Category: Brandpoint Health

2023-03-23T13:01:00

(BPT) – We often talk about breast cancer as if it is one disease. “Yeah, she had breast cancer,” or “she had a lump removed.” Even, “she has breast cancer. She’s going through chemo.”

But all breast cancers may not be the same. And chances are good that unless you or someone you are close to has been impacted directly, you may not know that.

Most breast cancers are defined by the presence of certain cancer cell receptors – specifically, hormone receptors called estrogen and progesterone receptors and a protein called human epidermal growth factor 2 (HER2). Knowing which receptors are present helps a doctor choose a treatment that a cancer type is most likely to respond to.

About 10-15% of all breast cancers, however, have little to no presence of any of these three receptors. In fact, they’re so named: “triple-negative” (TNBC), for the absence of all three.

Triple-negative breast cancers tend to spread faster than other breast cancers, and because they don’t have the hormone receptors or HER2 protein, there are fewer medicines that work against them. This makes TNBC more aggressive than other invasive breast cancers.

“It’s triple-negative breast cancer” is often a much different diagnosis than “it’s breast cancer.”

Younger Women and People of Color Are Most Likely to Receive a TNBC Diagnosis

TNBC can take an especially hard toll. It affects younger women, before many have even started thinking seriously about mammograms or screenings. It is more likely to be diagnosed in women under 40 than most other types of breast cancer, and it is more common in Black and Hispanic women. To add to this, because it’s aggressive, it can become very serious very quickly. Once it spreads, only about 12% of women with metastatic disease survive 5 years.

Treatment Options For TNBC Are Expanding

For women who are facing an advanced TNBC diagnosis, it’s important to talk to the doctor about treatment options. Most patients with advanced or metastatic disease (TNBC that has spread) will receive chemotherapy, but many will progress at some point – even if the chemotherapy works initially. Until recently, there have been no other options after chemotherapy stops working. That is changing.

Trodelvy^® (sacituzumab govitecan-hziy) is a different kind of medicine, called an antibody-drug conjugate (ADC), that is approved for adults with second-line and later metastatic TNBC (after two or more prior treatments, including one for metastatic disease). Trodelvy is indicated for TNBC (negative for estrogen and progesterone hormone receptors and HER2) that has spread to other parts of the body (metastatic) or cannot be removed by surgery, and who have received two or more prior treatments, including at least one treatment for metastatic disease. That means when chemotherapy stops working, people with metastatic TNBC have another option.

Please click to see Important Facts about Trodelvy, including Important Warning for low white blood cell count and diarrhea.

If you or someone you know has metastatic TNBC, speak with a doctor about potential therapies, including Trodelvy. For more information, please visit https://www.trodelvy.com/.

IMPORTANT SAFETY INFORMATION

TRODELVY can cause serious side effects, including low white blood cell count and diarrhea:

• Low white blood cell count (neutropenia) which is common and can sometimes be severe and lead to infections that can be life-threatening or cause death. Your healthcare provider should check your blood cell counts during treatment. If your white blood cell count is too low, your healthcare provider may need to lower your dose, give you a medicine to help prevent low blood cell count with future doses of TRODELVY, or in some cases may stop TRODELVY. Your healthcare provider may need to give you antibiotic medicines if you develop fever while your white blood cell count is low. Call your healthcare provider right away if you develop any of the following signs of infection: fever, chills, cough, shortness of breath, or burning or pain when you urinate.
• Severe diarrhea. Diarrhea is common and can be severe. Severe diarrhea can lead to loss of too much body fluid (dehydration) and kidney problems. Your healthcare provider should monitor you for diarrhea and give you medicine as needed to help control it. If you lose too much body fluid, your healthcare provider may need to give you fluids and electrolytes to replace body salts. If you develop diarrhea during your treatment with TRODELVY, your healthcare provider should check to see if it may be caused by an infection. Your healthcare provider may decrease your dose or stop TRODELVY if your diarrhea is severe and cannot be controlled with anti-diarrheal medicines.
• Call your healthcare provider right away the first time that you get diarrhea during treatment with TRODELVY; if you have black or bloody stools; if you have symptoms of dehydration, such as lightheadedness, dizziness, or faintness; if you are unable to take fluids by mouth due to nausea or vomiting; or if you are not able to get your diarrhea under control within 24 hours.

Do not receive TRODELVY if you have had a severe allergic reaction to TRODELVY. Ask your healthcare provider if you are not sure.

Allergic and infusion-related reactions which can be serious and life-threatening. Tell your healthcare provider or nurse right away if you get any of the following symptoms during your infusion of TRODELVY or within 24 hours after: swelling of your face, lips, tongue, or throat; hives; skin rash, itching, or flushing of your skin; fever; difficulty breathing or wheezing; lightheadedness, dizziness, feeling faint, or pass out; or chills or shaking chills (rigors).

Nausea and vomiting are common with TRODELVY and can sometimes be severe. Before each dose of TRODELVY, you will receive medicines to help prevent nausea and vomiting along with medicines to take home with instructions about how to take them. Call your healthcare provider right away if you have nausea or vomiting that is not controlled with the medicines prescribed for you. Your healthcare provider may decide to decrease your dose or stop TRODELVY if your nausea and vomiting is severe and cannot be controlled with anti-nausea medicines.

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

• have been told that you carry a gene for UGT1A1*28, which can increase your risk of getting side effects with TRODELVY, especially low white blood cell counts, with or without a fever, and low red blood cell counts.
• have liver problems.
• are pregnant or plan to become pregnant. TRODELVY can harm your unborn baby. Your healthcare provider should check to see if you are pregnant before you start receiving TRODELVY. TRODELVY may cause fertility problems in females, which could affect your ability to have a baby. Talk to your healthcare provider if fertility is a concern for you.
• Females who can become pregnant should use effective birth control during treatment and for 6 months after your last dose of TRODELVY. Talk to your healthcare provider about birth control choices that may be right for you during this time. Tell your healthcare provider right away if you become pregnant during treatment with TRODELVY.
• Males with a female partner who can become pregnant should use effective birth control during treatment and for 3 months after your last dose of TRODELVY.
• are breastfeeding or plan to breastfeed. It is not known if TRODELVY passes into your breastmilk and can harm your baby. Do not breastfeed during treatment and for 1 month after your last dose of TRODELVY.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain medicines may affect the way TRODELVY works.

The most common side effects of TRODELVY include decreased white blood cell (leukocyte and lymphocyte) and red blood cell counts, feeling tired or weak, hair loss, constipation, increased sugar levels in the blood, decreased protein levels (albumin) in the blood, decreased appetite, changes in kidney function test, increased levels of enzyme called alkaline phosphatase in the blood (test for liver or bone problems), and decreased levels of magnesium, potassium, and sodium in the blood.

These are not all of the possible side effects of TRODELVY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

WHAT IS TRODELVY?

TRODELVY^® (sacituzumab govitecan-hziy) is a prescription medicine used to treat adults with triple-negative breast cancer (negative for estrogen and progesterone hormone receptors and HER2) that has spread to other parts of the body (metastatic) or cannot be removed by surgery, and who have received two or more prior treatments, including at least one treatment for metastatic disease.

It is not known if TRODELVY is safe and effective in people with moderate or severe liver problems or in children.

Please click to see Important Facts about Trodelvy, including Important Warning.

A message from Gilead Sciences, Inc.

TRODELVY and GILEAD are trademarks of Gilead Sciences, Inc., or its related companies. All other marks are the property of their respective owners.

© 2023 Gilead Sciences, Inc. All rights reserved. US-TROC-0263 02/23

2023-03-22T11:01:00

(BPT) – “It’s the stuff fans can’t see that’s hard to deal with.”

Pushing through challenges is something professional soccer player, coach, and avid runner Rosie White* knows well. In a career that has spanned over a decade, she’s competed at the university-level to the world’s biggest athletic stage. But at a major international tournament, Rosie faced her biggest challenge yet: ulcerative colitis.

Ulcerative colitis (UC) is a disease of the large intestine and rectum in which the lining of the colon becomes inflamed and can develop sores, which are also called ulcers. UC is a chronic, lifelong condition that can be diagnosed at any age; however, many are diagnosed between the ages of 15 and 30. It is estimated that about 600,000 to 900,000 people in the United States have been diagnosed with UC.

For White, her challenges with UC began while playing at an international game with the New Zealand National Team. White started to feel unwell, experiencing abnormal bowel function, pain, and blood in her stool, and decided to step off the field because she didn’t understand what was happening with her body.

White sought the opinion of a gastroenterologist in the U.S., who suspected she had UC and confirmed her diagnosis after a series of tests and was put on an initial treatment.

For White, her diagnosis was difficult to process: “It was a relief to know that there was something real happening and there was a way to help manage symptoms, but it also felt like a burden to be facing a lifelong disease.”

The symptoms of UC can vary from person to person, but often includes urgent and frequent bowel movements, bloody stool, abdominal cramps and pain, and diarrhea. While patients can find it difficult or embarrassing to discuss these symptoms, it is important to talk to a healthcare provider and be as open as possible.

Creating the Playbook

For patients with chronic conditions, such as UC, managing their disease and finding the right treatment plan for them may take years. For White, managing her UC while playing soccer professionally brought its own set of obstacles.

“I tend to internalize stress and I don’t always recognize emotional stress until it affects me physically,” said White.

She experienced multiple flares over several years, many of which coincided with important tournaments and competitions. The constant travel and not having control over her schedule or when or what she ate impacted her ability to manage her condition.

“Preparing for tournaments was an especially stressful time as we were supposed to be at our very best, but I was, in fact, at my worst,” explained White. “As an athlete, it’s your job to be in control of your body and your performance. Playing soccer on the world stage, I experienced a lot of worry over having a flare while I needed to perform at a major soccer tournament.”

Over several years, White was prescribed a variety of treatments for her UC, but whenever she started to feel better, she would stop taking her treatment as prescribed, thinking she would no longer need it. But then, her symptoms continued to come back.

White was determined to take back control of her condition and find an option that helped her symptoms. After moving to Seattle, her new physician explained her options and helped her find a treatment that worked best for her new diagnosis of moderate to severe UC and her lifestyle.

Today, progress in research has led to the development of additional treatment choices for UC, including those outside of biologics and injectables, like the once-daily pill Zeposia.

Zeposia™ (ozanimod) is the first and only FDA-approved treatment of its kind for adults with moderate to severely active UC. As an S1P receptor modulator, Zeposia targets a specific part of immune cells called an S1P receptor. The S1P receptor plays a role in the UC inflammation process. The exact way Zeposia works is not known.

Zeposia has been shown to help patients achieve and maintain remission, while reducing symptoms such as rectal bleeding and stool frequency in as early as two weeks.

For White, Zeposia offered a treatment option that fit with her schedule: “It made sense for the way I wanted to live my life and the fact that it is a pill makes it a lot less daunting to me.”

White’s doctor helped her understand the serious side effects that are possible with Zeposia, including an increased risk of serious infections, PML—a rare brain infection, slow heart rate, liver problems, increased blood pressure, breathing problems, a vision problem called macular edema, and swelling and narrowing of blood vessels in the brain. See additional Important Safety Information below.

Settling The Score

It is important for patients experiencing UC symptoms to seek medical attention and advocate for themselves to find the right diagnosis and treatment plan that works for them. For White, the turning point in her UC journey was being able to communicate with her physician who helped find her a treatment plan that worked for her lifestyle.

With a treatment plan that works well for her, White is able to continue doing the things she loves, such as coaching soccer and advocating the importance of physical activities for children.

Zeposia may not work for everyone. Individual results may vary. Patients should speak with their health care provider to learn more.

Her advice for others? Always advocate for yourself, have an open conversation with your healthcare professional, and most importantly, never give up.

*Rosie White is an actual Zeposia patient who was compensated by Bristol Myers Squibb for her time

Source: Bristol Myers Squibb

INDICATION

ZEPOSIA^® (ozanimod) is a prescription medicine used to treat moderately to severely active ulcerative colitis (UC) in adults.

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

IMPORTANT SAFETY INFORMATION

Do not take ZEPOSIA if you:

• have had a heart attack, chest pain (unstable angina), stroke or mini-stroke (transient ischemic attack or TIA), or certain types of heart failure in the last 6 months

• have or have had a history of certain types of an irregular or abnormal heartbeat (arrhythmia) that is not corrected by a pacemaker

• have untreated, severe breathing problems during your sleep (sleep apnea)

• take certain medicines called monoamine oxidase (MAO) inhibitors (such as selegiline, phenelzine, linezolid)

Talk to your healthcare provider before taking ZEPOSIA if you have any of these conditions or do not know if you have any of these conditions.

ZEPOSIA may cause serious side effects, including:

• Infections. ZEPOSIA can increase your risk of serious infections that can be life-threatening and cause death. ZEPOSIA lowers the number of white blood cells (lymphocytes) in your blood. This will usually go back to normal within 3 months of stopping treatment. Your healthcare provider may do a blood test of your white blood cells before you start taking ZEPOSIA.

Call your healthcare provider right away if you have any of these symptoms of an infection during treatment with ZEPOSIA and for 3 months after your last dose of ZEPOSIA:

• fever

• feeling very tired

• flu-like symptoms

• cough

• painful and frequent urination (signs of a urinary tract infection)

• rash

• headache with fever, neck stiffness, sensitivity to light, nausea, or confusion (these may be symptoms of meningitis, an infection of the lining around your brain and spine)

Your healthcare provider may delay starting or may stop your ZEPOSIA treatment if you have an infection.

•Progressive multifocal leukoencephalopathy (PML). ZEPOSIA can increase your risk for PML, which is a rare brain infection that usually leads to death or severe disability. If PML happens, it usually happens in people with weakened immune systems but has happened in people who do not have weakened immune systems. Symptoms of PML get worse over days to weeks. Call your doctor right away if you have any new or worsening symptoms of PML that have lasted several days, including: weakness on one (1) side of your body, changes in your vision, changes in your thinking or memory, confusion, changes in your personality, loss of coordination in your arms or legs, decreased strength, and/or problems with balance.

• Slow heart rate (also known as bradyarrhythmia) when you start taking ZEPOSIA. ZEPOSIA may cause your heart rate to temporarily slow down, especially during the first 8 days. You will have a test to check the electrical activity of your heart called an electrocardiogram (ECG) before you take your first dose of ZEPOSIA.

Call your healthcare provider if you experience the following symptoms of slow heart rate:

• dizziness

• lightheadedness

• feeling like your heart is beating slowly or skipping beats

• shortness of breath

• confusion

• chest pain

• tiredness

Follow directions from your healthcare provider when starting ZEPOSIA and when you miss a dose.

Continue reading for additional possible serious side effects of ZEPOSIA.

Before taking ZEPOSIA, tell your healthcare provider about all of your medical conditions, including if you:

• have a fever or infection, or are unable to fight infections due to a disease, or take or have taken medicines that lower your immune system

• received a vaccine in the past 30 days or are scheduled to receive a vaccine. ZEPOSIA may cause vaccines to be less effective

• before you start ZEPOSIA, your healthcare provider may give you a chickenpox (Varicella Zoster Virus) vaccine if you have not had one before

• have had chickenpox or have received the vaccine for chickenpox. Your healthcare provider may do a blood test for the chickenpox virus. You may need to get the full course of the vaccine and wait 1 month before taking ZEPOSIA

• have a slow heart rate

• have an irregular or abnormal heartbeat (arrhythmia)

• have a history of stroke

• have or have had heart problems, including a heart attack or chest pain

• have high blood pressure

• have liver problems

• have breathing problems, including during your sleep

• have eye problems, especially an inflammation of the eye called uveitis

• have diabetes

• are or plan to become pregnant or if you become pregnant within 3 months after you stop taking ZEPOSIA. ZEPOSIA may harm your unborn baby. If you are a female who can become pregnant, talk to your healthcare provider about what birth control method is right for you during your treatment with ZEPOSIA and for 3 months after you stop taking ZEPOSIA.

• are breastfeeding or plan to breastfeed. It is not known if ZEPOSIA passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take ZEPOSIA

Tell your healthcare provider about all the medicines you take or have recently taken, including

prescription and over-the-counter medicines, vitamins, and herbal supplements. Using ZEPOSIA with other medicines can cause serious side effects. Especially tell your healthcare provider if you take or have taken:

• medicines that affect your immune system, such as alemtuzumab

• medicines to control your heart rhythm (antiarrhythmics), or heartbeat

• CYP2C8 inducers such as rifampin

• CYP2C8 inhibitors such as gemfibrozil (medicine to treat high fat in your blood)

• opioids (pain medicine), medicines to treat depression, and medicines to treat Parkinson’s disease

• medicines to control your heart rate and blood pressure (beta blocker medicines and calcium channel blocker medicines)

You should not receive live vaccines during treatment with ZEPOSIA, for at least 1 month before taking ZEPOSIA and for 3 months after you stop taking ZEPOSIA. Vaccines may not work as well when given during treatment with ZEPOSIA.

ZEPOSIA can cause serious side effects, including:

• liver problems. Your healthcare provider will do blood tests to check your liver before you start taking ZEPOSIA. Call your healthcare provider right away if you have any of the following symptoms:

• unexplained nausea

• vomiting

• stomach area (abdominal) pain

• tiredness

• loss of appetite

• yellowing of the whites of your eyes or skin

• dark colored urine

• increased blood pressure. Your healthcare provider should check your blood pressure during treatment with ZEPOSIA. A sudden, severe increase in blood pressure (hypertensive crisis) can happen when you eat certain foods that contain high levels of tyramine.

• breathing problems. Some people who take ZEPOSIA have shortness of breath. Call your healthcare provider right away if you have new or worsening breathing problems.

• a problem with your vision called macular edema. Your risk of macular edema is higher if you have diabetes or have had an inflammation of your eye called uveitis. Your healthcare provider should test your vision before you start taking ZEPOSIA if you are at higher risk for macular edema or any time you notice vision changes during treatment with ZEPOSIA. Call your healthcare provider right away if you have any of the following symptoms:

• blurriness or shadows in the center of your vision

• sensitivity to light

• a blind spot in the center of your vision

• unusually colored vision

• swelling and narrowing of the blood vessels in your brain. Posterior Reversible Encephalopathy Syndrome (PRES) is a rare condition that has happened with ZEPOSIA and with drugs in the same class. Symptoms of PRES usually get better when you stop taking ZEPOSIA. If left untreated, it may lead to stroke. Your healthcare provider will do a test if you have any symptoms of PRES. Call your healthcare provider right away if you have any of the following symptoms:

• sudden severe headache

• sudden confusion

• sudden loss of vision or other changes in your vision

• seizure

The most common side effects of ZEPOSIA can include:

• upper respiratory tract infections

• elevated liver enzymes

• low blood pressure when you stand up (orthostatic hypotension)

• painful and frequent urination (signs of urinary tract infection)

• back pain

• high blood pressure

• headache

These are not all of the possible side effects of ZEPOSIA. For more information, ask your healthcare provider or pharmacist.

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

Please see full Prescribing Information, including Medication Guide.

To learn more, visit Zeposia.com.

2084-US-2201520 03/23

2023-03-21T17:29:00

(BPT) – On a Friday night in 1999, Al saw a TV commercial about a new cancer treatment that was enrolling patients in a clinical trial — a novel, targeted therapy that scientists were investigating for the treatment of chronic myeloid leukemia (CML), a cancer that develops in the blood-forming cells of the bone marrow.

Two years prior, Al had been diagnosed with CML. At that time, his treatment options were limited. Most people with this diagnosis faced a five-year survival rate below 40%.

Al called his doctor the following Monday to find out if the new treatment — a tyrosine kinase inhibitor (TKI) — might be right for him. He was accepted into the trial a few months later — an impactful step that is indicative of the future of Al’s treatment journey, and the bravery he continually displayed through every high and low.

A Long and Winding Road

The clinical trial Al enrolled in led to the FDA approval of the first TKI for the treatment of CML, and the first-ever targeted therapy acting on specific cancer cells while causing less damage to normal cells.

With the introduction of TKIs, the five-year survival rate for patients diagnosed with CML improved, increasing to over 70%, bringing the lifespan of a patient with CML closer to the lifespan of a person without cancer.

However, despite the significant positive impact on the treatment of CML, it is not uncommon for some patients to not respond to certain TKIs, or struggle with side effects, or find that their response or tolerability to a specific TKI changes over time.

After the clinical trial was complete, Al decided to stay on the treatment. However, while the treatment was easy to tolerate — giving him few side effects — Al’s doctors told him that his CML was not responding as well as it should have been and there was a risk that his CML would progress and become more severe.

Al participated in more clinical trials before finding a treatment that was right for him in his fourth trial. This treatment was for a different type of TKI known as Scemblix^® (asciminib) tablets. Scemblix is approved by the FDA for adults with Philadelphia chromosome-positive CML in chronic phase (Ph+ CML-CP) who have previously been treated with two or more TKIs¹. More information about Scemblix can be found at us.scemblix.com.

Scemblix targets CML differently than other TKIs. Because cancer can mutate when it gets accustomed to how a treatment works, approaching it in a new way can outsmart the mutations. Scemblix may help patients overcome the resistance and side effects patients with CML may experience with other TKIs.

In a clinical trial, Scemblix showed how well it works to counteract cancer compared with Bosulif^® (bosutinib), another TKI, in patients who had previously tried two or more TKIs¹. Nearly twice as many patients on Scemblix achieved major molecular response, or MMR (25% for Scemblix [40 of 157] vs. 13% for Bosulif [10 of 75]) at 24 weeks, which is an important treatment milestone in CML, meaning that there is a low amount of the BCR::ABL in blood cells¹.

This efficacy trend continued at 96 weeks, almost two years after the trial started, when more patients on Scemblix achieved MMR compared to those on Bosulif (38% [59 of 157] vs. 16% [12 of 76])¹.

Additionally, in this trial [one study for 3L CML], three times fewer patients treated with Scemblix needed to stop treatment due to side effects compared to those taking Bosulif (8% for Scemblix vs. 26% for Bosulif) at the Week 96 analysis¹. The most common adverse reactions in patients who received Scemblix in this trial were upper respiratory tract infections, musculoskeletal pain, headache, and fatigue¹.

Al’s journey to the right treatment was made possible not only by his bravery in trying new treatment options, but also by good communication with his doctor. While Scemblix may not be right for everybody, it helped Al achieve his milestones.

Want to learn more about Al’s story and Scemblix? Visit us.scemblix.com.

APPROVED USES for SCEMBLIX^® (asciminib) Tablets

SCEMBLIX is a prescription medicine used to treat adults with:

• Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with 2 or more tyrosine kinase inhibitors (TKIs)
• Ph+ CML in CP with the T315I mutation

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

IMPORTANT SAFETY INFORMATION for SCEMBLIX^® (asciminib) Tablets

Before taking SCEMBLIX, tell your doctor about all your medical conditions, including if you:

• have a history of inflammation of your pancreas (pancreatitis)
• have a history of heart problems or blood clots in your arteries and veins (types of blood vessels)
• are pregnant or plan to become pregnant. SCEMBLIX can harm your unborn baby
  • Your doctor will do a pregnancy test before you start treatment with SCEMBLIX
  • Females who are able to become pregnant should use effective birth control during treatment and for 1 week after your last dose of SCEMBLIX. Talk to your doctor about birth control methods that may be right for you
  • Tell your doctor right away if you become pregnant or think you may be pregnant during treatment with SCEMBLIX
• are breastfeeding or plan to breastfeed. It is not known if SCEMBLIX passes into your breast milk. Do not breastfeed during treatment and for 1 week after your last dose of SCEMBLIX

Tell your doctor about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. SCEMBLIX and other medicines may affect each other and cause side effects.

SCEMBLIX may cause serious side effects, including:

• Low blood cell counts: SCEMBLIX may cause low platelet counts (thrombocytopenia), low white blood cell counts (neutropenia), and low red blood cell counts (anemia). Your doctor will do blood tests to check your blood cell counts every 2 weeks for the first 3 months of treatment and then monthly or as needed during treatment with SCEMBLIX. Tell your doctor right away if you have unexpected bleeding or easy bruising, blood in your urine or stools, fever, or any signs of an infection
• Pancreas problems: SCEMBLIX may increase enzymes in your blood called amylase and lipase, which may be a sign of pancreatitis. Your doctor may do blood tests monthly or as needed during treatment with SCEMBLIX to check for problems with your pancreas. Tell your doctor right away if you have sudden stomach-area pain or discomfort, nausea, or vomiting
• High blood pressure: Your doctor may check your blood pressure and treat any high blood pressure during treatment with SCEMBLIX as needed. Tell your doctor if you develop elevated blood pressure or symptoms of high blood pressure including confusion, headaches, dizziness, chest pain, or shortness of breath
• Allergic reaction: Stop taking SCEMBLIX and get medical help right away if you get any signs or symptoms of an allergic reaction, including:
  • trouble breathing or swallowing
  • swelling of the face, lips, or tongue
  • skin rash or flushing of your skin
  • feeling dizzy or faint
  • fever
  • fast heartbeat
• Heart and blood vessel (cardiovascular) problems: SCEMBLIX may cause heart and blood vessel problems, including heart attack, stroke, blood clots, blockage of your arteries, heart failure, and abnormal heartbeat, which can be serious and may sometimes lead to death. These heart and blood vessel problems can happen in people with risk factors or a history of these problems, and/or previously treated with other TKI medicines. Your doctor may monitor you for heart and blood vessel problems and treat you as needed during treatment with SCEMBLIX. Tell your doctor or get medical help right away if you get:
  • shortness of breath
  • chest pain or pressure
  • a feeling like your heart is beating too fast or you feel abnormal heartbeats
  • swelling in your ankles or feet
  • dizziness
  • weight gain
  • numbness or weakness on one side of your body
  • decreased vision or loss of vision
  • trouble talking
  • pain in your arms, legs, back, neck, or jaw
  • headache
  • severe stomach-area pain

The most common side effects of SCEMBLIX include:

• nose, throat, or sinus (upper respiratory tract) infections
• muscle, bone, or joint pain
• headache
• tiredness
• nausea
• rash
• diarrhea
• decreased blood platelet counts, white blood cell counts, and red blood cell counts
• increased blood fat (triglycerides) levels
• increased blood creatine kinase levels
• increased blood liver enzyme levels
• increased blood pancreas enzyme (amylase and lipase) levels
• increased blood uric acid levels

Your doctor may change your dose, temporarily stop, or permanently stop treatment with SCEMBLIX if you have certain side effects.

SCEMBLIX may cause fertility problems in females. This may affect your ability to have a child. Talk to your doctor if this is a concern for you.

These are not all the possible side effects of SCEMBLIX. 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 accompanying full Prescribing Information, including Patient Information.

Reference

1. Scemblix [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp.

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2023-03-17T07:01:00

(BPT) – “Tobacco’s Starring Role,” Truth Initiative’s fifth annual “While You Were Streaming” study of the most popular 2021 onscreen entertainment among 15- to 24-year-olds released on March 7 has found that this content continued to normalize and glamorize tobacco usage which research shows drives youth vaping initiation. The report identified that 25 million young people were exposed to tobacco imagery by top streaming shows, with a separate 25 million through box office movies. The report also analyzed chart-topping music videos featuring tobacco depictions, which were collectively viewed over 2 billion times on YouTube.

As youth vaping persists with over 2.5 million middle and high school students using e-cigarettes, research shows on-screen exposure to smoking imagery makes young people three times more likely to start vaping nicotine. Even more concerning is that tobacco is often depicted as a stress reliever, which sends a particularly harmful message in the wake of youth depression and anxiety rates spiking in recent years resulting in the Surgeon General issuing a youth mental health crisis advisory. Nicotine can amplify feelings of anxiety and depression while increasing stress, establishing a worrisome link to the growing youth mental health crisis.

“Images have influence, and by giving highly addictive nicotine products a starring role, entertainment platforms and celebrities alike are serving as unpaid spokespeople for the tobacco industry whether they realize it or not, with tremendous consequences for young audiences nationwide,” said Robin Koval, CEO and President of Truth Initiative. “With youth tobacco use on the rise, and the youth e-cigarette crisis continuing to be a serious public health threat, the entertainment industry can play a major role in changing this picture to protect our nation’s youth and not be complicit with the tobacco industry in addicting a new generation to nicotine.”

Tobacco Imagery is Pervasive

Across the 15 shows most popular with young people in 2021, 60% contained depictions of tobacco, a persistently high and unchanged number from 2020. Showtime ousted Netflix as the top offender, becoming the platform with the most tobacco imagery, largely due to “Shameless” characters. Netflix stayed on the list in second place, however, despite their 2019 pledge to eliminate depictions in youth-rated shows.

Animated cartoon shows, even those created for the youth audience, continued to feature tobacco imagery. Netflix cartoon comedy “Big Mouth,” Fox’s “Simpsons” and “Family Guy” and Adult Swim’s “Rick and Morty” were repeat tobacco offenders in this year’s list.

Onscreen tobacco use was also common among the year’s top movies. According to an analysis by NORC at the University of Chicago, nearly half (47%) of top 2021 films contained tobacco imagery, exposing an estimated 25 million youth and young adults. Youth-rated movies contained, on average, 30 tobacco depictions per film. The PG-rated “The Girl Who Believes in Miracles” and 17 films rated PG-13 or under contained depictions of tobacco, with several nominated for major industry awards. And while the report focuses on 2021 movies, this year’s Academy Award nominees make clear the issue continues to persist. Nine out of 10 Best Picture nominees contain tobacco imagery, including the PG-13 rated “Elvis,” “The Fabelmans,” “Top Gun: Maverick,” and “Women Talking.”

Music videos were another platform for youth exposure to tobacco and often portrayed tobacco use as edgy, glamorous and cool. Although there was a decrease in the total number of tobacco depictions in Billboard songs, 2021 music videos still exposed many to tobacco imagery as they were viewed on YouTube more than 2 billion times. Top 2021 Billboard songs with accompanying music videos featuring tobacco were headlined by major recording artists such as Silk Sonic, Farruko, Elle King and Miranda Lambert, and The Weeknd.

Tobacco Imagery Harms Adolescent Mental Health

Nicotine can harm adolescent mental health. As the true scale of youth mental health needs comes into focus, celebrities and other public figures have a responsibility to model healthy behaviors. Instead, watching celebrities smoke and vape in influential movies, shows and music videos normalizes these unhealthy behaviors and creates unwitting tobacco spokespeople out of public figures.

“The proliferation of tobacco imagery in entertainment content is particularly alarming when you consider how frequently smoking and vaping are portrayed as a stress reliever when we know the exact opposite is true,” said Koval. “Years of scientific research show that nicotine can amplify feelings of anxiety and depression while increasing stress, but so many young people are seeing tobacco depictions and turn to e-cigarettes to cope with stress. As the entertainment industry claims to be concerned with the very real youth mental health crisis facing our nation, we encourage content creators and distributors to partner with us to tackle the portrayal of tobacco use on their platforms, especially given the established connection between nicotine use and mental health.”

Truth Initiative provides support and resources for young people to quit e-cigarettes with This is Quitting, a free and anonymous text message quit vaping program for teens and young adults from truth that now serves more than 550,000 young people. A randomized clinical trial found that young adults aged 18-24 who used This is Quitting had nearly 40% higher odds of quitting compared to a control group. Teens and young adults can text “DITCHVAPE” to 88709 to get immediate help to quit. Resources for parents of young people who vape are available for free at BecomeAnEX.org.

The pervasiveness of onscreen tobacco imagery is a symptom of a larger issue with the normalization and glamorization of smoking and vaping in entertainment media and pop culture. The entertainment industry should not be complicit with the tobacco industry in helping addict a new generation of young people to nicotine. They have the power, and the facts about the impact of smoking and vaping imagery on youth, to change the picture for good.

2023-03-17T06:01:00

(BPT) – Of all the things to love about spring — coming out of winter blues, seeing trees start to bud and flowers begin to bloom — another one is how it can help us re-focus on our health.

Between the ability to spend stretches of time outside again, and a renewed sense of purpose as the days start to get longer, spring is the perfect time to reassess our health goals and take stock of how we’ve been doing since the start of the new year.

One of the ways you can reprioritize your health is getting vaccinated against pneumococcal pneumonia. To help you understand your risk, Pfizer is sharing important information about pneumococcal pneumonia and the importance of vaccination.

Pneumococcal pneumonia is a potentially serious bacterial lung disease that can disrupt your life for weeks and can even put you in the hospital or be life-threatening. If you’re 65 or older, or 19 or older with certain underlying medical conditions, like asthma, diabetes or chronic heart disease, you’re at increased risk and vaccination is one of the ways to help protect your health.

People often think that pneumococcal pneumonia can only be caught in the winter or during flu season, but it can strike any time of year. However, vaccination is available all year round, so spring is the perfect time to get vaccinated as you refocus on your health.

Even if you’ve already been vaccinated against pneumococcal pneumonia previously, your healthcare provider may recommend another pneumococcal vaccine for additional protection.

Pneumococcal pneumonia can strike at any time of year, so don’t wait to ask your doctor or pharmacist about pneumococcal pneumonia vaccination and visit knowpneumonia.com to learn more.

Brought to you by Pfizer.

2023-03-16T16:51:00

(BPT) – Shopping online has radically changed since the early days of the internet. Nowadays, because of the rise of global e-commerce, you can find hundreds of thousands of products from around the world in seconds. Currently, about 75% of Americans shop for items online, according to Statista, and it’s easy to see why. Online shopping is more affordable and convenient than shopping in person. Check out five ways you can benefit by shopping more online.

1. Selection

One of the most significant benefits of shopping online is the sheer number of products available to consumers. Instead of settling for whatever brands your local shops carry, you can browse thousands of brands online before picking the ones you love the most or trying new ones. Online marketplaces like AliExpress give you access to hundreds of thousands of products and retailers from around the world.

2. One-stop shop

If you wanted to shop travel products and accessories, wellness items and clothing, more likely than not, you’d have to go to several stores to find all you need. However, e-commerce platforms allow you to search several categories all on one site. Whether you’re looking for a carry-on bag for your long weekend trip, supplements, skin care products or jeans, you can find it all in one convenient place.

3. Save on quality items

Shopping online isn’t just convenient; it can also help you save money. According to Adobe’s Digital Price Index, online prices in all categories dropped by 1.6% last year. You can save even more on certain items like electronics, which dropped by as much as 12% in price online.

One thing to keep in mind with shopping online is that cheaper items don’t always translate to bigger savings. Quality products generally last longer than cheaper products, because cheaper items tend to break more easily. You may find that you spend more money replacing a cheap product than you would have purchasing a better quality one.

Finding quality products at affordable prices can be challenging. Luckily, the new AliExpress CHOICE program can make it easier for you. This program offers shoppers more than 50,000 curated products such as fashion, tech, kitchen accessories, home décor and fitness equipment. These products are handpicked by specialists because of their quality and price, so you can get great items at a value.

4. Cut out the middleman

When you buy from a store, you’re buying from a distributor, not the source. By buying online, you can cut out the middleman and buy directly from a retailer. Purchasing from a retailer means there are fewer intermediate steps between you and the product. This means you’ll likely experience fewer problems with supply chain issues, customer service and quality oversight.

5. Shipping and returns

Products you normally would not be able to find near you are right at your fingertips online. However, the logistics of shipping and returns can turn off some consumers from the online shopping experience. However, many online retailers now offer free shipping and returns. That means you can buy the latest fashion trend, and if it’s not for you or doesn’t fit, you can package it up and return it without having to schedule a trip to the store.

To get the most out of your online shopping experience, you’ll want to buy from a reputable source. AliExpress has been in the online retail game for more than 13 years and is dedicated to bringing you a selection of quality products at unbeatable prices that you can access from the comfort of your own home. To learn more and start shopping today, visit AliExpress.us.

2023-03-16T14:01:00

(BPT) – More Americans are shopping online than ever before. According to the U.S. Department of Commerce, e-commerce sales increased by 7.7% in 2022, with yearly total sales of $103.4 billion. There are many reasons why more and more shoppers are choosing online retailers, but one popular reason to shop online is lower prices.

Typically, online shopping is more affordable because online retailers don’t have to pay for overhead costs like rent and utilities like they would for a brick-and-mortar store. In turn, these cost savings allow retailers to offer consumers better prices.

If you want to buy quality products without breaking the bank, check out these five categories you can browse and buy on a budget on AliExpress.us.

1. Electronics

One type of product you’ll save the most on by shopping online is electronics. According to Adobe’s Digital Price Index, electronic products are 12% cheaper now than a year ago. Whether you’re shopping for gaming headphones for playing with your friends, Bluetooth headphones for your morning run or a Bluetooth speaker to play tunes when hosting a party, you’ll be able to buy quality electronics at affordable prices.

2. Kitchen goods and home decor

It can be expensive to buy kitchen items and decorate your home. However, online, home cooks can find an electric milk frother to make lattes at home or silicone kitchen utensils for cooking and baking at a fraction of the cost. If you want to liven up your living room with colorful tasseled throw pillows or make your bedroom cozy with a dimmable lamp, you can save nearly 60% by buying online.

3. Fashion

Staying current with fashion trends can be a tall order when shopping on a budget. When shopping online, you can buy a colorful and eye-catching set of earrings for less than a dollar, so you’ll have a pair to match almost all of your outfits.

If you want to upgrade your sleep wardrobe, you can find luxurious silk pajamas to wear to bed or lounge around your home. Best of all, shopping online allows you to browse thousands of styles that you wouldn’t be able to find in just one store.

4. Beauty

When you invest in a beauty and personal care routine, you’re investing in yourself, but doing so can quickly add up. Americans spend more than $322 a year on skincare alone. You likely budget for these items, but wouldn’t it be nice to save so you can buy more of what you need? You can find jade rollers, makeup brushes and facial cleansing brushes online, so you can continue to invest in your beauty and care routine.

5. Sports gear

Getting active is a healthy and worthwhile goal, but you’ll need the right gear to maximize your workouts. Online, you can browse several styles of sports bras and other activewear to help you look and feel your best while you exercise. You can also find sports equipment like resistance bands and yoga pads to take your workout to the next level.

If you want to save big on these five types of products, you can do so by shopping on an e-commerce website like AliExpress. This popular online shopping destination offers hundreds of thousands of high-quality products worldwide at the best prices. Its new AliExpress CHOICE offering makes shopping for electronics, kitchen and household products, beauty products and more even easier, with more than 50,000 quality products at unbeatable prices specially curated by shopping experts. There’s something to fit every lifestyle and you can find them all in one place — and enjoy free shipping and returns. To learn more, visit AliExpress.us.

2023-03-16T08:01:00

(BPT) – We have all been taught about the importance of getting a good night’s sleep. But do you know why? Healthy sleep doesn’t just help us feel rested and fully charged during the day, although it’s the first thing we notice. Sleep is a natural process that is affected by our body clocks (or circadian rhythm) and helps us do everything from restore our bodies, consolidate memory, and clear out toxins in our brain to help improve other health conditions. When we think about these health benefits, one of the most powerful is the connection between our sleep and an area of growing public concern: our mental health.

As part of its commitment to helping educate the public about the importance of sleep and its effect on overall health and well-being, the National Sleep Foundation (NSF) set out to understand even more about the link between our sleep health and mental health, with a focus on depressive symptoms among American adults.

Another Wake-up Call: Understanding the Connection Between Sleep and Mental Health

Recently released findings from the NSF’s Sleep in America^® Poll highlight important relationships between sleep and depression in the general population. In fact, nearly 65% of Americans who are dissatisfied with their sleep experience mild or greater levels of depressive symptoms. What’s more, 50% of all adults who sleep less than the NSF-recommended 7-9 hours of sleep a night experience mild or greater levels of depressive symptoms.

We Can Do This: The Importance of Good Sleep

But there is good news. Practicing healthy sleep habits is not only associated with better sleep, but also better mood and mental health. More than 90% of adults who practice high levels of healthy sleep behaviors are free of significant depressive symptoms.

Being Your Best Slept Self^®

To help people get more of the quality sleep they need, the NSF gives science-backed recommendations to help anyone and everyone be their Best Slept Self^®. Just three small steps during the day and three small steps at night can make a big difference in your sleep health.

Daytime Tips for Being Your Best Slept Self^®

Basic things like spending time in bright light during the day, natural light, or equivalent brightness, and exercising regularly, can all point to a deeper sleep. When exercising, aim for 30 minutes a day, five days a week. The NSF also recommends eating meals at consistent times day after day.

Nighttime Tips for Being Your Best Slept Self^®

Before bedtime, it is important to avoid things like heavy meals, nicotine, caffeine, and alcohol. The NSF also recommends putting your devices away an hour before bed and sleeping in a quiet, cool and dark environment. In addition, using a consistent routine with a relaxing wind-down can help you get the sleep you need each night. For most adults, the recommended amount of sleep is 7-9 hours, with the same sleep and wake times.

For more sleep health information, visit www.theNSF.org.

Sometimes, even after including healthy sleep behaviors into our routine, we still don’t feel like we’re getting the sleep we need. If you have lasting symptoms or continue to be concerned about your sleep after taking some basic steps, it’s a good idea to seek professional help from a clinician.

If you are having challenges with your mood or feelings of depression, you are not alone. For anyone experiencing suicidal thoughts, please seek care. Contact the Suicide and Crisis Lifeline by calling or texting 988.

National Sleep Foundation celebrates the 25^th Anniversary of Sleep Awareness Week^® from March 12-18, 2023. Sleep Awareness Week is supported by a range of sponsors who help NSF spread sleep health messages. Our lead sponsor Primasun believes sleep is the foundation of physical and mental health. Their goal is to help educate people on how sleep impacts our overall well-being and build a more equitable path to clinical sleep care to ultimately unlock happier, healthier days for all.

Visit Primasun’s resource hub to hear more from them about the importance of sleep, get physician insights on improving sleep, and find care at www.jointhesleepmovement.com.

2023-03-15T06:01:00

(BPT) – This content is sponsored and provided by Novartis.

“I have cancer. Cancer doesn’t have me.”

Lisa, a Maryland mother, grandmother, travel agent and minister, is adamant about not letting breast cancer prevent her from living her life to the fullest. After an initial diagnosis of stage II hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) breast cancer, Lisa underwent chemotherapy, had a lymph node removal, and a mastectomy on one side. Then, her cancer went into remission.

Several years later, Lisa developed a chronic cough and had difficulty breathing but thought it may be allergies. However, during her annual follow-up with her oncologist, she shared this new symptom, and her provider urged her to get testing done to rule out if her cancer had returned. After her bloodwork came back with extremely high tumor markers, a PET scan also revealed that her cancer had come back and had spread to her lungs and bones. A CT scan and MRI later found the cancer had also spread to her brain. Cancer returning was something Lisa never expected. And this time it was in the form of HR+/HER2- metastatic breast cancer.

More than 150,000 women are living with metastatic breast cancer in the United States, three-fourths of whom were originally diagnosed with stage I-III cancer¹. HR+/HER2- breast cancer is the most common subtype, with 68% of all female breast cancer cases being HR+/HER2-².

While the majority of patients are diagnosed with early breast cancer, many see their cancer come back after initial treatment, with 87-94% of these recurrences leading to metastatic disease^3,4. Being diagnosed with metastatic breast cancer means cancer has spread from the breast to other parts of the body, such as the brain, bones, or liver. While there is no cure for metastatic breast cancer, there are treatments available that can help those living with the disease live longer and well.

It hasn’t been an easy road for Lisa, but with the support of her family, her friends, and her faith, she continues to face each day by advocating for herself, communicating with her healthcare provider and being an active participant in her own treatment journey.

Here are some tips she wants to give others who might be facing a similar journey.

Be your best advocate

Throughout the diagnosis and treatment process, Lisa continued having conversations with her doctor, along with doing her own research, making sure to share her concerns, field any questions and let her doctor know of any side effects from treatment. She took notes during every appointment, looking up things that she didn’t understand when she got home.

When Lisa’s doctor suggested chemotherapy as the first line of treatment for her metastatic breast cancer, she was resistant, as she had experienced complicated side effects from it in the past. When she decided to give it a try and again had difficulty with the side effects, she spoke up for herself.

“It’s important to trust your doctor, but you should always practice your due diligence to make sure you’re getting the care you need,” says Lisa.

Lisa became her biggest advocate having honest and open conversations with her doctor, determined to find the best course for her treatment journey.

Do what works for you

After Lisa spoke up to her doctor about the chemotherapy side effects, her doctor recommended trying KISQALI^® (ribociclib) 200 mg tablets, a prescription medicine approved to treat adults with HR+/HER2- metastatic breast cancer in combination with either an aromatase inhibitor or fulvestrant as the first endocrine-based therapy, or following disease progression on endocrine therapy in postmenopausal women or in men.

For Lisa, who recently traveled to England as part of her ministry work, it was extremely important to find a treatment that would allow her the flexibility to continue her regular practices, including her ability to travel.

“This medication has been working very well for me. It’s as close as I can get to feeling like I have a chronic condition and not a terminal illness,” explains Lisa. “I don’t have to sit in a doctor’s office for a day, I can manage my symptoms and I’m able to show up every day — both for myself and for others.”

Lisa has been able to continue socializing with her support network, including close friends and family, and visiting with 3 new grandbabies.

While KISQALI worked for Lisa, all medications affect people differently and it’s important to find the treatment option that works best for you.

Continue to live your life

Lisa decided cancer would not have dominion over her when she was first diagnosed with early breast cancer. When she learned she had metastatic breast cancer, and that the 10-year survival rate was 13%, she reframed her remission narrative and found empowerment in the fact that life is never guaranteed, with or without a cancer diagnosis⁵. Her focus became to overcome any challenges and obstacles she would face and make the most of the time she has.

“My mentality became ‘long live life,’” says Lisa. “Life is worth living no matter what. You have to choose to live life. You have to choose to make each day count.”

You can read inspiring stories about others like Lisa who are living with HR+/HER2- metastatic breast cancer at KISQALI.com.

Please see full Prescribing Information, including Patient Information.

References

1. American Cancer Society. Breast Cancer Facts & Figures 2022-2024. Atlanta: American Cancer Society, Inc. 2022
2. Ibid.
3. Ibid.
4. Wangchinda P, Ithimakin S. Factors that predict recurrence later than 5 years after initial treatment in operable breast cancer. World J Surg Oncol. 2016 Aug 24;14(1):223. doi: 10.1186/s12957-016-0988-0
5. Eng LG, Dawood S, Sopik V, et al. Ten-year survival in women with primary stage IV breast cancer. Breast Cancer Res Treat. 2016 Nov;160(1):145-152. doi: 10.1007/s10549-016-3974-x

Indications

KISQALI is a prescription medicine used to treat adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has gotten worse or has spread to other parts of the body (metastatic), in combination with:

• an aromatase inhibitor as the first endocrine-based therapy; or
• fulvestrant as the first endocrine-based therapy or following disease progression on endocrine therapy in postmenopausal women or in men.

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

IMPORTANT SAFETY INFORMATION

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

KISQALI may cause serious side effects, including:

Lung problems. KISQALI may cause severe or life-threatening inflammation of the lungs during treatment that may lead to death. Tell your health care provider right away if you have any new or worsening symptoms, including:

• trouble breathing or shortness of breath
• cough with or without mucus
• chest pain

Severe skin reactions. Tell your health care provider or get medical help right away if you get severe rash or rash that keeps getting worse; reddened skin; flu-like symptoms; skin pain/burning; blistering of the lips, eyes, or mouth; or blisters on the skin or skin peeling, with or without fever.

Heart rhythm problems (QT prolongation). KISQALI can cause a heart problem known as QT prolongation. This condition can cause an abnormal heartbeat and may lead to death. Your health care provider should check your heart and do blood tests before and during treatment with KISQALI. Tell your health care provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you feel dizzy or faint.

Liver problems (hepatobiliary toxicity). KISQALI can cause serious liver problems. Your health care provider should do blood tests to check your liver before and during treatment with KISQALI. Tell your health care provider right away if you get any of the following signs and symptoms of liver problems:

• yellowing of your skin or the whites of your eyes (jaundice)
• dark or brown (tea-colored) urine
• feeling very tired
• loss of appetite
• pain on the right side of your stomach area (abdomen)
• bleeding or bruising more easily than normal

Low white blood cell counts (neutropenia). Low white blood cell counts are very common during treatment with KISQALI and may result in infections that may be severe. Your health care provider should check your white blood cell counts before and during treatment with KISQALI. Tell your health care provider right away if you have signs and symptoms of low white blood cell counts or infections such as fever and chills.

Your health care provider may tell you to decrease your dose, temporarily stop, or completely stop taking KISQALI if you develop certain serious side effects during treatment with KISQALI.

What should I tell my health care provider before taking KISQALI?

Before you take KISQALI, tell your health care provider if you:

• have any heart problems, including heart failure, irregular heartbeats, and QT prolongation
• have ever had a heart attack
• have a slow heartbeat (bradycardia)
• have problems with the amount of potassium, calcium, phosphorus, or magnesium in your blood
• have fever, chills, or any other signs or symptoms of infection
• have liver problems
• have any other medical conditions
• are pregnant, or plan to become pregnant. KISQALI can harm your unborn baby

• If you are able to become pregnant, your health care provider should do a pregnancy test before you start treatment with KISQALI.
• Females who are able to become pregnant and who take KISQALI should use effective birth control during treatment and for at least 3 weeks after the last dose of KISQALI.
• Talk to your health care provider about birth control methods that may be right for you during this time.
• If you become pregnant or think you are pregnant, tell your health care provider right away.

• are breastfeeding or plan to breastfeed. It is not known if KISQALI passes into your breast milk. Do not breastfeed during treatment with KISQALI and for at least 3 weeks after the last dose of KISQALI

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. KISQALI and other medicines may affect each other, causing side effects. Know the medicines you take. Keep a list of them to show your health care provider or pharmacist when you get a new medicine.

What should I avoid while taking KISQALI?

Avoid eating grapefruit and avoid drinking grapefruit juice during treatment with KISQALI since these may increase the amount of KISQALI in your blood.

The most common side effects of KISQALI include:

• decreased white blood cell counts
• decreased red blood cell counts
• abnormal liver function tests
• infections
• nausea
• increased kidney function test
• tiredness
• decreased platelet counts
• diarrhea
• vomiting
• headache
• constipation
• hair loss
• cough
• rash
• back pain
• low blood sugar level

KISQALI may cause fertility problems if you are male and take KISQALI. This may affect your ability to father a child. Talk to your health care provider if this is a concern for you.

Tell your health care provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of KISQALI. For more information, ask your health care provider 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.

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2023-03-13T08:01:00

(BPT) – One of the worst things a woman can hear is: “You have cancer.”

The unfortunate reality is that one in every eight women in the U.S. is diagnosed with breast cancer at some point in their life. In fact, breast cancer is the most common kind of cancer nationally, and there are different subtypes. The most common subtype is HR+/HER2- breast cancer.

What Does HR+/HER2- Mean for the Women Who Have It?

Most breast cancers are distinguished by the presence or absence of certain receptors that play a role in driving their growth. These most commonly include hormone receptors (HR) – estrogen or progesterone – and human epidermal growth factor receptor 2 (HER2), which are involved in certain processes that allow the cancer cells to grow. Breast cancers that test positive for HR (“HR+”) and negative for HER2 (“HER2-”) have hormone receptors but have little to no HER2 receptors.

Thousands of women each year will be diagnosed with HR+/HER2- in early stages and may survive – and will likely live for years beyond their diagnosis.

But it’s women who have metastatic breast cancer, or cancer that has spread beyond breast tissue, who need more help. For these women, their life expectancy is much shorter, and treatment may continue for the rest of their life.

“Researchers estimate that there are more than 150,000 women in the U.S. living with metastatic breast cancer,” said Laura Carfang, Executive Director at SurvivingBreastCancer.org. “Unlike women who have earlier stage breast cancer who aim to say, ‘I am a survivor,’ ‘I am cancer-free’ or ‘I have no evidence of disease,’ women with metastatic breast cancer may say, ‘I am living with cancer,’ or ‘I have no evidence of active disease.’”

For these women, tomorrow becomes uncertain without treatment options.

Metastatic Breast Cancer Requires More

Stage IV breast cancer, or metastatic disease, is when cancer cells break away from the original tumor in the breast and travel to other parts of the body. Nearly 1 in 3 people diagnosed with early-stage breast cancer will develop metastatic disease.

Once cancer is metastatic, surgery to remove the tumor or the breasts themselves is unlikely to get rid of all the cancer. People with HR+/HER2- metastatic breast cancer typically receive treatments called endocrine-based therapies that target and try to block the activity of the hormone receptors driving the cancer growth. Despite how successful these treatments may be, resistance often develops, which means they could stop working.

“Women living with metastatic HR+/HER2- metastatic breast cancer have a unique and challenging experience,” said Carfang. “Endocrine-based therapies may work for them initially, but then, after possibly many successful years of being stable, it comes back or starts growing again, and suddenly they are left asking, ‘What now? What will my next line of treatment be and what options do I have?’ We have had so little to offer for these women who have endured so much.”

Historically, once women stop responding to endocrine-based therapy, treatment has been limited to single-agent chemotherapy. Many of these women will cycle through multiple chemotherapies and may decide to discontinue treatment.

“It can feel like time is running out,” said Carfang.

Treatment Options for HR+/HER2- Metastatic Breast Cancer Are Expanding

A recent FDA approval provides a new option for certain adults with pre-treated HR+/HER2- metastatic breast cancer. Trodelvy^® (sacituzumab govitecan-hziy) is a different kind of treatment called an antibody-drug conjugate (ADC) that is approved for adults with HR+/HER2- breast cancer that has spread to other areas of the body (metastatic) or cannot be removed by surgery, and who have received endocrine therapy and at least two additional treatments for metastatic disease. It is not known if Trodelvy is safe and effective in people with moderate or severe liver problems or in children.

Trodelvy is a new option in HR+/HER2- metastatic breast cancer for women who want to continue treatment.

Please click to see Important Facts about Trodelvy, including Important Warnings for low white blood cell count and diarrhea.

If you or someone you know has HR+/HER2- metastatic breast cancer that is resistant to endocrine-based therapies and has received at least 2 additional treatments for metastatic disease, speak with your doctor about potential treatment options, including Trodelvy. For more information, please visit www.trodelvy.com/.

IMPORTANT SAFETY INFORMATION

TRODELVY can cause serious side effects, including low white blood cell count and diarrhea:

• Low white blood cell count (neutropenia) which is common and can sometimes be severe and lead to infections that can be life-threatening or cause death. Your healthcare provider should check your blood cell counts during treatment. If your white blood cell count is too low, your healthcare provider may need to lower your dose, give you a medicine to help prevent low blood cell count with future doses of TRODELVY, or in some cases may stop TRODELVY. Your healthcare provider may need to give you antibiotic medicines if you develop fever while your white blood cell count is low. Call your healthcare provider right away if you develop any of the following signs of infection: fever, chills, cough, shortness of breath, or burning or pain when you urinate.
• Severe diarrhea. Diarrhea is common and can be severe. Severe diarrhea can lead to loss of too much body fluid (dehydration) and kidney problems. Your healthcare provider should monitor you for diarrhea and give you medicine as needed to help control it. If you lose too much body fluid, your healthcare provider may need to give you fluids and electrolytes to replace body salts. If you develop diarrhea during your treatment with TRODELVY, your healthcare provider should check to see if it may be caused by an infection. Your healthcare provider may decrease your dose or stop TRODELVY if your diarrhea is severe and cannot be controlled with anti-diarrheal medicines.
• Call your healthcare provider right away the first time that you get diarrhea during treatment with TRODELVY; if you have black or bloody stools; if you have symptoms of dehydration, such as lightheadedness, dizziness, or faintness; if you are unable to take fluids by mouth due to nausea or vomiting; or if you are not able to get your diarrhea under control within 24 hours.

Do not receive TRODELVY if you have had a severe allergic reaction to TRODELVY. Ask your healthcare provider if you are not sure.

Allergic and infusion-related reactions which can be serious and life-threatening. Tell your healthcare provider or nurse right away if you get any of the following symptoms during your infusion of TRODELVY or within 24 hours after: swelling of your face, lips, tongue, or throat; hives; skin rash, itching, or flushing of your skin; fever; difficulty breathing or wheezing; lightheadedness, dizziness, feeling faint, or pass out; or chills or shaking chills (rigors).

Nausea and vomiting are common with TRODELVY and can sometimes be severe. Before each dose of TRODELVY, you will receive medicines to help prevent nausea and vomiting along with medicines to take home with instructions about how to take them. Call your healthcare provider right away if you have nausea or vomiting that is not controlled with the medicines prescribed for you. Your healthcare provider may decide to decrease your dose or stop TRODELVY if your nausea and vomiting is severe and cannot be controlled with anti-nausea medicines.

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

• have been told that you carry a gene for UGT1A1*28, which can increase your risk of getting side effects with TRODELVY, especially low white blood cell counts, with or without a fever, and low red blood cell counts.
• have liver problems.
• are pregnant or plan to become pregnant. TRODELVY can harm your unborn baby. Your healthcare provider should check to see if you are pregnant before you start receiving TRODELVY. TRODELVY may cause fertility problems in females, which could affect your ability to have a baby. Talk to your healthcare provider if fertility is a concern for you.
• Females who can become pregnant should use effective birth control during treatment and for 6 months after your last dose of TRODELVY. Talk to your healthcare provider about birth control choices that may be right for you during this time. Tell your healthcare provider right away if you become pregnant during treatment with TRODELVY.
• Males with a female partner who can become pregnant should use effective birth control during treatment and for 3 months after your last dose of TRODELVY.
• are breastfeeding or plan to breastfeed. It is not known if TRODELVY passes into your breastmilk and can harm your baby. Do not breastfeed during treatment and for 1 month after your last dose of TRODELVY.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain medicines may affect the way TRODELVY works.

The most common side effects of TRODELVY include decreased white blood cell (leukocyte and lymphocyte) and red blood cell counts, feeling tired or weak, hair loss, constipation, increased sugar levels in the blood, decreased protein levels (albumin) in the blood, decreased appetite, changes in kidney function test, increased levels of enzyme called alkaline phosphatase in the blood (test for liver or bone problems), and decreased levels of magnesium, potassium, and sodium in the blood.

These are not all of the possible side effects of TRODELVY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

WHAT IS TRODELVY?

TRODELVY^® (sacituzumab govitecan-hziy) is a prescription medicine used to treat adults with hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body (metastatic) or cannot be removed by surgery, and who previously received endocrine therapy and at least two additional treatments for metastatic disease.

It is not known if TRODELVY is safe and effective in people with moderate or severe liver problems or in children.

Please click to see Important Facts about Trodelvy, including Important Warning.

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TRODELVY and GILEAD are trademarks of Gilead Sciences, Inc., or its related companies. All other marks are the property of their respective owners.

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