sport. It’s a way of life. This is especially true for Holly Reitsema, who was raised in a family of freestyle skiers. Not only is she a competitive freestyle skiing athlete, but she also coaches at the prestigious Woodward Copper snowboard and ski training camp.

“I’ve been skiing since I was 3 years old. I ski over 200 days a year and it’s my livelihood,” said Reitsema.

Everything changed for Reitsema when she tore her anterior cruciate ligament (ACL) when she hit a jump while skiing. “Midair, I felt off-axis and shoulder heavy, so I knew I was about to fall. I then did the worst thing possible and fought my fall, so my body was twisted when I landed.”

Not an uncommon story

Skiers like Reitsema are well acquainted with ACL injuries. According to Miach Orthopaedics, about 400,000 ACL injuries occur each year in the U.S. Of those injuries, 20,000 happen while skiing. Even with gear maintenance, proper warmup and strengthening exercises, ACL tears still happen to skiers of all levels and ages.

Unlike many other ligaments in the body, the ACL cannot heal on its own and often requires ACL reconstruction (ACLR) surgery. During ACLR, an orthopedic surgeon removes the torn ACL and replaces it with a graft from another part of the body or a deceased donor.

Although ACL reconstruction is effective, the procedure has drawbacks. When a graft is taken from the knee, many patients experience long-term knee pain. And when a graft is taken from the hamstring, patients may have persistent weakness in that muscle. Regardless of the graft type, many people cannot return to the same level of daily activities or sports.

Reitsema’s father had ACLR years previously with a patellar tendon graft, and she saw how the injury changed him. Hesitation, pain and multiple operations held him back from his prior feats, and this was not something Reitsema nor her father wanted.

“My local orthopedic surgeon initially suggested I get ACL reconstruction with a patellar tendon graft,” said Reitsema. “I was very hesitant because I wasn’t experiencing pain from the ACL tear, but the doctor said I would have pain after getting the graft. I was concerned that I wouldn’t be able to return to skiing or coaching. Something just didn’t feel right about the patellar tendon graft procedure to me.”

A novel treatment for ACL injuries

Luckily for Reitsema, she was an excellent candidate for a novel ACL tear treatment. The BEAR Implant is the first medical advancement that enables the ACL to heal on its own. The implant works by using your own blood to heal the torn ends of your ACL back together, restoring its natural anatomy and function.

During the procedure, the orthopedic surgeon adds your own blood to the BEAR Implant and attaches it between the torn ends of your ACL. The implant holds and protects the blood to allow clot formation. Over time, the BEAR Implant — made of collagen — is resorbed by your body and replaced with native ACL tissue.

“I think the BEAR Implant has the potential to change the entire paradigm around ACL injuries,” said Dr. Alex Meininger, an orthopedic surgeon at Steamboat Orthopaedic and Spine Institute in Steamboat Springs, Colorado. “Previously, we as surgeons thought an ACL tear was incompatible with healing and the stump of native ACL tissue unsalvageable. The regenerative medicine potential of the BEAR Implant has turned that notion on its head.”

After speaking with Reitsema, Meininger felt that she was a great fit for the BEAR Implant. After the procedure and diligent rehab, Reitsema’s ACL healed, and she was able to return to skiing and coaching.

“After hitting the slopes for the first time, I was so proud that my knee didn’t tire out,” said Reitsema. “Since skiing and coaching again, I have been building my stamina and am more self-aware of my energy levels. These days, once I properly warm up, I feel like I did before I got injured. Being able to hit a rail and demonstrate tricks for my students while coaching is an extreme accomplishment for me.”

Reitsema’s story isn’t the only success of this innovative treatment. To date, over 300 patients with snow-related injuries have been treated with the BEAR Implant. To learn more about the procedure and read safety information, visit BEARImplant.com/Snow.