Living with Tardive Dyskinesia and Mental Illness: A Testimonial

2023-10-02T07:01:00

(BPT) – Davitria lives with two mental illnesses and tardive dyskinesia.

This article was sponsored and developed by Neurocrine Biosciences, Inc. Davitria was compensated by Neurocrine Biosciences to share her story.

Every year during the first week of October, Mental Illness Awareness Week is recognized nationwide to raise awareness and support those living with a mental illness. More than one in five adults live with a mental illness in the United States, and of those, up to 30 percent of people who are taking antipsychotic treatment also develop a condition called tardive dyskinesia (TD). TD is a movement disorder associated with prolonged use of certain antipsychotics.

Davitria, an only child from Tennessee, has had a lifelong journey with mental illness and also lives with TD. Davitria’s journey with mental illness started when she was five years old and triggered after witnessing her parents have intense arguments. She believes discovering her passion for basketball as a child helped her cope.

“The coach of the boys’ basketball team walked past, pointed at me, and said ‘You play basketball?’ I said, ‘No, sir.’ He said, ‘You do now.’ I believe that man and basketball saved my life,” said Davitria.

Despite finding solace in playing basketball, later in her life, Davitria was diagnosed with major depressive disorder in college and bipolar disorder in 2015.

Over the years, Davitria was prescribed a variety of antidepressant and antipsychotic medications. Working with her healthcare providers, she found a treatment plan that helped control her underlying mental illnesses. But a few years later, she began to experience uncontrollable movements, first impacting her shoulder, then other body parts including her head, arms and mouth.

“For about three years, I suffered with these movements and saw different doctors. I started with my primary care physician, then switched to psychiatrists and then two neurologists,” said Davitria. She was finally referred to a nurse practitioner (NP), who diagnosed her with TD.

TD is a chronic condition that affects approximately 600,000 people in the U.S. It may lead to mild, moderate or severe uncontrollable, abnormal and repetitive movements in different parts of the body. These movements can impact people physically, socially and emotionally. People with TD have reported feeling judged, ashamed, and misunderstood.

As a dedicated basketball player and coach, Davitria valued her ability to be in control of her body. The uncontrollable movements quickly began to affect her, so her NP prescribed INGREZZA® (valbenazine) capsules. Only INGREZZA offers simple dosing that’s always one capsule, once daily to treat adults with the uncontrollable movements of TD.

INGREZZA® (valbenazine) capsules is a prescription medicine used to treat adults with:

  • movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia).

It is not known if INGREZZA is safe and effective in children.

IMPORTANT SAFETY INFORMATION

INGREZZA can cause serious side effects in people with Huntington’s disease, including: depression, suicidal thoughts, or suicidal actions. Tell your healthcare provider before you start taking INGREZZA if you have Huntington’s disease and are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is especially important when INGREZZA is started and when the dose is changed. Call your healthcare provider right away if you become depressed, have unusual changes in mood or behavior, or have thoughts of hurting yourself.

Do not take INGREZZA if you are allergic to valbenazine, or any of the ingredients in INGREZZA.

Please see full Important Safety Information, including Boxed Warning, below and Prescribing Information.

After starting INGREZZA, Davitria saw a reduction in her movements and was able to return to the activities she enjoyed, including basketball and other everyday activities. “Now that I have fewer uncontrollable body movements, I feel like I can get back to doing my favorite things,” she said.

During this year’s Mental Illness Awareness Week, Davitria wants to share her story to raise awareness of TD, its impact, and the importance of working with healthcare professionals to find a once-daily treatment like INGREZZA that helps with the persistent, uncontrollable movements associated with TD.

“Mental Illness Awareness Week means more people will hear about mental health,” she said. “It is important to me to have the opportunity to help spread awareness about TD and empower people to seek the treatment they need, like how I did with INGREZZA.”

Visit INGREZZA.com to learn more about TD and talk to your doctor about possible treatment options, including INGREZZA.

Important Information

Approved Uses

INGREZZA® (valbenazine) capsules is a prescription medicine used to treat adults with:

  • movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia).
  • involuntary movements (chorea) of Huntington’s disease. INGREZZA does not cure the cause of involuntary movements, and it does not treat other symptoms of Huntington’s disease, such as problems with thinking or emotions.

It is not known if INGREZZA is safe and effective in children.

IMPORTANT SAFETY INFORMATION

INGREZZA can cause serious side effects in people with Huntington’s disease, including: depression, suicidal thoughts, or suicidal actions. Tell your healthcare provider before you start taking INGREZZA if you have Huntington’s disease and are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is especially important when INGREZZA is started and when the dose is changed. Call your healthcare provider right away if you become depressed, have unusual changes in mood or behavior, or have thoughts of hurting yourself.

Do not take INGREZZA if you:

  • are allergic to valbenazine, or any of the ingredients in INGREZZA.

INGREZZA may cause serious side effects, including:

  • Sudden swelling from an allergic reaction (angioedema). Sudden swelling has happened after the first dose or after many doses of INGREZZA. Signs and symptoms of angioedema include: swelling of your face, lips, throat, and other areas of your skin, difficulty swallowing or breathing, and raised, red areas on your skin (hives). Swelling in the throat can be life-threatening and can lead to death. Go to the nearest emergency room right away if you develop these signs and symptoms. Your healthcare provider should stop your treatment with INGREZZA.
  • Heart rhythm problems (QT prolongation). INGREZZA may cause a heart problem known as QT prolongation. Symptoms of QT prolongation may include: fast, slow, or irregular heartbeat, dizziness or fainting, or shortness of breath.

Tell your healthcare provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you faint.

  • Neuroleptic Malignant Syndrome (NMS): NMS is a serious condition that can lead to death. Call a healthcare provider right away or go to the nearest emergency room if you develop these symptoms and they do not have another obvious cause: high fever, stiff muscles, problems thinking, very fast or uneven heartbeat, or increased sweating.
  • Abnormal movements (Parkinson-like). Symptoms include: shaking, body stiffness, trouble moving or walking, or keeping your balance.

Before taking INGREZZA, tell your healthcare provider about all of your medical conditions including if you: have liver or heart problems, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.

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

Sleepiness (sedation) is a common side effect with INGREZZA. While taking INGREZZA, do not drive a car or operate dangerous machinery until you know how INGREZZA affects you. Drinking alcohol and taking other drugs that may also cause sleepiness while you are taking INGREZZA may increase any sleepiness caused by INGREZZA.

The most common side effect of INGREZZA in people with tardive dyskinesia is sleepiness (somnolence).

The most common side effects of INGREZZA in people with Huntington’s disease are sleepiness (somnolence), allergic itching, rash, and trouble getting to sleep or staying asleep.

These are not all of the possible side effects of INGREZZA. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see INGREZZA full Prescribing Information, including Boxed Warning.

This article was sponsored and developed by Neurocrine Biosciences Inc. Davitria was compensated by Neurocrine Biosciences to share her story.

©2023 Neurocrine Biosciences, Inc. All Rights Reserved. CP-VBZ-US-2936 10/2023

1 in 3 People Don’t Know They Have Afib, A Serious Heart Issue That Can Cause Problems If Undetected

2023-09-28T08:05:00

(BPT) – Atrial fibrillation (Afib) is a common cardiac arrhythmia, or heart rhythm disorder,[1] with an irregular and often very rapid heart rhythm. Afib is incredibly common, especially in older persons, and adults over the age of 40 have a one in four lifetime risk[2] of developing the condition. Today, around 6 million people in the U.S. have Afib, and the Centers for Disease Control and Prevention (CDC) projects that by 2030, this number will double to 12 million.[3] Even more concerning is that there are up to 1.5 million adults living with Afib who don’t know they have it.[4]

Potential Risks of Afib

Some people are aware of Afib the second they have an episode – they have symptoms of a heaving heart or palpitations. But others may have no awareness that they have Afib, with approximately one in three Afib patients experiencing no symptoms at the time of diagnosis.[5] But even if you can’t feel it, Afib can cause silent and ongoing damage to your heart,[6] making awareness and early detection vital.

Untreated Afib can lead to high-stakes health consequences, including a fivefold increase in risk of stroke[7] (and more severe strokes) and a threefold increase in heart failure.[8] Afib is responsible for one out of every seven strokes,[9] hospitalizes half a million people every year[10] and leads to 160,000 deaths per year.[11] Delayed diagnosis and treatment of Afib directly leads to these complications, but they can be prevented with prompt, clinically-proven, and widely available treatments.[12]

Getting Diagnosed Is Critical…

While Afib is treatable and treatment goals will vary based on your specific condition, you first need a diagnosis.

“Afib can be treated, and its complications can be prevented – which is why early detection and treatment are crucial. It’s important to raise awareness of Afib so we can help people get diagnosed and treated before they face the serious health consequences of Afib,” said Mellanie True Hills, founder of StopAfib.org and creator of National Atrial Fibrillation Awareness Month.

…But Hasn’t Always Been Easy

The path to Afib diagnosis hasn’t always been easy. It wasn’t long ago that you needed to be in the hospital to see a doctor and get an in-clinic electrocardiogram (ECG) to find out if you have Afib. Because Afib symptoms often come and go, and because the ECG needs to capture the exact time you are in Afib, getting a diagnosis has sometimes meant getting repeat ECGs or that the condition was missed altogether.

Today, doctors still widely use Holter monitors. These are wired, clunky devices that were introduced in the 1960s and are worn for 24 to 48 hours. Clinical studies have shown that the longer the recording period the better[13] – because again, Afib often comes and goes with some people going days or weeks without an episode. In fact, three out of four patients using a Holter monitor do not get a diagnosis on the first test.[14]

Hope for the Future

Now, even a smartwatch can tell you that you might have Afib by tracking your pulse to see if it becomes irregular, but the accuracy is not perfect. If you have any symptoms or get a smartwatch alert, you will likely need an ECG.

Now, modern ECG monitors, some of which are smaller than a dollar bill, can be worn at home and continuously record your heart’s electrical signal for longer than 24 to 48 hours if your doctor prescribes it. iRhythm has been creating these types of ECG monitors since 2008 and is now launching its next generation Zio® monitoring device, the Zio monitor. The device is small and discreet when worn, with no wires and no need to change batteries during the wear period.

Recordings from these Zio ECG monitoring devices continuously record your heart for up to 14 days – capturing up to 1.5 million heart beats[15] – and help doctors accurately diagnose Afib.

“If you or your loved one has symptoms of Afib or other arrhythmias, it’s worth talking to your physician or care team,” said Mintu Turakhia, MD, MAS, a cardiologist and the chief medical and scientific officer at iRhythm. “Getting diagnosed early is critical, and modern technology now allows patients to go about their daily lives uninterrupted. Our technology can meet patients where they are, ensuring they have the data to get a diagnosis for Afib or other heart rhythm conditions — or provide reassurance that their heart is beating normally.”

Early detection and treatment of arrhythmias are important to reduce the burden of cardiac disease.[16] Newer heart monitoring technology is helping in the shift to more preventative and proactive treatment and care, providing an effective way to diagnose Afib and protect your health.


[1] Atrial Fibrillation. Centers for Disease Control and Prevention (CDC), 2022. https://www.cdc.gov/heartdisease/atrial_fibrillation.htm [accessed September 2023]
[2] Staerk, et al., Lifetime risk of atrial fibrillation according to optimal, borderline, or elevated levels of risk factors: cohort study based on longitudinal data from the Framingham Heart Study. BMJ. 2018
[3] Colilla S., et al. Estimates of current and future incidence and prevalence of atrial fibrillation in the U.S. adult population. The American Journal of Cardiology, 2013.
[4] Turakhia MP, et al., Contemporary prevalence estimates of undiagnosed and diagnosed atrial fibrillation in the United States. Clin Cardiol, 2023.
[5] Sgreccia, et al., Comparing Outcomes in Asymptomatic and Symptomatic Atrial Fibrillation: A Systematic Review and Meta-Analysis of 81,462 Patients. Journal of Clinical Medicine MDPI, 2021.
[6] What is an arrhythmia? National Heart Lung and Blood Institute, 2022. https://www.nhlbi.nih.gov/health/arrhythmias Accessed November 18, 2022
[7] Wolf, et al., Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke, 1991.
[8] Kotecha, et al., Atrial fibrillation in heart failure: what should we do? Eur Heart J., 2015.
[9] Atrial Fibrillation. Centers for Disease Control and Prevention (CDC), 2022. https://www.cdc.gov/heartdisease/atrial_fibrillation.htm [accessed September 2023]
[10] Nisar, et al., Trends in atrial fibrillation hospitalizations in the United States: A report using data from the National Hospital Discharge Survey. Indian Pacing and Electrophysiology Journal, 2018.
[11] Atrial Fibrillation. Centers for Disease Control and Prevention (CDC), 2022. https://www.cdc.gov/heartdisease/atrial_fibrillation.htm [accessed September 2023]
[12] Rilig et al. Early Rhythm Control in Patients With Atrial Fibrillation and High Comorbidity Burden. Circulation, 2022.
[13] Reynolds et al. Comparative effectiveness of ambulatory monitors for arrhythmia diagnosis: A retrospective analysis of Medicare beneficiaries managed with ambulatory cardiac monitors between 2017 and 2019. Accepted for ACC.23 presentation, presented at New Orleans, LA.
[14] Tsang, et al., Benefits of monitoring patients with mobile cardiac telemetry (MCT) compared with the Event or Holter monitors. Medical Devices: Evidence and Research, 2013.
[15] Data on file. iRhythm Technologies, 2019.
[16] Rilig et al. Early Rhythm Control in Patients With Atrial Fibrillation and High Comorbidity Burden. Circulation, 2022.

One man’s story gives hope to those with treatment-resistant depression

2023-09-28T10:49:00

(BPT) – When the COVID-19 pandemic hit in 2020, Ben, who had already been diagnosed with clinical depression in 2018, felt his depressive symptoms increase the more isolated he became. As an information technology consultant in New York City, his daily routine changed drastically. He woke up, immediately began work from bed and joined work meetings with his camera off with little to no participation.

Ben was in survival mode. Eventually, small tasks like showering, eating, sleeping, and attending meetings with his team felt overwhelming and close to impossible. After feeling like every day was a living nightmare, Ben decided to go to a new psychiatrist, who recommended he start taking antidepressants.

Finding the right treatment option isn’t an easy task. Like many people with clinical depression, Ben struggled to find a treatment that worked for him. He cycled through a couple of medications but, to his dismay, none of his depressive symptoms were relieved. Impatient and frustrated, he couldn’t believe it took a 12-week trial period for each new medication to see if it would work for him.

Eventually, after trying a few medications, Ben was diagnosed with treatment-resistant depression or TRD — a term that validated his experience cycling through a couple of treatments without relief. According to the Agency for Healthcare Research and Quality, TRD occurs when a patient has not achieved significant benefit with at least two different antidepressants of adequate dose and duration. Like Ben, about one-third of adults with depression may have this condition, according to a study published in the American Journal of Psychiatry.

Even with treatment and therapy, Ben continued to have depressive episodes. “One day, I received a last-minute meeting invite from my boss — I immediately went into a downward spiral,” he said. “Curled in a ball and sobbing, my chest pain was so severe that I thought I was having a heart attack. I could see the hospital through my window but had no motivation to walk across the street and ask for help.”

Soon after this episode, Ben moved across the country to live with his older sister in Oregon. Together, they researched many other treatment options. Ben was searching for a medication studied specifically to help someone like him and for the confidence that comes with a medicine approved by the U.S. Food and Drug Administration (FDA) specifically for his condition. During his search, he learned about a different treatment option for people diagnosed with TRD, called SPRAVATO® (esketamine) CIII nasal spray.

When he brought up this treatment option, Ben’s psychiatrist walked him through the risks and benefits and administration and dosing requirements, which include going into a certified SPRAVATO® treatment center twice a week for the first four weeks of treatment. They also discussed some of the most serious side effects of this treatment, including dizziness, sedation, dissociation, increases in blood pressure, the risk of abuse and misuse, and increased risk of suicidal thoughts or actions. As with all SPRAVATO® patients, Ben was enrolled in the Risk Evaluation and Mitigation Strategy (REMS) program to track any serious side effects he may experience.

Please see the Important Safety Information, including BOXED WARNINGS, and a list of side effects below.

Once Ben was enrolled in the REMS program, he was able to start his twice-weekly SPRAVATO® treatments in conjunction with an oral antidepressant.

“I started to feel clearer and lighter as my depressive symptoms improved after my treatments, which gave me a new perspective,” he said. “Through treatment and lots of work, my days are no longer completely consumed with self-hate and darkness but rather more self-love and light.”

And, although this treatment may not work for everyone, SPRAVATO® became a key piece of Ben’s treatment plan to help him manage his TRD during one of the most difficult times in his life. Ben advises others who may be struggling to have open communication: “I understand how alone and isolated you may feel when you’re navigating depression, but just know you are not alone. Ask for help — your support system can help advocate for you when you’re unable to advocate for yourself.”

If you or someone you know needs mental health support, call or text 988 Suicide and Crisis Lifeline, available nationwide to people with a mental health counselor.

IMPORTANT SAFETY INFORMATION

What is SPRAVATO® (esketamine) CIII nasal spray?

SPRAVATO® is a prescription medicine, used along with an antidepressant taken by mouth to treat:

  • Adults with treatment-resistant depression (TRD)
  • Depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions

SPRAVATO® is not for use as a medicine to prevent or relieve pain (anesthetic). It is not known if SPRAVATO® is safe or effective as an anesthetic medicine.

It is not known if SPRAVATO® is safe and effective for use in preventing suicide or in reducing suicidal thoughts or actions. SPRAVATO® is not for use in place of hospitalization if your healthcare provider determines that hospitalization is needed, even if improvement is experienced after the first dose of SPRAVATO®.

It is not known if SPRAVATO® is safe and effective in children.

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

What is SPRAVATO® (esketamine) CIII nasal spray?

SPRAVATO® is a prescription medicine, used along with an antidepressant taken by mouth to treat:

  • Adults with treatment-resistant depression (TRD)
  • Depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions

SPRAVATO® is not for use as a medicine to prevent or relieve pain (anesthetic). It is not known if SPRAVATO® is safe or effective as an anesthetic medicine.

It is not known if SPRAVATO® is safe and effective for use in preventing suicide or in reducing suicidal thoughts or actions. SPRAVATO® is not for use in place of hospitalization if your healthcare provider determines that hospitalization is needed, even if improvement is experienced after the first dose of SPRAVATO®.

It is not known if SPRAVATO® is safe and effective in children.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about SPRAVATO®?

SPRAVATO® can cause serious side effects, including:

  • Sedation and dissociation. SPRAVATO® may cause sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, space and time (dissociation).
    • Tell your healthcare provider right away if you feel like you cannot stay awake or if you feel like you are going to pass out.
    • Your healthcare provider must monitor you for serious side effects for at least 2 hours after taking SPRAVATO®. Your healthcare provider will decide when you are ready to leave the healthcare setting.

  • Abuse and misuse. There is a risk for abuse and physical and psychological dependence with SPRAVATO® treatment. Your healthcare provider should check you for signs of abuse and dependence before and during treatment with SPRAVATO®.
    • Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
    • Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.

  • SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS). Because of the risks for sedation, dissociation, and abuse and misuse, SPRAVATO® is only available through a restricted program called the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS) Program. SPRAVATO® can only be administered at healthcare settings certified in the SPRAVATO® REMS Program. Patients treated in outpatient healthcare settings (e.g., medical offices and clinics) must be enrolled in the program.

  • Increased risk of suicidal thoughts and actions. Antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed.

SPRAVATO® is not for use in children.

  • Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression or a history of suicidal thoughts or actions.

  • How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
    • Pay close attention to any changes, especially sudden changes, in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.
    • Tell your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings.
    • Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.

  • Tell your healthcare provider right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you:
  • suicide attempts
  • worsening depression
  • thoughts about suicide or dying
  • other unusual changes in behavior or mood

Do not take SPRAVATO® if you:

  • have blood vessel (aneurysmal vascular) disease (including in the brain, chest, abdominal aorta, arms and legs)
  • have an abnormal connection between your veins and arteries (arteriovenous malformation)
  • have a history of bleeding in the brain
  • are allergic to esketamine, ketamine, or any of the other ingredients in SPRAVATO®.

If you are not sure if you have any of the above conditions, talk to your healthcare provider before taking SPRAVATO®.

Before you take SPRAVATO®, tell your healthcare provider about all of your medical conditions, including if you:

  • have heart or brain problems, including:
    • high blood pressure (hypertension)
    • slow or fast heartbeats that cause shortness of breath, chest pain, lightheadedness, or fainting
    • history of heart attack
    • history of stroke
    • heart valve disease or heart failure
    • history of brain injury or any condition where there is increased pressure in the brain
  • have liver problems
  • have ever had a condition called “psychosis” (see, feel, or hear things that are not there, or believe in things that are not true).
  • are pregnant or plan to become pregnant. SPRAVATO® may harm your baby. You should not take SPRAVATO® if you are pregnant.
    • Tell your healthcare provider right away if you become pregnant during treatment with SPRAVATO®.
    • If you are able to become pregnant, talk to your healthcare provider about methods to prevent pregnancy during treatment with SPRAVATO®.
    • There is a pregnancy registry for women who are exposed to SPRAVATO® during pregnancy. The purpose of the registry is to collect information about the health of women exposed to SPRAVATO® and their baby. If you become pregnant during treatment with SPRAVATO®, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or online at https://womensmentalhealth.org/clinical-and-research- programs/pregnancyregistry/antidepressants/.
  • are breastfeeding or plan to breastfeed. You should not breastfeed during treatment with SPRAVATO®.

Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Taking SPRAVATO® with certain medicine may cause side effects.

Especially tell your healthcare provider if you take central nervous system (CNS) depressants, psychostimulants, or monoamine oxidase inhibitors (MAOIs) medicines. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

How will I take SPRAVATO®?

  • You will take SPRAVATO® nasal spray yourself, under the supervision of a healthcare provider in a healthcare setting. Your healthcare provider will show you how to use the SPRAVATO® nasal spray device.
  • Your healthcare provider will tell you how much SPRAVATO® you will take and when you will take it.
  • Follow your SPRAVATO® treatment schedule exactly as your healthcare provider tells you to.
  • During and after each use of the SPRAVATO® nasal spray device, you will be checked by a healthcare provider who will decide when you are ready to leave the healthcare setting.
  • You will need to plan for a caregiver or family member to drive you home after taking SPRAVATO®.
  • If you miss a SPRAVATO® treatment, your healthcare provider may change your dose and treatment schedule.
  • Some people taking SPRAVATO® get nausea and vomiting. You should not eat for at least 2 hours before taking SPRAVATO® and not drink liquids at least 30 minutes before taking SPRAVATO®.
  • If you take a nasal corticosteroid or nasal decongestant medicine take these medicines at least 1 hour before taking SPRAVATO®.

What should I avoid while taking SPRAVATO®?

Do not drive, operate machinery, or do anything where you need to be completely alert after taking SPRAVATO®. Do not take part in these activities until the next day following a restful sleep. See “What is the most important information I should know about SPRAVATO®?”

What are the possible side effects of SPRAVATO®?

SPRAVATO® may cause serious side effects including:

  • See “What is the most important information I should know about SPRAVATO®?”
  • Increased blood pressure. SPRAVATO® can cause a temporary increase in your blood pressure that may last for about 4 hours after taking a dose. Your healthcare provider will check your blood pressure before taking SPRAVATO® and for at least 2 hours after you take SPRAVATO®. Tell your healthcare provider right away if you get chest pain, shortness of breath, sudden severe headache, change in vision, or seizures after taking SPRAVATO®.
  • Problems with thinking clearly. Tell your healthcare provider if you have problems thinking or remembering.
  • Bladder problems. Tell your healthcare provider if you develop trouble urinating, such as a frequent or urgent need to urinate, pain when urinating, or urinating frequently at night.

The most common side effects of SPRAVATO® when used along with an antidepressant taken by mouth include:

  • feeling disconnected from yourself, your thoughts, feelings and things

around you

  • dizziness
  • nausea
  • feeling sleepy
  • spinning sensation
  • decreased feeling of sensitivity (numbness)
  • feeling anxious
  • lack of energy
  • increased blood pressure
  • vomiting
  • feeling drunk
  • feeling very happy or excited

If these common side effects occur, they usually happen right after taking SPRAVATO® and go away the same day.

These are not all the possible side effects of SPRAVATO®.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO® and discuss any questions you may have with your healthcare provider.

cp-170363v1

Ben is a volunteer with the SHARE Network, a Janssen Pharmaceuticals, Inc., program made up of people who are dedicated to inspiring others through their personal health journeys and stories of caring. He is a real patient with treatment-resistant depression and was compensated by Janssen Pharmaceuticals, Inc., for his time to develop this content.

If a Janssen treatment has made a difference in your life or the life of a loved one, we hope you will consider joining the?SHARE Network.

Every story is unique. If you are an adult living with TRD, talk to your doctor to figure out a treatment plan that’s right for you.

This information is intended for the use of patients and caregivers in the United States and its territories only. Laws, regulatory requirements and medical practices in pharmaceutical products vary from country to country. The Prescribing Information included here may not be appropriate for use outside the United States and its territories.

References:

  1. Rush AJ et al. Am J Psychiatry. 2006;163(11):1905-1917.
  2. Agency for Healthcare Research and Quality. Treatment-Resistant Depression: A Narrative and Systematic Review of Definitions and Methods in Clinical Research Studies. Accessed August 18, 2023. https://www.ahrq.gov/sites/default/files/wysiwyg/research/findings/ta/topicrefinement/trdepression-protocol-amendment.pdf.

© Janssen Pharmaceuticals, Inc. 2023 08/23 cp-406942v1

What is the most important information I should know about SPRAVATO®?

SPRAVATO® can cause serious side effects, including:

  • Sedation and dissociation. SPRAVATO® may cause sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, space and time (dissociation).
    • Tell your healthcare provider right away if you feel like you cannot stay awake or if you feel like you are going to pass out.
    • Your healthcare provider must monitor you for serious side effects for at least 2 hours after taking SPRAVATO®. Your healthcare provider will decide when you are ready to leave the healthcare setting.
  • Abuse and misuse. There is a risk for abuse and physical and psychological dependence with SPRAVATO® treatment. Your healthcare provider should check you for signs of abuse and dependence before and during treatment with SPRAVATO®.
    • Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
    • Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
  • SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS). Because of the risks for sedation, dissociation, and abuse and misuse, SPRAVATO® is only available through a restricted program called the SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS) Program. SPRAVATO® can only be administered at healthcare settings certified in the SPRAVATO® REMS Program. Patients treated in outpatient healthcare settings (e.g., medical offices and clinics) must be enrolled in the program.
  • Increased risk of suicidal thoughts and actions. Antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. SPRAVATO® is not for use in children.
    • Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression or a history of suicidal thoughts or actions.
  • How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
    • Pay close attention to any changes, especially sudden changes, in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.
    • Tell your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings.
    • Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.
  • Tell your healthcare provider right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you:
  • suicide attempts
  • thoughts about suicide or dying
  • worsening depression
  • other unusual changes in behavior or mood

Do not take SPRAVATO® if you:

  • have blood vessel (aneurysmal vascular) disease (including in the brain, chest, abdominal aorta, arms and legs)
  • have an abnormal connection between your veins and arteries (arteriovenous malformation)
  • have a history of bleeding in the brain
  • are allergic to esketamine, ketamine, or any of the other ingredients in SPRAVATO®.

If you are not sure if you have any of the above conditions, talk to your healthcare provider before taking SPRAVATO®.

Before you take SPRAVATO®, tell your healthcare provider about all of your medical conditions, including if you:

  • have heart or brain problems, including:
    • high blood pressure (hypertension)
    • slow or fast heartbeats that cause shortness of breath, chest pain, lightheadedness, or fainting
    • history of heart attack
    • history of stroke
    • heart valve disease or heart failure
    • history of brain injury or any condition where there is increased pressure in the brain
  • have liver problems
  • have ever had a condition called “psychosis” (see, feel, or hear things that are not there, or believe in things that are not true).
  • are pregnant or plan to become pregnant. SPRAVATO® may harm your baby. You should not take SPRAVATO® if you are pregnant.
    • Tell your healthcare provider right away if you become pregnant during treatment with SPRAVATO®.
    • If you are able to become pregnant, talk to your healthcare provider about methods to prevent pregnancy during treatment with SPRAVATO®.
    • There is a pregnancy registry for women who are exposed to SPRAVATO® during pregnancy. The purpose of the registry is to collect information about the health of women exposed to SPRAVATO® and their baby. If you become pregnant during treatment with SPRAVATO®, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or online at https://womensmentalhealth.org/clinical-and-research- programs/pregnancyregistry/antidepressants/.
  • are breastfeeding or plan to breastfeed. You should not breastfeed during treatment with SPRAVATO®.

Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Taking SPRAVATO® with certain medicine may cause side effects.

Especially tell your healthcare provider if you take central nervous system (CNS) depressants, psychostimulants, or monoamine oxidase inhibitors (MAOIs) medicines. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

How will I take SPRAVATO®?

  • You will take SPRAVATO® nasal spray yourself, under the supervision of a healthcare provider in a healthcare setting. Your healthcare provider will show you how to use the SPRAVATO® nasal spray device.
  • Your healthcare provider will tell you how much SPRAVATO® you will take and when you will take it.
  • Follow your SPRAVATO® treatment schedule exactly as your healthcare provider tells you to.
  • During and after each use of the SPRAVATO® nasal spray device, you will be checked by a healthcare provider who will decide when you are ready to leave the healthcare setting.
  • You will need to plan for a caregiver or family member to drive you home after taking SPRAVATO®.
  • If you miss a SPRAVATO® treatment, your healthcare provider may change your dose and treatment schedule.
  • Some people taking SPRAVATO® get nausea and vomiting. You should not eat for at least 2 hours before taking SPRAVATO® and not drink liquids at least 30 minutes before taking SPRAVATO®.
  • If you take a nasal corticosteroid or nasal decongestant medicine take these medicines at least 1 hour before taking SPRAVATO®.

What should I avoid while taking SPRAVATO®?

Do not drive, operate machinery, or do anything where you need to be completely alert after taking SPRAVATO®. Do not take part in these activities until the next day following a restful sleep. See “What is the most important information I should know about SPRAVATO®?”

What are the possible side effects of SPRAVATO®?

SPRAVATO® may cause serious side effects including:

  • See “What is the most important information I should know about SPRAVATO®?”
  • Increased blood pressure. SPRAVATO® can cause a temporary increase in your blood pressure that may last for about 4 hours after taking a dose. Your healthcare provider will check your blood pressure before taking SPRAVATO® and for at least 2 hours after you take SPRAVATO®. Tell your healthcare provider right away if you get chest pain, shortness of breath, sudden severe headache, change in vision, or seizures after taking SPRAVATO®.
  • Problems with thinking clearly. Tell your healthcare provider if you have problems thinking or remembering.
  • Bladder problems. Tell your healthcare provider if you develop trouble urinating, such as a frequent or urgent need to urinate, pain when urinating, or urinating frequently at night.

The most common side effects of SPRAVATO® when used along with an antidepressant taken by mouth include:

  • feeling disconnected from yourself, your thoughts, feelings and things around you
  • dizziness
  • nausea
  • feeling sleepy
  • spinning sensation
  • decreased feeling of sensitivity (numbness)
  • feeling anxious
  • lack of energy
  • increased blood pressure
  • vomiting
  • feeling drunk
  • feeling very happy or excited

If these common side effects occur, they usually happen right after taking SPRAVATO® and go away the same day.

These are not all the possible side effects of SPRAVATO®.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO® and discuss any questions you may have with your healthcare provider.
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Ben is a volunteer with the SHARE Network, a Janssen Pharmaceuticals, Inc., program made up of people who are dedicated to inspiring others through their personal health journeys and stories of caring. He is a real patient with treatment-resistant depression and was compensated by Janssen Pharmaceuticals, Inc., for his time to develop this content.

If a Janssen treatment has made a difference in your life or the life of a loved one, we hope you will consider joining the SHARE Network.

Every story is unique. If you are an adult living with TRD, talk to your doctor to figure out a treatment plan that’s right for you.

This information is intended for the use of patients and caregivers in the United States and its territories only. Laws, regulatory requirements and medical practices in pharmaceutical products vary from country to country. The Prescribing Information included here may not be appropriate for use outside the United States and its territories.

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3 Must-Know Child Safety Tips for Peace of Mind at Home or On the Go

2023-09-28T05:01:00

(BPT) – As a parent, you want your child to be happy, healthy and safe. As little ones begin to explore the world around them, parents face more challenges and safety becomes top of mind. Fortunately, a few simple steps can significantly reduce the chance of injury and accidents whether you’re home or away.

The safety experts at the Juvenile Products Manufacturing Association (JPMA), a proud partner of Safety 1st, share three important safety steps all caregivers should take:

Step 1: Move risky items up and add lock systems

Inquisitive kids love to open drawers and cabinets to discover what’s inside. While some spaces may be safe, others may contain things like medicine, cleaning products or breakables like glass. An insider tip: Get on the floor and view the world as your child does — you may be surprised at what you notice from this perspective.

The first step to a safer home is to move items that pose a risk to a high place out of reach of infants and children. Then, install lock systems for any drawers or cabinets that may be within reach.

One of the easiest locking systems to install and use are adhesive magnetic locking systems from Safety 1st. Just peel and stick these low-profile locks on the inside of spaces — the perfect choice for renters or anyone who doesn’t want to damage their cabinets.

Step 2: Install gates and be mindful of stairs

Once children begin to crawl and walk, they take more risks as they explore. This is an important part of their development, but they don’t yet fully understand the dangers. That’s why all caregivers should install gates at the top and bottom of stairs.

Adding a safety gate to a home or apartment doesn’t have to be a complicated process. The Ready to Install Gate from Safety 1st, for example, is a hardware-mounted security gate with a no-trip design. The no-threshold design means no trip hazard at the top of the stairs and one-hand operation with a swing-open door makes it easier for bigger kids and adults to pass through.

On average, every 6 minutes a child in the U.S. goes to the emergency room due to an injury related to falling on the stairs, according to a study by the Nationwide Children’s Hospital. Safety gates can dramatically lower the risk of a child falling on the stairs. Caregivers should also be careful when using stairs if they are holding children. In these cases, go slow, use the handrail with your free hand and move one step at a time.

Step 3: Use safety gear on the go

Child safety isn’t just a priority when at home — it’s important to keep kids secure when out and about as well. Life gets busy and adventures abound, so if you need to get around with ease even when you have your child in tow, make sure you invest in high-quality gear to keep little ones safe.

Vehicle safety is a must, so always use a car seat appropriate for your child’s height and weight. One of the most important car seat safety tips is to make sure to install the car seat correctly. If you’re unsure, some health care offices, public safety departments and local fire departments offer complimentary child safety seat checks.

Depending on your child’s age and your preferences, you may also need a baby carriage or a stroller to keep you moving with safety and ease. Consider a travel system like the Deluxe Grow and Go Flex 8-in-1 that combines these components so you have options to help keep kids secure no matter where you go, with options that can change as they age.

As for stroller safety, make sure to correctly secure and adjust straps and harnesses every time you use them, even if it’s for a short distance. Always apply brakes when stationary to prevent roll-aways. Finally, remember to practice pinch prevention by ensuring baby’s hands are clear when folding and unfolding strollers.

A proactive approach to safety can keep families safe, even when little ones are on the move. Let these three steps guide you at home or while away.

Get to know your cataracts this Healthy Aging Month

2023-09-27T06:01:00

(BPT) – Alcon, the global leader in eye care dedicated to helping people see brilliantly, is highlighting the results of its Alcon Eye On Cataract Survey in light of Healthy Aging Month (September). The global survey, conducted between March and April 2023 in Australia, Brazil, China, Germany, India, Italy, Japan, Spain, South Korea and the United States, set out to evaluate vision and cataract insights among the world’s rapidly aging population.1

The results are clear: healthy vision is a priority for active agers across the globe, and cataract surgery can help turn back the clock for patients’ vision.1 Read more at the infographic below to learn more about the survey results, cataracts and the benefits of presbyopia-correcting intraocular lenses (PC-IOLs) for cataract correction.

References:

  1. Alcon Data on File, 2023

Cooperman Barnabas Medical Center Places Final Steel Beam for New Cancer Center Building

2023-09-26T12:01:00

(BPT) – Cooperman Barnabas Medical Center (CBMC) — part of RWJBarnabas Health, the largest and most comprehensive academic healthcare system in New Jersey — recently raised the final steel beam on its $225 million, freestanding Cancer Center, scheduled for 2025 completion.

Cancer survivors, oncology department staff, board members, and donors added their signatures to the steel beam of the five-story, 137,000-square-foot facility located in Livingston, New Jersey.

The outpatient facility will serve as the northern hub for the integrated oncology services offered by RWJBarnabas Health and Rutgers Cancer Institute of New Jersey, the state’s only National Cancer Institute-designated Comprehensive Cancer Center.

“Cooperman Barnabas Medical Center is a regional leader in cancer care, and with the construction of this state-of-the-art facility, we are setting a new standard for top-quality care,” said Richard L. Davis, the hospital’s President and CEO. “With world-class amenities and a team that includes some of the top cancer specialists in the nation, the new Cancer Center will be a premier destination for patient-centered and research-driven cancer care in this region and beyond.”

“There is absolutely nothing more important to our community than having best-in-class health care. The creation of a state-of-the-art cancer center here at CBMC represents one of the most significant events in this community and continues the ongoing growth and transformation of the Medical Center,” said Bruce Schonbraun, Chair of the Board of Trustees at CBMC.

“Our vision of reimagining cancer care could not have occurred without the generosity and support of our many donors. We are grateful for their support and to everyone who has played a role in bringing this project to life,” Schonbraun added.

Patients will have access to medical, surgical, and radiation oncology services at the new Cancer Center, with amenities that include a wig and prosthetic studio, yoga classes, music therapy, and psychosocial support services. Private infusion rooms and short-term and extended-stay facilities will also be available.

“The Cancer Center at Cooperman Barnabas Medical Center is part of an overall major investment by RWJBarnabas Health and Rutgers Cancer Institute to transform oncology services across the state including the construction of the Jack and Sheryl Morris Cancer Center, the state’s first freestanding cancer hospital,” said Steven K. Libutti, M.D., Director of Rutgers Cancer Institute of New Jersey and Senior Vice President, Oncology Services at RWJBarnabas Health.

The medical center’s partnership with Rutgers Cancer Institute of New Jersey provides patients access to the most advanced treatment options, including clinical trials, CAR T-cell therapy, immunotherapy, and precision medicine.

“This new Cancer Center will be synonymous with clinical excellence, collaboration, and a commitment to integrated care, delivered by world-class physicians and specialists,” said Michael Scoppetuolo, M.D., Medical Director of the Cancer Center at CBMC. “This is what the future of cancer care looks like in the Garden State and beyond. I’m honored to be a part of it.”

“Cancer treatment is getting more targeted and precise every year,” added Alison Grann, M.D., Chair of the hospital’s Department of Radiation Oncology and the Northern Region Director of Radiation Oncology, RWJBarnabas Health. “The Cancer Center will provide patients with the most advanced multidisciplinary, patient-centric cancer care available in one central location.”

More information about the new center is available online, at rwjbh.org/cbmccancercenter.

How new legislation can help address the health care workforce shortage

2023-09-22T05:01:00

(BPT) – If you’ve recently scheduled medical appointments or procedures, you may have noticed longer wait times than you expected. There’s a reason for that: The U.S. currently needs more than 17,000 additional healthcare practitioners to keep up with demand, according to the Health Resources and Services Administration. Although healthcare provider shortages are occurring across the country, the problem is particularly acute in underserved rural and urban areas.

One specific area of need is anesthesia care. Certified Registered Nurse Anesthetists (CRNAs) are often the only anesthesiology providers in rural hospitals and are the predominant providers in underserved communities, yet current regulations regarding how these highly qualified healthcare professionals can practice limit the ability of CRNAs to care for patients to the full extent of their training and experience.

To address this issue, the Improving Care and Access to Nurses (ICAN) Act introduced in Congress with bipartisan support will help eliminate unnecessary barriers to practice, so patients and healthcare facilities can fully benefit from the expertise of CRNAs for anesthesia care.

Senators Jeff Merkley (D-OR) and Cynthia Lummis (R-WY) introduced the ICAN Act (Senate Bill 2418) in the Senate, joining more than a dozen representatives from both parties sponsoring the House version of the bill. The ICAN Act would remove barriers for advanced practice registered nurses (APRNs) such as CRNAs, allowing them to provide more comprehensive healthcare services to patients nationwide. The American Association of Nurse Anesthesiology (AANA), plus over 200 other nursing and healthcare organizations, support the legislation, which will remove unnecessary supervision of CRNAs and provide access to CRNA services in Medicaid.

“CRNAs play a vital role in maintaining critical access in communities across the country,” said AANA President Dru Riddle, PhD, DNP, CRNA, FAAN. “However, superfluous regulations serve as barriers to expanding care, especially when those same communities face a shortage of providers. This critical legislation helps ensure everyone who needs access to high-quality care provided by advanced practice registered nurses such as CRNAs can have it.”

CRNA training and experience

CRNAs and other APRNs are trained at the master’s or doctoral level to provide anesthesia and pain management services, treat and diagnose illnesses, advise the public on health issues, manage chronic disease, provide care during pregnancy, childbirth and the postpartum period, order and interpret diagnostic tests and prescribe medication and non-pharmacologic treatments.

Despite the critical role APRNs such as CRNAs serve in the U.S. healthcare system, some federal statutes and regulations as well as institutional rules currently limit their practice, preventing them from practicing to the full extent of their education and clinical training.

CRNAs currently represent over 80% of anesthesia providers in rural counties. Rural hospitals and critical access hospitals often rely on independently practicing CRNAs for anesthesia care so the facilities can provide a wide range of surgical care, including obstetrics and pain management, close to home, when and where patients need it most. Even with CRNAs’ vital role in maintaining critical access in communities nationwide, current Medicare restrictions require physician supervision of CRNAs. However, in many cases, there are no physician anesthesia providers available in a rural hospital to offer this unnecessary supervision, so the federal requirement creates a barrier to expanding care and worsens the current provider shortage, especially in underserved communities — without improving patient outcomes.

Additional support for the ICAN Act

Removing barriers to practice for CRNAs and other APRNs has widespread support. The National Academies of Science, Engineering and Medicine recommended in “The Future of Nursing 2020-2030: Charting a Path to Achieve Health Equity” that “all relevant state, federal and private organizations enable nurses to practice to the full extent of their education and training by removing practice barriers that prevent them from more fully addressing social needs and social determinants of health and improve health care access, quality and value.”

These recommendations are echoed by multiple bipartisan stakeholders including the American Enterprise Institute, Brookings Institution, the Bipartisan Policy Center and AARP.

Improving access to care

Passing the ICAN Act will mean removing many barriers between patients and nurses in Medicare and increasing access to care for all Americans. Removing redundant supervision requirements for CRNAs will help lower costs in Medicare and Medicaid programs — and ensure proper reimbursement for services to maintain the highest standard and quality of care.

“We’ve seen how much nurses can do when they’re allowed to reach the full potential of their education and scope of practice,” added Riddle. “Removing barriers between nurses and patients is critical for achieving a more compassionate, efficient, affordable and equitable healthcare system for all Americans.”

Learn more about the ICAN Act and how you can support this life-saving legislation at AnesthesiaFacts.com.

Reach Out and Play: Fueling multigenerational connection through game nights

2023-09-20T15:59:00

(BPT) – When you were younger, you might have had “family game night,” huddled around the kitchen table with dice and tokens. Besides the happy memories this brings, those game nights may actually help boost one’s health. Social connections, sense of purpose and an active mind can be key parts of healthier aging. Coming together to play games can be one way to encompass all three — while helping to reduce isolation.

In light of this, Ageless Innovation’s Reach Out and Play campaign, sponsored by AARP, will host board game events across the country through the end of the year.

Various organizations will host board game events across the country, and people are also encouraged to host their own with family and friends. These activities will bring people of all ages together through the power of play, and create meaningful connections for older adults.

Social isolation and loneliness for older adults can have a massive effect on their health. Loneliness has been found to lead to health risks, such as depression, cognitive decline, hypertension and more. Social isolation may lead to cardiovascular disease, a reduced quality of life and other health issues. Personal connections, no matter what the activities, can help foster better health.

“Social connection, camaraderie, and even some problem-solving — all of these things can be important contributors to the health of older adults,” said Dr. Philip Painter, chief medical officer at UnitedHealthcare Medicare & Retirement. “Events like this can bring people of all ages together for fun, but also drive a sense of wellness, which is so vital as we age.”

For information on Reach Out and Play, including how to find and register for an event in your area, visit aarp.org/agelessplay. And, check out reimagined versions of Scrabble, The Game of Life, and Trivial Pursuit — interpretations that encourage intergenerational play.

If you’re 65, there is one piece of mail you shouldn’t ignore this month

2023-09-20T13:31:00

(BPT) – Are you or someone you love on Medicare? As the annual Medicare Annual Enrollment Period approaches (it starts on October 15 and runs through December 7), no doubt your mailbox will be flooded with letters, flyers and postcards from insurance companies and brokers pushing many Medicare options. But the one piece of mail you need to pay attention to is your current Medicare plan’s Annual Notice of Change, commonly referred to as ANOC.

All Medicare Advantage Plans and Part D Prescription plans are required to send out this important letter before the end of September. They must tell you if your current plan is changing in any way, because if there are changes that you don’t like, you have the right to change your plan during the Annual Enrollment Period. And yes, Medicare plans can change from year to year — and sometimes not for the better. What if your prescription drugs are no longer covered? Your doctor leaves the network? Your premium suddenly increases? Your co-payments jump? Protect your health and your wallet … read that ANOC letter!

Each insurance company has their own version of the ANOC letter, which may be up to 20 pages long, so grab a cup of coffee and get comfortable! Here are 6 things to look out for when reviewing your ANOC.

  1. Change in plan premium. It’s likely that a plan’s premium may change from year to year. How much is dependent on what the individual carrier changes, but you could even see a plan with a $0 monthly premium change to having an actual dollar amount for you to pay.
  2. Changes in co-pays. Check to make sure your doctor co-pays, including primary and specialists in and out of network, have not changed.
  3. Network changes. This will show you if your doctors and pharmacies are no longer in your plan’s network or are no longer a preferred provider.
  4. Drug list changes. It’s so important that you look at this list, also called the drug formulary. Prescriptions fall in and out of coverage or change price levels, so please review to see if your drugs are still covered and if there are any new restrictions.
  5. Out-of-pocket maximum. This is the amount of money you will pay out-of-pocket for all Medicare-covered expenses. Make sure to review this section to see if your out-of-pocket limit has changed.
  6. Additional benefits in Medicare Advantage plans. For those with a Medicare Advantage plan, you may have coverage for additional benefits like dental, vision, hearing, telehealth and more.

Caution! If you ignore the ANOC letter and you do nothing during the Annual Enrollment Period, your current plan will renew for 2024 — and you won’t be able to make any changes until October 2024.

But if you review your plan’s annual notice and decide that your current plan may not be right for you in the coming year, it’s time to consider changing your plan for 2024. According to the Kaiser Family Foundation, “The average Medicare beneficiary in 2023 has access to 43 Medicare Advantage plans, the largest number of options ever.” That means there are more plans for you to choose from this year (great news!).

Confused? Overwhelmed? Free help is just a phone call away. ClearMatch™ Medicare is dedicated to making Medicare easier to understand so you can choose the plan that’s right for you. Their highly trained licensed agents are patient and helpful, and if they find you are already in a great plan, they’ll tell you so. If you’d like help, call 1-888-441-7030 (TTY:711) for a free, no-obligation Medicare review, Monday-Friday, 9 a.m.-9 p.m., Saturday, 9 a.m.-6 p.m. (ET) or visit ClearMatchMedicare.com, open 24-7.

The Power of Self-Advocacy in Pompe Disease

2023-09-14T23:01:00

(BPT) – When Amy was trying to get back in shape after giving birth to her second child, she noticed lower back pain and core weakness she was struggling to re-strengthen. After numerous attempts at physical therapy and consulting with numerous doctors, she finally met with a neurologist and received a diagnosis of Late-Onset Pompe Disease (LOPD), a rare, genetic disorder which causes progressive weakness and can affect the major muscle groups used for breathing and mobility.

Amy’s self-advocacy and motivation to understand what was happening to her body has helped her to keep moving forward day by day, while living with a rare disease, with the help and support of her family, friends and care team. In fact, living with a rare disease may not be as rare as you would think – affecting one in 10 Americans, there are more than 7,000 known rare diseases in the U.S.

Here are some tips to ensure you too are proactively prioritizing your health, listening to your body and getting checked out by a doctor if you are experiencing symptoms such as shortness of breath, trouble eating or chewing or difficultly walking.

  • Listen to Your Body: As someone who exercised regularly, Amy immediately took notice of her fatigue and difficulties when exercising. Speaking with physicians from multiple disciplines, eventually including a neurologist, helped lead her toward a Pompe diagnosis.
  • Communicate Your Needs: While at work as a physician’s assistant, a job that often requires being on your feet for many hours, Amy takes breaks when needed, and remains mindful of how she is feeling throughout the day. These adjustments in her schedule have helped Amy to continue working and be there for her own patients. Similar to Amy, it is important to let others know when you need help and support if you are experiencing a challenging moment.
  • Work With Your Doctor to Monitor Your Progress: Two months after her Pompe diagnosis, Amy began an enzyme replacement therapy (ERT) regimen every two weeks and visited her doctor every six months to monitor progress. In between those appointments, Amy paid close attention to her body to inform her doctor on any changes, helping ensure she maintained the muscle function she had for as long as possible. Taking note of any new symptoms also helped her make the most of her conversations with her doctor, and as a result, better-informed care decisions.
  • Understand Your Options: When diagnosed with a rare disease, knowledge is power. Making the effort to familiarize oneself with rare diseases, symptoms and resources could be key to a diagnosis and proper treatment. Even though Amy was stable on the treatment she was using, she stayed up-to-date on scientific innovations. A year after beginning her initial ERT, Amy learned about NEXVIAZYME (avalglucosidase alfa-ngpt), a monotherapy for LOPD given every two weeks. After talking it through with her doctor, she decided to change her treatment. By keeping an open dialogue with her physician and advocating for herself, Amy was able to take the best next step for her to manage her LOPD.

Like Amy and her journey, remaining persistent and curious is a critical part of one’s journey. “I hope my story helps other people. At the end of the day, everybody has something they’re dealing with. But we will get through it, if we use each other for support,” said Amy, who is being treated with NEXVIAZYME for her LOPD.

For those living with Pompe disease, it is essential to continuously speak to your healthcare provider about ways to support the management of the disease. Being informed of Pompe disease, its signs and symptoms and potential treatment options are all key to helping advocate for yourself or a loved one. If you are currently living with LOPD and on an enzyme replacement therapy, but your symptoms are worsening or you are unable to do the things you want to do, talk to your doctor to see if NEXVIAZYME could be a treatment option for your late-onset Pompe disease management.

Patient stories reflect the real-life experiences of persons diagnosed with LOPD who have been prescribed NEXVIAZYME. However, individual experiences may vary. Patient stories are not necessarily representative of what another person using NEXVIAZYME may experience.

This patient was compensated for their time in creating this content.

INDICATION

NEXVIAZYME (avalglucosidase alfa-ngpt) is used for the treatment of patients 1 year of age and older with late-onset Pompe disease [lysosomal acid alpha-glucosidase (GAA) deficiency].

IMPORTANT SAFETY INFORMATION

WARNING: SEVERE HYPERSENSITIVITY REACTIONS, INFUSION-ASSOCIATED REACTIONS, and RISK OF ACUTE CARDIORESPIRATORY FAILURE IN SUSCEPTIBLE PATIENTS

Hypersensitivity Reactions Including Anaphylaxis

If you are taking NEXVIAZYME, you should know that severe and potentially life threatening allergic-type reactions known as anaphylaxis and severe hypersensitivity reactions have occurred during and after NEXVIAZYME treatment. You should seek immediate medical care if signs and symptoms of anaphylaxis or hypersensitivity reactions occur. If such a reaction is severe enough, your doctor may decide to immediately discontinue the infusion and provide immediate medical care. Appropriate medical support measures may be administered during your infusion, and you may require close observation during and after NEXVIAZYME administration.

Infusion-Associated Reactions (IARs)

If you are taking NEXVIAZYME, you should know that severe IARs have occurred during and after NEXVIAZYME treatment. If severe IARs occur during your NEXVIAZYME infusion, your doctor may decide to immediately discontinue the infusion and provide appropriate medical care. If you have an acute underlying illness at the time of NEXVIAZYME infusion you may be at greater risk for IARs. If you have advanced Pompe disease you may have compromised heart and breathing function, which may put you at a higher risk of severe complications from IARs.

Risk of Acute Cardiorespiratory Failure in Susceptible Patients

If you are likely to develop fluid volume overload, or have acute underlying breathing problems or compromised heart or breathing function that may require fluid restriction, there may be a risk of worsening of your heart or breathing status during NEXVIAZYME infusion. Your doctor may decide that close observation during NEXVIAZYME administration may be necessary.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions Including Anaphylaxis: See Boxed WARNING. Your doctor may decide to give you antihistamine, anti-fever and/or steroid medications before your infusions. Your doctor should consider the risks and benefits of restarting the infusion if you have a severe hypersensitivity reaction (including anaphylaxis) to NEXVIAZYME. If a mild or moderate hypersensitivity reaction occurs, your healthcare provider may slow the infusion rate or temporarily stop the infusion.

Infusion-Associated Reactions (IARs): See Boxed WARNING. Your doctor may decide to give you medications before your infusions to decrease the risk of IARs; however, IARs may still occur after receiving these medications. If mild or moderate IARs occur, your healthcare provider should consider decreasing the infusion rate or temporarily stopping the infusion which may help improve the symptoms.

Risk of Acute Cardiorespiratory Failure in Susceptible Patients: See Boxed WARNING.

ADVERSE REACTIONS

The most common adverse reactions (>5%) were headache, fatigue, diarrhea, nausea, joint pain, dizziness, muscle pain, itching, vomiting, shortness of breath, rash, “pins-and-needles” sensation, and hives.

Please see full Prescribing Information for complete details, including Boxed WARNING.

Sanofi does not provide medical advice, diagnosis, or treatment. The health information contained herein is provided for general educational purposes only. Your healthcare professional is the best source of information regarding your health. Please consult your healthcare professional if you have any questions about your health or treatment.