Category: Brandpoint Health

2022-08-04T08:17:00

(BPT) – With so many cleanser options on shelves, choosing the right one for your skin type and daily routine can be an intimidating feat. To help you identify your skin type and decode the cleanser aisle, New York City-based board-certified dermatologist Dr. Kiran Mian shares her go-to cleansing tips to help build an expert-approved routine.

Identify your skin type

“Before cleansing or using any skincare products, it’s important to identify your skin type to help determine your skin’s individual needs,” says Mian. “From there, you can choose the right ingredients and products that are the best and most effective for treating your unique concerns.” When it comes to identifying your skin type, Mian says there are a few standard types, which you can identify based on how your skin feels throughout the day. According to Dr. Mian:

• Normal skin: Your skin likely doesn’t experience excess dryness or oiliness, and is generally free of visible pores, acne and sensitivity.
• Dry or sensitive skin: Your skin can feel tight throughout the day and may be easily irritated by certain products or using them too often.
• Oily skin: You skin may feel “degreased” after washing but may start feeling sticky or oily throughout the day. You may see a sheen develop on the whole face as the day progresses.
• Combination skin: You may see or feel oiliness on your T-zone — forehead, nose and chin — where oil glands are more prominent.

Cleanse your skin according to skin’s needs

Once you’ve identified your skin type, it’s time to pick a cleansing routine that’s suitable for your skin’s needs.

• For normal skin: Cleanse one to two times a day in the morning and at night.
• For dry or sensitive skin: Look for products with hydrating ingredients to prevent further drying out skin and replenish hydration. Be careful not to over-wash as it could cause irritation. Simply rinse your face with lukewarm water in the morning and cleanse your skin only at night.
• For oily skin: In addition to cleansing in the morning and at night, it’s recommended to also use a cleanser immediately after working out or sweating to help prevent breakouts.
• For combination skin: You may need to cleanse more often, both in the morning and at night.

Use derm-approved products

No matter your skin type, Mian recommends using products developed with dermatologists from CeraVe, which gently, yet effectively cleanse skin without over-drying or stripping the skin barrier of moisture. Two of Dr. Mian’s favorites are CeraVe Hydrating Facial Cleanser and new Makeup Removing Cleanser Balm, which can be used together as a two-step, double cleansing routine:

Step 1: Remove Makeup

Removing your makeup before bed is non-negotiable! The CeraVe Makeup Removing Cleanser Balm is the perfect first step in a cleansing routine, as it gently removes stubborn long-wear makeup, including waterproof mascara, as well as excess oils, dirt and debris accumulated throughout the day. Formulated with 3 essential ceramides along with plant-based jojoba oil, the Cleanser Balm helps retain the skin’s moisture during cleansing, leaving skin feeling comfortable, and helping to maintain the protective skin barrier.

Step 2: Cleanse Away the Bad, While Keeping the Good

As the second step in a double-cleansing routine, use a facial cleanser formulated for your skin type to give you an effective, balanced cleanse. CeraVe’s Hydrating Facial Cleanser is best for normal-to-dry skin, as it was designed to cleanse and refresh skin without leaving skin feeling tight and dry. The Hydrating Cleanser supports your protective skin barrier long after applying, and also gently removes dirt and oil, and provides hydration with hyaluronic acid and 3 essential ceramides.

The best way to cleanse your skin

Treating your skin with care while washing also makes a difference, according to Mian, no matter what skin type you have. When cleansing, Dr. Mian recommends:

• Gently massage your cleanser onto skin in a light, circular motion.
• Rinse well using lukewarm water, rather than cold or hot water.
• Pat dry. Avoid rubbing, as it can cause irritation and inflame your skin.
• Avoid direct contact of the cleanser with your eyes. If contact occurs, rinse thoroughly with water.

“Cleansing is the foundation for an effective skincare routine,” advises Mian. “By choosing a cleanser specific to your skin type and incorporating into a regimen that fits your skin needs, you can maintain not only your skin barrier, but your overall skin health.”

Learn more about how to care for your skin at CeraVe.com.

2022-07-29T08:01:00

(BPT) – Sponsored by Janssen

Imagine finding simple tasks, such as getting out of bed, dressing yourself or turning a faucet on and off, difficult to do because they’re too painful.¹ That’s what a typical day can feel like for people living with active psoriatic arthritis (PsA). About 1.5 million Americans are living with PsA, and although patients may experience symptoms differently, the condition can often interfere with basic daily activities.^1,2

Active PsA is a chronic condition that occurs when your body’s immune system attacks healthy cells and tissue, which causes inflammation in the joints as well as overproduction of skin cells. ³ Common symptoms of active PsA include joint stiffness, pain and swelling.⁴ Some patients with active PsA can also experience fatigue, which is an underestimated and underreported concern that can interfere with daily life. ^4-6

PsA symptoms can vary and differ in severity from patient to patient, so it’s critical for healthcare providers and patients to have an open dialogue to build a personalized management plan together. ⁴ A PsA management plan may incorporate lifestyle changes as well as medication potentially to help address the disease symptoms.

“The symptoms of active psoriatic arthritis may be hard to describe or feel invisible at times, but that doesn’t make them any less real,” said Soumya D. Chakravarty, MD, PhD, Senior Director, Strategic Lead, Rheumatology Therapeutic Area at Janssen. “PsA can have debilitating effects on the lives of patients. It’s important for patients to speak about symptoms with their rheumatologist because there are strategies they can implement to help see improvement.”

Here are some top tips for managing symptoms of PsA:

Consider a Healthy Diet

While there isn’t a specific diet for PsA, research shows that certain foods can help reduce inflammation in the body, which contributes to the disease.⁷ Consider incorporating more anti-inflammatory foods, such as fruits, vegetables, beans, whole grains and healthy fats like fish and avocado, while reducing foods like fatty red meats, dairy, refined sugars and processed foods. ^7,8

Think About Finding a Workout That Feels Good

Exercise while living with active PsA can feel daunting, but physical activity has many benefits, including helping to maintain a healthy weight, taking extra pressure off painful joints, keeping joints flexible and increasing endorphins, which can provide an energy boost. ^8,9 Make sure to speak with your healthcare provider or a physical therapist about a workout routine that is right for you. As a general guide, try to target 30 minutes of movement each day if you’re able and consider lower impact workouts. ⁸

Lean On a Support System

For people living with PsA, the disease can have an impact beyond just physical symptoms. ¹⁰ Connecting with other patients who understand what you’re experiencing, whether in a support group or an online community, can help if you’re feeling overwhelmed, misunderstood or isolated. ¹⁰

Start a Dialogue With Your Healthcare Provider About Treatment Options

In addition to physical tests to assess the severity of your PsA, rheumatologists are also building treatment plans based on outcomes that are more personally significant to patients.⁶ “It’s important to speak openly with your rheumatologist because there are treatments that may help improve PsA symptoms,” said Dr. Chakravarty.

Be sure to describe your symptoms — such as joint pain, stiffness and swelling — with specific details about how they impact your daily activities. Also, let your rheumatologist know if you are experiencing fatigue from your active PsA. This information will help them develop an individualized treatment plan that is right for you, which may include a biologic therapy, such as TREMFYA^® (guselkumab) — a prescription medicine used to treat adults with active PsA. Talk to your doctor to see if TREMFYA^® is appropriate for you. TREMFYA^® is the first FDA-approved medication of its kind to selectively block interleukin 23 (IL-23), one of the key proteins thought to be responsible for symptoms of PsA. TREMFYA^® can help reduce the joint pain, stiffness, and swelling that make everyday tasks harder to do. In two medical studies, more than half of patients treated with TREMFYA^® had at least a 20% improvement in joint pain, stiffness, and swelling at 24 weeks. Furthermore, at 24 weeks, people taking TREMFYA^® showed an overall improvement in their ability to perform daily activities such as getting dressed, eating and walking. Some patients also reported improvement in fatigue as measured by the Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F), a questionnaire to measure self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue.

TREMFYA^® is not for everyone; only your doctor can decide if it’s right for you. Do not use if you are allergic to TREMFYA^®. TREMFYA^® is a prescription medicine that may cause serious side effects, including serious allergic reactions and infections. It affects your immune system and may increase your risk of infections and lower your ability to fight them. Patients should be instructed to seek medical advice if signs and symptoms of clinically important chronic or acute infection occur. Patients should also be evaluated for tuberculosis before being treated with TREMFYA^®. Please read the Important Safety Information and the Medication Guide for TREMFYA^® available at www.tremfya.com to learn more about these and other risks for TREMFYA^®. Discuss any questions you have with your doctor.

Coping with PsA can be overwhelming at times, but as difficult as it may be, don’t get discouraged. There’s no one-size-fits-all approach to PsA management and it’s important to remember you have options. There are various steps you can take with your rheumatologist to help alleviate symptoms and better manage the disease.

WHAT IS TREMFYA^®? (guselkumab)

TREMFYA^® is a prescription medicine used to treat adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light).

TREMFYA^® is a prescription medicine used to treat adults with active psoriatic arthritis.

IMPORTANT SAFETY INFORMATION

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

TREMFYA^® is a prescription medicine that may cause serious side effects, including:

• Serious Allergic Reactions. Stop using TREMFYA^® and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction:
• fainting, dizziness, feeling lightheaded (low blood pressure)
• swelling of your face, eyelids, lips, mouth, tongue or throat
• trouble breathing or throat tightness
• chest tightness
• skin rash, hives
• itching

• Infections. TREMFYA^® may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with TREMFYA^® and may treat you for TB before you begin treatment with TREMFYA^® if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with TREMFYA^®.

Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:

• fever, sweats, or chills
• muscle aches
• weight loss
• cough
• warm, red, or painful skin or sores on your body different from your psoriasis
• diarrhea or stomach pain
• shortness of breath
• blood in your phlegm (mucus)
• burning when you urinate or urinating more often than normal

Do not take TREMFYA^® if you have had a serious allergic reaction to guselkumab or any of the ingredients in TREMFYA^®.

Before using TREMFYA^®, tell your healthcare provider about all of your medical conditions, including if you:

• have any of the conditions or symptoms listed in the section “What is the most important information I should know about TREMFYA^®?”
• have an infection that does not go away or that keeps coming back.
• have TB or have been in close contact with someone with TB.
• have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with TREMFYA^®.
• are pregnant or plan to become pregnant. It is not known if TREMFYA^® can harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if TREMFYA^® passes into your breast milk.

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

What are the possible side effects of TREMFYA^®?

TREMFYA^® may cause serious side effects. See “What is the most important information I should know about TREMFYA^®?”

The most common side effects of TREMFYA^® include: upper respiratory infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections, herpes simplex infections, and bronchitis.

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

Use TREMFYA^® exactly as your healthcare provider tells you to use it.

Please read the full Prescribing Information, including Medication Guide for TREMFYA^®, and discuss any questions that you have with your doctor.

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.

cp-82626v3

References

1. Kavanaugh, A., Helliwell, P., & Ritchlin, C. T. Psoriatic Arthritis and Burden of Disease: Patient Perspectives from the Population-Based Multinational Assessment of Psoriasis and Psoriatic Arthritis (MAPP) Survey. Rheumatology and therapy, 3(1), 91–102. (2016). Accessed April 1, 2022. https://doi.org/10.1007/s40744-016-0029-z
2. Johns Hopkins. Psoriatic Arthritis. Accessed April 1, 2022. https://www.hopkinsarthritis.org/arthritis-info/psoriatic-arthritis/#:%7E:text=What%20is%20Psoriatic%20Arthritis%3F,may%20also%20affect%20the%20spine.
3. Mayo Clinic. Psoriatic Arthritis. Accessed April 1, 2022. https://www.mayoclinic.org/diseases-conditions/psoriatic-arthritis/symptoms-causes/syc-20354076.
4. National Psoriasis Foundation. About Psoriatic Arthritis. Accessed June 1, 2022. https://www.psoriasis.org/about-psoriatic-arthritis/.
5. CreakyJoints. What Does Psoriatic Arthritis Fatigue Really Feel Like? Accessed June 1, 2022. https://creakyjoints.org/about-arthritis/psoriatic-arthritis/psa-symptoms/what-psoriatic-arthritis-fatigue-feels-like/
6. Nowell, W.B., Gavigan, K., Kannowski, C.L. et al. Which Patient-Reported Outcomes Do Rheumatology Patients Find Important to Track Digitally? A Real-World Longitudinal Study in ArthritisPower. Arthritis Res Ther 23, 53 (2021). https://doi.org/10.1186/s13075-021-02430-0
7. National Psoriasis Foundation. What’s the Deal with the Anti-Inflammatory Diet? Accessed June 1, 2022. https://www.psoriasis.org/advance/whats-the-deal-with-the-anti-inflammatory-diet/.
8. Arthritis Foundation. Psoriatic Arthritis Self-Care Tips. Accessed April 1, 2022. https://www.arthritis.org/diseases/more-about/psoriatic-arthritis–self-care-tips.
9. Creaky Joints. Psoriatic Arthritis Fatigue: 20+ Daily Routine Changes to Improve Energy. Accessed April 1, 2022. https://creakyjoints.org/about-arthritis/psoriatic-arthritis/psa-healthy-living/psoriatic-arthritis-fatigue-routine-changes/.
10. CreakyJoints. Psoriatic Arthritis and Mental Health: Link to Depression, Anxiety, Fatigue. Accessed June 1, 2022. https://creakyjoints.org/about-arthritis/psoriatic-arthritis/psa-treatment/psoriatic-arthritis-mental-health/.

2022-07-26T11:01:00

(BPT) – The immune system is a complex and powerful network that protects the body from infection. Because the immune system weakens with age, older adults are at a higher risk for getting sick – and have more difficulty fighting off infection. Some illnesses, like the flu, may not be a health threat to most healthy adults but could be more dangerous to a person whose immune system has weakened with age.

Older adults represent the majority of flu-related hospitalizations and account for six times the number of deaths from flu-related complications – compared to other age groups combined. While many consider the flu to be a seasonable annoyance, the extent of the burden of influenza is underestimated and misunderstood. The Centers for Disease Control and Prevention (CDC) estimates that from 2010 to 2020, the flu resulted in 9 million to 41 million illnesses annually in the United States.

On June 22, 2022, the CDC’s Advisory Committee on Immunization Practices (ACIP) granted a preferential recommendation for the use of an adjuvanted vaccine and two higher dose vaccines (Fluzone High-Dose^® Quadrivalent (Influenza Vaccine) and Flublok^® Quadrivalent (Influenza Vaccine)) for adults 65+. If none of these three preferentially recommended vaccines is available at an opportunity for vaccine administration, then any other age-appropriate influenza vaccine should be used.

The updated recommendation from the CDC affirms that all flu vaccines are not created equal, and older populations require a specific level of protection. Of note, Sanofi was the first to offer a high-dose flu vaccine specifically for adults 65+, recognizing the significant need for this high-risk population.

Flublok Quadrivalent and Fluzone High-Dose Quadrivalent are indicated for immunization against disease caused by influenza A and B strains contained in the vaccine. Flublok Quadrivalent is given to people 18 years of age and older. Fluzone High-Dose Quadrivalent is given to people 65 years of age and older.

Select Important Safety Information for Flublok^® Quadrivalent and Fluzone^® High-Dose Quadrivalent

Flublok Quadrivalent and Fluzone High-Dose Quadrivalent should not be given to anyone who has had a severe allergic reaction to any component of the vaccine (including eggs or egg products for Fluzone High-Dose Quadrivalent) or after previous dose of the vaccine. In addition, Fluzone High-Dose Quadrivalent should not be given to anyone who has had a severe allergic reaction after previous dose of any influenza vaccine.

Please see Important Safety Information below.

Sanofi considers preventing the flu and its serious complications a global public health priority and is committed to ensuring all eligible adults age 65+ – regardless of race, ethnicity, economic status – have access to higher-dose flu vaccines.

While the updated CDC recommendation is an important first step in creating clearer guidance on protection against the flu for this high-risk population, we believe there is still more work to be done to help reduce the burden of influenza in older adults. A stronger preference for influenza vaccines with clinically proven data would help further reduce health disparities and disease burden across the entire 65+ population. By making clinically-driven and data-informed recommendations for the use of preferred influenza vaccines for older persons, healthcare agencies can help reduce the pressure caused by seasonal influenza on healthcare systems.

Important Safety Information for Flublok^® Quadrivalent (Influenza Vaccine) and Fluzone^® High-Dose Quadrivalent (Influenza Vaccine)

Flublok Quadrivalent and Fluzone High-Dose Quadrivalent should not be given to anyone who has had a severe allergic reaction to any component of the vaccine (including eggs or egg products for Fluzone High-Dose Quadrivalent) or after previous dose of the vaccine. In addition, Fluzone High-Dose Quadrivalent should not be given to anyone who has had a severe allergic reaction after previous dose of any influenza vaccine.

Tell your health care provider if you have ever had Guillain-Barré syndrome (severe muscle weakness) after a previous influenza vaccination.

If Flublok Quadrivalent and Fluzone High-Dose Quadrivalent are given to people with a compromised immune system, including those receiving therapies that suppress the immune system, the immune response may be lower than expected.

Vaccination with Flublok Quadrivalent and Fluzone High-Dose Quadrivalent may not protect all people who receive the vaccine.

For Flublok Quadrivalent, in adults 18 through 49 years of age, the most common side effects were tenderness, and/or pain where you got the shot; headache, tiredness, muscle aches, and joint pain. In adults 50 years of age and older the most common side effects were tenderness, and/or pain where you got the shot; headache, and tiredness.

For Fluzone High-Dose Quadrivalent, in adults 65 years of age and older, the most common side effects were pain, redness, and/or swelling where you got the shot; muscle aches, headache, and general discomfort.

For Flublok Quadrivalent and Fluzone High-Dose Quadrivalent, other side effects may occur.

Please see the Prescribing Information for Flublok Quadrivalent. Please see the Prescribing Information and Patient Information for Fluzone High-Dose Quadrivalent.

MAT-US-2204922-v1.0-07/2022

2022-07-26T06:01:00

(BPT) – Did you know that breakouts can start long before the anxiety of middle school? In fact, people can get acne at almost any age, and it affects both males and females alike. The causes of acne can range from heredity to stress and diet, but most doctors point to hormones as the main culprit. When androgens rise during puberty, the sebaceous glands enlarge and produce more sebum or oil. So, if one of your parents or another close blood relative suffered from severe acne that caused scarring, you may also be at greater risk.

According to Dermatologist Emmy Graber, MD, MBA, founder and President of The Dermatology Institute of Boston, “Acne is an exceedingly common condition in kids, teens and adults, and especially in the age of social media, where it can cause feelings of low self-esteem and impact an individual’s confidence. There are many treatments available, from drugstore washes and gels to prescription medications, but results are often variable and can be temporary.”

With a sea of acne treatment options to navigate, what solutions are dermatologists excited about? One to note is AviClear™, the first and only FDA-cleared energy device for the treatment of mild, moderate, and severe acne. The AviClear laser was designed to address acne by going right to the source. “This revolutionary laser technology uses a unique wavelength to selectively target the oil glands in the skin. The results we are seeing are a measurable improvement of acne over a series of three 30-minute treatments spaced one month apart with minimal downtime,” adds Dr. Graber.

According to Chicago-based Dermatologist Ashish Bhatia, MD, FAAD, “This is a unique method of treating acne at the source. AviClear’s new 1726 nm wavelength selectively targets and suppresses the sebaceous gland safely and effectively. The addition of AviCool™ contact cooling makes it a comfortable treatment experience for patients,” he says. “Clinical trials have shown that current and future breakouts are shorter, less intense, and less frequent, and results continue to improve over time,” adds Dr. Bhatia.

Among the many reasons doctors, skincare professionals, and their patients are excited about this new treatment, “AviClear is drug-free and safe for all skin types,” says Beverly Hills-based Facial Plastic Surgeon Arash Moradzadeh, MD. “After just 3 treatments, our celebrity patients are thrilled to experience a noticeable reduction in acne breakouts and an improvement in the overall appearance and texture of their skin that lasts. It’s truly a win-win.”

Find an AviClear practice near you at https://aviclear.com/locations/.

2022-07-19T10:23:00

(BPT) – Do you have trouble falling asleep and staying asleep? Do you wake up and still feel tired? Quality sleep is essential to every aspect of well-being, yet many Americans are plagued by troubles getting the deep sleep they need to feel their best. What’s worse, many people are reaching for common over-the-counter melatonin sleep supplements which may be doing more harm than good.

What is melatonin?

Your body naturally produces melatonin, which helps regulate your wake-sleep cycle, also known as circadian rhythms. The production and release of melatonin in the brain is connected to time of day, increasing when it’s dark and decreasing when it’s light, according to Mayo Clinic. Therefore natural levels of melatonin in the blood are highest at night.

Melatonin can also be manufactured and is used as an artificial ingredient in many sleep supplements. Melatonin supplement use has increased fourfold between 1999 and 2018, according to research published in the Journal of the American Medical Association. Medicine aisles are filled with supplements promoting sleep by using melatonin that they claim is safe and non-addictive.

The problem is, while artificial melatonin can help tell your body it’s time to rest, it doesn’t improve quality of sleep, and that’s what’s essential for your body and mind to fully rest and recover so you feel your best each morning.

Concerns with melatonin

Circadian rhythms help your body and mind follow a 24-hour cycle, regulating things like body temperature, hormonal activity, immune function, and of course, sleep. While melatonin is a hormone naturally produced in the body, taking too much in a supplement form can disrupt your circadian rhythm and sleep cycle, causing you to miss out on critical deep sleep. This can make you feel groggy or “off” all day, as deep sleep is needed for the human body to feel mentally and physically healthy.

Taking excessive supplemental melatonin is more common than you think. A study of 31 different melatonin supplements found that the actual melatonin amounts could be nearly 500% higher than labeled, reported in the Journal of Clinical Sleep Medicine. What’s more, this can occur within a particular product, meaning one evening a person might get the advertised dose and another they may unknowingly get much more.

Side effects are also becoming a growing concern with melatonin. Because over-the-counter melatonin doesn’t necessarily improve sleep quality, many people experience side effects like grogginess in the morning. Other side effects can include headaches, dizziness and nausea.

Melatonin alternatives

Natural alternatives are helping people get the restorative sleep they desire without the known risks and side effects of OTC melatonin. Developed by scientists, BrainLuxury DELTA is a unique, patent pending supplement you drink that contains the precursors for your body to naturally produce the melatonin it needs.

Tryptophan is one of the key ingredients of DELTA, an important amino acid converted by the body to stimulate production of natural melatonin. This ingredient along with essential fatty acids including omega-3 and omega-9 oil; vitamins C, E and D3; and minerals like zinc and magnesium create the proprietary formula that gives the brain what it needs for natural sleep. Better yet, all ingredients are vegan, gluten-free and have no added preservatives.

Many people take melatonin without realizing what it can and can’t do, and the numerous risks associated with its use. If you want to establish regular sleep cycles and get the deep sleep that helps you feel mentally and physically healthy, consider your options. A BrainLuxury user study found deep sleep improvements in over 75% of participants. Learn more at BrainLuxury.com.

2022-07-18T08:01:00

(BPT) – A diagnosis of interstitial lung disease can be devastating. This group of rare lung diseases is characterized by scarring and/or inflammation of the lungs causing lung damage that may worsen as the disease progresses.

Journey to Diagnosis

Patty was no stranger to interstitial lung disease when she was diagnosed with one of the most common forms of the disease—idiopathic pulmonary fibrosis—in 2017. Her father and one of her sisters passed away from idiopathic pulmonary fibrosis and after struggling with shortness of breath for several months, she knew she could no longer ignore her symptoms. “I remember turning to my sister and saying, ‘I think I have what Dad had,’” recounts Patty. She made an appointment with her primary care provider, who referred her to a pulmonologist for further care.

During the visit with a pulmonologist, Patty was quick to share her family history of idiopathic pulmonary fibrosis, but her pulmonologist expressed doubt that it was causing Patty’s symptoms. “He said it could be a possibility, but my CT scan wasn’t what you would typically see with idiopathic pulmonary fibrosis,” she recalls. After she underwent a lung biopsy, with labs and pulmonary function tests confirming, Patty was officially diagnosed with idiopathic pulmonary fibrosis.

Patty’s experience isn’t unique. Interstitial lung disease is often treated by pulmonologists, who specialize in the treatment and management of lung disease. Still, misdiagnosis is common. In fact, interstitial lung disease has a misdiagnosis rate as high as 50% because providers may confuse it with other conditions like asthma, chronic obstructive pulmonary disease, and congestive heart failure. Fortunately, Patty’s time as an idiopathic pulmonary fibrosis caregiver and a former nurse had prepared her well to be her own advocate. “I was lucky that I knew the importance of advocacy and research, but I know that not everyone has that background,” she says.

When her pulmonologist suggested OFEV^® (nintedanib) capsules, a twice-daily treatment approved to treat adults with idiopathic pulmonary fibrosis, Patty immediately began her research. “I went online and learned about the different types of testing and treatments available, and I liked that it [OFEV] might help slow the progression of my idiopathic pulmonary fibrosis,” Patty says. She started treatment and began tracking her side effects.

OFEV’s most common side effects are diarrhea, nausea, stomach pain, vomiting, liver problems, decreased appetite, headache, weight loss, and high blood pressure. These are not all the possible side effects of OFEV.

Connecting With the Interstitial Lung Disease Community

An accurate diagnosis can be a relief for patients like Patty, but it also has the potential to leave them feeling overwhelmed or wondering what comes next. Although interstitial lung disease covers a broad range of diseases—including idiopathic pulmonary fibrosis, systemic sclerosis-associated interstitial lung disease, and chronic fibrosing interstitial lung disease—there is limited information available following diagnosis. After her diagnosis, Patty recognized an opportunity to use her experiences to build a local support group for others navigating an interstitial lung disease diagnosis.

“I recognized how important it was to learn from the experiences of others with pulmonary fibrosis. People thanked me for putting it together, and it made me realize just how important something like a support group really is,” says Patty. While the support group was intended to offer support to others, Patty says it also helped her cope with her own diagnosis. “The support group really helped me with some of the difficult parts of daily life with idiopathic pulmonary fibrosis. Starting a support group made me feel like I was still helping people, and it continues to inspire me every day,” she says.

To learn more about OFEV^® as a treatment option and patient support services, visit www.OFEV.com.

What is OFEV?

• OFEV is a prescription medicine used:
  • to treat adults with a lung disease called idiopathic pulmonary fibrosis (IPF).
  • to treat adults with a long lasting (chronic) interstitial lung disease in which lung fibrosis continues to worsen (progress).
  • to slow the rate of decline in lung function in adults with systemic sclerosis-associated interstitial lung disease (SSc-ILD) (also known as scleroderma-associated ILD).
• It is not known if OFEV is safe and effective in children.

Important Safety Information

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

OFEV can cause harm, birth defects, or death to an unborn baby. Women should not become pregnant while taking OFEV. Women who are able to become pregnant should have a pregnancy test before starting treatment and should use highly effective birth control at the start of treatment, during treatment, and for at least 3 months after your last dose. Talk with your doctor about what birth control method is right for you during this time. Birth control pills may not work as well in women having vomiting, diarrhea, or other problems reducing the drug absorption. If you have any of these problems, talk with your doctor about what highly effective birth control method is right for you. If you become pregnant or think you are pregnant while taking OFEV, tell your doctor right away.

What should I tell my doctor before using OFEV?

Before you take OFEV, tell your doctor about all of your medical conditions, including if you have:

• liver problems.

• heart problems.

• a history of blood clots.

• a bleeding problem or a family history of a bleeding problem.

• had recent surgery in your stomach (abdominal) area.

Tell your doctor if you:

• are pregnant or plan to become pregnant.

• are breastfeeding or plan to breastfeed. It is not known if OFEV passes into your breast milk.

You should not breastfeed while taking OFEV.

• are a smoker. You should stop smoking prior to taking OFEV and avoid smoking during

treatment.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements such as St. John’s wort.

What are the possible side effects of OFEV?

OFEV may cause serious side effects.

TELL YOUR DOCTOR RIGHT AWAY if you are experiencing any side effects, including:

• Liver problems. Unexplained symptoms may include yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea-colored) urine, pain on the upper right side of your stomach area (abdomen), bleeding or bruising more easily than normal, feeling tired, or loss of appetite. Your doctor will do blood tests to check how well your liver is working before starting and during your treatment with OFEV.

• Diarrhea, nausea, and vomiting. Your doctor may recommend that you drink fluids or take medicine to treat these side effects. Tell your doctor if you have these symptoms, if they do not go away, or get worse, and if you are taking over-the-counter laxatives, stool softeners, and other medicines or dietary supplements.

• Heart attack. Symptoms of a heart problem may include chest pain or pressure, pain in your arms, back, neck, or jaw, or shortness of breath.

• Stroke. Symptoms of a stroke may include numbness or weakness on one side of your body, trouble talking, headache, or dizziness.

• Bleeding problems. OFEV may increase your chances of having bleeding problems. Tell your doctor if you have unusual bleeding, bruising, wounds that do not heal, and/or if you are taking a blood thinner, including prescription blood thinners and over-the-counter aspirin.

• Tear in your stomach or intestinal wall (perforation). OFEV may increase your chances of having a tear in your stomach or intestinal wall. Tell your doctor if you have pain or swelling in your stomach area.

• Increased protein in your urine (proteinuria). OFEV may increase your chances of having protein in your urine. Tell your doctor if you have any signs and symptoms of protein in the urine such as foamy urine, swelling, including in your hands, arms, legs, or feet, or sudden weight gain.

The most common side effects of OFEV are diarrhea, nausea, stomach pain, vomiting, liver problems, decreased appetite, headache, weight loss, and high blood pressure.

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

Click here for full Prescribing Information, including Patient Information or visit OFEV.com or contact Boehringer Ingelheim Pharmaceuticals at 1-800-542-6257.

2022-07-14T11:01:00

(BPT) – While many of us may know someone living with peanut allergy, what most of us may not know is how much it can impact daily life and key moments that we often take for granted. Peanut allergy can be a lifelong condition, and reactions to peanut can range from mild to potentially life-threatening. Some children with peanut allergy may not want to participate in certain activities due to the potential of accidental exposure.

Kirsten and her family have lived with peanut allergy for 13 years since her son Maddox was first diagnosed and have had to learn to navigate events such as birthdays, traveling and even family holidays to avoid accidental exposure to peanut. This has required constant vigilance daily as practicing a strict peanut-free diet alone might not be enough, since even a small amount of the allergen can prompt an allergic reaction. Maddox is currently taking PALFORZIA^® [Peanut (Arachis hypogaea) Allergen Powder-dnfp]. PALFORZIA is a treatment for people who are allergic to peanuts that can help reduce the severity of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. PALFORZIA can cause severe allergic reactions called anaphylaxis, please see below for important safety information.

However, despite his peanut allergy, Kirsten has been committed to making sure that Maddox and their family can still enjoy doing the things they love. Below, she shares six proactive tips for caregivers of children with a peanut allergy to consider.

1. Vacations/travel

Kirsten and her family have visited many places — they make sure to carry injectable epinephrine and ask everyone they are traveling with not to bring any food containing peanut. If traveling by plane, train or bus, contact the company to find out their peanut allergy protocol and board early to wipe down your child’s seat, seatbelt, tray table, and controls. If traveling to a foreign country, Kirsten has found it helpful to learn how to say “peanut allergy” in the country’s language or to bring laminated cards to hand to waiters with peanut warnings in the country’s language.

2. Summer camp

It is important to inform the camp staff before camp begins about your child’s allergy and the potential for allergic reactions. If it feels necessary, you can hold a call with the camp personnel to discuss your concerns and share an emergency action plan that includes your allergist’s contact details, epinephrine, and a recent picture of your child so people who are unfamiliar with your child know what they look like. Kirsten expressed how important it is for children to be able to recognize the symptoms of an allergic reaction and understand how to advocate for themselves. You should discourage your child from sharing foods, encourage them to read every label and be sure they know which snacks they can’t have. If the camp does not give out name tags where you could include a warning about your child’s peanut allergy, make sure they are wearing a medical alert bracelet or necklace. Lastly, make sure your child or your child’s counselor carries injectable epinephrine in case of an emergency.

3. Sports

At Maddox’s sporting events, Kirsten always comes prepared with plenty of snacks for during and after the game. Kirsten has found it helpful to have their coaches send an email home to all parents before practice starts asking them to please not share any food with the team that she has not approved of first. Since Maddox plays baseball, peanuts, a staple at ballparks, can be a big issue. Because of this, Kirsten is constantly reminding the coaches and other parents throughout the season of Maddox’s peanut allergy and stays close during halftime and post-game activities to monitor any snacks being passed around. She shares that sunflower seeds have served as a great alternative to peanuts, and they are always sure to bring extra in case anyone forgets and brings peanuts.

4. Birthday parties

Since birthday parties are common events in children’s lives, the risk of accidental exposure for children with peanut allergy at these events is clearly present. As a little boy, Maddox would go to birthday parties but wasn’t allowed to eat the cake — or anything for that matter. Kirsten would go with him to the parties and bring foods he could eat — typically cake or something fun so he did not feel left out. Kirsten typically calls the host beforehand to find out what they are serving. She also notes that you must always carry injectable epinephrine with you just in case.

5. Holidays

Holiday gatherings are an important time for many families to be with loved ones. Prior to parties, Kirsten calls the host to find out what kind of food they are serving. If you are able, ask the host to take pictures of/keep the food labels so you can read the ingredients. If the holiday dinner is buffet style, Kirsten makes sure Maddox can be served first to limit cross contact. Kirsten usually gives Maddox a snack or meal before the event so that he is not tempted to grab appetizers that may contain peanut. As she does with birthday parties, Kirsten will also bring a peanut-free dish or dessert so Maddox has something to look forward to that he knows he can eat. These proactive tips for holiday dinners also hold true for any large gathering such as summer barbecues and picnics.

6. Peanut Oral Immunotherapy (OIT)

No matter how hard families try to remain vigilant, accidental exposure to peanut can still occur. Kirsten wanted to do something proactive to help manage Maddox’s peanut allergy in addition to avoidance alone. When she heard about an FDA-approved treatment that could potentially be an option for her son, she was eager to learn more and find out if it could be a fit. PALFORZIA is the first and only FDA-approved OIT that is intended to gradually decrease sensitivity to small amounts of peanuts that may be hidden in foods. PALFORZIA does NOT treat allergic reactions and should not be given during an allergic reaction. You must maintain a strict peanut-free diet while taking PALFORZIA. Peanut OIT is an approach that can help reduce the severity of allergic reactions by introducing small daily doses of an allergen into an individual’s diet to gradually build up to larger amounts over time. While Maddox must continue to avoid peanut and carry injectable epinephrine, Kirsten is grateful for PALFORZIA because it can help reduce the severity of allergic reactions, including anaphylaxis, that may occur if Maddox was accidentally exposed to peanut.

WHAT IS PALFORZIA?

PALFORZIA is a treatment for people who are allergic to peanuts. PALFORZIA can help reduce the severity of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. PALFORZIA may be started in patients aged 4 through 17 years old. If you turn 18 years of age while on PALFORZIA treatment you should continue taking PALFORZIA unless otherwise instructed by your doctor.

PALFORZIA does NOT treat allergic reactions and should not be given during an allergic reaction.

You must maintain a strict peanut-free diet while taking PALFORZIA.

IMPORTANT SAFETY INFORMATION

PALFORZIA can cause severe allergic reactions called anaphylaxis that may be life-threatening.

• You will receive your first dose in a healthcare setting under the observation of trained healthcare staff.
• You will receive the first dose of all dose increases in a healthcare setting.
• In the healthcare setting, you will be observed for at least 1 hour for signs and symptoms of a severe allergic reaction.
• If you have a severe reaction during treatment, you will need to receive an injection of epinephrine immediately and get emergency medical help right away.
• You will return to the healthcare setting for any trouble tolerating your home doses.

Stop taking PALFORZIA and get emergency medical treatment right away if you have any of the following symptoms after taking PALFORZIA:

• Trouble breathing or wheezing
• Chest discomfort or tightness
• Throat tightness
• Trouble swallowing or speaking
• Swelling of your face, lips, eyes, or tongue
• Dizziness or fainting
• Severe stomach cramps or pain, vomiting, or diarrhea
• Hives (itchy, raised bumps on skin)
• Severe flushing of the skin

Because of the risk of severe allergic reactions, PALFORZIA is only available through a restricted program called the PALFORZIA Risk Evaluation and Mitigation Strategy (REMS) Program. Talk to your healthcare provider for more information about the PALFORZIA REMS program and how to enroll.

You should NOT take PALFORZIA if you have uncontrolled asthma, or if you ever had eosinophilic esophagitis (EoE) or other eosinophilic gastrointestinal disease.

Tell your doctor if you are not feeling well prior to starting treatment with PALFORZIA. Your doctor may decide to delay treatment until you are feeling better. Also tell your doctor about any medical conditions you have and if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal supplements.

Your doctor may decide that PALFORZIA is not the best treatment if:

You are unwilling or unable to receive (or self-administer) injectable epinephrine.

You have a condition or are taking a medication that reduces the ability to survive a severe allergic reaction.

What are the possible side effects of PALFORZIA?

The most commonly reported side effects of PALFORZIA were: stomach pain, vomiting, feeling sick, itching or burning in the mouth, throat irritation, cough, runny nose, sneezing, throat tightness, wheezing, shortness of breath, itchy skin, hives, and/or itchy ears.

PALFORZIA can cause severe allergic reactions called anaphylaxis that may be life-threatening.

PALFORZIA can cause stomach or gut symptoms including inflammation of the esophagus (called eosinophilic esophagitis). Symptoms of eosinophilic esophagitis can include:

• Trouble swallowing
• Food stuck in throat
• Burning in chest, mouth, or throat
• Vomiting
• Regurgitation of undigested food
• Feeling sick

For additional information on the possible side effects of PALFORZIA, talk with your doctor or pharmacist or visit https://www.palforzia.com/.

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

Please see full Prescribing Information and Medication Guide, including an Important WARNING about anaphylaxis.

2022 Aimmune Therapeutics, Inc. PALFORZIA is a registered trademark of Aimmune Therapeutics, Inc.

2022-07-07T11:01:00

(BPT) – Sponsored by GSK

Despite ovarian cancer striking all races at similar rates, Black Americans are 20% more likely to receive a late-stage diagnosis¹ and 30% more likely to die from the disease than white Americans.²

The reasons are complex — a mix of biological, environmental and social factors.³

Obesity, certain genetic mutations, poor access to care and exposure to pollution all contribute to poor ovarian cancer outcomes. And all disproportionately strike the Black community.³

With the backdrop of these systemic disadvantages, rooted in hundreds of years of American history, an ambitious young Black woman finds herself faced with an insidious ovarian cancer diagnosis.

Dana’s story

Dana is a paid spokesperson for GSK. This is Dana’s story and others’ may be different.

When Dana, 49, of Texas, was in her early 20s, she had big plans for herself and her young son. After being passed over for a promotion, she wanted to make some changes to start building the life of her dreams. She was going to move home to Missouri, where she had lined up a new job for herself and school for her son.

Before leaving for Missouri, she set up a number of appointments, one being her annual physical.

What started as a routine exam led to a follow-up with a gynecologist and ultimately surgery to explore some mysterious masses in her abdomen.

Surgeons ended up removing Dana’s uterus, an ovary, a fallopian tube and her appendix to hopefully capture all of the tumors. Dana awoke to this news in the surgical recovery room. Testing revealed the masses were malignant.

“I sat there in disbelief. I was 25 years old being told I had stage III ovarian cancer,” says Dana. “In my mind, cancer was a disease of the elderly, not a young woman’s disease, definitely not this young woman.”

Dana was not wrong — the median age of ovarian cancer diagnosis is 63 years old.⁴ But, as she learned firsthand, ovarian cancer can strike at any age.

Unfortunately, like Dana, most people with ovarian cancer are diagnosed at an advanced stage of disease, which generally translates to worse outcomes.⁵

Dana underwent four rounds of chemotherapy and ultimately received a clean bill of health. Although she never made it back to Missouri, she did earn her associate degree that year, and got married a year later. Life was looking up.

Sixteen years passed with no major health issues. Then, at age 43, an annual screening test revealed that her ovarian cancer came back, as it does in 85% of those with the disease.⁶

Again, Dana underwent chemotherapy. Again, she went into remission. Again, her cancer came back, this time a mere two years later. Another round of chemotherapy. Dana pushed through and continued to pursue her education, receiving her bachelor’s and master’s degrees in Psychology while in periods of remission.

An alternative to “watch and wait”

Observation, or “watch and wait,” was previously the only option for cases like Dana’s,⁷ but there are maintenance therapies available that may extend the time before the cancer comes back.⁸

One maintenance therapy option is ZEJULA (niraparib, 100mg capsules), an oral medicine known as a PARP inhibitor, which works by preventing cells from repairing their damaged DNA in both healthy cells and cancer cells.

ZEJULA is a prescription medicine used for the maintenance treatment of adults with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that comes back. ZEJULA is used after the cancer has responded (complete or partial response) to treatment with platinum-based chemotherapy.

It is not known whether ZEJULA is safe and effective in children.

ZEJULA may cause serious side effects such as bone marrow problems called myelodysplastic syndrome (MDS) or a type of blood cancer called acute myeloid leukemia (AML), which may lead to death. Symptoms of low blood counts include weakness and can be a sign of serious bone marrow problems. Routine monitoring of blood counts is required. Contact your doctor for new bleeding, fever, or infection. New onset of bleeding could include bruising, bleeding more easily, or blood in urine or stool. High blood pressure is common and can become serious. Routine monitoring of blood pressure and heart rate is required. ZEJULA has been associated with Posterior Reversible Encephalopathy Syndrome (PRES), a brain condition. Tell your doctor if you have headache, vision changes, confusion, or seizure. Tell your doctor about all your medical conditions and medications, including liver problems and if you are pregnant or breastfeeding or plan to be. Some common side effects include nausea, low blood counts, tiredness, constipation, muscle and back pain, headache, and trouble sleeping.

Please see additional Important Safety Information below and full Prescribing Information.

Considering she had a positive response to her most recent round of platinum-based chemotherapy and her history with recurrence, Dana’s doctor suggested she give ZEJULA a try.

“I liked the idea of doing something active that might help delay the cancer from returning, instead of waiting and hoping for the best,” Dana says.

Initially, Dana did experience some side effects from ZEJULA, including stomach pains, nausea, diarrhea and fatigue, but after working with her doctor to adjust her dose, she found a dose that worked for her.

She still goes for routine tests to monitor her blood counts and vitals and check for signs of cancer in her blood, and she regularly checks in with her doctor about any side effects she experiences.

Dana urges anyone facing advanced ovarian cancer to talk with their doctor about all the possible benefits and risks and whether a maintenance therapy might be an option for them — the way ZEJULA is for her — and to read more at zejula.com.

Don’t discount DNA

Although Dana’s family doesn’t have a history of ovarian cancer, the genetic mutations associated with ovarian and other gynecologic cancers can run in families.⁹ Of particular note are mutations in the genes BRCA1 and BRCA2 — short for BReast CAncer genes 1 and 2 — that disrupt the body’s ability to repair DNA damage.¹⁰

There are no routine screening tests recommended for ovarian cancer for women who do not have symptoms and are not at high risk of developing the disease.¹¹ However, genetic tests for BRCA mutations can help assess ovarian cancer risk for those with known family history and can help guide treatment for those who have already received a diagnosis.¹²

There are now also genomic tests — analyzing a person’s entire genetic makeup, rather than searching for a handful of individual genes — that can detect another marker of ovarian cancer called HRD, which stands for homologous recombination deficiency.¹³

With HRD, the body is specifically unable to fix breaks in the DNA strand, which may change how cancer cells grow and respond to certain treatments.¹⁴ About 50% of women with advanced ovarian cancer have tumors that test positive for HRD,¹⁴ and while it can coincide with BRCA mutations, it doesn’t always, which is why it’s important to test for both.¹⁵ HRD is more common among Black patients, compared to whites.¹⁶ Yet, Black patients are less likely to be referred for genetic testing¹⁷ and also less likely to receive maintenance therapy.¹⁸

ZEJULA can be used as a maintenance treatment for women with and without a positive test for BRCA or HRD.¹⁹

Being a health advocate

As with most forms of cancer, early diagnosis and treatment of ovarian cancer are key factors that determine outcomes.

Yet, the signs and symptoms of ovarian cancer — bloating, abdominal pain or pressure, trouble eating, feeling full quickly and urinary urgency or frequency — aren’t noticeable early in the course of disease and can easily be mistaken for other conditions.²⁰

Dana had no reason to suspect anything was wrong when she went for that fateful physical over two decades ago. She made that appointment because she’s proactive and vigilant about her health, and today, she advocates for others to do the same, by knowing family history, being vocal with their doctors and never ignoring what may seem like small health concerns.

That’s an especially important message in the Black community, since deeply ingrained barriers to access have resulted in Black Americans receiving a lower level of preventative health care than white Americans,²¹ which serves to perpetuate inequities in cancer outcomes.²²

Dana makes a point of telling her story as often as she can and offering a listening ear to others who may be facing similar health challenges, as a way to lift up her community.

“Knowing that I’m doing everything I can to actively support my own care, along with being able to encourage my fellow sisters in the fight, provides me that extra nudge to keep pressing,” says Dana.

Indications and Important Safety Information

Indications

ZEJULA is a prescription medicine used for the:

• maintenance treatment of adults with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. ZEJULA is used after the cancer has responded (complete or partial response) to treatment with platinum-based chemotherapy
• maintenance treatment of adults with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that comes back. ZEJULA is used after the cancer has responded (complete or partial response) to treatment with platinum-based chemotherapy
• treatment of adults with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have been treated with 3 or more prior types of chemotherapy and who have tumors with:
  • a certain BRCA gene mutation, or
  • gene mutation problems and who have progressed more than 6 months after their last treatment with platinum-based chemotherapy.
  • Your healthcare provider will perform a test to make sure that ZEJULA is right for you

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

Important Safety Information

ZEJULA may cause serious side effects, including:

Bone marrow problems called Myelodysplastic Syndrome (MDS) or a type of blood cancer called Acute Myeloid Leukemia (AML). Some people who have ovarian cancer and who have received previous treatment with chemotherapy or certain other medicines for their cancer have developed MDS or AML during treatment with ZEJULA. MDS or AML may lead to death.

Symptoms of low blood cell counts (low red blood cells, low white blood cells, and low platelets) are common during treatment with ZEJULA. They can be a sign of serious bone marrow problems, including MDS or AML. These symptoms may include the following:

Your doctor will do blood tests to check your blood cell counts before treatment with ZEJULA. You will be tested weekly for the first month of treatment with ZEJULA, monthly for the next 11 months of treatment, and from time to time afterward.

High blood pressure is common during treatment with ZEJULA, and it can become serious. Your doctor will check your blood pressure and heart rate at least weekly for the first two months, then monthly for the first year, and as needed thereafter during your treatment with ZEJULA.

Posterior reversible encephalopathy syndrome (PRES) is a condition that affects the brain and may happen during treatment with ZEJULA. If you have headache, vision changes, confusion, or seizure, with or without high blood pressure, please contact your doctor.

Before starting to take ZEJULA, tell your doctor about all of your medical conditions, including if you:

• Have heart problems
• Have liver problems
• Have high blood pressure
• Are allergic to FD&C Yellow No. 5 (tartrazine) or aspirin. ZEJULA capsules contain tartrazine, which may cause allergic-type reactions (including bronchial asthma) in certain people, especially people who also have an allergy to aspirin
• Are pregnant or plan to become pregnant. ZEJULA may harm an unborn baby and may cause loss of pregnancy (miscarriage)
• If you are able to become pregnant, you should use effective birth control (contraception) during treatment with ZEJULA and for 6 months after taking the last dose of ZEJULA
• If you are able to become pregnant, your doctor may perform a pregnancy test before you start treatment with ZEJULA
• You should tell your doctor right away if you become pregnant
• Are breastfeeding or plan to breastfeed
• ZEJULA may harm your baby. You should not breastfeed your baby during treatment with ZEJULA and for 1 month after taking the last dose of ZEJULA

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

The most common side effects of ZEJULA include the following:

Heart not beating regularly Nausea Constipation Vomiting Pain in the stomach area Mouth sores Diarrhea Indigestion or heartburn Dry mouth

Tiredness Loss of appetite Urinary tract infection Changes in liver function or other blood tests Pain in your muscles and back Headache Dizziness

Change in the way food tastes Trouble sleeping Anxiety Sore throat Shortness of breath Cough Rash Changes in the amount or color of your urine

If you have certain side effects, then your doctor may change your dose of ZEJULA, temporarily stop, or permanently stop treatment with ZEJULA.

These are not all the possible side effects of ZEJULA. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see Prescribing Information.

Trademarks are owned by or licensed to the GSK group of companies.
©2022 GSK or licensor.
NRPCOCO220001 June 2022
Produced in USA.

References

1. Sakhuja S, Yun H, Pisu M, Akinyemiju T. Availability of healthcare resources and epithelial ovarian cancer stage of diagnosis and mortality among Blacks and Whites. J Ovarian Res. 2017;10(1):57. Published 2017 Aug 22. doi:10.1186/s13048-017-0352-1
2. Collins Y, Holcomb K, Chapman-Davis E, Khabele D, Farley JH. Gynecologic cancer disparities: a report from the health disparities taskforce of the Society of Gynecologic Oncology. Gynecol Oncol. 2014;133:353–361. doi: 10.1016/j.ygyno.2013.12.039.
3. Srivastava SK, Ahmad A, Miree O, et al. Racial health disparities in ovarian cancer: not just black and white. J Ovarian Res. 2017;10(1):58. Published 2017 Sep 21. doi:10.1186/s13048-017-0355-y
4. American Cancer Society. Key Statistics for Ovarian Cancer. https://www.cancer.org/cancer/ovarian-cancer/about/key-statistics.html. Accessed: April 115, 2022.
5. Rauh-Hain JA, Krivak TC, Del Carmen MG, Olawaiye AB. Ovarian cancer screening and early detection in the general population. Rev Obstet Gynecol. 2011;4:15–21.
6. Lorusso D, Mancini M, Di Rocco R, Fontanelli R, Raspagliesi F. The role of secondary surgery in recurrent ovarian cancer. Int J Surg Oncol. 2012;2012:613980. doi:10.1155/2012/613980.
7. Khalique S, Hook JM, Ledermann JA. Maintenance therapy in ovarian cancer. Curr Opin Oncol. 2014;26(5):521-528
8. Lin Q, Liu W, Xu S, Shang H, Li J, Guo Y, Tong J. PARP inhibitors as maintenance therapy in newly diagnosed advanced ovarian cancer: a meta-analysis. BJOG 2020; https://doi.org/10.1111/1471-0528.16411
9. National Cancer Institute. BRCA Mutations: Cancer Risk and Genetic Testing. https://www.cancer.gov/about-cancer/causes-prevention/genetics/brca-fact-sheet. Last Updated November 19, 2020. Accessed February 2022
10. Neff, R. T., Senter, L., & Salani, R. (2017). BRCA mutation in ovarian cancer: testing, implications and treatment considerations. Therapeutic advances in medical oncology, 9(8), 519–531. https://doi.org/10.1177/1758834017714993
11. American Cancer Society. Tests For Ovarian Cancer. https://www.cancer.org/cancer/ovarian-cancer/detection-diagnosis-staging/howdiagnosed.html. Last Updated May 10, 2020. Accessed May 2022
12. National Cancer Institute. Genetic Testing for Inherited Cancer Susceptibility Syndromes. https://www.cancer.gov/about-cancer/causes-prevention/genetics/genetictesting-fact-sheet. Accessed May 2022
13. WebMD. What Is Genomic Testing in Cancer? https://www.webmd.com/cancer/cancergenomes-21/what-is-genomic-testing. Accessed May 2022
14. Target Ovarian Cancer. (2021). Homologous recombination deficiency. https://targetovariancancer.org.uk/about-ovarian-cancer/hereditary-ovariancancer/homologous-recombination-deficiency. Accessed May 2022
15. Haunschild CE, Tewari KS. The current landscape of molecular profiling in the treatment of epithelial ovarian cancer. Gynecol Oncol. 2021;160(1):333-345. doi:10.1016/j.ygyno.2020.09.04
16. Sinha S, Mitchell KA, Zingone A, et al. Higher prevalence of homologous recombination deficiency in tumors from African Americans versus European Americans. Nat Cancer. 2020;1(1):112-121. doi:10.1038/s43018-019-0009-
17. Chapman-Davis E, Zhou ZN, Fields JC, et al. Racial and Ethnic Disparities in Genetic Testing at a Hereditary Breast and Ovarian Cancer Center. J Gen Intern Med. 2021;36(1):35-42. doi:10.1007/s11606-020-06064-
18. Dawood S. Use of PARPi among patients with advanced ovarian cancer: Results from a real-world database. Poster presented at: ESMO Congress; Sept 16-21, 2021; Paris, France
19. Foo T, George A, Banerjee S. PARP inhibitors in ovarian cancer: An overview of the practice-changing trials. Genes Chromosomes Cancer. 2021;60(5):385-397. doi:10.1002/gcc.2293
20. American Cancer Society. Signs and Symptoms of Ovarian Cancer. https://www.cancer.org/cancer/ovarian-cancer/detection-diagnosis-staging/signs-and-symptoms.html. Accessed: April 2022
21. Fiscella K, Sanders MR. Racial and Ethnic Disparities in the Quality of Health Care. Annu Rev Public Health. 2016;37:375-394. doi:10.1146/annurev-publhealth-032315-02143
22. Islami F, Guerra CE, Minihan A, et al. American Cancer Society’s report on the status of cancer disparities in the United States, 2021. CA Cancer J Clin. 2022;72(2):112-143. doi:10.3322/caac.21703

2022-07-07T08:01:00

(BPT) – While COVID-19 restrictions continue to ease across the country and the pandemic begins to subside for many, a group of people remain “left behind.” Despite the battle to bolster immunity and prevent severe illness or death from COVID-19, many immunocompromised individuals remain insufficiently protected.¹

While COVID-19 vaccinations can protect a majority of the population, 3% of adults in the United States are considered immunocompromised and at the highest risk for COVID-19,² including those who have received a solid organ or bone marrow transplant, are on active chemotherapy or other immunosuppressive drugs, have advanced or untreated HIV, or who have a primary immune deficiency.³ These individuals may be unable to mount an adequate immune response to vaccines, leaving them vulnerable to COVID-19.¹ In the weeks following vaccination, their immune systems may react, but not produce enough antibodies to protect against COVID-19 in the event of an exposure.¹

There are therapies, however, such as long-acting monoclonal antibodies, that may help immunocompromised individuals, by providing additional protection prior to virus exposure.⁴

Another option in the fight against COVID-19

Unlike a vaccine that helps stimulate and prepare your immune system to respond if you are exposed to a virus, monoclonal antibodies imitate the body’s normal infection-fighting abilities.⁴

While these antibodies do not replace a vaccine, when used as prophylaxis (prevention), they can be a helpful tool in protecting high-risk individuals from severe COVID-19 outcomes.⁴

EVUSHELD^TM (tixagevimab co-packaged with cilgavimab) is a long-acting monoclonal antibody combination authorized for emergency use during the COVID-19 pandemic. EVUSHELD is for certain people with moderate to severe immune compromise for prevention of COVID-19 before being exposed to the virus and can be used in addition to vaccinations. EVUSHELD is not authorized for post-exposure prophylaxis or treatment of COVID-19.⁵

EVUSHELD has shown neutralizing activity against the Omicron variant, which is the current dominant circulating variant globally.^6,7 The duration of protection from EVUSHELD may change with certain viral variants. Prescribing healthcare providers should consider the prevalence of SARS-CoV-2 variants in their area, where data are available, when considering prophylactic treatment options.⁶

Available resources for patients

Alongside the Centers for Disease Control and Prevention’s (CDC) recommended preventative measures like wearing a mask, social distancing and getting vaccinated, immunocompromised individuals can protect themselves from COVID-19 by receiving therapies like EVUSHELD.^6,8

EVUSHELD is still being studied, so it is possible that all the risks are not known at this time. Allergic reactions can happen during and after injection of EVUSHELD. These reactions may be severe or life-threatening.

In clinical trials, serious cardiac events have happened more often in people with cardiac risk factors who received EVUSHELD than in those who did not receive EVUSHELD.

EVUSHELD is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of EVUSHELD under Section 564(b)(1) of the Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

To learn more, speak with your healthcare provider to find out if you’re a candidate for monoclonal antibodies such as EVUSHELD and visit EVUSHELD.com for more information. To find out if EVUSHELD is available in your local area, visit the US HHS COVID-19 Therapeutics Locator to locate an authorized provider near you.

Please see the Fact Sheet for Patients, Parents and Caregivers to learn more.

IMPORTANT SAFETY INFORMATION

Do not take EVUSHELD if you have had a severe allergic reaction to EVUSHELD.

What are the important possible side effects of EVUSHELD?

Allergic reactions: Allergic reactions can happen during and after injection of EVUSHELD and can sometimes be serious or life-threatening. You may be at an increased risk of an allergic reaction to EVUSHELD if you have had a severe allergic reaction to a COVID-19 vaccine or to a vaccine component. Your healthcare provider may consult with an allergist-immunologist before giving you EVUSHELD if you have had a serious allergic reaction to a COVID-19 vaccine.

Tell your healthcare provider right away if you get any of the following signs and symptoms of an allergic reaction during or after you receive EVUSHELD:

Trouble breathing or shortness of breath	Wheezing
Chills	Itching
Tiredness or weakness	Skin flushing
Fast heart rate	Sweating
Chest pain or discomfort	Muscle aches
Nausea and vomiting	You may feel lightheaded or faint
Swelling of your face, lips, mouth and tongue	Throat tightness
Hives

Cardiac (heart) events:

In the clinical trial for EVUSHELD, more people with cardiac risk factors (including a history of heart attack) experienced serious cardiac events than those who did not receive EVUSHELD.

It is not known if these events are related to EVUSHELD or to underlying medical conditions. Contact your healthcare provider or get medical attention right away if you get any symptoms of cardiac events, including pain, pressure, or discomfort in the chest, arms, neck, back, stomach or jaw, as well as shortness of breath, feeling tired or weak (fatigue), feeling sick (nausea), or swelling in your ankles or lower legs.

The side effects of getting any medicine by intramuscular injection may include pain, bruising of the skin, soreness, swelling and possible bleeding or infection at the injection site.

These are not all the possible side effects of EVUSHELD. Not a lot of people have been given EVUSHELD. Serious and unexpected side effects may happen. EVUSHELD is still being studied, so it is possible that all the risks are not known at this time.

It is possible that EVUSHELD may reduce your body’s immune response to a COVID-19 vaccine. If you have received a COVID-19 vaccine, you should wait to receive EVUSHELD until at least 2 weeks after COVID-19 vaccination.

Before you receive EVUSHELD, tell your healthcare provider about all your medical conditions, including if you:

• Have any allergies, including if you have had a severe allergic reaction to a COVID-19 vaccine
• Have low numbers of blood platelets (which help blood clotting), a bleeding disorder, or are taking anticoagulants (to prevent blood clots)
• Have had a heart attack or stroke, have other heart problems, or are at high-risk of cardiac (heart) events
• Are pregnant or plan to become pregnant
• Are breastfeeding a child
• Have any serious illnesses
• Are taking any medications (prescription and over-the-counter medicines, vitamins and herbal products)

What if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider.

What prevention choices are there?

Vaccines to prevent COVID-19 are approved or available under Emergency Use Authorization. Use of EVUSHELD does not replace vaccination against COVID-19.

It is your choice to receive or not receive EVUSHELD. Should you decide not to receive EVUSHELD, it will not change your standard medical care.

AUTHORIZED USE

EVUSHELD is an unapproved medicine used in adults and adolescents (12 years of age and older who weigh at least 88 pounds [40 kg]) for pre-exposure prophylaxis for prevention of COVID-19 in persons who are:

• not currently infected with SARS-CoV-2 and who have not had recent known close contact with someone who is infected with SARS-CoV-2 and

• Who have moderate to severe immune compromise due to a medical condition or have received immunosuppressive medicines or treatments and may not mount an adequate immune response to COVID-19 vaccination or
• For whom vaccination with any available COVID-19 vaccine, according to the approved or authorized schedule, is not recommended due to a history of severe adverse reaction to a COVID-19 vaccine(s) or COVID-19 vaccine ingredient(s).

EVUSHELD is investigational because it is still being studied. There is limited information known about the safety and effectiveness of using EVUSHELD for pre-exposure prophylaxis for the prevention of COVID-19. EVUSHELD is not authorized for post-exposure prophylaxis for prevention of COVID-19.

The FDA has authorized the emergency use of EVUSHELD for pre-exposure prophylaxis for prevention of COVID-19 under an Emergency Use Authorization.

How do I report side effects with EVUSHELD?

Contact your healthcare provider if you have any side effects that bother you or do not go away. Report side effects to FDA MedWatch or call AstraZeneca at 1-800-236-9933.

You may report side effects related to AstraZeneca products by clicking here.

References

1. Haidar G, Agha M, Bilderback A, et al. Prospective evaluation of COVID-19 vaccine responses across a broad spectrum of immunocompromising conditions: the COVICS study [published online ahead of print, 2022 Feb 18]. Clin Infect Dis. 2022; ciac103. doi:10.1093/cid/ciac103, Accessed June 13, 2022.
2. Harpaz R, Dahl RM, Dooling KL. Prevalence of Immunosuppression Among US Adults, 2013. JAMA. 2016 Dec 20;316(23):2547-2548. doi: 10.1001/jama.2016.16477. Accessed June 15, 2022.
3. Covid-19 vaccines for people who are moderately or severely immunocompromised. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/immuno.html?s_cid=10483%3Aimmunocompromised+and+covid+vaccine%3Asem.ga%3Ap%3ARG%3AGM%3Agen%3APTN%3AFY21. Accessed May 26, 2022.
4. Taylor PC, Adams AC, Hufford MM, de la Torre I, Winthrop K, Gottlieb RL. Neutralizing monoclonal antibodies for treatment of COVID-19. Nat Rev Immunol. 2021;21(6):382-393. doi:10.1038/s41577-021-00542-x. Accessed June 15, 2022.
5. US Food and Drug Administration FACT SHEET FOR PATIENTS, PARENTS AND CAREGIVERS: EMERGENCY USE AUTHORIZATION (EUA) of EVUSHELD^TM (Tixagevimab Co-Packaged with Cilgavimab) for Coronavirus Disease 2010 (COVID-19). Available at: https://www.fda.gov/media/154701/download. Accessed June 15, 2022.
6. US Food and Drug Administration FACT SHEET FOR HEALTHCARE PROVIDERS: EMERGENCY USE AUTHORIZATION FOR EVUSHELD^TM (Tixagevimab Co-Packaged with Cilgavimab). Available at: https://www.fda.gov/media/154701/download. Accessed June 15, 2022.
7. World Health Organization. (n.d.). Tracking sars-COV-2 variants. World Health Organization. Available at https://www.who.int/activities/tracking-SARS-CoV-2-variants. Accessed June 15, 2022.
8. Centers for Disease Control and Prevention. (n.d.). How to protect yourself & others. Centers for Disease Control and Prevention. Retrieved June 15, 2022, from https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html. Accessed June 15, 2022

EVUSHELD is a trademark of the AstraZeneca group of companies.

©2022 AstraZeneca. All rights reserved.

2022-07-06T12:59:00

(BPT) – Warm breezes and long, sunny days beckon people of all ages outdoors. Being in Mother Nature has numerous benefits, including a positive boost to mental wellness. After your time outside, you need to make sure you care for your skin, a regimen to look as good as you feel. Fortunately, natural ingredients can help you with your after-sun care needs so you can feel your best inside and out.

Whether you’re relaxing on your patio, gardening in the backyard or having an outdoor adventure at a local park, any time outside is time well spent. According to the American Psychological Association, spending time in nature is linked to both cognitive benefits and improvements in mood, mental health and emotional well-being.

Even on cloudy days or in open shade, UV rays can still cause damage to the skin, according to the Centers for Disease Control. SunBurnt product formulas are ideal for after-sun care, with soothing ingredients ideal for when you’re done with summer activities like hiking, boating and swimming, which leaves the skin vulnerable. These ingredients include:

Aloe vera: With natural healing and soothing properties, aloe vera has been used for centuries as a natural remedy for sunburn. Aloe contains vitamins, minerals, amino acids and antioxidants that help reduce infections, speed up healing time, and reduce redness and itch while providing a cooling effect.

Calendula: Commonly known as pot marigold, this ingredient is rich in antioxidants and has anti-inflammatory properties that soothe irritated skin and promote hydration to help remedy sunburn.

Coconut oil: The medium-chain fatty acids found in coconut oil possess antimicrobial properties that can help treat acne and protect the skin from harmful bacteria, in addition to keeping it moist.

Cucumber: Cucumber provides a base for hydration, something needed after being in the sun. It also reduces swelling and puffiness while soothing irritation. It contains Vitamin C which is known to aid in new skin cell growth as well as folic acid, which helps to fight off toxins.

Echinacea: Echinacea extracts are used topically to soothe and reduce irritated skin, and even diminish wrinkles.

Algae extract: Algae and kelp (or seaweed) revitalize and tone the skin. Algae improves skin elasticity and helps restore moisture to dry skin.

Maintaining a sun-safe skin routine is essential year-round, especially when spending time outdoors in summer. Ciara Johnson, a solo traveler enthusiast @hey_ciara and lifestyle influencer collaborating with SunBurnt, knows the joy that comes with natural places but is also aware of how important it is to take care of your skin.

“I can attest to the fact that being outdoors is good for the soul but without the right regimen can be rough on the skin,” says Johnson. “My travels through my company Hey Ciara have transported me to every kind of climate imaginable and caring for my skin after hitting the trails, strolling the beach or exploring a local landmark is a must, which is why having a product like SunBurnt in my travel kit is essential.”

Because she’s so passionate about spending time outdoors, Johnson is excited to announce that the SunBurnt #SummerNaturally sweepstakes is back for the second year! The social media photo and video sweepstakes Grand Prize includes an $800 gift card to HipCamp, which hosts various outdoor adventures across the U.S., and a $700 gift card for American Airlines to help with travel to the selected destination. People who enter the sweepstakes are also eligible for three monthly drawings to receive a cash prize of $100.

People can enter on Facebook by following @SunBurnt then including the hashtag #SummerNaturally in the post with their picture; and on Instagram by following @TheSunBurntBrand and then uploading a photo using the hashtag #SummerNaturally. Profiles must be set to public through the duration of the sweepstakes which ends September 6, 2022. Monthly winners for the three $100 gift cards will be revealed on SunBurnt social media channels. Visit https://woobox.com/2e6obo to learn more.

“’Self-care’ in the form of a unique outdoor experience best describes our intent with our #SummerNaturally social media photo and video sweepstakes,” said Anne Brolly, senior vice president of product development and marketing at Quest Products Inc. makers of SunBurnt. “We look forward to seeing entries of people enjoying the summer outdoors and of course will be reminding everyone to nurture their skin after being in nature.”