Category: Brandpoint Health

2021-08-26T10:15:00

(BPT) – Modern design celebrates the elimination of unnecessary elements, keeping only the beautiful details that enhance a space. Purposeful, exquisite nuances from finishings and natural materials to functional details bring life to modern design. Designers can redefine a modern space with these principles in mind to create a stunning, yet timeless aesthetic that embodies luxury in its truest form.

Stunning refinement

Curate a design with clean and streamlined architectures to create a bold yet minimalistic look that maintains sensible simplicity while appreciating modern refinement. In the bath, creatively integrate natural materials such as marble, wood and caning for a sense of elegance that enables the space to transcend residential design. Selecting an understated palette provides a base upon which to accent with rich tones and create a luxurious space that maintains a timeless aura.

Dimensional details

Elevate the design in a bath or kitchen space by adding depth through intentional geometric patterns, tactile textures and layered styling. Add a note of modern sophistication by selecting handcrafted details made to last, such as a faceted side table made from marble or a textured wallpaper. Consider also adding iconic details and textiles that transform a space without adding clutter. Channel these rich, intentional details to accentuate the natural beauty of the design aesthetic.

Exquisitely crafted

Source fixtures that embody an innate design versatility and make a statement. Create a focal point in a space through an elegant faucet with refined lines and add a touch of the sublime through purposeful nuances like the knurling details featured in the The Litze^® Bath Collection by Brizo^®. Each of the six handles in the expanded collection, from the new Wheel Handle to the Notched Lever, combine exquisite form with raw beauty to create an undeniably modern look that maintains an element of timelessness. Build upon these elements by selecting a color palette that highlights contrast. Bringing temperate tones into a warm space or incorporating warm accents against cool materials such as marble vanities or walls will add a sense of modernity to the design.

Functional luxury

A simple, yet intricate design can have a significant impact on overall aesthetics and functionality. Find the perfect intersection between artistry and innovative utility for a modern take on artisan design. Make decisions that strike a balance between curated, luxe pieces and the overall space to create an intentional design with clear lines that highlights form in its simplicity. Bring form and function together with deliberate décor. Add atmospheric lighting that simultaneously serves a purpose and adds a soothing quality to a space. Layer in exquisite details like functionally placed knurling in The Litze® Bath Collection by Brizo^® or an artful sculpture that acts as both table and statement as a final finishing touch.

2021-08-25T17:57:00

(BPT) – Wildfires are already impacting communities in the Western and Southwestern United States even ahead of the fall winds that threaten to push them into more populated areas. Wildfires spread in hot, dry and windy conditions, so continuing maintenance and reducing fuels, especially in dense suburban communities particularly at risk, is key. The upcoming Labor Day weekend is the ideal time to improve your home’s wildfire preparedness.

Ninety percent of homes ignited by wildfire will result in a complete loss. Adapting a home to wildfire can be overwhelming, yet we must take action to drive down the devastating impacts of these events. Daniel Gorham is a firefighter and wildfire research engineer at the Insurance Institute for Business & Home Safety (IBHS), a nonprofit whose wildfire research translates into actionable guidance for homeowners. According to Daniel, “We are not helpless against these fires. Now is the time for homeowners, neighborhoods and communities to map the journey to a more resilient home. This is so important, because firefighters simply can’t be everywhere and protect every home during an active wildfire.”

One part of a home may be wildfire-resistant while another remains highly vulnerable, leaving the structure, and neighboring homes, at risk. To make the greatest impact in driving down that risk, homeowners should start by addressing the most vulnerable areas of the home and then continue with additional improvements paired with ongoing maintenance and debris removal.

Wildfire preparedness tips

Create a 0- to 5-foot home ignition zone – The first five feet immediately around a home is critical. It should be designed and maintained to keep fire or embers from igniting materials in this area and spreading to the home. Use hardscape like gravel, pavers, concrete and other noncombustible mulch materials in this 5-foot zone around your home.

5-30 feet – Do not plant vegetation aligned with the corner line of the home in the 5- to 30-foot zone. Prune trees so the distance between canopies is at least 10 feet, more if you’re on a slope. Space shrubs at a distance double the height of the shrub on flat terrain or triple the height on a slope.

30+ feet – Use this area for sheds and other accessory structures like gazebos and kids’ playsets.

Remove items under your deck – Embers easily collect under decks, and if a deck ignites it will likely spread to the rest of the home and result in a total loss. Remove debris, vegetation like leaves or pine straw that may have collected underneath over the summer, and any items stored under your deck, like outdoor gear or lawn care supplies. Do not store wood on or underneath your deck. All of these materials can easily ignite and fuel a fire, putting your home at considerable risk.

Fencing – If you have fencing attached to your home that is made of combustible materials such as wood or plastic, replace at least the first 5 feet with metal or other noncombustible versions (including replacing combustible gates attached to your home). This helps stop fire from spreading from the fence to your home.

If you and your neighbor have fences that overlap, this creates a small gap between the fences where debris and embers can accumulate and ignite both fences. Additionally, the two fences together create more fuel for a more intense fire, increasing your home’s exposure to heat and burning embers. Talk to your neighbor and work together to take down any sections that overlap.

2021-08-25T09:01:00

(BPT) – Ilana, a board-certified emergency medicine physician, lived with chronic hives for almost as long as she can remember. “I’ve had them since I was at least 8 years old,” she says. “It’s something that was a regular part of my high school and college life. I was just always a person who was itchy, and I didn’t know why. I had accepted it as a normal part of my life.”

Even as she grew older, she never considered being treated for chronic hives. She was often the student in class who was distracted and itching during exams, but dismissed the hives as something brought on by stress as a medical student or her allergies.

It’s estimated that about 1 in 5 people experience hives, or itchy, red or skin-colored welts, at some point in their lives. They’re often caused by an allergic reaction, but not always. If the hives come back over and over again for more than six weeks, and don’t have a known cause, it’s called chronic spontaneous urticaria, or CSU. It’s also commonly referred to as chronic idiopathic urticaria (CIU).

Finally, after many years of searching for answers as well as trying antihistamines, Ilana shared her symptoms with a medical school classmate and friend, Dr. Ari Zelig, who suggested that she come in for an appointment with him. Dr. Zelig is an allergist, which means he specializes in treating allergies and immune system diseases that can affect different parts of the body. He diagnosed her with CIU and recommended considering treatment. She finally felt relief. “It was nice to have a name for what I was experiencing,” she says. “It made it ‘real.’ It’s an actual condition that can be treated.”

Dr. Zelig says the severity and number of CSU outbreaks vary from person to person. “A common misconception is that chronic hives are caused by undiagnosed food allergies or an allergy to topical products, but that’s not the case with CSU. CSU is a condition where chronic hives occur without a known cause. While many patients think this is an external skin issue, chronic hives stem from within,” he says.

There are four common signs and symptoms that are indicative of CSU. These include:

• Red or skin-colored welts, or “wheals,” appearing anywhere on the body and varying in size, change shape and appear and fade repeatedly
• Itching that is intense
• Hives that turn white, or “blanch,” when they are pressed in the center
• Signs and symptoms persisting for more than six weeks and recurring frequently and unpredictably

Ilana was prescribed Xolair^® (omalizumab), which is the first and only FDA-approved biologic treatment used to treat CSU in people 12 years of age and older who continue to have hives after receiving treatment with antihistamines. Ilana and Dr. Zelig discussed the side effects, including the risk for a severe life-threatening allergic reaction, called anaphylaxis.

While experiences may vary, Ilana has noticed she experiences less hives and itching. “I’ve learned that chronic hives don’t have to be accepted as a ‘normal’ part of my life anymore,” she says. “I wish that I had known about the condition and potential treatment options earlier. It doesn’t have to be like that.”

Dr. Zelig encourages others who may be experiencing the symptoms of CSU to talk to an allergist about treatment options.

“It’s important to talk to an allergist about ways to control chronic hive outbreaks,” says Dr. Zelig. “CSU can be truly debilitating. No one should have to suffer in silence with CSU.”

Xolair U.S. Indication

What is XOLAIR?

XOLAIR^® (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat chronic spontaneous urticaria (CSU, previously referred to as chronic idiopathic urticaria (CIU), chronic hives without a known cause) in people 12 years of age and older who continue to have hives that are not controlled with H1 antihistamine treatment. It is not known if XOLAIR is safe and effective in people with CSU under 12 years of age.

XOLAIR is not used to treat other forms of hives.

What is the most important information I should know about XOLAIR?

Severe allergic reaction. A severe allergic reaction called anaphylaxis can happen when you receive XOLAIR. The reaction can occur after the first dose, or after many doses. It may also occur right after a XOLAIR injection or days later. Anaphylaxis is a life-threatening condition and can lead to death. Go to the nearest emergency room right away if you have any of these symptoms of an allergic reaction:

• wheezing, shortness of breath, cough, chest tightness, or trouble breathing
• low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of “impending doom”
• flushing, itching, hives, or feeling warm
• swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing

Your healthcare provider will monitor you closely for symptoms of an allergic reaction while you are receiving XOLAIR and for a period of time after treatment is initiated. Your healthcare provider should talk to you about getting medical treatment if you have symptoms of an allergic reaction.

Do not receive and use XOLAIR if you are allergic to omalizumab or any of the ingredients in XOLAIR.

Before receiving XOLAIR, tell your healthcare provider about all of your medical conditions, including if you:

• have a latex allergy or any other allergies (such as food allergy or seasonal allergies). The needle cap on the XOLAIR prefilled syringe contains a type of natural rubber latex
• have ever had a severe allergic reaction called anaphylaxis
• have or have had a parasitic infection
• have or have had cancer
• are pregnant or plan to become pregnant. It is not known if XOLAIR may harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if XOLAIR passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby while you receive and use XOLAIR.

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

How should I receive and use XOLAIR?

• When starting treatment XOLAIR should be given by your healthcare provider in a healthcare setting.
• If your healthcare provider decides that you or a caregiver may be able to give your own XOLAIR prefilled syringe injections, you should receive training on the right way to prepare and inject XOLAIR.
• Do not try to inject your XOLAIR prefilled syringe until you have been shown the right way to give XOLAIR injections by a healthcare provider. Use XOLAIR exactly as prescribed by your healthcare provider. For children 12 years of age and older, XOLAIR prefilled syringe may be self-injected under adult supervision.
• See the detailed Instructions for Use that comes with XOLAIR for information on the right way to prepare and inject XOLAIR.
• XOLAIR is given in 1 or more injections under the skin (subcutaneous), 1 time every 2 or 4 weeks.
• In people with chronic hives, a blood test is not necessary to determine the dose or dosing frequency.
• Do not decrease or stop taking any of your other hive medicine unless your healthcare providers tell you to.
• You may not see improvement in your symptoms right away after XOLAIR treatment.
• If you inject more XOLAIR than prescribed, call your healthcare provider right away.

What are the possible side effects of XOLAIR?

XOLAIR may cause serious side effects, including:

• Cancer. Cases of cancer were observed in some people who received XOLAIR.
• Fever, muscle aches, and rash. Some people get these symptoms 1 to 5 days after receiving a XOLAIR injection. If you have any of these symptoms, tell your healthcare provider.
• Parasitic infection. Some people who are at a high risk for parasite (worm) infections, get a parasite infection after receiving XOLAIR. Your healthcare provider can test your stool to check if you have a parasite infection.
• Heart and circulation problems. Some people who receive XOLAIR have had chest pain, heart attack, blood clots in the lungs or legs, or temporary symptoms of weakness on one side of the body, slurred speech, or altered vision. It is not known whether these are caused by XOLAIR.

The most common side effects of XOLAIR in people with chronic spontaneous urticaria: nausea, headaches, swelling of the inside of your nose, throat or sinuses, cough, joint pain, and upper respiratory tract infection.

These are not all the possible side effects of XOLAIR. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555 or Novartis Pharmaceuticals Corporation at (888) 669-6682.

Please see full Prescribing Information, including Medication Guide for additional Important Safety Information.

2021-08-25T08:01:00

(BPT) – Receiving an organ transplant can be a life-changing event for both recipients and donors. While a new organ can provide hope for the future for recipients, there are still many challenges they face living with a transplant beyond just medical care.

1) Living with a transplant can take an immense physical toll, not only from the impact of the surgery, but also from anti-rejection medication side effects. However, there is an emotional impact, as well.

• Some recipients wish their doctors would pay more attention to the psychological difficulties that come after surgery.¹
• Recipients feel guilt from the physical toll and potential medical risk that they may have caused for their living donors.²
• Recipients can have a constant fear of graft failure.²

2) While everyone’s emotional journey is different, many organ transplant recipients may struggle with depression and anxiety, or other negative feelings.

• Development of anxiety, depression and intense feelings of loneliness and guilt.³
• Recipients may feel socially isolated, causing stress in their relationships.⁴
• They may worry about being a financial burden to their family.²

3) Organ transplant recipients can feel isolated from their loved ones, as they cannot always participate in the same physical or social activities they did before receiving their transplant.

• Some organ transplant patients may feel less able to participate in physical activities due to reduced stamina and fatigue.⁴

4) The pandemic has not made it easy for those with a transplant to connect through in-person support groups and local patient meetings due to being immunocompromised.

• There are many online support platforms and advocacy groups that transplant recipients can participate in or join to feel connected.
• Utilizing technology is a great resource for transplant recipients. Tablets and smartphones allow recipients to connect with their doctors, nurses, psychiatrists, colleagues, and friends.⁵

5) There are online support platforms, like TransplantLyfe, where recipients can connect one-on-one with others like them, and even discuss their transplant journey on forums anonymously.

• TransplantLyfe offers a variety of resources for transplant recipients including: COVID-19 resources, transplant center locater, online journaling, community forums and virtual chat rooms to connect with other transplant recipients.
• TransplantLyfe offers different categories for both recipients and care partners to join and partake in online discussions to ask questions.
• It is important for transplant recipients to feel connected and supported continuously before and after surgery. TransplantLyfe offers a network of transplant recipients, care partners, donors, and transplantation experts to bring communities together.

It’s important for transplant recipients to know they’re not going through their journeys alone. TransplantLyfe, sponsored by CSL Behring, is dedicated to providing organ transplant recipients, their support partners and donors with the support they need in the transplant journey. To sign up, visit transplantlyfe.com/signup.

References

1. Yang, F, Chen H, Huang, C et al. The Difficulties and Needs of Organ Transplant Recipients during Postoperative Care at Home: A Systematic Review. IJERPH. (2020). https://doi.org/10.3390/ijerph17165798. Accessed June 8, 2021.
2. Ettenger, R, Albrecht, R, Alloway, R, et al. Meeting report: FDA public meeting on patient-focused drug development and medication adherence in solid organ transplant patients. Am J Transplant. (2018). 18: 564– 573. https://doi.org/10.1111/ajt.14635. Accessed June 8, 2021.
3. De Pasquale, C, Veroux M, Indelicato, L, et al. Psychopathological aspects of kidney transplantation: Efficacy of a multidisciplinary team. WJT. (2014). Accessed June 8, 2021. https://doi.org/10.5500/wjt.v4.i4.267.
4. U.S. Food and Drug Administration. The Voice of the Patient. (2017). https://www.fda.gov/media/105219/download. Accessed June 8, 2021.
5. “Managing Anxiety as a Transplant Patient in a COVID-19 World.” CareDx, caredx.com/patients-and-caregivers/patient-resources/managing-anxiety-as-a-transplant-patient-in-a-covid-19-world/. https://caredx.com/patients-and-caregivers/patient-resources/managing-anxiety-as-a-transplant-patient-in-a-covid-19-world/. Accessed June 8, 2021.

2021-08-20T16:09:00

(BPT) – –

2021-08-19T06:01:00

(BPT) – A fall, a broken wrist and a misdiagnosis. That’s how Julie’s story started.

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

References

1. Freeman R. Clinical practice. Neurogenic orthostatic hypotension. N Engl J Med. 2008;358(6):615-624.
2. Bryarly M, Phillips L, Fu Q, et al. Postural orthostatic tachycardia syndrome: JACC focus seminar. J Am Coll Cardiol. 2019;73(10):1207-1228.
3. Isaacson SH. Managed care approach to the treatment of neurogenic orthostatic hypotension. Am J Manag Care. 2015;21(13 Suppl):s258-268.
4. Freeman R, Wieling W, Axelrod FB, et al. Consensus statement on the definition of orthostatic hypotension, neurally mediated syncope and the postural tachycardia syndrome. Clin Auton Res. 2011;21(2):69-72.
5. Gibbons CH, Schmidt P, Biaggioni I, et al. The recommendations of a consensus panel for the screening, diagnosis and treatment of neurogenic orthostatic hypotension and associated supine hypertension. J Neurol. 2017;264(8):1567-1582.
6. Ha AD, Brown CH, York MK, Jankovic J. The prevalence of symptomatic orthostatic hypotension in patients with Parkinson’s disease and atypical parkinsonism. Parkinsonism Relat Disord. 2011;17(8):625-628.
7. Goldstein DS, Sharabi Y. Neurogenic orthostatic hypotension: a pathophysiological approach. Circulation. 2009;119(1):139-146.
8. Palma JA, Kaufmann H. Epidemiology, diagnosis, and management of neurogenic orthostatic hypotension in Parkinson’s disease: evaluation, management and emerging role of droxidopa. Vasc Health Risk Manag. 2014:10:169-176.
9. NORTHERA [package insert]. Deerfield, IL: Lundbeck.

©2021 Lundbeck. All rights reserved. NORTHERA is a registered trademark of Lundbeck NA Ltd. DRX-B-100471

2021-08-17T11:35:00

(BPT) – Most people are familiar with heart disease and understand this serious condition can lead to a heart attack, chest pain or stroke. Unfortunately, few people know about vascular disease, which affects your circulatory system and can include diseases of your veins and arteries. Some vascular diseases are quite widespread, such as abdominal aortic aneurysm, which affects nearly 200,000 people in the United States each year and can be deadly without treatment. Additionally, patients with diabetes are more likely to develop vascular disease, and those individuals living with both are at an increased risk of amputation, blindness, kidney failure, and other serious disabilities.

You may be familiar with another common vascular condition, varicose veins, the large bulging veins in the legs that affect as many as 40 million Americans and can cause many different symptoms. There is much more to know about vascular disease and the ways to keep your veins and arteries healthy.

1. Learn about your risk

Depending on your age, family health history and health, you may have an increased risk for certain illnesses. For example, if you are over the age of 50, smoke, are diabetic, or have high blood pressure, you may be at risk for vascular disease and would benefit from starting a relationship with a vascular surgeon.

2. See a specialist

Symptoms such as pain in your legs or persistent sores on your feet could be a sign of a poor health. See your primary care physician to get the issue evaluated. If your doctor suspects you might have peripheral artery disease (PAD) or an abdominal aortic aneurysm, for example, they may refer you to a vascular surgeon. Vascular surgeons provide comprehensive care and specialize in treatments of all vascular problems except those of the heart (treated by cardiovascular surgeons) and the brain (treated by neurosurgeons). Being proactive may help get you the necessary care and treatment before the problem worsens.

3. Know your numbers

“When it comes to vascular disease, cholesterol is enemy No. 1b, behind smoking,” says Benjamin Pearce, M.D., of the University of Alabama at Birmingham and a member of the Society for Vascular Surgery. Over time, a buildup of extra cholesterol, or plaque, can narrow the insides of blood vessels, causing hardening of the arteries. Aim for a total cholesterol level of less than 200, and be sure to have your good and bad cholesterol, as well as your triglyceride levels, checked.

4. Don’t smoke

Every health care professional will tell you, don’t smoke. When you smoke, you ingest nicotine and hundreds of other deadly chemicals, causing serious harm to multiple organs. For example, smoking narrows the arteries in your brain and the carotid arteries in your neck, increasing your risk of stroke. The good news is when you stop smoking, you’ll experience physical benefits within 48 hours. Furthermore, within the first year after quitting, your circulation and lung functions increase, and there is a decrease in coughing, sinus congestion and shortness of breath.

5. Get physical

Studies show daily exercise has a significant, positive effect on vascular health. Regular exercise may reduce the risk of stroke, and for patients diagnosed with peripheral artery disease, exercise may help them avoid interventions. The Centers for Disease Control and Prevention (CDC) recommends 150 minutes of physical activity per week for adults ages 18 to 64. Find exercises you enjoy, such as brisk walking, jogging, dancing or water aerobics, and keep moving.

2021-08-17T11:15:00

(BPT) – After a year of remote learning, students will hopefully be returning to in-person classes this fall. Of the estimated 56 million children who attend elementary, middle and high school each year in the US,¹ approximately two students per classroom have food allergies² – and up to one in four children have their first food allergy reaction at school.³

This year the Biden Administration signed the Food Allergy Safety, Treatment, Education and Research Act (FASTER Act) ⁴ into law, making sesame the ninth major allergen, alongside peanut, tree nuts, soy, wheat, egg, cow’s milk, fish and shellfish.⁵ So, now is a good time to review how to help keep the classrooms safe for children living with life-threatening allergies.

According to the United States Food and Drug Administration (FDA), sesame allergies can be particularly pesky because they may be hidden behind labels such as “natural flavors” or “spices.”⁶ Under the FASTER Act, however, sesame must be declared on food labels beginning January 1, 2023⁷ – providing those with a life-threatening sesame allergy the information needed to help remain safe and confident in their environments.

“The FASTER Act is an important step forward in raising awareness of life-threatening allergies in and outside of the classroom,” said Kelly Barlow, BSN, RN, President of Wisconsin Association of School Nurses. “While foods such as peanuts, tree nuts, wheat and shellfish have long been recognized as potential causes of anaphylaxis, identifying sesame as the ninth major allergen can help prevent allergic emergencies at school – especially since 25% of schools reported that they did not employ a school nurse.”⁸

To prepare for the upcoming school year, Nurse Barlow recommends that children living with life-threatening allergies visit their pediatricians to receive routine immunizations and refill their epinephrine auto-injectors – because epinephrine is the only medication that can reverse anaphylactic symptoms.⁹

It’s also important that children with life-threatening allergies have an Anaphylaxis Emergency Plan and share it with their teachers, school nurses, and other academic officials, so that everyone knows what to do if an allergic emergency occurs.

One important part of an Anaphylaxis Emergency Plan is that children with life-threatening allergies should carry an epinephrine auto-injector, such as AUVI-Q^® (epinephrine injection, USP), a pocket-sized epinephrine auto-injector with innovative features. AUVI-Q is the only epinephrine auto-injector with a voice instruction system to guide step-by-step through administration on how to administer a potentially life-saving dose of epinephrine in an emergency, allowing trained and untrained teachers, nurses, and caregivers to administer AUVI-Q.¹⁰ AUVI-Q is for immediate self (or caregiver) administration and does not take the place of emergency medical care. Seek immediate medical treatment after using AUVI-Q.

Visit www.auvi-q.com to learn more and talk to your doctor to see if AUVI-Q is right for your family. To create an Allergen Profile Card to share with teachers, nurses, coaches and after school caregivers, visit https://activities-hub.auvi-q.com/create-profile-card.

Kelly Barlow is a paid spokesperson for Kaléo.

Indication

AUVI-Q^® (epinephrine injection, USP) is a prescription medicine used to treat life-threatening allergic reactions, including anaphylaxis, in people who are at risk for or have a history of serious allergic reactions.

Important Safety Information

AUVI-Q is for immediate self (or caregiver) administration and does not take the place of emergency medical care. Seek immediate medical treatment after using AUVI-Q. Each AUVI-Q contains a single dose of epinephrine. AUVI-Q should only be injected into your outer thigh, through clothing if necessary. If you inject a young child or infant with AUVI-Q, hold their leg firmly in place before and during the injection to prevent injuries. Do not inject AUVI-Q into any other part of your body, such as into veins, buttocks, fingers, toes, hands, or feet. If this occurs, seek immediate medical treatment and make sure to inform the healthcare provider of the location of the accidental injection. Only a healthcare provider should give additional doses of epinephrine if more than two doses are necessary for a single allergic emergency.

Rarely, patients who use AUVI-Q may develop infections at the injection site within a few days of an injection. Some of these infections can be serious. Call your healthcare provider right away if you have any of the following symptoms at an injection site: redness that does not go away, swelling, tenderness, or the area feels warm to the touch.

If you have certain medical conditions, or take certain medicines, your condition may get worse or you may have more or longer lasting side effects when you use AUVI-Q. Be sure to tell your healthcare provider about all the medicines you take, especially medicines for asthma. Also tell your healthcare provider about all of your medical conditions, especially if you have asthma, a history of depression, thyroid problems, Parkinson’s disease, diabetes, heart problems or high blood pressure, have any other medical conditions, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Epinephrine should be used with caution if you have heart disease or are taking certain medicines that can cause heart-related (cardiac) symptoms.

Common side effects include fast, irregular or ‘pounding’ heartbeat, sweating, shakiness, headache, paleness, feelings of over excitement, nervousness, or anxiety, weakness, dizziness, nausea and vomiting, or breathing problems. These side effects usually go away quickly, especially if you rest. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

Please see the full Prescribing Information and the Patient Information.

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

References:

1. National Center for Education Statistics (NCES). Back to School Statistics. Retrieved June 21, 2021, from https://nces.ed.gov/fastfacts/display.asp?id=372.
2. Centers for Disease Control and Prevention. Food Allergies. Retrieved June 21, 2021, from https://www.cdc.gov/healthyschools/foodallergies/index.htm.
3. McIntyre CL, Sheetz AH, Carroll CR, Young MC. Administration of epinephrine for life-threatening allergic reactions in school settings. Pediatrics 2005; 116(5):1134-1140.
4. The White House. Bills Signed: S. 164, S. 415, S. 422, S. 578. Retrieved July 21, 2021, from https://www.whitehouse.gov/briefing-room/legislation/2021/04/23/bills-signed-s-164-s-415-s-422-s-578/.
5. Allergy & Asthma Network. Sesame Allergy and Food Labels. Retrieved June 21, 2021, from https://allergyasthmanetwork.org/news/sesame-the-9th-food-allergen/.
6. U.S. Food & Drug Administration. Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new consideration of labeling for sesame allergies. Retrieved July 21, 2021, from https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-fdas-new-consideration-labeling-sesame-allergies.
7. U.S. Food & Drug Administration. Food Allergies. Retrieved July 21, 2021, from https://www.fda.gov/food/food-labeling-nutrition/food-allergies.
8. Willgerodt, M.A., Brock, D. M., & Maughan, E.M. (2018). Public School Nursing Practice in the United States. Journal of School Nursing, 34(3), 232-244.
9. Shaker MS, Wallace DV, Golden DBK, et al. Anaphylaxis-a 2020 practice parameter update, systematic review, and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) analysis. J Allergy Clin Immunol. 2020;145(4):1082-1123. doi:10.1016/j.jaci.2020.01.017
10. AUVI-Q [Prescribing Information]. Richmond, VA: kaleo Inc.; https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=6180fb40-7fca-4602-b3da-ce62b8cd2470&type=display.

2021-08-12T16:52:55

(BPT) – When Phil Green, a husband and father to four children, was diagnosed with ALS in 2018, he decided he was going to dedicate his life to advocating for other people and families affected by the disease.

“To me, I was still the same person that I had always been,” Green says as he recounts the day he first had to ask for help buttoning up his shirt. “Suddenly, I felt like I was the only person in the world that was diagnosed. I didn’t know anyone who had ALS and there wasn’t much information to help me and my family better understand what was going to happen to me. The first thing we did was try to figure out what treatments were available to slow down the disease, and we found that there were limited options.”

ALS, which stands for amyotrophic lateral sclerosis (also known as Lou Gehrig’s disease), eventually robs people of their ability to walk, talk, swallow and breathe. Green’s diagnosis hasn’t stopped him from becoming an advocate and ally to make the ALS community’s voice heard. He is one of thousands aiming to spark conversations about ALS with hopes that progress can be made to better understand and treat the disease.

Over the last three years, Green has been actively supporting many other people with ALS and their caregivers throughout their journeys, hoping to make as big a difference as he can, while he can. He is also on the boards of various ALS organizations across the country. For example, a former football player at the University of Washington, Green is on the board of Team Gleason, a nonprofit founded by former New Orleans Saints player, Steve Gleason, and also part of the patient-led organization, I AM ALS. He says more attention, research and funds are needed to bring new treatment options forward. Currently, there is no cure for ALS.

ALS is a relentlessly progressive neurodegenerative disease. For reasons that are not well understood, in people with ALS, motor neurons that allow the brain to communicate with muscles throughout the body begin to deteriorate. People with ALS experience loss of muscle control, and ultimately, death. Many individuals suffer from significant symptoms and impaired ability to function independently as early as six months from diagnosis or 18 months from symptom onset.

“From my point of view, the more people that know about ALS and how uniquely cruel it is, the more support we can get for broader funding and more compassion for the disease,” Green says. “I feel like too many people are just OK with us progressing and dying because the disease has mystified scientists. The more researchers we can have focused on the mechanisms of the disease and the identification of biomarkers, the greater the chance of actually moving forward in a disease that historically has not seen much knowledge gain.”

Green has had a lasting impact on many touched by ALS. He has even impacted those with no connection to ALS until they met him. Take Dan White, for example, who befriended Green when they bonded over their love of sports. Almost a decade later, when Green and others in the ALS community participated in Amylyx Pharmaceutical’s annual INKEDforALS campaign for ALS Awareness Month in May by stamping temporary tattoos on themselves, White took it to the next level and tattooed the symbol on his arm — for life.

White says, “I did it for many reasons, the primary one being selfish. I wanted to see the symbol every day because even if I felt I was having a bad day, I could look down and remember that my day is not so bad. My friend has been dealt a much worse hand in life, and he’s making the most out of it. The world needs to know that people as strong as Phil exist.”

Green and White ask that others join in to help shine a light on ALS to promote advancing the science and potentially disrupting the disease’s course.

“It’s unacceptable that when Lou Gehrig made a speech 80 years ago, he felt we would be able to cure this in his lifetime. We need to move at what we call the ‘ALS clock’ and help save the people living with the disease today.”

ALS remains a devastating disease, but some researchers believe this is a hopeful and exciting time in ALS research with many promising clinical trials and investigational products being tested at a faster pace than ever.

An unmet need continues to exist in ALS, but advocates like Green continue to spark conversations that inspire hope and could lead to life-changing advances.

To learn more about ALS and available resources, visit www.als.org and www.alsfindingacure.org.

2021-08-11T12:25:00

(BPT) – By now, you have likely seen the term “gene therapy” used somewhere. While it may seem like something out of a sci-fi movie, gene therapy approaches are already being used to treat people living with rare genetic diseases today. Still, you might be wondering, “What is gene therapy?”

Gene therapy and PKU

Gene therapy is a type of genetic medicine that is designed to introduce a functional copy of a gene, or an “instruction manual” that tells the body how to make a specific protein, into a person’s cells where there is a missing or mutated (nonworking) gene that is causing a disease. The goal of gene therapy is for the functional copy of the gene to begin working as it should and thereby address the genetic disorder. Gene therapies can be made in different ways and are most commonly delivered using an adeno-associated virus (AAV) vector, which is a virus that will not cause disease.

A unique characteristic of gene therapy is that it is designed to be given to a patient just one time but to have long-term effects, especially for cells of the body that are not dividing rapidly, such as an adult liver. There are FDA-approved gene therapies that are being used to treat patients with rare genetic disorders and many more that are being developed and tested in human clinical research studies. One disease that could potentially be addressed with a gene therapy approach is phenylketonuria, or PKU, a rare, genetic metabolic disorder that affects nearly 16,500 people in the U.S.

PKU is caused by mutations in the PAH gene and results in a loss of function of the enzyme phenylalanine hydroxylase, or PAH, which is responsible for the metabolism of phenylalanine, or Phe, an amino acid that a person gets exclusively from their diet. If left untreated, toxic levels of Phe can accumulate in the blood. Currently, there are no treatment options that target the underlying genetic cause of PKU, and the vast majority of patients are required to follow a life-long, difficult diet that is incredibly low in protein and requires use of medical foods.

pheNIX: A clinical trial for adults with PKU

A clinical trial called pheNIX is evaluating an investigational gene therapy for adults with PKU. This gene therapy is designed to be given to the patient through a single intravenous, or I.V., administration, with follow-up appointments with a physician to monitor the patient’s health.

The pheNIX trial is enrolling adults with PKU at clinical sites throughout the U.S. Candidates for pheNIX include PKU patients who are:

• Aged 18-55 years
• Willing and able to maintain their existing diet
• Willing to commit to required study visits and tests for the duration of the trial

There are additional requirements to participate, which your doctor can explain. Does this sound like something you or someone you know would be interested in? If so, talk to your doctor or take this short questionnaire to see if you are a candidate for pheNIX.