How a digital tool may help college students living with mental illness

2022-10-13T09:01:00

(BPT) – This article is sponsored by Otsuka America Pharmaceutical, Inc. Britney Pridgen, NP, is a paid consultant for Otsuka America Pharmaceutical, Inc.

Attending college is one of the most exciting times in a young adult’s life. During this time, many students begin to experience more independence and learn to navigate the world on their own terms. While exciting, the transition to college life can also present challenges as students acclimate to new surroundings, additional responsibilities, and full accountability for themselves.

For students living with a mental illness, this transition may be challenging during the traditional college years. One U.S. study reported that young adults aged 18-25 years old had the highest prevalence of any mental illness1, and an additional study reported that dropout rates for students with diagnosed mental health conditions can range from 43% to as high as 86%2.

“Many young adults experience an onset of mental illness or an exacerbation of their symptoms around or during their transition to college,” says Britney Pridgen, Psychiatric Nurse Practitioner from Houston Adult Psychiatry. “We also know that mental illness, regardless of age, may impact not only patients, but also families and caregiver support systems. When considered together, the college years can raise the level of concern for students and their families.”

Pridgen says, “Continuity of care is key for people living with a mental illness. Maintaining good habits in managing their condition. Taking medication appropriately, getting enough rest, and finding ways to stay active are all lifestyle habits that can help keep patients healthy and engaged when away at school.”

The transition to college can be challenging for parents who have played an active role in their young adult’s treatment, by monitoring medication or by accompanying them to appointments. Parents may feel less connected their loved one and unsure of their wellbeing while they are away3. However, technology is one way to help young adults living with mental illness, and their parents and support team, be more connected by sharing data even when they are miles apart.

One example of this kind of technology, the ABILIFY MYCITE® System, helps the patient to capture important data and share it with their health care provider, their care team and even their family members.

ABILIFY MYCITE® (aripriprazole tablets with sensor) is a prescription medicine of an aripiprazole tablet with an Ingestible Event Marker (IEM) sensor inside it used in adults for the treatment of schizophrenia; treatment of bipolar I disorder alone or when used with the medicine lithium or valproate for acute (short-term) treatment of manic or mixed episodes, or maintenance treatment; and the treatment of major depressive disorder (MDD) along with other antidepressant medicines. The ABILIFY MYCITE System® is meant to track if you have taken your ABILIFY MYCITE®. It is not known if ABILIFY MYCITE® can improve how well you take your aripiprazole (patient compliance) or for changing your dose of aripiprazole. Please read full INDICATIONS and IMPORTANT SAFETY INFORMATION below, including BOXED WARNING for Increased Risk of Death in Elderly People with Dementia-Related Psychosis and Increased Risk of Suicidal Thoughts or Actions.

The System includes a smart pill and a non-medicated Bluetooth patch that captures and records medication ingestion; a smartphone app that receives the information from the patch and also enables the patient to record other important data like time spent resting and activity level; and a dashboard that the patient can choose to share with their healthcare team and their family members if they choose, to help inform treatment on an ongoing basis.

“I have found the ABILIFY MYCITE System to be useful for some of my patients who are adjusting to a new schedule or need help logging their daily routine, like when they go to college,” says Pridgen. “I’ve also seen how the app can help patients and their family members stay connected by seeing information on their medication ingestion, rest, activity, and mood on a certain day, week, or even over the course of a month. For parents, it can provide greater awareness while supporting the patient during college.”

For more information on the ABILIFY MYCITE System, and to hear from other patients, visit www.abilifymycite.com.

Only functions related to tracking drug ingestion have been evaluated or approved by FDA.

INDICATIONS and IMPORTANT SAFETY INFORMATION for
ABILIFY MYCITE® (aripiprazole tablets with sensor) 2, 5, 10, 15, 20, 30 mg

INDICATIONS:

ABILIFY MYCITE is a prescription medicine of an aripiprazole tablet with an Ingestible Event Marker (IEM) sensor inside it used in adults for the:

  • Treatment of schizophrenia
  • Treatment of bipolar I disorder alone or when used with the medicine lithium or valproate for:
    • acute (short-term) treatment of manic or mixed episodes
    • maintenance treatment
  • Treatment of major depressive disorder (MDD) along with other antidepressant medicines

The ABILIFY MYCITE System is intended to track if you have taken your ABILIFY MYCITE. There may be a delay in the detection of the ABILIFY MYCITE tablet and sometimes the detection of the tablet might not happen at all. If the MYCITE APP does not indicate that you have taken your medicine, do not repeat the dose. It is not known if ABILIFY MYCITE can improve how well you take your aripiprazole (patient compliance) or for changing your dose of aripiprazole. ABILIFY MYCITE is not for use as real-time or emergency monitoring.

IMPORTANT SAFETY INFORMATION:

  • Increased risk of death in elderly patients with dementia-related psychosis: Medicines like ABILIFY MYCITE can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). ABILIFY MYCITE is not approved to treat patients with dementia-related psychosis.
  • Increased risk of suicidal thoughts or actions in children and young adults: Antidepressant medicines may increase suicidal thoughts or actions in some children and young adults within the first few months of treatment and when the dose is changed. Pay close attention to any changes, especially new and sudden changes, in mood, behaviors, thoughts, or feelings and report them to the healthcare provider. It is not known if ABILIFY MYCITE is safe and effective for use in children.

Do not take ABILIFY MYCITE if you are allergic to aripiprazole or any of the ingredients in ABILIFY MYCITE. Allergic reactions may include: rash, hives, itching, difficulty breathing, tightness in the chest, swelling of the mouth, face, lips, or tongue.

ABILIFY MYCITE may cause serious side effects, including:

  • Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death.
  • Neuroleptic malignant syndrome (NMS), a rare and serious condition that can lead to death. Call your healthcare provider or go to the nearest hospital emergency room right away if you have some or all of the following signs and symptoms of NMS: high fever, stiff muscles, confusion, sweating, changes in pulse, heart rate, and blood pressure.
  • Uncontrolled body movements (tardive dyskinesia or TD). ABILIFY MYCITE may cause movements that you cannot control in your face, tongue, or other body parts. TD may not go away, even if you stop taking ABILIFY MYCITE. TD may also start after you stop taking ABILIFY MYCITE.
  • Problems with your metabolism such as:
    • feel very thirsty
    • need to urinate more than usual
    • feel very hungry
    • feel weak or tired
    • feel sick to your stomach
    • feel confused, or your breath smells fruity
    • high blood sugar (hyperglycemia) and diabetes. Increases in blood sugar can happen in some people who take ABILIFY MYCITE. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes), your healthcare provider should check your blood sugar before starting ABILIFY MYCITE and during your treatment.
      Call your healthcare provider if you have any of these symptoms of high blood sugar while receiving ABILIFY MYCITE:
    • increased fat levels (cholesterol and triglycerides) in your blood.
    • weight gain. You and your healthcare provider should check your weight regularly.
  • Unusual urges. Some people taking aripiprazole have had unusual urges, such as gambling, binge eating or eating that you cannot control (compulsive), compulsive shopping and sexual urges. If you or your family members notice that you are having unusual urges or behaviors, talk to your healthcare provider.
  • Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.
  • Falls
  • Low white blood cell count. Your healthcare provider may do blood tests during the first few months of treatment with ABILIFY MYCITE.
  • Seizures (convulsions)
  • Problems with control of your body temperature so that you feel too warm. Do not become too hot or dehydrated during treatment with ABILIFY MYCITE. Avoid getting over-heated or dehydrated. Do not exercise too much. In hot weather, stay inside in a cool place if possible. Stay out of the sun, and do not wear too much or heavy clothing. Drink plenty of water.
  • Difficulty swallowing

ABILIFY MYCITE may make you drowsy. Do not drive, operate heavy machinery, or do other dangerous activities until you know how ABILIFY MYCITE affects you.

Before taking ABILIFY MYCITE, tell your healthcare provider if you:

  • have or had diabetes or high blood sugar in you or your family; your healthcare provider should check your blood sugar before starting and during therapy with ABILIFY MYCITE
  • have or had seizures (convulsions)
  • have or had low or high blood pressure
  • have or had heart problems or stroke
  • have or had low white blood cell count
  • are pregnant or have plans to become pregnant. It is not known if ABILIFY MYCITE will harm your unborn baby.
  • are breast-feeding or have plans to breast-feed. ABILIFY MYCITE can pass into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you receive ABILIFY MYCITE
  • have or had any other medical conditions

Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ABILIFY MYCITE and other medicines may affect each other causing possible serious side effects. ABILIFY MYCITE may affect the way other medicines work, and other medicines may affect how ABILIFY MYCITE works. Do not start or stop any medicines while taking ABILIFY MYCITE without talking to your healthcare provider first.

The most common side effects of ABILIFY MYCITE in adults include: restlessness or need to move (akathisia); dizziness; nausea; insomnia; shaking (tremor); anxiety; constipation; sedation

These are not all the possible side effects of ABILIFY MYCITE. Call your doctor for medical advice about side effects. You are encouraged to report side effects to Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please read FULL PRESCRIBING INFORMATION, including BOXED WARNING, and MEDICATION GUIDE.

©2022 Otsuka America Pharmaceutical, Inc. All rights reserved.

AUGUST 2022 12US22EBC0022

References

1. Mental Illness, N. I. of. (2022, January). Mental illness. National Institute of Mental Health. https://www.nimh.nih.gov/health/statistics/mental-illness 2. Sciences, C. N. A. of. (2021, January 13). Mental health, substance use, and wellbeing in Higher Education: Supporting the whole student. The National Academies Press. https://nap.nationalacademies.org/catalog/26015/mental-health-substance-use-and-wellbeing-in-higher-education-supporting 3. Dorrance Hall, E. (2018). The challenges of parenting while in college. Psychology Today. https://www.psychologytoday.com/us/blog/conscious-communication/201806/the-challenges-parenting-while-in-college

Ear pain, pressure, crackling and ringing: What is it?

2022-10-11T17:01:00

(BPT) – Ear pain, pressure, ringing, crackling and popping in the ears? These symptoms can often be mistaken for allergies, a cold or wax buildup — but it could be Eustachian tube dysfunction. And for people who fly, it is a major inconvenience.

The Eustachian tube is a dynamic, tubular structure linking the middle ear to the nasal cavity. It ventilates and clears fluid from the middle ear, and prevents transmission of pathogens, material and sounds when closed.[1] When the lining of the Eustachian tube becomes inflamed it can narrow or block the tube, resulting in Eustachian tube dysfunction (ETD). According to a study in JAMA Otolaryngology – Head & Neck Surgery, ETD affects 4.6% of adults or 11 million individuals in the United States.[1] Symptoms can include chronic ear problems like pain, pressure and ringing in the ears.[2] It’s important to see an ear, nose and throat (ENT) physician to receive a proper diagnosis and treatment plan. A potential solution is a relatively new minimally invasive procedure, called balloon dilation. Eustachian tube balloon dilation has associated risks, including tissue and mucosal trauma, infection or possible carotid artery injury.

Jonathan W. was treated with balloon dilation of the Eustachian tubes after developing ear pain and fullness that worsened significantly when flying. Jonathan has a long history of ear challenges including tympanic membrane perforation (ear drum rupture) and surgery to restore his hearing. He had a tube placed in his ear that alleviated some pain, but tubes fall out.

“Before I had the balloon dilation procedure done, I would try using over the counter decongestant medications. I would try to pop my ears on planes, but had little success, which made flying uncomfortable and difficult. On several occasions my ear drum would rupture while in flight. I knew a more permanent solution was needed.”

Like many people, over-the-counter medication wasn’t working for Jonathan’s ETD. In discussion with his ENT, Jonathan opted for Eustachian tube balloon dilation in both ears.

“Since having the balloon dilation procedure, I have not had any problems with ear pain or pressure, and no longer have to think about my ears on a regular basis when traveling. I can get on a plane and not have any discomfort or worsening in my hearing,” said Jonathan. “This has been a huge blessing in allowing me to fully enjoy international travel and has made a tremendous improvement in my quality of life. I would absolutely recommend the procedure to others who have similar symptoms.”

Jonathan’s ENT, Karen Hoffmann, MD, a board-certified ENT physician, notes, “The most important thing is to confirm that the ear fullness and pressure symptoms are due to obstructive ETD and not another cause. We do this with objective testing and visualizing the ET in the office with a scope. Many patients prefer to have the procedure done in their ENT physician’s office, which provides a level of convenience, familiarity, and comfort.”

“I have been pleased to work with many patients with Eustachian tube problems, including Jonathan, and find great joy knowing that I can help improve their quality of life with a simple procedure. For balloon dilation of the Eustachian tube, which may directly treat inflammation of the lining of the ET, we use medications to anesthetize the nose and the opening of the ET. During the brief procedure, a patient can expect to feel a bit of pressure when the balloon is placed in the ET and then slowly inflated. The balloon is usually left inflated for 2 minutes, then deflated and removed. There can be some temporary ear fullness after the procedure, but typically a patient can get back to normal daily activities a day following their procedure.”

What You Need to Know About Eustachian Tube Dysfunction

ETD symptoms can be mild and may resolve after a few days. However, persistent ETD occurs when symptoms such as muffled hearing, fullness of the ear, tinnitus, and fluid in the middle ear last more than 12 weeks.[2] If you have mild symptoms, simple actions such as swallowing, yawning, chewing or gentle exhalation with a closed mouth and nose (Valsalva maneuver) can help to equalize pressure in the middle ear and resolve mild symptoms. For people who have persistent symptoms, medical management may be an option determined by an ENT.

Your doctor should determine the right treatments based on your symptoms, but the following are treatment options for obstructive ETD available to consider:

Medical Management includes oral and topical decongestants, nasal spray preparations, antihistamines, steroids, and antibiotics. Your ENT will determine if these medical management options are the best treatment for your ETD, and they are often used in conjunction with surgical procedures.

Surgical Procedures may be recommended when medical management methods are not enough to relieve symptoms.

  • Ear tubes are tiny cylinders inserted through the eardrum to equalize the pressure in the middle ear. It’s important to note tubes typically fall out in 6 months to 1-2 years; if needed the procedure can be repeated.
  • Eustachian tube balloon dilation is a minimally invasive procedure that inserts and inflates a small balloon in the Eustachian tube to open a narrow or clogged tube. This is typically an outpatient operating room or office surgical procedure with no cuts or incisions that preserves your natural anatomy and requires a short recovery time.

To find an ENT near you to discuss your ETD symptoms, treatment options, new technologies from companies like Acclarent, or general questions about your ENT health, visit https://www.jnjmedtech.com/en-US/locator to find a doctor in your area.



[1] Shan A, Ward BK, Goman AM, et al. Prevalence of Eustachian Tube Dysfunction in Adults in the United States. JAMA Otolaryngol Head Neck Surg. 2019;145(10):974–975. doi:10.1001/jamaoto.2019.1917

[2] Randrup, TS & Ovesen, T. Balloon Eustachian Tuboplasty: A Systematic Review. Otolaryngology–Head and Neck Surgery, 2015;152(3); 383–392. doi:10.1177/0194599814567105

5 Ways to Evolve Culture in a Hybrid Work Environment

2022-10-11T10:01:00

(BPT) – As many employers are welcoming employees back to the workplace, others have committed to the shifts they made during the pandemic and embracing the opportunities that come with working hybrid or remotely. The most successful organizations are going so far as to take advantage of the opportunity to inspire culture in a hybrid work environment.

EVP Chief Operating Officer Troy Dunmire at The Leukemia & Lymphoma Society (LLS), a leading healthcare nonprofit, describes some of the ways that the organization continues to grow together, despite the challenges of working apart.

1. Encourage a growth-mindset: Working remotely or in hybrid situations has stretched us all in terms of how we structure leadership and work ethic, challenging the way we “normally” do things. Working from home also introduced the element of bringing our personal and work lives together in a way that can impact the learning we do in each place. LLS addressed this head-on by naming our new way of working “The Growthplace — the intersection of life, work and learning.” We wanted to acknowledge the challenges this shift presented and assure our employees that we trust their ability to get their work done and manage other commitments that may be happening simultaneously. Our employees delivered and were given the opportunity to work from home, in the office or a combination of both, alongside the option for a flex schedule that would allow them to do their job while meeting their individual needs for work/life balance.

2. Invest in talent development: Honoring the Growthplace requires honoring our commitment to help employees thrive. Sometimes this means encouraging them to grow outside the scope of their current roles, so that they naturally develop according to their strengths and interests to be the best they can for the organization. LLS’s former Chief of Staff stepped down for a year to take part in the CEO action for Racial Equity Fellowship and will return to apply her learnings in a new role. LLS also helps employees take personal ownership of their career trajectories, by incorporating their own professional goals — regardless of how they fit with their current roles — into individualized career development plans. Recently, this has resulted in three new job opportunities for experienced leaders, which allowed for growth opportunities for several other employees as a result.

3. Let culture inform strategy and vice versa: Culture can be an incredibly productive asset, and one that is often overlooked when thinking about how teams work together. When LLS’s Strategy & Innovation team started bringing departments together in person for the first time to work on developing a team strategic roadmap they posed the question, “If we are going to map the goals and priorities we are working toward, shouldn’t we also map how we are going to collaborate together to achieve those goals and why?” This led naturally to a conversation about culture in which everyone around the table had a voice and all were able to contribute to the strategy in a more meaningful way.

4. Create a listening environment: Many organizations were inspired to change the way they listen. This was true for LLS, both in how the organization listens to patients and caregivers through the Information Resource Center and in how they listen to their employees. Our Employee Resource Groups (ERGs) provide an opportunity to empower employees to use their voices independently, and a channel through which to share them, ultimately impacting how we operate. Our Kudos platform for providing recognition and feedback, our annual Employee Opinion Surveys, shorter pulse surveys throughout the year, and the anonymous All Voices platform moderated by our HR team, all provide opportunities for employees at all levels to weigh in and provide input on key business decisions. Additionally, our Employee Engagement team creates listening/feedback loops through Employee Ambassadors, and everything implemented through that team is based on direct feedback from our employees. We try to do our best to be inclusive in how we listen and in who is listening, to get the largest breadth of feedback possible.

5. Give employees time to reflect: While there are benefits to being in a more flexible work environment, there are obvious stressors as well. LLS believes that having time to reflect and write is critical to learning and growing. We started the LLS Growthplace Writing Group, an open meeting in which employees are given 30 minutes to consider a challenge or opportunity they are currently facing through writing and reflection. Employees are invited but not required to share their writing and can attend the group as frequently as they want.

Culture can feel unattainable in many respects, especially while working apart. But finding ways to encourage culture with the tools and resources available is, in and of itself, an opportunity to build culture. Watching teams learn that they can change and shift how they do things, while maintaining — and in many ways exceeding — our commitment to our mission is one of the greatest parts of my job. This awareness creates endless possibility for positive change for our employees, our organization and the people our mission touches.

Blood cancer patients and their families can contact the LLS Information Resource Center for one-on-one support at (800) 955-4572, Monday through Friday, 9 a.m. to 9 p.m., ET.

New survey: In challenging times, Americans appreciate simple things most

2022-10-10T13:23:00

(BPT) – What makes you smile? While you may think fame and fortune are what would put a smile on most people’s faces, a new national survey reveals that it’s actually the small, simple things Americans appreciate the most. The national survey, which Smile Train commissioned The Harris Poll to conduct among over 2,000 Americans to honor World Smile Day®, showed surprising results: Especially during turbulent and challenging times, it’s the little things in life that really bring people hope and make them smile.

Here are the top 10 survey results for what makes people smile:

1. Nice weather
2. Life in general/being alive
3. Watching a TV show/movie
4. Being healthy
5. Good food/beverage
6. Funny video or GIF on social media
7. Someone smiling at me
8. Spending time with my significant other
9. Spending time with child(ren) or grandchild(ren)
10. A joke

“These survey results are refreshing and heartwarming, and they made me smile,” said Susannah Schaefer, president and CEO of Smile Train. “We work daily to create smiles across the globe by offering free surgeries and other essential cleft care to children born with clefts. Giving folks a reason to smile is in our DNA.”

What a difference a smile makes

Smile Train, the world’s largest cleft-focused organization, believes a smile can change the world. The nonprofit provides free surgery and other essential cleft care to children around the world who are born with clefts. To date, Smile Train has supported safe, high-quality cleft care for over 1.5 million children. Unfortunately, clefts not only negatively affect a child’s ability to smile, which impacts their social development and sense of belonging, but can also make it difficult for children to eat, breathe, hear and even speak.

“I’m proud to partner with Smile Train for World Smile Day®, as a smile can truly change a person’s life,” said supermodel, entrepreneur and Smile Train Ambassador Kimora Lee Simmons. “Nothing puts a smile on my face faster than my five beautiful children. I can be at my wit’s end from a day of juggling the demands of work and single parenting, but something as simple as a hug from my little one or a call from my daughter at college will immediately get me centered and smiling again.”

How Smile Train helps to keep children smiling

In an effort to provide smiles to children all over the world, Smile Train provides free surgeries and other essential care to treat clefts. The organization embraces a sustainable approach using the “teach a man to fish” model, using education, training, funding and partnerships with local hospitals to enable local medical professionals to continue providing safe, timely, high-quality cleft treatment to children in their own communities, 365 days a year.

Smile Train-supported comprehensive cleft care includes not just the crucial surgery, but also much-needed nutrition programs, orthodontic and dental care, speech therapy plus social and emotional support. Smile Train gives each child access to a full range of cleft treatment services they would otherwise likely never receive — and ultimately the opportunity for a better quality of life.

Learn more about Smile Train and what makes people smile at SmileTrain.org/wsd2022.

5 tips for maintaining a healthy lifestyle after 50

2022-10-07T16:37:00

(BPT) – While 50 may not be the new 30, you still have a lot of time and energy to do the things you love in this season of your life. You may even find that you have more time now and less stress than in previous decades, which means you can do more of the things you love.

However, to make sure that you can continue to enjoy your independence as you age, it’s important to have a lifestyle that promotes lifelong health. You probably already know that you should continue to eat healthily and stay physically active as you get older, but you can do plenty of other things to improve your quality of life.

Check out these five tips that can help you maintain a healthy lifestyle after 50.

1. Don’t skip your yearly physical

While everyone at every age should have an annual physical, it’s especially important to have routine medical exams to create a baseline for your health and to catch and treat health problems early on.

In addition to a regular physical exam, men over 50 should discuss prostate cancer screenings with their health care provider. Similarly, women should ask their doctors about breast cancer screenings as well as bone mineral density screenings to stay ahead of osteoporosis.

2. Adopt a pet

Whether you’re an empty nester looking to fill the space your kids left when they went to college or simply looking for companionship, consider adopting a pet. Cats and dogs, in particular, are furry friends that can have positive effects on your physical and mental health.

There are several studies that point to pet ownership as a contributing factor to a healthy lifestyle. For example, a study in Sweden found that people aged 40-80 who owned a dog decreased their risk of death by 33% and cardiovascular-related death by 36% compared to those without a pet. Petting a dog or cat can also lower your stress and potentially deter depression and other mood disorders.

3. Invest in your vision health

At 50, you may find that while your eyesight is still sharp, you may need reading glasses or a stronger eyesight prescription. These changes are a natural part of getting older, so it’s important that you continue to schedule routine eye exams to stay on top of your vision health.

Vision insurance is an important tool for maintaining eye health. If you don’t have access to employer-sponsored vision insurance, you can find affordable individual vision plans from VSP Direct. Plans start as low as $13 per month and give you access to the largest independent doctor network. To find a vision insurance plan that works best for you, visit VSPDirect.com.

4. Be a lifelong learner

As you age, your cognitive abilities naturally slow down, but one way to combat cognitive decline is to learn a new skill. According to Harvard Health, enrolling in a class to learn a new language, subject or skill provides new information and experiences that stimulate new brain cell growth even in older adults.

5. Get your teeth checked regularly

In addition to regular brushing and flossing, you should have a dental checkup twice a year. This is especially important for aging adults as your teeth take a lot of wear and tear over the years. Going to the dentist regularly can help prevent future oral health problems like tooth decay, gum disease, tooth loss and oral cancer.

If you need dental insurance, VSP has partnered with Guardian Direct to provide affordable dental insurance plans. It’s easy to add on a dental plan to a new or existing vision insurance plan. To learn more, visit VSPDirect.com/Dental-Insurance.

Be proactive and start investing in your future today. Using these five tips, you can ensure you can continue doing the things you enjoy with the people you love for years to come.

The cause of hot flashes, and why it’s time to talk about it

2022-10-06T23:01:00

(BPT) – Hot flashes and night sweats — the common terms for vasomotor symptoms (VMS) associated with menopause — are experienced by up to 80% of women during the menopausal transition.1 They can be sudden1, disruptive2 and downright embarrassing.3 VMS can range in severity and frequency, and also lasts for a longer period of time for some women.4

“VMS can have a negative impact on quality of life since these symptoms can occur day or night, and can impact sleep, work and relationships,”2 said Dr. Mary Jane Minkin, MD and clinical professor in the Department of Obstetrics, Gynecology and Reproductive Sciences at the Yale University School of Medicine. “We now have a new understanding of why these occur and it’s not just due to a decrease in estrogen like previously thought.”1

The science behind the symptoms

Dr. Minkin explains that VMS originates in a part of your brain called the hypothalamus, which regulates your body’s temperature.1 To keep your internal thermostat in check, your body relies on having a balance between estrogen and a brain chemical called neurokinin B (NKB).1 During the menopausal transition, levels of estrogen and NKB become unbalanced.1 This imbalance causes neurons in the hypothalamus to tell your body you’re hot when you’re not.5 To cool down, the hypothalamus triggers hot flashes and night sweats.5

Little-known facts about VMS

  • VMS can last for years: Women experience VMS for a median duration of 7.4 years6 and some women for as long as 10 or more years.4
  • VMS can impact a number of aspects of daily life: Women who have experienced menopause report that VMS negatively impacts sleep (82%), concentration (69%), mood (69%), energy (63%) and sexual activity (41%).7
  • VMS can be intense: Hot flashes are a sudden intense sensation of heat in the upper body (usually in the face, neck and chest), which last between 1 and 5 minutes, and may be accompanied by sweating, chills, anxiety and heart palpitations.1 Night sweats are hot flashes that occur during sleep.1
  • VMS impact some women more than others: VMS disproportionately impacts African American women (46%) and Hispanic women (35%). The prevalence is lower in Caucasian women (31%), Chinese women (21%) and women of Japanese ethnicity (18%).8
  • VMS can start before your final menstrual period and last postmenopause: VMS may begin up to two years prior to the final menstrual period and are most common in the first two years postmenopause9, yet 10% of women continue to experience VMS for more than 10 years.4

“VMS can leave a woman feeling exhausted if sleep is interrupted and feel anxious in social and work situations as no one wants to turn the color of a beet and start profusely sweating in public,”2 continued Dr. Minkin. “This can last for years and impact so many women.”4

October is World Menopause Month, celebrated annually around the globe to raise awareness of the impact menopausal symptoms can have on everyday life. It’s also a time to encourage more open dialogue and action so women can feel empowered to speak openly about their journey10 through this normal life stage.7

Dr. Minkin explains she wants to normalize talking about it because no one woman is alone in experiencing it. She encourages women experiencing VMS to reach out to a friend and have a conversation. And most importantly, to talk to a health care provider and not hide your hot flashes. For more information about VMS, visit WhatsVMS.com.

Sponsored by Astellas Pharma US, Inc.



1 Thurston RC. Vasomotor symptoms. In: Crandall CJ, Bachman GA, Faubion SS, et al., eds. Menopause Practice: A Clinician’s Guide. 6th ed. Pepper Pike, OH: The North American Menopause Society, 2019:43-55.

2 English M, Stoykova B, Slota C, et al. Qualitative study: burden of menopause-associated vasomotor symptoms (VMS) and validation of PROMIS sleep disturbance and sleep-related impairment measures for assessment of VMS impact on sleep. J Patient Rep Outcomes 2021;5(37):1-13. Erratum in: J Patient Rep Outcomes 2021;5:42.

3 Pinkerton JV, Abraham L, Bushmakin AG, Cappelleri JC, Komm BS. Relationship between changes in vasomotor symptoms and changes in menopause-specific quality of life and sleep parameters. Menopause 2016;23(10):1060-6.

4 Utian WH. Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: a comprehensive review. Health Qual Life Outcomes 2005;3:47.

5 Padilla SL, Johnson CW, Barker FD, Patterson MA, Palmiter RD. A neural circuit underlying the generation of hot flushes. Cell Rep 2018;24(2):271-7.

6 Avis NE, Crawford SL, Greendale G. Duration of menopausal vasomotor symptoms over the menopause transition. JAMA Intern Med 2015;175(4):531-9.

7 Williams RE, Levine KB, Kalilani L, Lewis J, Clark RV. Menopause-specific questionnaire assessment in US population-based study shows negative impact on health-related quality of life. Mauritas 2009;62(2):153-9.

8 Freeman EW, Sharif K. Prevalence of hot flushes and night sweats around the world: a systemic review. Climacteric 2007;10(3):197-214.

9 Avis NE, Crawford SL, Green R. Vasomotor symptoms across the menopause transition: differences among women. Obstet Gynecol Clin North Am 2018;45(4):629-40.

10 Parish SJ, Nappi RE, Kingsberg S. Perspectives on counseling patients about menopausal hormone therapy: strategies in a complex data environment. Menopause 2018;25(8):937-49.

The Truth about Living with Plaque Psoriasis

2022-10-05T08:01:00

(BPT) – For millions of people around the world, hitting the snooze button in the morning offers a few more minutes of relaxation — a little quiet time before the day starts or some time to catch up on the news before breakfast. But for the millions of people like Lori who are living with plaque psoriasis, hitting the snooze button in the morning is often an act of desperation, following an exhausting night of tossing and turning and being unable to sleep due to the physical symptoms brought on by the condition.

“For me, the most difficult part of living with plaque psoriasis is the itching, the burning, the waking up in the middle of the night because of how uncomfortable it is,” says Lori, who has been living with plaque psoriasis for 15 years. “And then on top of that having to deal with how society sees me, the looks, and the questions… It’s a very difficult disease to live with. I’m embarrassed a lot of times when I go out because it’s so visible.”

Psoriasis is a complex and chronic inflammatory disease that impacts approximately 8 million Americans and 125 million people worldwide. Plaque psoriasis is the most common form of psoriasis, accounting for about 80% to 90% of cases.[1],[2],[3]

Signs and symptoms of plaque psoriasis may vary from person to person but typically include raised patches of skin with silvery-white or gray scale that can be itchy, painful and disfiguring. It can appear on any part of the body, but is most common on the elbows, torso, scalp and legs. It can also appear in less common areas, such as the soles of a person’s feet, hands, and even sensitive areas like the eyelids or groin.[1]

Beyond the outward symptoms of plaque psoriasis, the condition can take a significant toll on a person’s day-to-day life — impacting their psychological health and overall quality of life.[4]

“As my plaque psoriasis progressed and my flare ups got worse, it affected what I wore, what I did and even my self-esteem,” says Lori. “I began avoiding clothes that didn’t cover up my plaques, and when my flares were at their worst with the constant itching and bleeding, I would avoid going out in public at all because the stares and questions were difficult to address.”

Because there is not a “one-size-fits all” treatment option, and because many treatment options may force people with plaque psoriasis to make compromises in treatment safety and tolerability, people like Lori who live with this chronic and debilitating disease may endure a frustrating trial-and-error process managing their condition. The journey to find a treatment that is right for them can be difficult.[5],[6]

“The challenges of living with plaque psoriasis are more than skin deep. Typically, patients start with topical steroids which vary in their regimen instructions, are limited by where they can be used on the body and are limited in how long and how often they can be used overall,” says board-certified dermatologist Sandra M. Johnson, MD, FAAD, of Johnson Dermatology in Fort Smith, AR.

She adds, “Because of this, patients tend to cycle on and off steroid treatments, which can lead to reports of a lower quality of life, particularly when the condition interferes with their sleep, work, and social activities. Higher quality of life can be linked to treatment adherence, but treatment adherence can be difficult when patients may be unhappy with their plaque psoriasis treatment. This is why it’s critical to introduce novel topical therapies that are safe and effective that patients want to use and can use long term.”

Lori shares many of these common treatment experiences, noting that she tried different creams that were both prescribed and over the counter, in addition to biologics. Eventually she would find these topical treatments did not give her the results she was looking for and that biologics were not the right choice for her. A couple of years ago, she decided to join a clinical trial to see if a new type of topical treatment would help.

“I see a lot of patients living with plaque psoriasis, and finding the right treatment for each individual can take some trial and error,” says Jennifer Soung, MD, a board-certified dermatologist, and the director of clinical research at Southern California Dermatology in Santa Ana, CA. “Though the plaque psoriasis treatment landscape has evolved significantly to make room for oral treatments and biologics that treat more severe forms of plaque psoriasis, there is a large need for new topical treatments and particularly for non-steroids.”

Fortunately, there’s hope. On May 23, 2022, the Food and Drug Administration (FDA) approved VTAMA® (tapinarof) cream, 1%, a once daily, cosmetically elegant, prescription topical treatment for adults living with mild, moderate, and severe plaque psoriasis. Thanks to clinical trial participants like Lori, this approval makes VTAMA cream the first and only steroid-free topical medication in its class in the U.S. following 25 years of minimal innovation in the topical psoriasis treatment landscape.[7]

With this FDA approval, people like Lori living with plaque psoriasis have access to a steroid-free topical treatment, in the form of a convenient, once-daily cream, that is backed by extensive clinical trial data supporting its strong safety and efficacy profile — even with long-term use, as demonstrated in clinical trials over 52 weeks, and on sensitive areas, such as the face, groin and underarms.[8]

For Lori, the FDA approval of VTAMA cream means that she can effectively treat her plaque psoriasis. With control over her psoriasis, she doesn’t always have to hide visible, itchy and painful plaques behind her clothes, and she is able to attend events without feeling ashamed.

Lori is sharing her story to encourage others going through a similar experience with plaque psoriasis to never give up hope. “While in the VTAMA cream clinical trials, my plaques started clearing. Knowing I have a plaque psoriasis treatment that works for me put a smile back on my face again.”

The most common side effects (incidence ≥1%) of VTAMA cream include red raised bumps around the hair pores (folliculitis), pain or swelling in the nose and throat (nasopharyngitis), skin rash or irritation including itching and redness, peeling, burning or stinging (contact dermatitis), headache, itching (pruritus), and flu (influenza).

If you’re struggling with plaque psoriasis, talk to your doctor to learn if VTAMA cream may be right for you. “Never stop advocating for your health — don’t accept that your disease controls you,” says Dr. Johnson.

Sandra M. Johnson, MD, FAAD and Jennifer Soung, MD are paid consultants of Dermavant Sciences, Inc.

For more information about VTAMA cream, speak to your dermatologist or visit www.VTAMA.com.

IMPORTANT SAFETY INFORMATION

Indication: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults. Adverse Events: The most common adverse reactions (incidence ≥ 1%) in subjects treated with VTAMA cream were folliculitis (red raised bumps around the hair pores), nasopharyngitis (pain or swelling in the nose and throat), contact dermatitis (skin rash or irritation, including itching and redness, peeling, burning, or stinging), headache, pruritus (itching), and influenza (flu).

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information here.

VTAMA is a registered trademark of Dermavant Sciences, GmbH.


[1] National Psoriasis Foundation. About psoriasis. Available at: https://www.psoriasis.org/about-psoriasis/. Accessed August 2022.

[2] National Psoriasis Foundation. Psoriasis statistics. Available at: https://www.psoriasis.org/psoriasis-statistics/. Accessed August 2022.

[3] Menter A, Gottlieb A, Feldman SR, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. J Am Acad Dermatol. 2008;58(5), pp.826-850.

[4] National Psoriasis Foundation. Psoriatic disease affects more than skin and joints. Available at: https://www.psoriasis.org/advance/psoriatic-disease-affects-more-than-skin-and-joints/. Accessed August 2022.

[5] Schaarschmidt M, Schmieder A, Umar N, et al. Patient preferences for psoriasis treatments: process characteristics can outweigh outcome attributes. Arch Dermatol. 2011;147(11):1285-1294.

[6] National Psoriasis Foundation. Treatments for psoriatic disease. Available at: https://www.psoriasis.org/treatments-for-psoriatic-disease/. Accessed August 2022.

[7] FDA approves Dermavant’s VTAMA® (tapinarof) cream, 1% for the treatment of plaque psoriasis in adults: first topical novel chemical entity launched for psoriasis in the U.S. in 25 years. Available at: https://www.dermavant.com/u-s-fda-approves-our-novel-topical-treatment-for-adults-with-plaque-psoriasis/. Accessed August 2022.

[8] VTAMA Cream. Prescribing Information. Long Beach, CA. Dermavant Sciences.

Gvoke HypoPen (glucagon injection) is premixed and ready-to-use for low blood sugar emergencies

2022-10-05T08:01:00

(BPT) – Michelle Trites, her husband and their 3-year-old daughter all have Type 1 diabetes. Diabetes is an ever-present part of their lives and ensuring that they have tools in their tool kits to handle low blood sugar emergencies is a top priority.

Ever since Michelle was diagnosed at 13 years old, the Glucagon Emergency Kit has been a constant presence — at school, at work, and on her person at all times. But not anymore. After learning about ready-to-use glucagon, Michelle made sure that everyone in her family replaced the old red kit with Gvoke HypoPen®, a ready-to-use rescue pen for treatment of very low blood sugar in adults and kids ages 2 and older.

Michelle believes the emergency glucagon kit is cumbersome to use due to its 12-step administration process. “That was a lot to ask from non-medical professionals who could get squeamish just looking at a needle, much less completing so many steps in a high-stakes emergency,” Michelle said. In a usability study, only 31% of users could use the glucagon injection kit correctly.

Eli Lilly and Company, a producer of the GEK kit, recently announced that it is discontinuing distribution of the kit on December 31, 2022. The decision was reportedly made due to innovations in the glucagon market and highlights the importance of providing patients with products that enable simpler administration during critical moments of need.

As a result of this news, all patients that currently have a prescription for Eli Lilly’s GEK will need to be transitioned to another option.

The Trites recommend that people with diabetes and their caregivers ask their physician for Gvoke HypoPen®. “Everyone should have Gvoke HypoPen in their tool kit,” said Michelle. “It can help you confidently manage a low blood sugar emergency.”

Gvoke HypoPen®, the simple solution you can count on:

  • Ready-to-use: Premixed and ready-to-go1
  • Simple to administer: Simple 2-step administration. Pull red. Push yellow
  • Reliable method of delivery: 99% of people (trained and untrained) were able to give correctly in usability studies1
  • Proven to work: >99% of adults and pediatrics patients had their blood glucose raised to safe levels

Talk to your doctor about adding Gvoke HypoPen® to your diabetes toolkit and visit GvokeGlucagon.com to learn more.

“We are focused on making our treatments simple for patients or caregivers to administer,” said Ken Johnson, senior vice president for Global Development and Medical Affairs at Xeris Pharmaceuticals. “Xeris is committed to offering historically hard-to-administer and potentially life-saving medications in innovative ready-to-use injectables.”

INDICATION AND SAFETY SUMMARY
GVOKE is a prescription medicine used to treat very low blood sugar (severe hypoglycemia) in adults and kids with diabetes ages 2 years and above. It is not known if GVOKE is safe and effective in children under 2 years of age.

WARNINGS

Do not use GVOKE if:

  • you have a tumor in the gland on top of your kidneys (adrenal gland), called a pheochromocytoma.
  • you have a tumor in your pancreas called an insulinoma.
  • you are allergic to glucagon or any other inactive ingredient in GVOKE.

GVOKE MAY CAUSE SERIOUS SIDE EFFECTS, INCLUDING:

High blood pressure. GVOKE can cause high blood pressure in certain people with tumors in their adrenal glands.

Low blood sugar. GVOKE can cause low blood sugar in certain people with tumors in their pancreas called insulinomas by making too much insulin in their bodies.

Serious allergic reaction. Call your doctor or get medical help right away if you have a serious allergic reaction including:

  • rash
  • difficulty breathing
  • low blood pressure

COMMON SIDE EFFECTS

The most common side effects of GVOKE in adults include:

  • nausea
  • vomiting
  • swelling at the injection site
  • headache

The most common side effects of GVOKE in children include:

  • nausea
  • low blood sugar
  • high blood sugar
  • vomiting
  • abdominal pain
  • headache
  • pain or redness at the injection site
  • itching

These are not all the possible side effects of GVOKE. For more information, ask your doctor.

Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

BEFORE USING

Before using GVOKE, tell your doctor about all your medical conditions, including if you:

  • have adrenal gland problems
  • have a tumor in your pancreas
  • have not had food or water for a long time (prolonged fasting or starvation)
  • have low blood sugar that does not go away (chronic hypoglycemia)
  • are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed

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

HOW TO USE

  • Read the detailed Instructions for Use that come with GVOKE.
  • Use GVOKE exactly how your healthcare provider tells you to use it
  • Make sure your relatives, close friends, and caregivers know where you store GVOKE and how to use it the right way before you need their help.
  • Act quickly. Having very low blood sugar for a period of time may be harmful.
  • Your healthcare provider will tell you how and when to use GVOKE.
  • After giving GVOKE, your caregiver should call for emergency medical help right away.
  • If you do not respond after 15 minutes, your caregiver may give you another dose, if available. Tell your healthcare provider each time you use GVOKE. Low blood sugar may happen again after receiving an injection of GVOKE. Your diabetes medicine may need to be changed.

HOW TO STORE

  • Keep GVOKE in the foil pouch until you are ready to use it.
  • Store GVOKE at temperatures between 68°F and 77°F.
  • Do not keep it in the refrigerator or let it freeze.

Keep GVOKE and all medicines out of the reach of children.

For more information, call 1-877-937-4737 or go to https://gvokeglucagon.com/

Please see the Full Prescribing Information for Gvoke: https://gvokeglucagon.com/pdf/gvoke-prescribing-information.pdf

5 expert tips for tackling stinky workout clothes

2022-10-05T08:01:00

(BPT) – You’ve probably smelled it: Clothes from yesterday’s workout, your kids’ ball games, the contents of your spouse’s gym bag. Few things are tougher to tackle than the stink from these kinds of clothes.

Why is that? According to the Cleveland Clinic, when bacteria that naturally occurs on your skin comes in contact with sweat, that mix can cause unpleasant odors. And that odor-causing bacteria grows in damp, warm conditions — so the longer the clothes sit at the bottom of a hamper or inside a duffel bag, the worse the smell gets.

Here are some expert tips to get even your family’s stinkiest loads smelling fresh.

1. Wash the stinkiest clothes as soon as you can. The longer that odor-causing bacteria sits in the clothing, the more time it will have to grow — and smell even worse.

2. Give them some air. Especially if you can’t wash workout clothes or athletic gear right away, air the items out in your laundry room instead of leaving stinky items in a damp, warm heap in a gym bag, basket or hamper.

3. Consider a pre-soak. If you can’t wash smelly clothes right away, soak them in either a solution of white vinegar and cold water (one part vinegar to four parts water), or in a sink with one-half cup of baking soda mixed with cold water.

4. Use Lysol Laundry Sanitizer. A quick, easy and effective way to get clothes smelling fresh is to add Lysol Laundry Sanitizer to your laundry load. This liquid laundry additive is specially formulated to kill 99.9% of odor-causing bacteria when added to your laundry routine (when used as directed).

5. Give smelly clothes the cold shoulder. Hot temps in your washer — and dryer — can help the bad smells set into your clothes, so be sure to wash the stinkiest items in cold water, and use the lowest dryer setting rather than drying with high heat.

Passing the smell test

Did you know feet have over 250,000 sweat glands? This creates an environment where bacteria can thrive, which explains why socks can be among the worst smell offenders.

To test the effectiveness of Lysol Laundry Sanitizer, the company’s scientists created the “World’s Stinkiest Sock,” using a synthetic formula that represents the worst foot stink, inspired by live, odor-causing bacteria. If Lysol Laundry Sanitizer can handle the World’s Stinkiest Sock, it can handle your stinky loads, too!

Outside Boston’s famed Fenway Park in September, actress, comedian, author and mom Rachel Dratch helped launch the #LysolLaundryChallenge, challenging consumers to try Lysol Laundry Sanitizer on their stinkiest laundry loads, or get their money back if they don’t love the results. Fans had the opportunity to smell the World’s Stinkiest Sock alongside a sock sanitized using Lysol Laundry Sanitizer

To learn more about the World’s Stinkiest Sock and the #LysolLaundryChallenge, visit LysolLaundryChallenge.com.

Breakthroughs in cancer testing could impact lives

2022-10-05T05:01:00

(BPT) – Jim Ford felt completely healthy. He didn’t have any symptoms and kept up with recommended cancer screenings. When his doctor suggested he participate in a clinical trial for a new cancer screening test that could detect a shared cancer signal across 50 different types of cancer, he figured he had nothing to lose.

But then the test—a multi-cancer early detection test called Galleri®—showed a positive signal. Ford’s diagnosis was confirmed with a CT scan and a PET scan. He was shocked to learn he had stage 2 pancreatic cancer.*

He worked with his doctor and had surgery, radiation and chemotherapy.

Treating cancer starts with knowing you have it

Early detection of cancer can improve outcomes, including higher survival rates and better quality of life. It also can reduce the cost and complexity of cancer treatment.

The challenge is that, although there are more than 100 different types of cancers, only five cancers have recommended screenings in the United States—breast, cervical, colon, prostate, and lung for smokers considered at risk. In fact, approximately 70% of cancer deaths are caused by cancers that don’t have widespread screening recommendations.

In addition, because most cancers don’t show symptoms until later stages, they may be found too late when they have already spread and there may not be as many treatment options.

Detecting multiple cancers through a simple blood draw

Multi-cancer early detection tests, like Galleri, can be used alongside existing recommended screenings to detect cancer earlier. Using the power of next-generation sequencing and artificial intelligence, the Galleri test can detect a shared cancer signal across more than 50 types of cancer through a simple blood draw.

The Galleri test does this by examining DNA isolated from blood. All cells in the body shed DNA into the bloodstream, but DNA released by cancer cells is different from the DNA released by healthy cells. This DNA may contain specific patterns that allow cancer to be distinguished from non-cancer.

The test looks for a signal present in the blood that could indicate the presence of cancer. If a cancer signal is detected, the test can predict where in the body the cancer signal is coming from with high accuracy and help a healthcare provider determine appropriate next steps.

The Galleri test must be prescribed by a healthcare provider and can be incorporated into annual health checks or routine blood work, if appropriate. It is generally recommended for adults with an elevated risk of cancer, such as those aged 50 or older. False-positive and false-negative results do occur, and the test should be used in addition to routine screening tests healthcare providers recommend.

Be proactive and take action

One in two men and one in three women in the United States risk getting a cancer diagnosis in their lifetime, according to the American Cancer Society.

Although Ford is now part of that number, the multi-cancer early detection test gave him an opportunity to treat his cancer early, when he had a higher chance of successful treatment.

“The surgeon said that I was probably one of the luckiest people she’d ever met, because she almost never sees stage 2 pancreatic cancer. Usually people at this stage have no symptoms, and you don’t find it early,” said Ford.

Galleri was designed to improve detection of cancers like Ford’s that are more aggressive and deadly.

Thinking about the possibility of cancer can be overwhelming, but people can now take proactive steps to test for many cancers, increasing the chances of finding them early and before symptoms. Learn more about multi-cancer early detection screenings and the Galleri test at galleri.com.

* Based on a clinical study of patients ages 50-79, around 1% are expected to receive a Cancer Signal Detected result, which includes Cancer Signal Origin(s). After diagnostic evaluation, about 40% of people are expected to have a confirmed cancer diagnosis. Galleri test overall sensitivity in participants with pancreatic cancer was 83.7% (61.9% for stage 1, 60.0% for stage 2, 85.7% for stage 3 and 95.9% for stage 4).

Important Safety Information

The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those aged 50 or older. The Galleri test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a healthcare provider. Galleri is intended to detect cancer signals and predict where in the body the cancer signal is located. Use of Galleri is not recommended in individuals who are pregnant, 21 years old or younger or undergoing active cancer treatment.

Results should be interpreted by a healthcare provider in the context of medical history, clinical signs and symptoms. A test result of “No Cancer Signal Detected” does not rule out cancer. A test result of “Cancer Signal Detected” requires confirmatory diagnostic evaluation by medically established procedures (e.g., imaging) to confirm cancer.

If cancer is not confirmed with further testing, it could mean that cancer is not present or testing was insufficient to detect cancer, including due to the cancer being located in a different part of the body. False-positive (a cancer signal detected when cancer is not present) and false-negative (a cancer signal not detected when cancer is present) test results do occur. Rx only.

Laboratory/Test Information
GRAIL’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists. The Galleri test was developed, and its performance characteristics were determined by GRAIL. The Galleri test has not been cleared or approved by the U.S. Food and Drug Administration. GRAIL’s clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes.