Category: Brandpoint Health

2022-10-21T09:01:00

(BPT) – For the more than 643 million people worldwide with type 2 diabetes, the disease’s health-related issues can be serious, deadly, and costly. Diet and exercise can help control diabetes. But a recent study shows that the remission of type 2 diabetes is achieved more effectively and with longer-lasting results with bariatric surgery, rather than through medications and lifestyle changes.

Reversing a diagnosis of life-altering diabetes is empowering. April Ammons of Florida (a patient of bariatric surgeon Michael Baptista, M.D. of Jacksonville) was diagnosed with type 2 diabetes on her 40th birthday. She progressed from oral diabetes medication to an insulin pump combined with oral medications and insulin injections. But today, she says she has been released from “diabetic prison” thanks to the 110 pounds she lost after having an adjustable gastric band (AGB) surgically placed.

“The band made it possible for me to discontinue use of the insulin pump, and as the weight came off, the diabetic medications decreased,” says April. “I would never dream that I would be free of the horrible effects of diabetes — pain when walking, sleeping with a CPAP machine, depression, overall exhaustion. My A1C was once in the 15s and is now in the 7s. To say my doctor is thrilled is an understatement.”

Backed by 25 years of clinical evidence, the FDA-approved Lap-Band^® system features an AGB placed around the upper stomach to help limit food intake and promote a feeling of fullness. It involves a short, outpatient procedure and brings power over hunger and more control because of its adjustability over weight loss than other bariatric surgery options. On average, patients kept off 60% of their excess body weight after five years of having the minimally invasive Lap-Band surgery¹.

Lap-Band can be a powerful option for those with diabetes. In fact, of people with diabetes who had a Lap-Band placed, 73% reported remission of type 2 diabetes due to weight loss after two years².

The Lap-Band system is for those with a body mass index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity-related comorbid conditions, like diabetes. The band can be tightened or loosened as a patient’s body or physical needs change over time, helping to provide sustainable weight loss over the long term. Regular adjustments by a surgeon help continue weight loss. Think about it like having to tighten your belt as the weight comes off.

April, who had her Lap-Band surgery in 2021, now takes line dancing, stretching, and yoga classes at a gym. She’s enjoying going to the beach and traveling again.

“For me, my new life began after the 45-minute procedure to place the band and a couple of days of recuperation,” says April. “I’m in awe of the changes I have experienced since my surgery, and I finally feel like I am an active participant in my life again. I encourage any diabetic battling weight issues to talk to your surgeon about the procedure.”

Visit Lap-Band.com to find a Lap-Band surgeon near you.

Actual patient. The views and opinions expressed here are patient’s own. Patients’ experience and results may vary.

Important Safety Information

Patients’ results and experiences may vary. The LAP-BAND^® System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity-related comorbid conditions. It is indicated for use only in adult patients who have failed more conservative weight-reduction alternatives. This surgery requires significant changes in eating habits. This system is contraindicated in non-adult patients (patients under 18 years of age) with inflammatory diseases of the gastrointestinal tract, severe cardiopulmonary diseases, esophageal or gastric varices, portal hypertension, or who currently are or may be pregnant. Placement of the system is major surgery and, therefore, death can occur. Most common related adverse events include: band slippage, pouch dilatation, stoma obstruction, gastroesophageal reflux, esophageal dilation, cholelithiasis, incisional infection, abdominal pain, gastroenteritis, or nausea and vomiting.

For full safety information: https://www.lapband.com/safety/. CAUTION: Rx only

¹ Ray James, Ray Shahla. Surgery for Obesity and Related Diseases. Safety, efficacy, and durability of laparoscopic adjustable gastric banding in a single surgeon U.S. community practice

² Dixon, John et al. JAMA Vol 299 No 3 Jan 2008 Adjustable Gastric Banding and Conventional Therapy for Type 2 Diabetes: A Randomized Controlled Trial

2022-10-18T11:37:01

(BPT) – Nearly 2,000 U.S. HCPs Have Prescribed RADICAVA^® (edaravone) and RADICAVA ORS Since the Products Became Available in August 2017 and June 2022

RADICAVA and RADICAVA ORS Have Been Used to Treat 8,000 Patients with Over 1.1 Million Days of Therapy

Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced that nearly 2,000 people with amyotrophic lateral sclerosis (ALS) have received RADICAVA ORS^® (edaravone).¹ Since RADICAVA^® (edaravone) and RADICAVA ORS became available in the U.S. in August 2017 and June 2022, respectively, nearly 2,000 U.S. healthcare providers (HCPs) have prescribed the therapies to one or more of their patients.²

RADICAVA ORS is an oral formulation that offers the same efficacy as RADICAVA, an intravenous (IV) treatment that was shown in a pivotal trial to help slow the loss of physical function in ALS.^3,4 RADICAVA and RADICAVA ORS have been used to treat 8,000 patients in the U.S. with over 1.1 million days of therapy.⁵

“Our driving focus at MTPA is to ensure we’re making a meaningful difference in the lives of people living with ALS, and this milestone exemplifies our commitment to this goal,” said Atsushi Fujimoto, President, MTPA. “We are pleased by the amount of ALS patients that have received RADICAVA ORS over the past few months, including new patients as well as those who have switched from RADICAVA, and we look forward to seeing this number rise as more patients gain access to this new oral treatment option.”

“ALS affects patients in varying ways, which means their treatment needs are continuously evolving,” said Terry Heiman-Patterson, M.D., Professor, Neurology, Lewis Katz School of Medicine at Temple University, Director, Temple MDA/ALS Center of Hope. “RADICAVA ORS offers patients the flexibility of an alternate delivery option, and I am eager to continue to see this medication reach more people in the coming years.”

In clinical trials, the most common adverse reactions (≥10%) reported in RADICAVA-treated patients were contusion (15%), gait disturbance (13%), and headache (10%).³ In an open-label study, fatigue was also observed in 7.6% of patients receiving RADICAVA ORS.³ RADICAVA and RADICAVA ORS are contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients. See Important Safety Information below.

RADICAVA ORS is approved as a 5 mL dose that can be taken orally or via feeding tube, providing a portable and flexible administration option to ALS patients, with no infusion required. With appropriate instruction from a HCP, RADICAVA ORS may take only a few minutes to administer on treatment days.³ RADICAVA ORS should be taken in the morning after overnight fasting for eight hours.³ To learn more about RADICAVA ORS, visit RADICAVA.com.

As a part of MTPA’s commitment to helping people with ALS access RADICAVA and RADICAVA ORS, MTPA created the JourneyMate Support Program™, which provides educational resources to help patients and caregivers on their ALS treatment journey.

The JourneyMate Support Program™ helps to give patients understanding, answers, and resources to supplement what their doctor provides. Experienced program team members are trained to address patient educational needs and provide them with personalized answers and resources for living with ALS. For more information, call 1-866-684-7737 or visit RADICAVA.com/journeymate.

An estimated 5,000-6,000 Americans are diagnosed each year with ALS, a neurodegenerative disease that currently has no cure and can progress rapidly, as well as lead to muscle weakness and eventual loss of function.^6-8 The majority of ALS patients succumb to the disease within two to five years of receiving a diagnosis, but progression of the disease can vary significantly.^7,8

About RADICAVA^® (edaravone) and RADICAVA ORS^® (edaravone)
The U.S. Food and Drug Administration (FDA) approved RADICAVA^® (edaravone) on May 5, 2017, and the oral formulation RADICAVA ORS^® (edaravone) on May 12, 2022, for the treatment of amyotrophic lateral sclerosis (ALS). RADICAVA is administered in 28-day cycles by IV infusion. It takes 60 minutes to receive each 60 mg dose. For the initial cycle, the treatment is infused daily for 14 consecutive days, followed by a two-week drug-free period. All cycles thereafter are infused daily for 10 days within a 14-day period, followed by a two-week drug-free period. RADICAVA ORS is taken daily for 14 consecutive days followed by a 14-day drug-free period for the initial treatment cycle. For subsequent treatment cycles, RADICAVA ORS is taken for 10 days within a 14-day period followed by a 14-day drug-free period. RADICAVA ORS should be taken in the morning after overnight fasting. Patients should not eat or drink (except water) within one hour after taking RADICAVA ORS.³

Edaravone was discovered and developed for ALS by Mitsubishi Tanabe Pharma Corporation (MTPC) and Mitsubishi Tanabe Pharma Development America, Inc. (MTDA), commercialized in the U.S. by Mitsubishi Tanabe Pharma America, Inc. (MTPA). The MTPC group companies began researching ALS in 2001 through an iterative clinical platform over a 13-year period. In 2015, RADICAVA was approved for the treatment of ALS in Japan and South Korea. Marketing authorizations were subsequently granted in Canada (October 2018), Switzerland (January 2019), China (July 2019), Indonesia (July 2020), Thailand (April 2021) and Malaysia (December 2021).To date, in the U.S., RADICAVA and RADICAVA ORS have been used to treat over 8,000 patients, with over 1.1 million days of therapy, and have been prescribed by nearly 2,000 HCPs.^1,2

IMPORTANT SAFETY INFORMATION

Hypersensitivity Reactions
RADICAVA (edaravone) and RADICAVA ORS (edaravone) are contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients of this product. Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) have occurred with RADICAVA.

Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue RADICAVA or RADICAVA ORS, treat per standard of care, and monitor until the condition resolves.

Sulfite Allergic Reactions
RADICAVA and RADICAVA ORS contain sodium bisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown but occurs more frequently in asthmatic people.

Adverse Reactions
The most common adverse reactions (≥10%) reported in RADICAVA-treated patients were contusion (15%), gait disturbance (13%), and headache (10%). In an open label study, fatigue was also observed in 7.6% of patients receiving RADICAVA ORS.

Pregnancy
Based on animal data, RADICAVA and RADICAVA ORS may cause fetal harm.

To report suspected adverse reactions or product complaints, contact Mitsubishi Tanabe Pharma America, Inc., at 1-888-292-0058. You may also report suspected adverse reactions to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

INDICATION
RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS).

For more information, including full Prescribing Information, please visit www.RADICAVA.com.

About JourneyMate Support Program™
The JourneyMate Support Program™ offers educational support and resources for patients who are considering or have already been prescribed an MTPA product. An ALS Clinical Educator is an educational resource for patients who have been prescribed a Mitsubishi Tanabe Pharma America, Inc. (MTPA) product. An ALS Clinical Educator is provided by MTPA and VMS and is not affiliated with or provided by a doctor. An ALS Clinical Educator does not provide medical advice. The program does not provide medical advice and does not take the place of a patient’s doctor. All questions about a condition, diagnosis, or treatment should be referred to the patient’s doctor. If a patient has a medical emergency, they should call 911. Adverse events or product complaints should be reported by calling 1-888-292-0058.

About Mitsubishi Tanabe Pharma America, Inc.
Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation’s (MTPC) 100 percent owned U.S. holding company, Mitsubishi Tanabe Pharma Holdings America, Inc. It was established by MTPC to commercialize approved pharmaceutical products in North America. For more information, please visit www.mt-pharma-america.com or follow us on Twitter, Facebook and LinkedIn.

About Mitsubishi Tanabe Pharma Development America, Inc.
The U.S. headquarters of Mitsubishi Tanabe Pharma Development America, Inc. (MTDA) is located in Jersey City, New Jersey. MTDA is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation’s 100 percent-owned U.S. holding company, Mitsubishi Tanabe Pharma Holdings America, Inc. For more information, please visit https://mt-pharma-development-america.com/.

About Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation (MTPC), the pharma arm of the Mitsubishi Chemical Group, is one of the oldest pharmaceutical companies in the world, founded in 1678, and focusing on ethical pharmaceuticals. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan’s pharmaceutical industry. The Mitsubishi Chemical Group has positioned health care as its strategic focus in its management policy, “Forging the future”. MTPC sets the MISSION of “Creating hope for all facing illness”. To that end, MTPC is prioritizing work on “precision medicine” to provide drugs with high treatment satisfaction by identifying patient populations with high potential for efficacy and safety, focusing on the disease areas of central nervous system and immuno-inflammation. In addition, MTPC is working to develop “around the pill solutions” to address specific patient concerns based on therapeutic medicine, including prevention of diseases, pre-symptomatic disease care, prevention of aggravation and prognosis. For more information, go to https://www.mt-pharma.co.jp/e/.

Media inquiries:
Media_MTPA@mt-pharma-us.com

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¹ Data on file. Mitsubishi Tanabe Pharma America, Inc.
² Data on file. Mitsubishi Tanabe Pharma America, Inc.
³ RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2022.
⁴ Edaravone (MCI-186) ALS 19 Study Group. Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2017;16(7):505-512.
⁵ Data on file. Mitsubishi Tanabe Pharma America, Inc.
⁶ Marin B, Boumediene F, Logroscino G, et al. (2016). Variation in worldwide incidence of amyotrophic lateral sclerosis: a metaanalysis. Int J Epidemiol, 00:1-18.
⁷ ALS Association. Facts You Should Know About ALS. http://web.alsa.org/site/PageServer?pagename=ALSA_Facts. Accessed July 2022.
⁸ Amyotrophic Lateral Sclerosis (ALS) Fact Sheet. National Institute of Neurological Disorders and Stroke, National Institutes of Health, June 2013, https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Amyotrophic-Lateral-Sclerosis-ALS-Fact-Sheet. Accessed July 2022.

2022-10-14T15:51:00

(BPT) – David was in his thirties and living a healthy life when doctors discovered a cancerous mass in his neck. He began treatment immediately, unsure about the journey ahead, and after enduring several therapies that left him feeling worse, his thyroid cancer was still spreading. Luckily, through a support group, David’s wife Kathleen discovered that he could have his tumor tested to see if it had a specific genetic alteration.

GAVRETO may affect fertility in males and females, which may affect a patient’s ability to have children. Patients should talk to their healthcare provider if this is a concern for them.

These are not all of the possible side effects of Gavreto. Patients should call their doctor for medical advice about side effects. Patients are encouraged to report side effects to the FDA. Visit FDA MedWatch or call 1-800-FDA-1088.

Please see the full Prescribing Information and Patient Information for Gavreto.

This content was developed by Blueprint Medicines Corporation and Genentech, Inc.

References:

1. American Cancer Society: Cancer Action Network. (2020, September). Survivor Views: Biomarker Testing. American Cancer Society.
2. Kris, M. G. et al (2014). Using Multiplexed Assays of Oncogenic Drivers in Lung Cancers to Select Targeted Drugs. JAMA, 311(19). https://doi.org/10.1001/jama.2014.3741.

M-US-00014101v(1.0)

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:

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.
• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ABILIFY MYCITE during pregnancy. For more information contact the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/
• 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

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.

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.

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.

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.

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.

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.