Category: Brandpoint Health

2023-08-03T16:51:00

(BPT) – Picture this: You’re walking down the dairy aisle at your local grocery store and see an assortment of milk, cheese and other delicious dairy products. You ask yourself: How do I choose? Well, here’s the thing — not all dairy products are created equal!

If you have yet to buy organic, now may be the time to switch. “Organic” isn’t just a slogan or a fancy marketing term — it’s backed by National Organic Program (NOP) standards. These standards are a set of rules established by the United States Department of Agriculture (USDA) to ensure that organic agricultural products are produced, handled and labeled correctly.

Let Organic Valley guide you through the dairy world and share its top five reasons organic is a game changer.

1. High-Quality Nutrition

Studies show that organic milk packs a nutritional punch with higher antioxidant levels and essential nutrients like omega-3 and CLA fatty acids. And, according to the National Library of Medicine, it has been shown that organic crops contain significantly fewer concentrations of cadmium — a toxic metal similar to lead and mercury. Toxic pesticides, antibiotics and GMOs are never used in the production of organic milk. By leaving out the bad stuff, organic dairy products have more room for the good stuff, with a taste that can’t be beat.

“I recommend drinking milk for anyone looking to add more protein and vitamins, such as vitamin A, B12 and D into their diet,” said Carly Knowles, MS, RD, LD — a registered dietitian and Organic Valley partner. “My personal favorite and go-to milk is Organic Valley’s Whole Milk Grassmilk^® for added health benefits of extra omega-3 fatty acids and CLA content, and that’s because their cows spend 50% more time outside than the organic standard.”

2. Positive Impact on Sustainability

Because NOP was built on the concept of sustainable farming practices, organic dairy farms are often at the cutting edge of sustainable practices, setting an example for conventional counterparts. According to a 2022 research study from the University of Wisconsin-Madison, Organic Valley’s small organic dairy farms focus on grazing and organic production techniques that produce 24% lower greenhouse gas emissions than conventional dairy farms.

Organic dairy farmers allow their cattle to graze in pastures. While cattle graze, they trample plants and other matters into the ground so it can decompose naturally, enriching the soil and trapping carbon. Organic dairy farming is a win-win for the environment and your taste buds.

3. Commitment to Animal Care

Organic dairy farming prioritizes the health and well-being of their cows and promotes the animal’s natural behaviors. Firstly, organic cows must have access to the outdoors. This means they can go outside and enjoy fresh air and sunlight. This freedom is crucial for them to engage in natural cow activities like chewing cud, grazing on grass and simply living as cows.

And small organic family farms are constantly innovating animal care and are often ahead of the industry with creative ways to care for their animals that fit their unique farm circumstances. A good example of this is how some farmers rely upon native bird species to control the fly population.

4. Supports Local Organic Dairy Farmers

Every time you purchase an organic dairy product, you nourish yourself and your loved ones and show your support to local organic dairy farmers. Look for brands like Organic Valley, a cooperative of more than 1,600 small family farms committed to sustainably growing food and raising animals through organic agriculture. For these family farmers who own and run their own farms, dairy isn’t just a business — it’s a way of life. To find a farm near you, visit OrganicValley.coop.

5. Versatile and Trend-forward

Chances are you’ve stumbled upon food tends that have gone viral: from baked feta to butter boards, pesto eggs to cottage cheese ice cream. And the list goes on! What do these have in common? You guessed it — dairy. These culinary trends are dairy-forward and with a few staples on hand, you can impress your friends and family with easy-to-make, delicious dishes. Next time you’re at the grocery store, remember to pick up organic dairy products to make a fun, easy and delicious summer dessert like PB&J cottage cheese ice cream!

These are just a few of the many reasons why you should be using organic dairy products in your meals and snacks. To learn more about how Organic Valley supports small family farms and brings consumers high-quality, delicious dairy products while reducing its impact on the environment, visit OrganicValley.coop and dive into their 2023 Impact Report.

2023-08-03T05:01:00

(BPT) – Acne is the most common skin condition in the U.S., affecting roughly 50 million people of all ages. In fact, about 85% of people between the ages of 12 and 24 experience at least minor acne,[1] and it doesn’t stop there. Even adult men and women may still suffer from acne breakouts on their face, chest and back.[2]

If you are like most people who suffer with acne, you’ve probably tried just about everything to keep pimples under control. From prescriptions to peels, facials and creams — the wide range of acne therapies keeps expanding.

You can try to control your acne with prescription and non-prescription products and diligent skin care, but these only last as long as they’re being used. AviClear^® by Cutera^® selectively targets and suppresses the sebaceous glands, eliminating acne at the source, offering a durable option for acne sufferers.

AviClear initially received FDA clearance in March 2022 and has recently announced an additional clearance as a long-term treatment for all severities of inflammatory acne vulgaris. Over the last year AviClear has also received various awards from Elle, Cosmopolitan, Good Housekeeping and more, earning the seal of approval from top skin and beauty experts.

“The US FDA acknowledgment of long-lasting results from AviClear further supports the results we are seeing in my practice,” says Dr. Jessica Weiser, Weiser Skin MD in New York City. “It gives our patients greater confidence in the efficacy and durability of AviClear results.”

According to Dr. Weiser, “as the first acne therapy to claim long-term effectiveness for mild, moderate and severe acne, we have found that the results get progressively better over time for our patients. AviClear is well tolerated and requires only three 30-minute treatment sessions.”

Cutera’s clinical data confirm these results. Recent clinical studies have shown that after three 30-minute treatment sessions, 90% of patients had a visible improvement in their acne at 6 months.[3] Furthermore, 12-month clinical data demonstrates an improvement of 92%, confirming long-term acne clearance.[3]

“AviClear is the first 1726nm laser on the market, and represents a state-of-the-art acne solution for our patients,” according to Dermatologist Nazanin Saedi from Dermatology Associates of Plymouth Meeting near Philadelphia.

“AviClear is paving the way for a faster and more effective way to clear your acne and keeping it clear. In three 30-minute treatment sessions, our patients have seen major long-term improvements in their facial skin over the course of just a few months,” she continues.

“The treatment is safe and effective for all types of skin and skin tones. It is an efficacious solution in our practice for patients who are suffering with acne breakouts and looking for an alternative to the potential side effects of medications,” says Dr. Saedi.

Ready to stop acne in its tracks without creams, medications, or heavy concealer?

Visit AviClear.com to find an AviClear provider near you.

2023-08-02T16:31:00

(BPT) – Did you know you can start protecting your baby against flu while you are still pregnant? For pregnant people, getting a flu shot is the first and most important action you can take to protect both yourself and your baby from flu and its potentially serious complications.

You may have heard that pregnant people are at higher risk of getting very sick and being hospitalized with flu. This may be because of changes in the immune system, heart and lungs during pregnancy. Flu also may be harmful to a pregnant person’s developing baby. A common flu symptom, fever, has been associated in some studies with adverse outcomes for a developing baby. Additionally, babies younger than 6 months are at higher risk of getting very sick from flu, but they are too young to be vaccinated themselves.

Flu shot benefits for you and your baby

But there is some great news about flu shots for pregnant people and their babies. Studies show a flu shot during pregnancy protects pregnant people from flu during and after pregnancy. Vaccination during pregnancy also protects the infant during the first few months after birth when they are too young to get vaccinated themselves. One study showed fewer cases of infants with influenza in mothers who received the vaccine compared to those mothers who were not vaccinated, displaying a high degree of vaccine effectiveness. This is because, as a pregnant parent, you pass your antibodies on to your developing baby during your pregnancy.

When to protect you and your baby

A flu shot can be given during any trimester of pregnancy. For most pregnant people, September and October are generally good times to be vaccinated. For pregnant people in their third trimester, however, vaccination during July or August can be considered to provide optimal protection against flu for the baby after birth, when they are too young to get vaccinated. This information is outlined in the Centers for Disease Control and Prevention’s (CDC) guidance for the prevention of flu through vaccination for the 2023-2024 season, which was adopted by CDC’s director as CDC policy on June 28, 2023.

Get your flu shot today!

There are many different options for you to get a flu shot, including at a health care provider’s office, at work, a pharmacy, some stores or even supermarkets. Speak to your health care provider today to learn more about how a flu shot can protect you and your baby, and to access information about the importance of all maternal vaccinations including Tdap, COVID-19 and HepB vaccines. You can learn more about flu and pregnancy at cdc.gov/flu/highrisk/pregnant.htm.

2023-08-02T10:43:51

(BPT) – Meal Detection™ Technology* provides real-time insulin adjustments and corrections to help cover undercounted carbs and occasionally missed meal doses.

Isabel (Izzi), a ninth-grade student and active teenager, is passionate about playing the violin in her school orchestra, as well as guitar and participating in several musical groups. In addition, she and her family enjoy outdoor activities like skiing and hiking. But unlike other teens, Izzi faces the challenge of managing type 1 diabetes (T1D) since her diagnosis in 2020.

“I remember it being Friday the 13th,” says her mom, Liz. “I knew the signs to look for because my mom, sister, and several aunts and uncles also had type 1. It’s a relentless disease. I lost my mom, an aunt, and two uncles to complications from type 1 diabetes, and I was determined not to let this happen to Izzi. I wanted her to be healthy, and more than that, I wanted her to continue to be a teenager — one that was not constantly worrying about her health.”

Approximately 1.6 million Americans, including Izzi, live with type 1 diabetes, an autoimmune disease that impairs the body’s ability to produce insulin, the hormone needed for glucose to enter cells and produce energy. Without daily management of blood sugars, hypoglycemia (low blood sugars) can be life-threatening and hyperglycemia (high blood sugars) can be dangerous over an extended period of time and lead to complications like kidney damage, heart problems and cognitive decline.[i]

On average, someone living with diabetes makes up to 180 diabetes-related decisions a day, including counting their carbohydrate intake before snacks and meals and then determining how much insulin to give themselves to cover for those carbs. It can feel like a constant math problem, and it’s cited as the biggest pain point for most. Nearly 50% of people consider carb counting the most burdensome aspect of diabetes care.[ii] When tested on carb-counting accuracy, people with T1D underestimate carbs 63% of the time[iii] and many forget or even skip them intentionally. This has an adverse impact on clinical outcomes and can lead to frequent highs.

Izzi needed a solution that would allow her to think less about her diabetes and just be a kid. Fortunately, she had the opportunity to participate in a clinical trial studying the MiniMed™ 780G system with Meal Detection™ Technology. The pump automates the delivery of insulin every five minutes and even covers for the times Izzi occasionally skips a meal bolus or underestimates her carbs.**

“As a mom, there’s nothing more I can ask for than a system that watches over her without us constantly needing to worry about whether she is going high or low — especially at night when the fear of her not waking up can feel incredibly stressful. It gave Izzi more independence and it really pushed her diabetes into the background,” says Liz. “It was a godsend.”

The clinical outcomes were the best they’d experienced, with Izzi spending over 90% of her time in her target glucose range. “With other technology, my highs and lows were much more severe, and we all lost a lot of sleep,” shared Izzi. “It was stressful for our whole family and my parents were even nervous about letting me drive eventually, because they didn’t think it would be safe. Now they’re not worried about that.”

Dr. Greg Forlenza, Associate Professor, Pediatrics-Barbara Davis Center, University of Colorado, and also Izzi’s doctor, says that mealtimes can be difficult. “Clinical outcomes are historically worst in adolescents — particularly when it comes to meal management and forgetting to bolus, but the MiniMed™ 780G system can bring them back into range quickly and safely.” Forlenza continues, “If you make a mistake, it’s OK because the system auto corrects in real-time. It also cuts down on potential conflicts between kids and their parents when they forget to bolus, and also ultimately allows parents to ease up a bit and give them more independence.”

With the MiniMed™ 780G system now approved in the U.S., Izzi is eager to get back on the system and is excited about her next big adventure: obtaining her learner’s permit.

“The MiniMed™ 780G system just makes life easier. I set my glucose target, and the pump does most of the work,” Izzi said. “Instead of spending time managing my glucose numbers, I can now focus on the things that I love! The best part is that my parents don’t have to worry about me as much.”

For more information about the MiniMed™ 780G, visit www.medtronicdiabetes.com/780G.

Important safety information: MiniMed^™ 780G system with SmartGuard^™ technology with Guardian^™ 4 sensor

The MiniMed^™ 780G system is intended for continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at selectable amounts for the management of type 1 diabetes mellitus in persons seven years of age and older requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed^™ 780G system includes SmartGuard^™ technology, which can be programmed to automatically adjust insulin delivery based on the continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin when the sensor glucose (SG) value falls below or is predicted to fall below predefined threshold values.

The Medtronic MiniMed^™ 780G system consists of the following devices: MiniMed^™ 780G insulin pump, the Guardian^™ 4 transmitter, the Guardian^™ 4 sensor, One-press serter, the Accu-Chek^™ Guide Link blood glucose meter, and the Accu-Chek^™ Guide test strips. The system requires a prescription from a healthcare professional.

The Guardian^™ 4 sensor is intended for use with the MiniMed^™ 780G system and the Guardian 4 transmitter to monitor glucose levels for the management of diabetes. The sensor is intended for single use and requires a prescription. The Guardian^™ 4 sensor is indicated for up to seven days of continuous use.

The Guardian^™ 4 sensor is not intended to be used directly to make therapy adjustments while the MiniMed^™ 780G is operating in manual mode. All therapy adjustments in manual mode should be based on measurements obtained using a blood glucose meter and not on values provided by the Guardian^™ 4 sensor. The Guardian^™ 4 sensor has been studied and is approved for use in patients ages 7 years and older and in the arm insertion site only. Do not use the Guardian^™ 4 sensor in the abdomen or other body sites including the buttocks, due to unknown or different performance that could result in hypoglycemia or hyperglycemia.

WARNING: Do not use the SmartGuard^™ feature for people who require less than 8 units or more than 250 units of total daily insulin per day. A total daily dose of at least 8 units, but no more than 250 units, is required to operate in the SmartGuard^™ feature.

WARNING: Do not use the MiniMed^™ 780G system until appropriate training has been received from a healthcare professional. Training is essential to ensure the safe use of the MiniMed^™ 780G system.

WARNING: Do not use SG values to make treatment decisions, including delivering a bolus, while the pump is in Manual Mode. When the SmartGuard^™ feature is active and you are no longer in Manual Mode, the pump uses an SG value, when available, to calculate a bolus amount. However, if your symptoms do not match the SG value, use a BG meter to confirm the SG value. Failure to confirm glucose levels when your symptoms do not match the SG value can result in the infusion of too much or too little insulin, which may cause hypoglycemia or hyperglycemia.

Pump therapy is not recommended for people whose vision or hearing does not allow for the recognition of pump signals, alerts, or alarms. The safety of the MiniMed^™ 780G system has not been studied in pregnant women, persons with type 2 diabetes, or in persons using other anti-hyperglycemic therapies that do not include insulin. For complete details of the system, including product and important safety information such as indications, contraindications, warnings and precautions associated with system and its components, please consult https://www.medtronicdiabetes.com/important-safety-information#minimed-780g and the appropriate user guide at https://www.medtronicdiabetes.com/download-library

* Taking a bolus 15 – 20 minutes before a meal helps to keep blood sugar levels under control after eating.

**Refers to SmartGuard™ feature. Individual results may vary.

[i] Mauras N, Buckingham B, White NH, Tsalikian E, Weinzimer SA, Jo B, Cato A, Fox LA, Aye T, Arbelaez AM, Hershey T, Tansey M, Tamborlane W, Foland-Ross LC, Shen H, Englert K, Mazaika P, Marzelli M, Reiss AL; Diabetes Research in Children Network (DirecNet). Impact of type 1 Diabetes in the Developing Brain in Children: A Longitudinal Study. Diabetes Care. 2021 Apr;44(4):983-992. doi: 10.2337/dc20-2125. Epub 2021 Feb 10. PMID: 33568403; PMCID: PMC7985430.

[ii] Medtronic data on file. 25-minute survey, N= 498 T1D individuals in Germany, Japan, US, Brazil, August 2019.

[iii] Sarah C. Westen, Jennifer L. Warnick, Anastasia Albanese-O’Neill, et al. Objectively Measured Adherence in Adolescents With type 1 Diabetes on Multiple Daily Injections and Insulin Pump.

2023-07-31T08:01:00

(BPT) – Let’s talk about decaf coffee. It’s been getting some well-deserved attention lately. For the longest time, decaf has been unfairly judged as inferior to its caffeinated counterpart. But guess what? Things have changed in the past couple of years, and more and more people are turning to decaf, either as a complement to their regular coffee or even as a complete replacement.

A recent Swiss Water Decaffeinated Coffee Inc. survey of 18- to 40-year-olds who drink decaf revealed that among those who drink both decaf and regular coffee (dual drinkers), 75% said their decaf consumption has actually gone up since the start of the pandemic. Even among those who exclusively drink decaf, two-thirds of them have also been sipping more decaf ever since.

It’s pretty clear — decaf is having a moment, and it’s not just a passing trend. If you’re decaf curious but still on the fence, here are some reasons why it’s worth giving decaf a chance.

1. Same coffee taste

A common myth about decaf is that it tastes bland or inferior compared to caffeinated coffee. However, according to Swiss Water’s survey, 66% of dual drinkers and 75% of decaf-only drinkers choose decaf because they enjoy the taste. You can enjoy the nuanced and complex characteristics and flavors of specialty coffee without caffeine effects, which means you can enjoy the taste and aroma all day long. The quality of the coffee beans and the method of decaffeination also have a big impact on the taste.

Even to experts, quality decaf coffee is largely indistinguishable from its caffeinated counterpart. Swiss Water’s proprietary chemical-free decaffeination method takes it a step further. Last year, a Swiss Water decaffeinated coffee from the Panama Chiriquí province was entered into the Golden Bean World Series competition without the judges knowing it was decaf. Out of 50 specialty coffees, the international judges placed it in the top 10.

2. Less anxiety and improved sleep

While a perfectly pulled shot of espresso or your favorite single-origin pour-over can help you wake up and start your day, drinking caffeinated coffee throughout the day can worsen your anxiety and prevent you from getting a good night’s sleep. Research shows that people afflicted with panic disorder are more susceptible to experiencing panic attacks and heightened anxiety levels due to caffeine intake. That’s why many individuals are cutting back on their caffeine intake and opting to drink decaf instead.

According to the survey, all respondents reported increasing decaf coffee consumption since COVID-19 for health reasons. Dual and decaf-only drinkers drank more decaf to reduce their anxiety (59% and 46%, respectively) and improve sleep quality (55% and 49%, respectively). The science backs this up too. Several studies show that decaf coffee offers most of the same health benefits as regular coffee. It’s all because decaf retains most of the beneficial compounds and polyphenols, like chlorogenic acids, which help reduce the risk of various diseases and promote overall well-being.

By minimizing caffeine consumption, decaf allows individuals to enjoy the ritual of drinking coffee without as much of a spike in anxiety or poor sleep quality.

3. Quality makes a difference

Quality matters when choosing decaf, and not all decaf coffee is created equal. The survey found that almost all decaf-only (97%) and dual drinkers (92%) consider overall quality highly important when purchasing decaf. Quality can vary depending on the decaf process.

Traditional decaffeination methods use chemicals such as methylene chloride and ethyl acetate, which have a greater impact on altering the taste of the coffee and can leave residuals in the cup. The Swiss Water Process proprietary decaffeination method is a chemical-free process that renders what many believe to be the purest decaf coffee on the market.

The Swiss Water Process involves combining green coffee beans with green coffee extract. The extract is made up of water and the natural soluble solids found in coffee, minus the caffeine.

Through osmosis, the caffeine molecules are naturally extracted from the beans into the solution, until all that’s left is 99.9% caffeine-free coffee that retains its natural flavor and aroma.

You can have it all

If you want to cut out the caffeine but don’t want to compromise on the integrity, variety, flavor or health benefits of drinking coffee, decaf just might be your beverage answer. To ensure you get quality decaf coffee that is chemical free, look for the words Swiss Water Process on the coffee brand’s label or website description.

Ready to feed your decaf curiosity? The next time you’re at the store or café, make it a habit to look for and ask whether the coffee has been decaffeinated by the Swiss Water Process. You can also visit SwissWater.com to find roasters who offer this high-quality decaf coffee you can enjoy at home, in the office or on the go.

2023-07-26T13:55:00

(BPT) – While SHEIN may be synonymous with affordable online shopping, local shoppers in Indianapolis were recently treated to a first-hand look at the brand’s products through a 4-day pop-up event. Customers browsed the physical retail space, interacting with exclusive SHEIN products they would typically only be able to shop online. In the past year, SHEIN has hosted multiple pop-ups around the world.

Connecting with local communities is an integral part of the online brand’s strategy. For a company as large and globally connected as SHEIN, it’s vital to use that market power for the greater good of the fashion industry as a whole and invest in the communities that customers and creators call home.

In May 2023, SHEIN formed a partnership with Girls Inc. of Greater Indianapolis, the central Indiana chapter of the nationwide non-profit organization. Girls Inc. Indy empowers girls, from ages 6 to 24, with evidence-based programming to support their whole selves, providing guidance and mentorship to nurture their strengths. SHEIN partnered with Girls Inc. Indy to support their 2023 STEM summer camp, an educational program for local high school girls to broaden their horizons in science, technology, engineering and math. SHEIN team members presented on multiple STEM disciplines, showing the campers a glimpse of the wide breadth of STEM careers they could pursue.

Participants of the Girls Inc. Indy program were invited to SHEIN’s pop-up activation in Indianapolis, joining 3,500 fans, all able to shop various collections from the brand. Local designer Tendai Phillips also made a special appearance at the event. Originally from Zimbabwe, Phillips moved to the U.S. and earned her degree from The Art Institute of Indianapolis. Her collection, SHEIN x Redefinition, is part of the SHEIN X Design Incubator program that gives independent designers and artists around the world the tools they need to share their brand with customers across global markets. “SHEIN X changed my future in the fashion industry by giving me a platform where I could express my creativity and share it with the rest of the world,” explained Phillips. “This is something that would have taken me time to build and bridge that gap between my brand and the rest of the world.”

Since kicking off SHEIN X in January 2021, SHEIN has invested over $55 million in the program and brought over 3,000 designers’ original collections to market. More than half of SHEIN X designers are based in the U.S., spread across 47 states. SHEIN X designers receive production, distribution, and marketing support to take their designs from paper to the global SHEIN site. Programs like this are vital to ensure the next generation of talent has the best tools at their disposal to be successful in the industry.

While the fashion industry continues to quickly evolve, it’s exciting to see a large global brand, like SHEIN, keep individual communities at the heart of their impact. By localizing operations, including the recent establishment of facilities in locations like Brazil, SHEIN helps prove that it’s possible to prioritize supporting local communities that are passionate about fashion to bring the newest trends to local customers and support designers in developing tomorrow’s favorites.

2023-07-20T15:31:00

(BPT) – Natural disasters alter more than an area’s landscape. They can also affect the quality of indoor air we breathe … because what happens outside does not always stay outside. In the wake of natural disasters such as tornados, floods, and fires, outdoor air can enter homes, and bring with it pollutants that impact indoor air quality. Here’s what you need to know about the potential risks, the need to be “air aware,” and the steps you can take to create cleaner, fresher breathing environments indoors.

2023-07-20T06:01:00

(BPT) – –

Imagine you have a rare bleeding disorder and have spent much of your life knowing you are at greater risk of uncontrollable bleeding. You self-infuse treatment on a strict, regular schedule to make sure your blood will clot. This restrictive infusion schedule can impact work, education, lifestyle, and even where you vacation.

Now, imagine a treatment option that can offer consistent bleed protection for years after a one-time infusion, lowering the risk of bleeds and reducing the burden you’ve experienced as a person with a rare bleeding disorder. This is now a reality for some people with hemophilia B after the U.S. Food and Drug Administration (FDA) approved HEMGENIX^® (etranacogene dezaparvovec-drlb), the first and only gene therapy for adults with hemophilia B who currently use factor IX prophylaxis therapy, or have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes.

The future of hemophilia B treatment is now

Hemophilia B is a rare bleeding disorder that affects around 6,000 people in the U.S. For people with the condition, their blood does not clot in the typical way because they lack sufficient factor IX, a protein primarily produced by the liver that helps blood clots form.

The more severe the condition, the less able a person is to form blood clots, making them more vulnerable to bleeding. If not adequately controlled, people with the condition are more vulnerable to trauma and spontaneous bleeding into their joints. Sometimes these bleeds can be life-threatening and can lead to permanent physical damage. The most common treatment for people with moderate to severe hemophilia B is lifelong prophylactic infusions to temporarily replace or supplement low levels of blood-clotting factor.

But with HEMGENIX, people with the condition can produce their own elevated and sustained levels of factor IX for years following a one-time single intravenous infusion. Now, people with hemophilia B are beginning to receive this innovative treatment at hemophilia treatment centers across the U.S.

How—and why—HEMGENIX breaks new ground for people with hemophilia B

HEMGENIX uses a gene therapy approach called gene transfer. This approach aims to introduce a working gene into the body to produce functional factor IX and support natural blood-clotting ability.

The working gene is loaded into an inactive viral shell, known as a vector. HEMGENIX uses an adeno-associated viral vector serotype 5, an AAV5 vector. Administered as a one-time IV infusion, HEMGENIX heads toward the liver with the working gene. Once it arrives in the liver, the working gene’s instructions are unloaded and the AAV vector shell is broken down and eliminated. The genetic instructions remain, however, so that the liver can produce elevated and protective factor IX on its own. Following administration of HEMGENIX, overall health, liver health, and factor IX activity levels should be tracked weekly for the first three months so the doctor can monitor the response to HEMGENIX.

Results from clinical trials of HEMGENIX showed people treated with the one-time infusion produced a mean factor IX activity of 37% and had a significant reduction in annual bleed rates. Encouragingly, 94% of people (51 out of 54) discontinued routine factor IX prophylaxis. The most common side effects reported in more than 5% of patients were liver enzyme elevations, headache, elevated levels of a certain blood enzyme, flu-like symptoms, infusion-related reactions, fatigue, nausea, and feeling unwell.

“I am proud to have been involved in a clinical trial program that had such good results and offers so much hope to the hemophilia B community,” said Dr. Steven Pipe, professor at the University of Michigan, Ann Arbor, and medical director of the Pediatric Hemophilia and Coagulation Disorders Program. “As I follow those who have gone through this treatment and see their lives blossom, I continue to be excited. I have a clinical trial participant who says he celebrates two birthdays—the day of his official birth and the date he received treatment.”

In addition to the potential long-term health benefits from greater bleed protection and liberation from infusion schedules, HEMGENIX could also generate significant cost savings for the healthcare system at-large. Healthcare costs can be 25 times higher for a person living with hemophilia B compared to individuals who do not have a bleeding disorder—amounting to a total adult lifetime cost of more than $20 million per person.

Talk with your doctor

People living with hemophilia B who are interested in HEMGENIX should talk to their doctor about the potential benefits and eligibility screening.

Those who decide with their doctor to move forward with treatment can enroll in HEMGENIX Connect^SM where they will be assigned a dedicated support team, including a Patient Resource Navigator and CSL Case Manager, who can:

• Provide education on gene therapy and how it works
• Provide support and guidance on the HEMGENIX treatment journey
• Assist with insurance questions and review, explaining benefits and determining eligibility for financial assistance programs

Get support

Having a rare disease can feel isolating and trying a new treatment can cause a mix of emotions, from excitement to anxiety. The B Support^TM app was designed specifically to help people with hemophilia B as they explore whether gene therapy is right for them.

The app allows people with hemophilia B to:

• Record bleeds, factor IX activity and how they are feeling to better track their current treatment and progress over time. Having this information at their fingertips, either on their phone or tablets, allows people with hemophilia B to have robust conversations with their healthcare professional about whether they are meeting their treatment goals, and if needed, other therapeutic options.
• Get valuable resources, reminders and support to enhance their experience managing hemophilia B.
• Access education on gene therapy, including information on eligibility.

The app is available in the Apple and Google Play stores in the U.S.

With advanced research and new treatments, people with hemophilia B may have more freedom from their treatment schedule. To learn more, visit HEMGENIX.com.

Important Safety Information?

What is HEMGENIX?

HEMGENIX^®, etranacogene dezaparvovec-drlb, is a one-time gene therapy for the treatment of adults with hemophilia B who:

• Currently use Factor IX prophylaxis therapy, or
• Have current or historical life-threatening bleeding, or
• Have repeated, serious spontaneous bleeding episodes.

HEMGENIX is administered as a single intravenous infusion and can be administered only once.

What medical testing can I expect to be given before and after administration of HEMGENIX?

To determine your eligibility to receive HEMGENIX, you will be tested for Factor IX inhibitors. If this test result is positive, a retest will be performed 2 weeks later. If both tests are positive for Factor IX inhibitors, your doctor will not administer HEMGENIX to you. If, after administration of HEMGENIX, increased Factor IX activity is not achieved, or bleeding is not controlled, a post-dose test for Factor IX inhibitors will be performed.

HEMGENIX may lead to elevations of liver enzymes in the blood; therefore, ultrasound and other testing will be performed to check on liver health before HEMGENIX can be administered. Following administration of HEMGENIX, your doctor will monitor your liver enzyme levels weekly for at least 3 months. If you have preexisting risk factors for liver cancer, regular liver health testing will continue for 5 years post-administration. Treatment for elevated liver enzymes could include corticosteroids.

What were the most common side effects of HEMGENIX in clinical trials?

In clinical trials for HEMGENIX, the most common side effects reported in more than 5% of patients were liver enzyme elevations, headache, elevated levels of a certain blood enzyme, flu-like symptoms, infusion-related reactions, fatigue, nausea, and feeling unwell. These are not the only side effects possible. Tell your healthcare provider about any side effect you may experience.

What should I watch for during infusion with HEMGENIX?

Your doctor will monitor you for infusion-related reactions during administration of HEMGENIX, as well as for at least 3 hours after the infusion is complete. Symptoms may include chest tightness, headaches, abdominal pain, lightheadedness, flu-like symptoms, shivering, flushing, rash, and elevated blood pressure. If an infusion-related reaction occurs, the doctor may slow or stop the HEMGENIX infusion, resuming at a lower infusion rate once symptoms resolve.

What should I avoid after receiving HEMGENIX?

Small amounts of HEMGENIX may be present in your blood, semen, and other excreted/secreted materials, and it is not known how long this continues. You should not donate blood, organs, tissues, or cells for transplantation after receiving HEMGENIX.

Please see full prescribing information for HEMGENIX.

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.

You can also report side effects to CSL Behring’s Pharmacovigilance Department at 1-866-915-6958.?

HEMGENIX is manufactured by uniQure Inc. and distributed by CSL Behring LLC.

HEMGENIX^® is a registered trademark and B Support^TM is a trademark of CSL Behring LLC.

HEMGENIX Connect^SM is a service mark of CSL Behring LLC.

©2023 CSL Behring LLC 1020 First Avenue, PO Box 61501, King of Prussia, PA 19406-0901 USA

USA-HGX-0456-JUL23

2023-07-18T08:01:00

(BPT) – Putting Data into Action

Drug overdoses are preventable, yet more than one million people died from a drug overdose between 1999 and 2021. Every day, almost 300 people lose their lives due to drug overdose. Public health professionals, policymakers and communities all play a role in preventing overdose deaths. Overdose Data to Action (OD2A) is a CDC-funded program that helps state and local health departments, and the communities they serve, to get high-quality, timelier data on nonfatal and fatal drug overdoses and use those data to inform prevention and response efforts. CDC supports OD2A-funded communities in their ability to address drug overdoses by providing access to subject matter experts and tailored technical assistance, and overdose prevention resources. “The impact of this crisis is far-reaching, touching the lives of our families, friends and neighbors in deeply personal and profound ways. By prioritizing successful prevention and response efforts and providing tailored tools and resources, we can help ensure everyone has access to the care and support they need to live healthy, fulfilling lives — building stronger, more resilient communities,” says Christopher M. Jones, PharmD, DrPH, MPH (CAPT U.S. Public Health Service), Director of CDC’s National Center for Injury Prevention and Control.

Sharing state and local overdose prevention and response strategies

CDC developed the OD2A Case Studies to capture in-depth information from funded jurisdictions about current and emerging practices related to overdose prevention and response. Designed for public health practitioners, these case studies share examples that can be adapted at the state and local levels. Partners on the ground asked for more relevant and applicable strategies, so CDC identified six key topic areas for interviews, analysis and write-ups in these case studies.

• Adverse childhood experiences (ACEs) are preventable, potentially traumatic events that occur in childhood (0-17 years). Recognizing the lasting negative effects ACEs can have and focusing on their intersection with substance use disorders, this case study highlights OD2A-funded initiatives addressing ACEs in Louisiana and South Carolina.
• Harm reduction is a public health approach that focuses on reducing the harmful consequences of drug use. It can include syringe services programs, naloxone distribution, fentanyl test strip distribution, and community overdose prevention and education. Focusing on the Illinois Harm Reduction Community Linkage Project, this case study describes a novel harm reduction program that funds local organizations.
• Linkage to care is the process of connecting people at risk of overdose to evidence-based treatment, services and support. Access to care and services is critical to addressing the overdose epidemic. Using an example from Massachusetts, CDC shares practices specific to improving linkage to care in non-public safety settings.
• Public safety-led post-overdose outreach can help identify people at higher risk of overdose by linking them to care and other overdose prevention and harm reduction efforts. Two case studies describe successful public safety-led post-overdose outreach initiatives in West Virginia and Franklin County, Ohio.
• State and local health departments are uniquely positioned to respond to the drug overdose crisis, with the authority to enact policies, deploy resources and coordinate various partners. State and local integration activities engage health departments, community organizations, coalitions and community members in working together on prevention. The case studies presented on this topic illustrate what successful state and local integration looks like in Rhode Island and California.
• Reducing stigma at multiple levels and creating a culture of change is important to helping people at risk of overdose. Stigma occurs when people with certain social identities are labeled, stereotyped and devalued, leading to discriminatory behavior and internalized shame that can negatively affect access to health care and other support services. CDC shared two examples of state programs addressing stigma related to people who use drugs, from Vermont, Motivational Interviewing and Compassion Training, and Stigma/Harm Reduction Training.

Helping communities put effective practices to work

When people’s lives are on the line, integrated data and effective programs help communities take action to protect people from drug overdose and related harms. The overdose crisis requires prevention, treatment, recovery and harm reduction efforts that are tailored to promote optimal health for all.

Communities are demonstrating innovation in reducing overdose and are sharing compelling examples of collaboration and teamwork. CDC is showcasing these so that communities can learn from each other. Beyond promoting the critical work that continues nationwide, tools and resources like the OD2A Case Studies encourage applying solutions that work to help communities that need it most.

For additional OD2A resources or to learn more about how CDC is working to prevent overdoses and substance use-related harms visit: https://www.cdc.gov/drugoverdose/od2a/index.html/.

2023-07-17T10:57:00

(BPT) – Living with a rare disease may not be as rare as you would think: Affecting one in 10 Americans, there are more than 10,000 known rare diseases in the U.S.¹ While significant strides to develop treatments have been made in recent decades, broadscale awareness of disease remains a challenge. The path to diagnosis and proper care can be long and frustrating.

For example, Fabry disease is a rare genetic disease. Classic Fabry disease affects approximately 1 in 40,000 males and 1 in 20,000 females in the U.S.² Fabry disease can affect multiple organs and tissues, including the heart, kidney and central nervous system in both males and females. Symptoms can include pain, gastrointestinal difficulties, fatigue, and skin lesions called angiokeratomas.³ Undiagnosed and untreated, Fabry disease can reduce life expectancy by 5-14 years in women and 16 years in men. Fabry disease is progressive and challenging to diagnose.⁴

Understanding a rare disease diagnosis can be cumbersome and stressful; for this reason, the power of community is exceptionally critical for these individuals. Through the collective sharing of Fabry journeys, hurdles and victories, valuable insights into the long-term impact of the disease can fuel ongoing research. These learnings have and continue to help the research and development of Fabry disease treatment — including Fabrazyme (agalsidase beta), which is approved in adults and pediatric patients two years of age and older with a confirmed Fabry diagnosis. Fabrazyme was approved in the United States 20 years ago and is currently used by more than 6,000 adult and pediatric patients worldwide and continues to serve as a safe and efficacious option for those living with Fabry.

“The path to receiving a Fabry diagnosis can be both time-consuming and overwhelming,” said Jennifer Ibrahim, Head of North America Medical Affairs, Rare Disease at Sanofi. “Since its approval in 2003, Sanofi has been proud to continue to offer hope to this important rare disease community.”

In the world of rare diseases, knowledge is power. Making the effort to familiarize oneself with rare diseases, symptoms and resources could be the key to a diagnosis and proper treatment.

“Sanofi wants those living with Fabry to know they’re not alone,” said Duane Clark, General Manager, Rare Disease at Sanofi. “We see you, we hear you and we will continue to put our science toward supporting you.”

For more information about Fabry disease, visit www.fabrazyme.com.

IMPORTANT SAFETY INFORMATION

Fabrazyme can cause serious side effects, including:

Severe Allergic (anaphylaxis) and Hypersensitivity Reactions

Approximately 1% of patients who have received Fabrazyme either during a clinical study or after Fabrazyme was approved have experienced anaphylactic (allergic) or severe hypersensitivity reactions during their infusion. Life-threatening severe anaphylactic (allergic) or severe hypersensitivity reactions have been seen in patients during Fabrazyme infusions.

• These reactions included: swelling of the face, mouth and throat, narrowing of breathing airways, low blood pressure, hives, difficulty swallowing, rash, trouble breathing, flushing, chest discomfort, itching and nasal congestion.
• People who have experienced these reactions have required treatment including heart/lung resuscitation, oxygen, fluids given through a vein, hospitalization, and treatment with inhaled drugs called beta-adrenergic agonists to help open the breathing airways, antihistamines, epinephrine (also known as adrenaline), and a medication given through the vein called a corticosteroid (or steroid) which helps to decrease the body’s allergic reaction by decreasing inflammation.
• If you experience a severe allergic or anaphylactic reaction, your healthcare professional will immediately stop the infusion of Fabrazyme and provide you the necessary emergency medical treatment. Because of the possibility that severe hypersensitivity reactions may occur, appropriate medical support should be available during your Fabrazyme infusion.

In the clinical studies, some patients developed IgE antibodies or a reaction to an allergy skin test specific to Fabrazyme. IgE antibodies are a specific kind of antibody that can sometimes be produced by the body’s immune system during an allergic reaction.

• Higher amounts of hypersensitivity reactions were seen in adult patients whose immune systems repeatedly made anti-Fabrazyme antibodies and in patients who had high antibody titers (units used to measure how much anti-drug-antibody your immune system is making) compared to adult patients with negative antibody titers.
• Your doctor should consider testing for IgE antibodies if you experience suspected allergic reactions. Providing Fabrazyme to patients who have experienced severe or serious allergic reactions to Fabrazyme should only be done after carefully considering the risks and benefits of continuing the treatment, and only under the direct supervision of a qualified healthcare professional and with appropriate medical support readily available.

Infusion-Associated Reactions

In clinical studies with Fabrazyme, 59% of patients experienced infusion-associated reactions during Fabrazyme administration, some of which were severe. Infusion-associated reactions are defined as adverse reactions occurring on the same day as your infusion. During the clinical trials, infusion-associated reactions occurred more frequently in patients who were positive for anti-Fabrazyme antibodies than in patients who did not have anti-Fabrazyme antibodies.

• For patients who have had reactions to their infusions, it is recommended that they be given anti-fever and antihistamine medications right before their next infusions. Infusion-associated reactions have happened in some patients even after taking these medications before their infusions.
• If an infusion-associated reaction occurs, slowing the infusion rate, stopping the infusion for a short time and/or giving more anti-fever and antihistamine medications and or steroids may improve the symptoms.
• If severe infusion-associated reactions happen, your healthcare professional should consider stopping the Fabrazyme infusion right away and should provide medical care for your condition. Severe reactions are generally managed by giving antihistamine medications, corticosteroids, fluids through the vein, and/or oxygen when needed. Because severe infusion-associated reactions may happen, medical treatment should be readily available during your Fabrazyme infusion.
• People with advanced Fabry disease may have heart problems which could put them at a higher risk for severe complications from infusion-associated reactions. These patients should be watched closely during their infusion if the decision is made to give them Fabrazyme.

Common and Other Possible Side Effects: Common side effects reported in 20% or more of Fabrazyme treated patients in clinical studies compared to placebo were upper respiratory tract infection, chills, fever, headache, cough, burning and/or tingling sensation, fatigue, swelling in the legs, dizziness and rash.

INDICATION AND USAGE

Fabrazyme^® is used to treat adults and children 2 years of age and older with confirmed Fabry disease.

Please see full Prescribing Information for Fabrazyme.

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[1] Genetic and Rare Diseases Information Center. What is a Rare Disease. Available at https://rarediseases.info.nih.gov/about. Accessed on May 16, 2023

[2] Fabry Institute. Epidemiology of Fabry Disease. Available at https://fabry-institute.com/burden-of-disease/epidemiology-of-fabry-disease. Accessed on May 16, 2023

[3] Genetic and Rare Diseases Information Center. Fabry disease. Available at https://rarediseases.info.nih.gov/diseases/6400/fabry-disease. Accessed on May 16, 2023

[4] Waldek S, Patel M, Banikazemi M, et al., American College of Medical Genetics. Life expectancy and cause of death in males and females with Fabry disease: Findings from Fabry. Accessed on May 16, 2023

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