Category: Brandpoint Health

2021-12-08T01:01:00

(BPT) – Being an advocate and prioritizing your own health is essential to your well-being. No one is in charge of your health but you. At the end of the day, it’s up to you to ensure you get the checkups that are key to staying well and preventing future problems.

With that in mind, here are the top five health evaluations you shouldn’t put off.

1. General checkup

You’ve heard it before, but getting a full physical examination annually is the best way to keep tabs on your health and prevent small issues from becoming big problems. A general checkup can include any number of individual evaluations including cardiovascular checks, pap screens, screenings for family history health issues, and more. Your provider will also likely order a full blood test to check for things like cholesterol levels, glucose levels, fluid balance and organ function.

2. Vision exam

Your sight is worth protecting. That’s why it’s so important to get an annual eye exam. There’s more to eye health than just seeing clearly. Your eye doctor can check for things like macular degeneration, astigmatism, glaucoma and other conditions that develop over time. Also, because vision can worsen gradually, you may not even realize you’re not seeing as well as you could be.

Experts recommend most adults get their eyes checked annually. If your current insurance portfolio doesn’t offer vision protection, consider an insurance partner like VSP Individual Vision Plans. It’s vision coverage you can buy on your own and there’s no waiting for specific enrollment periods.

3. Dental exam

There aren’t many people who enjoy going to the dentist, but that doesn’t make it any less important. Dental problems tend to snowball, and what starts as a cavity can turn into a more serious issue quickly. Put your reluctance aside and go see your dentist. They can screen for things like cavities, gingivitis and infections and make sure any prior dental procedures, like crowns or fillings, are still holding up.

4. Age-appropriate screenings

As you get older, your health needs change. You become more at-risk for different types of conditions, and the health evaluations you relied on in younger years may not be sufficient anymore. As you age, consider going in for more age-appropriate health screenings, like a colonoscopy to check for colon cancer, hearing tests and mole checks. Your doctor or primary care physician can tell you what screenings are right for your age and individual health concerns.

5. Flu shot

While the flu shot is not technically a health evaluation, it’s still one of those things many people put off or avoid altogether. This is unfortunate because a flu shot is one of the best ways to protect yourself and others from real health consequences. According to CDC estimates, there were up to 740,000 flu hospitalizations and up to 62,000 deaths in the 2019-2020 flu season. Getting a flu shot is especially important because people with compromised immune systems may not be eligible for the vaccine. By not protecting yourself, you may be putting others at risk.

2021-12-07T09:01:00

(BPT) – This content was sponsored by GSK. Jenna is a real patient who was on treatment at the time of these interviews. GSK paid for her time and expenses in sharing her unique experiences. Individual results may vary.

Can you remember a time when a teacher of yours positively impacted your life? According to a study conducted by the ING Foundation, 88% of Americans say they had a teacher who had a significant, positive impact on their life and 98% reported that they believe a good teacher can change the course of a student’s life. Teachers provide our children a space to learn and grow each day, whether virtual or in-person.

“A normal day for a teacher, you are always on your feet ready to move, ready to catch the next problem and solve it,” shared Jenna, an art teacher and artist.

When those daily responsibilities are met with respiratory conditions, like asthma, a teacher’s job can become even more difficult.

Asthma is a chronic lung disease where inflammation in the lungs causes the airways to narrow. Symptoms of asthma can include shortness of breath, chest tightness or pain, wheezing when exhaling and trouble sleeping due to asthma symptoms. Of the 25 million people in the U.S. living with asthma, 5-10% suffer from severe asthma. Severe asthma is often characterized by a higher frequency of symptoms.

During her first year of teaching, Jenna found that her severe asthma was negatively impacting her work. She felt disappointed that her condition was holding her back from being able to give her students her best while still maintaining her own health and well-being.

“Do I stay and just push through this stress, and this hurt and this not being able to breathe in my classroom? Do I stay for them, or do I have to go and take care of myself? It’s kind of a constant battle,” said Jenna.

Severe asthma did not only impact her work life but also her personal life. Jenna shared, “When you’re not able to teach and do the things that you want to with your students it’s really difficult. When you’re not able to partake in activities with your family, it’s really frustrating.”

After sharing her symptoms with her doctor, Jenna learned that not all asthma is the same, and for some people, including about half of those with severe asthma, elevated eosinophil levels can be a key factor. This type of asthma is called severe eosinophilic asthma (SEA). Jenna’s body was producing excess eosinophils, which likely contributed to the severity of her symptoms and the frequency of her asthma attacks. This led to her diagnosis of SEA by an asthma specialist.

The role of eosinophils [ee-uh-sin-uh-fils]

Jenna learned that everyone has eosinophils in their body, which are a type of white blood cell that plays an important role in maintaining the immune system and helping to fight off certain infections. Her doctor told her that if you have an increased number of eosinophils, your lungs may become swollen, or inflamed. This can cause severe asthma attacks. She learned that a simple blood test that measures eosinophil levels can help determine if you have SEA. Once you have an eosinophilic asthma diagnosis, together, you and your doctor will decide if adding a different kind of asthma treatment could help.

According to Dr. Tom Corbridge, Senior Medical Lead at GSK, eosinophils play a critical role in a handful of conditions, not just SEA, and symptoms can present themselves in a variety of ways: “In most healthy people, eosinophils make up less than 5% of the body’s white blood cells. When a person has higher numbers of eosinophils without a known cause, they may have an eosinophilic disease, which can cause severe symptoms long-term. Some of these persistent symptoms include frequent asthma attacks and reduced lung function.”

Eosinophils can impact other diseases in addition to asthma, including:

1. Chronic rhinosinusitis with nasal polyps (CRSwNP) is a disease of the nasal passages and sinuses with soft tissue growths called nasal polyps. Nasal polyp symptoms can include nasal congestion, nasal discharge, mucus in the throat, loss of smell, and facial pain. When people have CRSwNP, there is inflammation in the nasal passages and sinuses. Eosinophils play an important role in this inflammation.
2. Eosinophilic granulomatosis with polyangiitis (EGPA), formerly known as Churg-Strauss syndrome, is a condition characterized by asthma, an increase in eosinophils and inflammation of the blood vessels (also known as vasculitis). EGPA is characterized by the development of asthma as an adult, allergic rhinitis (hay fever), growths in the nose (nasal polyps) and an increased eosinophil count.
3. Hypereosinophilic syndrome (HES) is another condition connected to increased levels of eosinophils and is also a rare and under-diagnosed disease. People with HES often have eosinophil levels three times greater than the average, which causes inflammation and organ damage, and can significantly impact patients’ ability to function and complete day-to-day activities.

Treatment

A key protein in our body called IL-5 (interleukin-5) plays a key role in eosinophil production. While the mechanism of action of NUCALA (mepolizumab) is not fully understood, NUCALA targets eosinophils in the body. NUCALA binds to IL-5 and blocks IL-5 from making more eosinophils. Having less eosinophils can help reduce inflammation. This may lead to fewer asthma attacks.

NUCALA is the only anti-IL-5 biologic approved by the U.S. Food and Drug Administration (FDA) in four eosinophil-driven diseases: SEA, CRSwNP, EGPA, and HES.

NUCALA is a prescription medicine for the:

• add-on maintenance treatment of patients 6 and older with severe eosinophilic asthma. NUCALA is not used to treat sudden breathing problems.
• add-on maintenance treatment of CRSwNP in adults whose disease is not controlled with nasal corticosteroids.
• treatment of adults with EGPA.
• treatment of people 12 years of age and older with HES.

Do not use NUCALA if you are allergic to mepolizumab or any of the ingredients in NUCALA.

Not for sudden breathing problems. Allergic reactions can occur, including anaphylaxis. Get help right away for swelling of face, mouth, tongue, or trouble breathing. Infections that can cause shingles have occurred. Don’t stop taking steroids unless told by your doctor. Tell your doctor if you have a parasitic infection. May cause headache, injection site reactions, back pain, fatigue, mouth/throat and joint pain.

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

Finally Receiving a Diagnosis and Treatment

Ultimately, Jenna’s doctor diagnosed her with SEA and recommended she try NUCALA, which she now takes monthly (every four weeks).

Her advice to others with similar struggles: “Hang in there. Give things like NUCALA a chance.”

Learn more about NUCALA

Ask your primary care provider to refer you to a specialist for more information on a targeted treatment approach. A blood test can be administered to determine eosinophil levels and help diagnose certain diseases like SEA and EGPA.

Important Safety Information

Do not use NUCALA if you are allergic to mepolizumab or any of the ingredients in NUCALA.

Do not use to treat sudden breathing problems.

NUCALA can cause serious side effects, including:

• allergic (hypersensitivity) reactions, including anaphylaxis. Serious allergic reactions can happen after you get your NUCALA injection. Allergic reactions can sometimes happen hours or days after you get a dose of NUCALA. Tell your healthcare provider or get emergency help right away if you have any of the following symptoms of an allergic reaction:
• swelling of your face, mouth, and tongue
• breathing problems
• fainting, dizziness, feeling lightheaded (low blood pressure)
• rash
• hives
• Herpes zoster infections that can cause shingles have happened in people who received NUCALA.

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

• are taking oral or inhaled corticosteroid medicines. Do not stop taking your other medicines, including your corticosteroid medicines, unless instructed by your healthcare provider because this may cause other symptoms to come back.
• have a parasitic (helminth) infection.
• are pregnant or plan to become pregnant. It is not known if NUCALA may harm your unborn baby.
• A pregnancy registry for women with asthma who receive NUCALA while pregnant collects information about the health of you and your baby. You can talk to your healthcare provider about how to take part in this registry or you can get more information and register by calling 1-877-311-8972 or visit www.mothertobaby.org/asthma.
• are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will use NUCALA and breastfeed. You should not do both without talking with your healthcare provider first.
• are taking prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of NUCALA include: headache, injection site reactions (pain, redness, swelling, itching, or a burning feeling at the injection site), back pain, and tiredness (fatigue). Mouth/throat pain and joint pain have been reported with CRSwNP.

Please see full Prescribing Information including Patient Information for NUCALA.

NUCALA injection is available as a 100-mg/mL vial, Autoinjector, and prefilled syringe.

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.

For more information on NUCALA, visit www.nucala.com.

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Trademarks are owned by or licensed to the GSK group of companies.
©2021 GSK or licensor.
MPLPRSR210002 November 2021
Produced in USA.

2021-12-07T08:01:00

(BPT) – Everyone seems to have an opinion on winter weather. Some welcome the sparkling beauty of snow and look forward to beloved winter activities. For others, plummeting temperatures only bring them outside when necessary, often to shovel or run errands.

No matter your personal feelings about winter, the season can present some challenges to your body’s frame. Orthopaedic trauma surgeon and spokesperson for the American Academy of Orthopaedic Surgeons (AAOS), Yelena Bogdan, MD, FAAOS, offers tips to avoid common winter injuries and accidents during the cold months.

Dress for the weather

Wind and sleet. Ice and snow. The winter season can be unpredictable, so dressing appropriately for the weather is essential. Layers help you stay warm and can easily be removed if you get overheated. Water-resistant outerwear is a must to repel rain, snow, and ice. Remember to be mindful of the extremities, which can suffer frostbite quickly if not covered. Always wear high-quality hats, boots, and gloves or mittens for protection. Remind children to leave these items on when outside, but if clothing or winter attire becomes wet, to head inside to dry off or get fresh gear.

Know the signs of frostbite

Frostbite can occur in mere minutes when you are outside in extreme cold. It also can happen when temperatures are above freezing if there is strong wind. According to Dr. Bogdan, symptoms of frostbite include numbness, a frozen feeling on the skin or deeper tissue, and a waxy, white or grayish color. Seek shelter if you think someone has frostbite and gently rewarm the affected area in warm (not hot) water for at least 30 to 45 minutes, or until the area feels warm and sensation returns. Don’t rub or massage the frostbitten area with your hands or with anything else.

Remove ice and snow

Whether you live in an area blanketed with snow for months or you’re graced with just a few flurries a year, it’s important to take care of your home and those who live there by shoveling and removing ice. Use a snow shovel or snow blower to remove snowfall and store plenty of salt or sand to sprinkle on icy spots to prevent falls on walkways and other frequently accessed outdoor spaces.

Use proper snow shoveling technique

Removing snow is essential for household safety, but the activity itself comes with risks. To prevent injuries, use a shovel that is comfortable for your height and strength. Try to push the snow instead of lifting it. If you must lift, squat with your legs apart, knees bent, and back straight. Always lift with your legs and avoid bending at the waist or throwing snow over your shoulder or to the side. This requires a twisting motion that stresses your back. Finally, start early and shovel often, rather than waiting for a big snowfall to finish, which can mean heavier lifting.

Take winter sport precautions

Did you know that more than 200,000 people were treated at hospitals, doctors’ offices and emergency rooms for injuries related to winter sports in 2018? According to the U.S. Consumer Product Safety Commission, these injuries were the result of cold weather sports like skiing, snowboarding, ice skating and sledding. The AAOS urges sports enthusiasts to take precautions to avoid common injuries such as sprains, strains, dislocations, and fractures. When participating in your favorite winter activity, make sure to wear appropriate protective gear, including goggles, helmets, gloves and padding. Know and abide by all rules of the sport in which you are participating and never go out alone. Stay in areas designated for your activity, such as a groomed ski hill or community sledding hill, and make sure you can see adequately.

For more winter injury prevention tips for your bones and joints, visit OrthoInfo.org.

2021-12-06T14:09:00

(BPT) – Vitamin D is known for helping with bone health, but its benefits extend beyond that. Due to its positive effects on the respiratory and immune systems, more than 100 clinical trials have been conducted since the onset of the COVID-19 pandemic to look for links between vitamin D and COVID-19.

Higher blood levels of vitamin D correlated with lower incidence or severity of COVID-19 in most reviews of the research.

Thirteen recent meta-analyses (statistical reviews) examined the data from those 100-plus independent studies. Most of the studies focused on vitamin D blood levels and COVID-19, while two exclusively looked at vitamin D consumption in relationship to the illness. Most analyses reveal that higher blood levels of vitamin D appear to be correlated with lower incidence or severity of COVID-19, whereas lower blood levels of vitamin D appear to be correlated with a more severe case of COVID-19.

“Increasing evidence suggests a link between higher vitamin D levels and lower incidence of COVID-19,” said Luke Huber, ND, MBA, vice president of scientific and regulatory affairs at the Council for Responsible Nutrition (CRN). “We have known for years that vitamin D plays an important role in immune health, and now there are multiple meta-analyses that appear to demonstrate the benefits of this nutrient in COVID-19.”

One statistical review found that intervening with vitamin D in an active case of COVID-19 reduced chance of death, though another, smaller meta-analysis did not see a statistically significant relationship. Timing and dosage of those vitamin D interventions may have led to different results. Summaries of the meta-analyses and links to the research are available on the CRN Foundation’s “Vitamin D & Me!” website.

“Consumers need science-based evidence to make informed health decisions,” said Brian Wommack, executive director of the CRN Foundation. “We hope consumers use these findings to better understand how nutrients like vitamin D support their goal of living a healthy lifestyle.”

Prevalence of low vitamin D status

Low vitamin D status is increasingly common. The prevalence of vitamin D deficiency (VDD) was found to be 28.9%, and vitamin D insufficiency (VDI) 41% in a subset of 26,010 U.S. adults surveyed as part of the ongoing National Health and Nutrition Examination Survey (NHANES) from 2001-2010.

Recent studies in the British Journal of Nutrition, European Journal of Clinical Nutrition, and Aging Clinical and Experimental Research revealed that the following people are more at risk for VDD and VDI:

• People of color, especially the Black community
• Less educated populations
• Those of lower socioeconomic status
• Smokers
• Physically inactive people
• Obese individuals
• Infrequent milk drinkers
• Individuals with chronic diseases, especially of the liver, kidney and heart
• Anyone with a disease that leads to malabsorption, such as Crohn’s disease
• Older adults, due especially to aging skin’s reduced ability to synthesize vitamin D
• People with pre-existing conditions, such as diabetics
• Anyone with reduced exposure to sunlight, such as those hospitalized and institutionalized
• Those taking certain medications

How do we get vitamin D?

Vitamin D comes from three potential sources: food, sunlight-dependent production in the skin and supplements. Because vitamin D is not easily obtained from food, many countries, including the U.S. and Canada, have regulations that require vitamin D fortification of commonly consumed foods, such as milk, orange juice, other dairy products and cereals.

With regular sun exposure, a healthy diet and healthy kidneys, many people can make the vitamin D they need; however, most people are not regularly exposed to the sun, and diets vary. According to the American Journal of Clinical Nutrition, a peer-reviewed journal from the American Society for Nutrition, few people can obtain enough vitamin D from food sources alone, making supplementation important.

How much to supplement is less clear and will vary based on vitamin D status. It’s important to first discuss dosage with your doctor, as deficient and insufficient individuals will need a different supplement strategy than those who are not.

Takeaways

Simple supplementation may make you less likely to get sick and may lessen the degree of sickness if you do contract COVID-19. It isn’t a substitute for other measures, but it’s another step you can take to keep you and your family healthy.

“This growing body of research does not indicate that vitamin D is a substitute for vaccines, mask wearing, social distancing or other behaviors to mitigate the spread of the coronavirus,” said Huber. “But the data indicate that vitamin D levels may play a role, in combination with other therapies, in strengthening the immune system to resist the virus.”

The CRN Foundation, a nonprofit educational organization of the dietary supplement industry that provides information about responsible use of dietary supplements, has put together a “Vitamin D & Me!” educational initiative to explore the science: VitaminDAndMe.org.

2021-12-06T08:01:00

(BPT) – Sponsored by Astellas Pharma US, Inc.

Because you are unique, you want health care that is personalized to your needs. If you are at risk of developing or have cancer, you want more than personalization. You want precision. This is why precision medicine based on personal genetic information is important.

Precision medicine may also be called personalized medicine, and conversations with your doctor about this topic may include information about genetic changes, DNA sequencing, biomarker or molecular testing.¹ Once your health care team has your genetic profile or the genetic makeup of your cancer from tests like these, they have additional information to guide precision medicine.¹

Precision medicine uses genetic information of your tumor cells to inform diagnosis and treatment recommendations.^1,2 Your genetic profile may also include information about gene mutations, which are changes that could impact your health and, therefore, your care.³

According to the American Cancer Society, precision medicine might be used to help doctors³:

• Identify who might be at high risk for cancer
• Prevent some types of cancer
• Find certain cancers early
• Diagnose a specific type of cancer correctly
• Choose what treatment options are best
• Evaluate how a treatment is working

Understanding FLT3 mutations in AML

Genes are made up of long chains of DNA (deoxyribonucleic acid) that can be arranged in different ways that serve as codes, providing instructions for what happens in the body.⁴ Sometimes, abnormal changes known as mutations happen in the DNA of a cell, which can instruct the body to do harmful things, such as develop cancer like acute myeloid leukemia (AML).³

AML is an aggressive type of blood cancer in which the bone marrow makes abnormal blood cells.⁵ There are different subtypes of AML that are each caused by a unique gene mutation.⁴ FLT3 is just one of many gene mutations that can be present in AML.⁴ When a disease like AML does not improve after previous treatment(s), it is known as refractory. If a disease comes back after a period of improvement, it is known as a relapse.⁴

Generally, genetic testing is done with bone marrow or blood tests.⁵ If a genetic test reveals a gene mutation like FLT3, doctors can work with you to determine a treatment plan that may address the mutation.⁴ Your genes inform precision medicine.³

It’s important to remember that gene mutations can develop over time.¹ Even though you may have been tested at diagnosis, your physician may also perform tests to see if you have developed any genetic mutations since your initial diagnosis.⁴

“We are starting to see that mutations have functional impact that are going to have prognostic and therapeutic impact going forward.” – Naval Daver, M.D., MD Anderson Cancer Center.

AML is a journey

If you or a loved one is diagnosed with relapsed or refractory AML, it can be overwhelming. Finding answers throughout treatments can feel challenging, but these tips can help:

Ask questions: Feel free to discuss any questions you have with your health care team. You may want to write them down before your appointments to ensure you remember them. Visit BeAMLReady.com to access a discussion guide with foundational questions to help start the conversation.

Track symptoms: AML can change over time⁷ , so actively monitor your health and engage your doctor immediately if anything changes. Use a method that works best for you, whether that’s a personal notebook, a digital calendar or another tool.

Form a team: Maintain a strong partnership with your caregivers and health care providers throughout your treatment journey. Not only will the healthcare team provide important treatments and guidance, they’ll provide essential support and can recommend additional resources to help you if needed.

Find out mutation status: Your disease journey is unique to you. Knowing your genetic mutation status may impact your treatment options. Ask about getting tested and consider retesting at relapse or if your disease progresses.⁴

Find support: Your family, friends and health care teams provide important foundational support. Some people also appreciate connecting to others impacted by AML, so consider joining advocacy organizations or online AML support communities.

Visit BeAMLReady.com for more information on precision medicine, relapsed or refractory AML, the importance of genetic testing and how to prepare for every step of the treatment journey.

References

1. National Cancer Institute. Precision medicine in cancer treatment (10-03-2017). https://www.cancer.gov/about- cancer/treatment/types/precision-medicine. Accessed 04-08-2021.
2. American Cancer Society. How genes can help in the diagnosis and treatment of cancer (06-25-2014). https://www.cancer.org/cancer/cancer-causes/genetics/genes-and-cancer/genes-in-cancer-diagnosis-and- treatment.html. Accessed 09-15-2021.
3. National Comprehensive Cancer Network (NCCN). NCCN Guidelines for Patients Acute Myeloid Leukemia (06/01/2020). https://www.nccn.org/patients/guidelines/content/PDF/aml-patient.pdf. Accessed 11-09-2021.
4. National Cancer Institute. Adult acute myeloid leukemia treatment (PDQ®): patient version (03-06-2020). https://www.cancer.gov/types/leukemia/patient/adult-aml-treatment-pdq. Accessed 04-23-2021.
5. McCormick SR, McCormick MJ, Grutkoski PS, et al. FLT3 mutations at diagnosis and relapse in acute myeloid leukemia: cytogenetic and pathologic correlations, including cuplike blast morphology. Arch Pathol Lab Med 2010;134(8):1143- 51.
6. American Cancer Society. About acute myeloid leukemia (06-24-2019). https://www.cancer.org/content/dam/CRC/PDF/Public/8674.00.pdf. Accessed 09-13-2021.

2021-12-06T05:01:00

(BPT) – This COVID-19 vaccination hotline for people with disabilities offers assistance with finding vaccine locations, making appointments, answering common questions, and more. ACL.gov/DIAL.

2021-12-03T12:57:00

(BPT) – If you read it online, does that mean it’s true? Although the internet has undoubtedly made access to information easier than ever, not all of that “information” is born from a state of reality or truth. Myths and unwarranted “facts” around the COVID-19 vaccine and its potential impact on fertility continue to circulate, causing unnecessary alarm, spreading misinformation and perpetuating mistruths. How much truth is actually aligned with some of these increasingly common misconceptions? Dr. Sunny Jun, a board-certified reproductive endocrinologist and co-medical director of CCRM Fertility San Francisco, wants to set the record straight.

What concerns are you hearing about the COVID-19 vaccine?

Common questions around the COVID-19 vaccine and fertility include, “Will it disrupt my menstrual cycle? Will it increase my risk of miscarriage? Will it delay or interfere with my scheduled fertility treatments?” According to Jun, the short answer is no.

“There’s no scientific evidence that suggests the COVID-19 vaccine impacts fertility as it relates to women’s menstrual cycles, the ability to sustain a healthy pregnancy or its effect on in vitro fertilization (IVF) or other fertility treatments,” she said. “As with any new vaccine, there will always be things to look out for. Fortunately, current data does not demonstrate a link between vaccines and infertility.”

How did these myths originate?

It’s unclear where misinformation around the COVID-19 vaccine stems from. While some may attribute it to a variety of side effects that resulted from the second vaccine dose, it can also be traced back to the spike protein which is present in both the Pfizer and Moderna vaccines.

“The myth may have started based on the placental protein that nourishes a fetus during pregnancy, which shares an impossibly small part of the genetic code to that of the vaccine spike protein,” Jun said. “Because of this similarity, the body’s immune system may theoretically attack a pregnant woman’s placenta after vaccination. A thorough amount of research has disproved this theory — indicating that, overall, the protein is very different, and the body’s immune system will be able to differentiate it.”

A variety of recent studies have yielded a large amount of data, leading health organizations like The American College of Obstetricians and Gynecologists and Centers for Disease Control and Prevention (CDC) to reiterate their recommendations regarding the safety of the COVID-19 vaccine — even for pregnant and nursing mothers.

Are COVID-19 booster shots safe?

According to Jun, booster shots are exactly the same as the first two COVID-19 vaccine shots, (except the dose may be less in Moderna boosters) and the side effects are similar to the initial doses. Regardless of which COVID-19 vaccine a woman gets, booster shots from all three U.S.-approved manufacturers provide equivalent amounts of protection for mothers and their unborn children.

“Boosters have been authorized by the Food and Drug Administration (FDA) for certain populations, resulting in demonstrable improvements in protection against COVID-19,” she said. “In fact, it’s the only intervention (beyond social distancing, hand washing and wearing a mask) that can truly help protect someone against the worst effects of COVID-19.”

What should we be concerned about?

“Data regarding infertility and potential pregnancy complications due to a COVID-19 vaccination does not currently exist.” What could have a detrimental effect on fertility is the virus itself. If a woman experiences severe illness from COVID-19, the hypothalamic-pituitary-gonadal axis may be affected, causing variability in the production of hormones needed for fertility.

“Getting sick with COVID-19 while pregnant is serious. Deaths from COVID-19 among pregnant women is real,” Jun said. “In fact, new research from the CDC confirms that pregnant women and their babies are at increased risk of severe outcomes from COVID-19, including death and stillbirths.”

What about COVID-19 and male fertility?

The virus’ impact on fertility extends to men, as well. Jun said studies indicate COVID-19 can cause a robust inflammatory response in otherwise young, healthy and unvaccinated men. Any systemic inflammatory response can be associated with a decline in the number and/or swimming ability of sperm, or even their function or shape. Though research is still ongoing, it’s also been found that COVID-19 can cause other symptoms in men, including orchitis and erectile dysfunction.

“There is currently no evidence to support claims that the vaccine can affect sperm production or function, but what is known is that the virus itself might,” she said. “If fertility or sexual health is a concern for you or your partner, it would be wise to consider getting the COVID-19 vaccine.”

Should I be worried about my child’s future fertility if they get the vaccine?

Now that the FDA has authorized the vaccine to children ages 5 to 11, similar myths have swarmed the internet on whether the vaccine can negatively impact a child’s development to puberty or their future fertility. The Kaiser Family Foundation recently released a survey indicating that 66% of parents of children in eligible vaccine age groups carry a concern about the vaccine’s impacts on their child’s fertility.

“Similar to claims around the vaccine’s impact on adult fertility, no scientific facts indicate that the vaccine causes loss of fertility in any age,” Jun said. “While it’s normal to ask questions and express concern around a new vaccine, there is evidence to support the COVID-19 vaccine’s safety among children and several professional organizations have even endorsed their support, including the American Academy of Pediatrics.”

How do I protect myself and my family?

Simply put, anyone still hesitant about the vaccine out of fear of its impact on fertility should reconsider. The risks of COVID-19 infection during pregnancy far outweigh any perceived risks from COVID-19 vaccinations during pregnancy. Fertility health is dependent upon both partners and getting vaccinated is one of the many things that proactively ensure a successful conception and a healthy pregnancy.

“Due to a lack of evidence that demonstrates the vaccine’s negative effects on female and male fertility, we hope those who have yet to be vaccinated will change their minds sooner than later. COVID-19 is not going away any time soon,” adds Jun.

2021-11-30T23:01:00

(BPT) – When Nicole Clark’s son Brady was born, he was reaching his normal early milestones: holding his head up on his own, sitting and crawling. But when Nicole’s energetic and seemingly healthy nine-month baby boy started to struggle to pull himself up, Nicole knew something wasn’t quite right.

“My husband and I immediately enrolled Brady in occupational therapy when we noticed he was struggling to stand,” said Nicole. “We had no idea what journey we were about to face.”

Brady’s therapist suggested Nicole and her husband Tyler take him to a neurologist for further testing and evaluation. Shortly after, Brady was diagnosed with spinal muscular atrophy (SMA) Type 2. SMA is a rare, progressive disease that, left untreated, robs infants of their ability to walk, swallow and even breathe.¹ SMA is caused by the lack of a functional survival motor neuron 1 (SMN1) gene, which results in the irreversible loss of motor neurons.¹ On average babies with SMA Type 2 are diagnosed between six and 24 months of age; Brady was diagnosed shortly after his first birthday.²

Approximately one in every 11,000 babies is born in the U.S. with SMA.¹ SMA progresses quickly, meaning the earliest possible diagnosis and treatment is crucial.

“I remember being in denial when we received his diagnosis,” said Nicole. “He was such a happy baby; how could he have something like this? But his team assured me there were treatment options and that we’d get through it.”

Brady’s care team knew it was critical for him to receive treatment as soon as possible to stop irreversible motor neuron loss. They discussed options and, 19 days after his diagnosis, Brady was treated with Zolgensma^® (onasemnogene abeparvovec-xioi), a one-time gene therapy delivered through an intravenous infusion.³ Approved in the U.S. in May 2019, Zolgensma targets the genetic root cause of the disease by replacing the function of the SMN1 gene, halting disease progression.

Before and after the Zolgensma infusion, Brady received an oral corticosteroid. All children treated with Zolgensma need to receive an oral corticosteroid starting the day before infusion, and then after infusion for at least two months or longer depending on their liver function exams and labs. In addition, baseline and follow-up tests are required for at least three months post-infusion. Zolgensma has a risk of acute serious liver injury, and in clinical trials the most common side effects were elevated liver enzymes and vomiting. Please see additional Important Safety Information below and accompanying Full Prescribing Information.³

Two years later, following Zolgensma treatment and with the help of his occupational therapy team, Brady is reaching milestones his parents never thought were possible. He is often zooming around the house in his walker and riding horses in rodeos. However, while Nicole is thankful for Brady to be where he is, she often wishes she had known about SMA sooner.

One way he could have received an earlier diagnosis is through newborn screening. Millions of babies across the country are routinely screened at birth for conditions that can affect a child’s long-term health or survival. In 2018, SMA was added to the Recommended Uniform Screening Panel (RUSP), a federal list of often devastating disorders that require intervention as early as possible and have treatment options available.^4,5 Despite the fact there are now three treatments approved by the U.S. Food and Drug Administration for SMA, not every state screens for this devastating disease.⁴ The Clarks’ home state of Oklahoma didn’t screen newborns for SMA when Brady was born, but local policies have since changed and now every baby in the state is being tested within the first few days of their life.

In states where newborn screening is not yet implemented, understanding the signs of SMA – which can often be subtle, like poor head control, low muscle tone, a weak cry or not able to support weight on their legs – can help ensure a prompt diagnosis and timely access to treatment and supportive care, resulting in improved outcomes.

“I don’t like thinking of the what ifs,” said Nicole. “But what if he was diagnosed at birth? What if we didn’t start him in occupational therapy when we did? Parents shouldn’t have to wonder those things about their baby.”

For more information about SMA and to find out what you can do to ensure that babies in your state are screened for this disease, visit CureSMA.org/ActionCenter.

Results and outcomes vary among children based on several factors, including how far their SMA symptoms have progressed prior to receiving treatment.

Indication and Important Safety Information for ZOLGENSMA^® (onasemnogene abeparvovec-xioi)

What is ZOLGENSMA?

ZOLGENSMA is a prescription gene therapy used to treat children less than 2 years old with spinal muscular atrophy (SMA). ZOLGENSMA is given as a one-time infusion into a vein. ZOLGENSMA was not evaluated in patients with advanced SMA.

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

• ZOLGENSMA can cause acute serious liver injury. Liver enzymes could become elevated and may reflect acute serious liver injury in children who receive ZOLGENSMA.
• Patients will receive an oral corticosteroid before and after infusion with ZOLGENSMA and will undergo regular blood tests to monitor liver function.
• Contact the patient’s doctor immediately if the patient’s skin and/or whites of the eyes appear yellowish, or if the patient misses a dose of the corticosteroid or vomits it up.

What should I watch for before and after infusion with ZOLGENSMA?

• Viral respiratory infections before or after ZOLGENSMA infusion can lead to more serious complications. Contact the patient’s doctor immediately if you see signs of a possible viral respiratory infection such as coughing, wheezing, sneezing, runny nose, sore throat, or fever.
• Decreased platelet counts could occur following infusion with ZOLGENSMA. Seek immediate medical attention if the patient experiences unexpected bleeding or bruising.
• Thrombotic microangiopathy (TMA) has been reported to occur approximately one week after ZOLGENSMA infusion. Caregivers should seek immediate medical attention if the patient experiences any signs or symptoms of TMA, such as unexpected bruising or bleeding, seizures, or decreased urine output.

What do I need to know about vaccinations and ZOLGENSMA?

• Talk with the patient’s doctor to decide if adjustments to the vaccination schedule are needed to accommodate treatment with a corticosteroid.
• Protection against respiratory syncytial virus (RSV) is recommended.

Do I need to take precautions with the patient’s bodily waste?

Temporarily, small amounts of ZOLGENSMA may be found in the patient’s stool. Use good hand hygiene when coming into direct contact with bodily waste for 1 month after infusion with ZOLGENSMA. Disposable diapers should be sealed in disposable trash bags and thrown out with regular trash.

What are the possible or likely side effects of ZOLGENSMA?

The most common side effects that occurred in patients treated with ZOLGENSMA were elevated liver enzymes and vomiting.

The safety information provided here is not comprehensive. Talk to the patient’s doctor about any side effects that bother the patient or that don’t go away.

You are encouraged to report suspected side effects by contacting the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch, or Novartis Gene Therapies at 833-828-3947.

Please see the Full Prescribing Information.

References

1. Sugarman EA, et al. Eur J Hum Genet. 2012;20(1):27–32.
2. Cure SMA. Types of SMA. https://www.curesma.org/types-of-sma/. Accessed October 14, 2021.
3. ZOLGENSMA [prescribing information]. Bannockburn, IL: Novartis Gene Therapies, Inc; 2021.
4. Cure SMA. Newborn Screening for SMA. https://www.curesma.org/newborn-screening-for-sma/. Accessed October 7, 2021.
5. Health Resources & Services Administration. Recommended Uniform Screening Panel. https://www.hrsa.gov/advisory-committees/heritable-disorders/rusp/index.html. Accessed October 7, 2021.

© 2021 Novartis Gene Therapies, Inc. All rights reserved.

Bannonckburn, IL 60015

US-ZOL-21-0319 10/2021

2021-11-30T09:01:00

(BPT) – Despite being a healthy and active legal consultant and father of three, A.J. Patel had been experiencing persistent respiratory problems for some time.

“I had to constantly clear my throat when I spoke,” said A.J., “And I started noticing a wheezing sound in my breathing.”

Because he was otherwise healthy, his doctors did not seem concerned when he told them about his seemingly minor symptoms. However, this changed when A.J. started coughing up blood.

At that point, A.J. insisted on getting an X-ray which showed a small nodule on his lung. But again, his doctor did not sound the alarm and assured A.J. he had nothing to be worried about.

As his symptoms persisted for another month, A.J. went back to his doctor for further testing. He had a CT scan and then a biopsy which confirmed there were large cancerous tumors on his left lower lung. Following these results, an MRI of his brain revealed his cancer had metastasized, or spread, throughout his body.

“After my initial diagnosis, an oncologist had immediately set up chemotherapy,” said A.J. “But I needed to step back and take a breath and do my own research.”

Through his research, A.J. found support in the lung cancer community, including getting information about biomarker testing.

“When I received my stage 4 metastatic cancer result, I didn’t fully understand the [biomarker] testing process,” explained A.J.

His research spurred further discussions with his doctor about biomarker testing and possible treatments.

“Through a mentor and support groups, I started to realize there were potential treatment options beyond chemotherapy, radiation and surgery,” said A.J. “After talking to my doctor, I learned about the multitude of tests that could be conducted and potentially open the door to additional treatment options.”

His doctor ordered a test for genetic mutations called biomarkers. When the results came back, the test revealed that A.J. had ROS1-positive non-small cell lung cancer (NSCLC), a rare type of cancer. The important news was that for this type of cancer, there were other treatment options available.

The vital information gained from the biomarker test helped A.J.’s doctor decide to prescribe XALKORI^® (crizotinib).

A.J. believes that hearing about his journey during his lung cancer diagnosis is important for other patients, so he became a lung cancer advocate and mentor. While he continues his treatment, A.J. likes to say he is living each day to its fullest, spending time with his family and continuing his full-time legal career.

To learn more about ROS1-positive NSCLC and XALKORI^®, visit XALKORI.com

Indications

XALKORI is a prescription medicine used to treat people with non-small cell lung cancer (NSCLC) that has spread to other parts of the body and is caused by a defect in either a gene called ALK (anaplastic lymphoma kinase) or a gene called ROS1. It is not known if XALKORI is safe and effective in children.

Important Safety Information

XALKORI^® (crizotinib) may cause serious side effects, some of which may include:

Liver problems—XALKORI may cause life-threatening liver injury that may lead to death. Your healthcare provider should do blood tests to check your liver every 2 weeks during the first 2 months of treatment with XALKORI, then once a month. Tell your healthcare provider right away if you get any of the following new or worsening symptoms:

yellowing of your skin or the white part of your eyes	decreased appetite
severe tiredness	pain on the right side of your stomach
dark or brown (tea color) urine	bleed or bruise more easily than normal
nausea or vomiting	itching

Lung problems (pneumonitis)—XALKORI may cause life-threatening lung problems that may lead to death. Symptoms may be similar to those symptoms from lung cancer. Tell your healthcare provider right away if you have any new or worsening symptoms, including:

• trouble breathing or shortness of breath
• cough with or without mucous
• fever

Heart problems—XALKORI may cause very slow, very fast, or abnormal heartbeats. Your healthcare provider may check your pulse rate and blood pressure during treatment with XALKORI. Tell your healthcare provider right away if you feel dizzy or faint or have abnormal heartbeats. Tell your healthcare provider if you take any heart or blood pressure medicines.

Severe vision problems—Vision problems are common with XALKORI. These problems usually happen within 1 week of starting treatment with XALKORI. Vision problems with XALKORI can be severe and may cause partial or complete loss of vision in one or both eyes. Your healthcare provider may hold or stop XALKORI and refer you to an eye specialist if you develop any vision problems during treatment with XALKORI. Tell your healthcare provider right away if you have any new vision problems, loss of vision or any change in vision, including:

double vision	light hurting your eyes
seeing flashes of light	new or increased floaters
blurry vision

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

• have liver or kidney problems
• have lung problems
• have heart problems, including a condition called long QT syndrome
• have vision or eye problems
• Are pregnant, or plan to become pregnant. XALKORI can harm the unborn baby
  • Females who are able to become pregnant should use effective birth control during treatment with XALKORI and for at least 45 days after the final dose of XALKORI.
  • Your healthcare provider will check to see if you are pregnant before starting treatment with XALKORI
  • Males who have female partners who can become pregnant should use condoms during treatment with XALKORI and for at least 90 days after the final dose of XALKORI.
  • Talk to your healthcare provider about birth control methods that may be right for you.
  • If you or your partner becomes pregnant, tell your healthcare provider right away.

2021-11-30T09:01:00