Posted on

Approved treatment provides an option for adults with follicular lymphoma when the disease has come back after treatment with at least two prior medicines

2018-05-14T07:01:01

(BPT) – Recently, World Cancer Day was commemorated, which is an annual effort focused on raising awareness of cancer and those impacted by the disease around the world. This day is another reminder of the impact the progress being made in oncology has on the cancer community, particularly patients facing the need for additional treatment options. One patient’s story truly showcases just how the lives of people impacted by cancer are improved with a curative resolve through science and innovation.

Receiving a diagnosis of follicular lymphoma (FL) felt “like getting hit in the face with a brick,” recalls Brenda Montgomery of Carrollton, Kentucky. Active and healthy throughout her life, Montgomery never expected a routine gynecological checkup to lead to a nine-year battle with FL, the most common form of indolent non-Hodgkin’s lymphoma.1 Nor could she have guessed she would relapse after receiving first- and second-line treatment, leaving her with few options until the U.S. Food and Drug Administration (FDA) approval of another treatment option for patients like Brenda.

“When I was first diagnosed, my husband and I had a three-day pity party,” she says of her initial diagnosis. “I wondered why me, when I’d been so healthy my whole life. I felt like I was too young to die, so when we were done with our pity party, we got up and decided ‘What are we going to do next?’ and we started treatment.”

Some patients, like Montgomery, experience initial success with first- and second-line treatments, only to find out later on that their disease has come back.

“Often, patients who are diagnosed with lymphoma initially know little about the disease, and those diagnosed with a rarer form, such as follicular lymphoma, may be even less aware at first what their diagnosis means,” says Dr. Don Stevens, Medical Oncologist, Norton Cancer Institute, Louisville, KY, Montgomery’s physician and investigator in the clinical trial of this treatment that led to its approval. “They may have experienced no symptoms prior to diagnosis, or they may be diagnosed when their follicular lymphoma is in a more advanced stage. Many patients’ follicular lymphoma may come back after first- and second-line forms of treatments, but currently, only a small portion of patients receive systemic therapy in third-line and beyond after initial treatments fail. It’s important for these patients to know they now have another treatment option in the third-line that has been FDA-approved.”

A different option

In February 2016, Montgomery made the decision to participate in a clinical trial of Aliqopa (copanlisib) 60 mg vial for injection. The study, known as CHRONOS-1, was investigating the safety and effectiveness of Aliqopa in 104 adult patients with FL when the disease has come back after treatment with at least two prior medicines.2 Fifty-nine percent of patients (61 of 104) had a response to the drug in the clinical trial, and the average duration of response was about one year (median of 12.2 months).2

Following an FL diagnosis

If you’ve been diagnosed with FL, it’s important to know some basic facts about the disease, including:

  • Often, people with FL have no obvious symptoms of the disease at diagnosis; however, some common symptoms may include enlarged lymph nodes in the neck, armpits, abdominal area or groin. You may experience fatigue, feel short of breath, have night sweats or unexplained weight loss.3
  • Relapse is common, although remission may last for years.3

If your FL has come back after two prior treatments, consider talking to your doctor about Aliqopa as an appropriate treatment option.

What is ALIQOPA?2

ALIQOPA is a prescription medicine used to treat adults with follicular lymphoma (FL) when the disease has come back after treatment with at least two prior medicines.

Aliqopa went through a faster FDA approval process because of how it caused FL tumors to shrink. Data gathered from an additional trial may be needed for continued approval of its current use.

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

Important Safety Information

ALIQOPA can cause serious side effects, including:

Infections: ALIQOPA can cause serious infections that may lead to death. The most common serious infection was pneumonia. Tell your healthcare provider right away if you have a fever or any signs of an infection during treatment with ALIQOPA.

High blood sugar (hyperglycemia): High blood sugar is common following ALIQOPA infusion and can sometimes be serious. Tell your healthcare provider if you develop any symptoms of hyperglycemia during treatment with ALIQOPA. Symptoms of hyperglycemia may include being very hungry, being very thirsty, frequent urination and headaches.

High blood pressure (hypertension): High blood pressure is common following ALIQOPA infusion and can sometimes be serious.

Lung or breathing problems: Your healthcare provider may do tests to check your lungs if you have breathing problems during treatment with ALIQOPA. Tell your healthcare provider right away if you develop new or worsening cough, shortness of breath, or difficulty breathing.

Low white blood cell count (neutropenia): Neutropenia is common with ALIQOPA treatment and can sometimes be serious. Your healthcare provider will check your blood counts regularly during treatment with ALIQOPA. Tell your healthcare provider right away if you have a fever or any signs of infection during treatment with ALIQOPA.

Severe skin reactions: Skin peeling, rash, and itching are common with ALIQOPA and can sometimes be serious. Tell your healthcare provider if you develop skin peeling, itching, or rash during treatment with ALIQOPA. Your healthcare provider may withhold treatment, decrease your dose, or permanently stop treatment if you develop severe skin reactions during treatment with ALIQOPA.

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

  • have an infection
  • have lung or breathing problems
  • have high blood pressure (hypertension)
  • have diabetes or high blood sugar (hyperglycemia)
  • are pregnant or plan to become pregnant. ALIQOPA can harm your unborn baby.
    • Your healthcare provider will perform a pregnancy test before starting treatment with ALIQOPA.
    • Females who are able to become pregnant should use effective birth control (contraception) during treatment with ALIQOPA and for at least 1 month after the last dose of ALIQOPA. Talk to your healthcare provider about birth control methods that may be right for you. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with ALIQOPA.
    • Males with female partners who are able to become pregnant should use effective birth control (contraception) during treatment with ALIQOPA and for at least 1 month after the last dose of ALIQOPA.
  • are breastfeeding or plan to breastfeed. It is not known if ALIQOPA passes into your breast milk. Do not breastfeed during treatment with ALIQOPA and for at least 1 month after the last dose of ALIQOPA. Talk to your healthcare provider about the best way to feed your child during treatment with ALIQOPA.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain other medicines may affect how ALIQOPA works.

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

What should I avoid while receiving ALIQOPA?

  • Avoid taking St. John’s Wort during treatment with ALIQOPA.
  • Avoid drinking grapefruit juice during treatment with ALIQOPA.

The most common side effects of ALIQOPA include:

  • low white blood cell count (leukopenia)
  • low platelets in your blood (thrombocytopenia)
  • diarrhea
  • decreased strength and tiredness
  • lower respiratory tract infection
  • nausea

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

You may report side effects to FDA at 1-800-FDA-1088.

For full prescribing information, visit:

http://labeling.bayerhealthcare.com/html/products/pi/Aliqopa_PI.pdf

1Cancer.net. Lymphoma – Non-Hodgkin: Subtypes. http://www.cancer.net/cancer-types/lymphoma-non-hodgkin/subtypes. Accessed March 2018.

2Aliqopa™ injection [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, September 2017.

3Lymphoma Research Foundation. Follicular Lymphoma. 2017. Available at:

http://www.lymphoma.org/site/pp.asp?c=bkLTKaOQLmK8E&b=6300155. Accessed March 2018.

PP-860-US-0252


Posted on

How to Protect Your Heart Health This Mother’s Day

2018-05-11T11:01:00

(BPT) – Worldwide, cardiovascular disease remains the number one killer of women and men.[i] In the U.S., the disease leads to one in every three deaths — one death approximately every 38 seconds.[i] Although both genders suffer from the disease, women can experience more subtle symptoms than men, which may go unnoticed. That’s why it is important for women to know the heart disease risk factors that are specific to them. Here are four steps women should take to protect their heart health:

  1. Know the Signs.

Chest pain is the most common heart attack symptom for women, but women are more likely than men to experience symptoms unrelated to chest pain including shortness of breath, nausea or vomiting, sweating, lightheadedness/dizziness, or pain or discomfort in the neck, stomach, one or both arms, back, or jaw.[ii]

  1. Don’t Stall, Get Help Immediately.

Recent research found women have a higher risk of death in the first year after a heart attack than men.[iii] If you recognize any of these signs or symptoms, it is important to get help immediately. Stalling may worsen your condition.

  1. Prevention is Key.

Heart disease is preventable. Knowing and watching your heart health indicators, such as diet, exercise, smoking and alcohol consumption, are a few ways to protect your heart. If lifestyle modifications are not enough to lower your risk, you may need to speak with your doctor about alternate solutions.

  1. Talk to Your Doctor.

High triglycerides (fat in the blood) are an indicator of cardiovascular risk.[iv],[v],[vi] You should talk to your doctor about your triglyceride levels as well as your cholesterol, blood sugar and blood pressure levels — all important cardiovascular risk factors that can impact your heart health.


[i] American Heart Association/American Stroke Association. Heart Disease and Stroke Statistics 2018 At a Glance website. https://healthmetrics.heart.org/wp-content/uploads/2018/02/At-A-Glance-Heart-Disease-and-Stroke-Statistics-2018.pdf. February, 2018. Accessed April 29, 2018.

[ii] American Heart Association. Heart Attack Symptoms in Women website. http://www.heart.org/HEARTORG/Conditions/HeartAttack/WarningSignsofaHeartAttack/Heart-Attack-Symptoms-in-Women_UCM_436448_Article.jsp#.WvHCjqQvzRY. July, 2015. Accessed May 8, 2018.

[iii] Ubrich R, Barthel P, Haller B, Hnatkova K, Huster KM, Steger A, et al. (2017) Sex differences in long-term mortality among acute myocardial infarction patients: Results from the ISAR-RISK and ART studies. PLoS ONE 12(10): e0186783. https://doi.org/10.1371/journal.pone.0186783

[iv] Miller M, Cannon CP, Murphy SA, Qin J, Ray KK, Braunwald E, for the PROVE IT-TIMI 22 Investigators. Impact of Triglyceride levels beyond low-density lipoprotein cholesterol after acute coronary syndrome in the PROVE IT-TIMI 22 Trial. J Am Coll Cardiol. 2008;51;724-730.

[v] Faergeman O, Holme I, Fayyad R, Bhatia S, Grundy SM, Kastelein JJP, LaRosa JC, Lytken Larsen M, Lindahl C, Olsson AG, Tikkanen MJ, Waters DD, Pederson TR, on behalf of the Steering Committees of the IDEAL and TNT Trials. Plasma triglycerides and cardiovascular events in the treating to new targets and incremental decrease in end-points through aggressive lipid lowering trials of statins in patients with coronary artery disease. J Am Coll Cardiol. 2009;104:459-463.

[vi] Miller M, Stone NJ, Ballantyne C, Bittner V, Criqui MH, Ginsberg HN, Goldberg AC, Howard WJ, Jacobson MS, Kris-Etherton PM, Lennie TA, Levi M, Mazzone T, Pennathur S. Triglycerides and cardiovascular disease: A scientific statement from the American Heart Association. Circulation. 2011;123:2292-2333.


Posted on

If an injury or illness kept you out of work, could you pay your bills?

2018-05-03T07:01:01

(BPT) – You helped friends move their furniture; now your back is so sore you can’t move. You could be out of work and unable to collect at least three paychecks.

Your doctor says you’ve eaten your last bacon-wrapped hot dog, or your health could keep you out of work for four paychecks.

You made a diving catch to clinch the win for the company softball team. Though you were carried off the field a hero, you’ll be away from the office for eight paychecks.

We’re all temporarily able-bodied — no one is immune from an unexpected illness or injury. One in four of today’s 20-year-olds will experience a disability before they hit retirement age, according to a June 2016 Social Security Administration fact sheet.

Back injuries, heart attacks, knee replacements or other disabling conditions can leave workers without a paycheck and employers short-staffed. Based on the average time out of work for each ailment as reported by MDguidelines.com (which assumes a medium-duty job classification), these conditions could put employees out of commission for six weeks, eight weeks or 16 weeks, respectively.

Yet, less than 30 percent of American workers have disability coverage, according to a 2018 LIMRA survey. Those counting on the government to provide disability payments are often disappointed: The latest Annual Statistical Report on the Social Security Disability Insurance Program shows that nearly 70 percent of SSDI claims are denied and less than 40 percent of those claims are approved upon appeal.

Insurers like Prudential Insurance Company of America have come forward to fill the gap, offering employer-sponsored disability coverage, absence management and return-to-work solutions.

“No one imagines their livelihood being threatened by an injury or disability, even for a short time,” says Jim Gemus, a senior vice president for Prudential Group Insurance. “The statistics show it’s something we need to be concerned about.”

Risk of a debilitating injury isn’t limited to physically demanding, blue-collar work. Disabling illnesses and accidents often happen outside the workplace — like at a softball game.

With more than 1,170 short-term and 1,645 long-term disability clients, Prudential saw a need to provide easy-to-use tools to help workers and employers understand how much coverage they may need. Prudential’s Disability Insurance Needs Estimator calculates the expected amount based on age, marital status and income. Disability insurance helps pay a portion of these costs, reducing the financial burden at a time when individuals can least afford any additional stress.

“A good employer-sponsored disability insurance plan not only helps protect employees’ financial wellness, it also helps businesses handle the costs and complexities of disability management,” Gemus says. “Our main concern is helping individuals pay the bills so they can recover and get back to work.”

That may be the biggest benefit to employers who provide disability insurance. After all, every winning company softball team needs to keep its stars on the field.


Posted on

How to Take Diabetes by the Horns

2018-05-02T09:01:00

(BPT) – For the millions of Americans living with diabetes, every day can be a series of ups and downs. But it doesn’t have to be. That’s why Roche Diabetes Care, the maker of Accu-Chek® Guide, and country singer Ben Rue recently launched the #BuckOffDiabetes campaign to motivate people to take diabetes by the horns and help them live their lives as active and unrestricted as possible.

Ben Rue has been living with type 1 diabetes for the past 16 years and has teamed up with Roche Diabetes Care to ask everyone to get involved, whether they have diabetes, or if it affects someone they know and love. Here are 5 tips from Ben and Roche Diabetes Care to help take diabetes by the horns.

1. Knowledge is power. Stay up to date on the latest resources and technologies through online resources and communities such as the Accu-Chek® Facebook page, Accu-Chek.com, as well as advocacy groups like Beyond Type 1, the College Diabetes Network and Taking Control of Your Diabetes. These groups and communities aim to continue to educate and empower people living with diabetes and arm them with the latest tips and tools to help manage diabetes.

2. Eat healthy. It’s important to eat a balanced meal to not only help you manage diabetes but also give your body the fuel it needs to keep doing what you love. This can be difficult when traveling or when life gets busy, but by packing a meal or snacks to take on the go, it’ll help you stay on track.

3. Stay active. Regular activity is a key part of managing diabetes, along with eating healthy and taking medications as prescribed. Even getting 30 minutes to stretch or walk each day is better than sitting all day.

4. Show support for the community. Whether you have diabetes or know someone who does, show support for the 1 out of every 10 Americans living with diabetes.i Join the movement by turning your hand into bull horns and share a photo on social media with #BuckOffDiabetes. Each post will trigger a donation from Roche Diabetes Care to several diabetes related organizations.ii

5. Find ways to save. With the Accu-Chek® Guide SimplePay Savings programiii, people with diabetes can save a few bucks by always paying the same low price for every test strip refill to help them focus on what is best for their health, not what it costs.

Learn more about how to save a buck, donate a buck and better manage your diabetes by bucking the trend at www.buckoffdiabetes.com.

[1] https://www.cdc.gov/diabetes/pdfs/library/socialmedia/diabetes-infographic.pdf

[2] For full details, please read the terms and conditions at www.buckoffdiabetes.com

[3] The card is not insurance; it is a cash discount program and cannot be combined with any form of health insurance. Those insured by any government healthcare program, such as Medicare, Medicaid, the military or VA, are NOT eligible for this offer. Insurers may offer a lower cost option. 30- or 90-day Accu-Chek Guide test strip prescription required. Limit 12 vials per refill. Refills cannot be dispensed before 75% of previous days’ supply have elapsed. Program may be changed or discontinued at any time.


Posted on

Opioid Addiction – Are You At Risk? [Infographic]

2018-05-01T15:23:00

(BPT) – The opioid epidemic is the deadliest drug crisis in the past decade. This infographic highlights these harrowing statistics, as well as shares America’s views on the current situation captured by The Marist Poll. To learn more about NARCAN® Nasal Spray, an intranasal naloxone treatment that can help reverse an opioid overdose, please visit https://www.narcan.com.