Month: December 2020

2020-12-18T08:27:02

(BPT) – It’s the most wonderful time of the year, and while your holiday celebrations may look a little bit different this year, we all deserve to tune out from a world that doesn’t seem to stop spinning.

People find different things that spark joy for them. For some, it means buying a luxury present for themselves, taking extra time off work or reaching out to the ones they love. For others, it means loosening the reins on their diets by enjoying the sweet and savory foods of the season.

No matter how you do it, there’s no right or wrong way to get into the holiday spirit. Here are a few things you can do to keep the joy alive this season:

• Establish new traditions: You may not be carrying out the same old traditions you were in previous years, but that doesn’t mean you can’t try something new. This is the perfect time to try a new activity that may just become something that you can carry into years to come. For instance, you and your family could stay in your pajamas all day or implement a movie marathon day cozied up near the fireplace.
• Indulge in your favorite foods: The holidays always bring out the best of sweet and savory delights. Allow yourself to really enjoy them this year because Santa isn’t the only one who gets to enjoy holiday cookies. And don’t let the heartburn that can often come with these indulgences sweep in like the Grinch. America’s number one antacid brand, TUMS, can ensure you’re able to enjoy those indulgences without the heartburn or indigestion that can come with it.
• Leave the decorations up a little longer than usual: A season that’s merry and bright deserves to last forever and we can all use a little extra of that these days. Even when the holidays are technically over, why not leave your decorations up just a little while longer to bask in the simple pleasure they bring? If it puts a smile on your face and makes you happy, it’s always worth it.
• Have a fun, low-key New Year’s celebration: Most will agree we are eager to welcome the fresh start a new year brings, this year more than ever before. While celebrations are unlikely to be the same as other years, we can still bid the year farewell in a memorable way. Consider a virtual gathering with friends or just fast forward to 2021 and skip the midnight countdown in favor of hitting the hay early.

Everyone deserves to treat themselves

2020 has been a rough year for us all. Just because things look a little different this year, that doesn’t mean you can’t find ways to enjoy yourself, no matter how you decide to do it.

2020-12-18T11:01:01

(BPT) – It’s a fact: If you take safe, effective, FDA-approved generic prescription medicines, you are saving money. The average copay for a generic medicine is nearly $50 lower than the copay for a brand-name drug. More than 9 out of 10 generic prescriptions are filled for $20 or less.

The Association for Accessible Medicines’ Generic Drug & Biosimilars Access & Savings in the U.S. Report (with data provided by IQVIA) reveals that savings from generic drugs added up to $313 billion in 2019 and close to $2.2 trillion over the past decade. Biosimilars, which meet the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines, are a growing area of savings for America’s patients. They saved the health care system $2.2 billion in 2019 and $4.5 billion over the past 10 years.

The $96 billion in Medicare savings and $48.5 in Medicaid savings mean not just better health for participants but also a lighter burden on taxpayers. A majority of prescriptions, and thus generic savings, are attributed to commercially insured patients. If you get your health insurance through your own or a relative’s employer, your savings are part of the $153 billion in private savings.

Access to generic medicines matters more than ever today. The data show that generics are putting treatment within reach from sea to shining sea. The 50 states saved an average of $6.1 billion in 2019, including $1.9 billion in Medicare savings and $950 million in Medicaid savings. How did your state do? Find out with AAM’s interactive State Savings Map.

Here are some highlights:

• California: $28 billion in savings. This amount includes $8.9 billion and $6 billion in Medicare and Medicaid savings, respectively. (“I went from paying for a biologic that didn’t work well to not paying anything for a biosimilar that truly helped.” Meet Jeni of Newhall, CA)
• Connecticut: $3.7 billion in savings. Medicare savings came to $1.1 billion, while Medicaid savings totaled $656.6 million. (“My two generic prescription drugs, each only $2 per month, help me stay active. Everybody understands that kind of savings when they’re on a fixed income.” Meet Rich of Trumbull, CT)
• Florida: $19.1 billion in savings. Florida’s Medicare savings came to $6.9 billion, with Medicaid savings totaling $1.9 billion. (“My doctor recommended the generic, and it’s done everything that the brand-name drug did, plus it’s much cheaper. Those generic savings have really come in handy, because I’ve been able to help my grandchildren with their college savings.” Meet Doug of Pembroke Pines, FL)
• Maryland: $5.1 billion in savings. Medicare savings for Maryland came to $1.2 billion, and Medicaid savings totaled $885 million. (“Without access to generic medicines, I don’t know what I’d do.” Meet Rich of Laurel, MD)
• New Jersey: $9.6 billion in savings. New Jersey’s Medicare savings totaled $3.1 billion, and its Medicaid savings totaled $1.8 billion. (“If I didn’t have generic prescriptions, I probably wouldn’t be here, because the brand name drugs are expensive—sometimes over $200 a bottle.” Meet Ariel of Bloomfield, NJ)
• New York: $25.6 billion in savings. New York’s generic Medicare savings came to $8.6 billion, with $5.4 billion in Medicaid savings. “I don’t have a lot of time or money to spare, so I tell the doctors to just give me the generic because they work the same, and it’s way less than half the cost of the brand name. I’ve been able to use the savings to go back to school.” Meet Raeanne of New York, NY)
• Pennsylvania: $14.3 billion in savings. Pennsylvania’s generic Medicare savings totaled $4.7 billion, and its Medicaid savings were $2.3 billion. (“I have a very good relationship with my pharmacist. He said, ‘Don’t waste your money on the brand names.’ I’m on a fixed income, and those savings really do add up.” Meet Michelle of Stroudsburg, PA)
• Utah: $2.5 billion in savings. Medicare savings for Utah came to $506.6 million, with $180.5 million in Medicaid savings. (“I’m pretty much living paycheck to paycheck, and without generic medicine, I probably wouldn’t even be able to put gas in my tank.” Meet McKenzie of Salt Lake City, UT)
• Wyoming: $431.4 million in savings. Wyoming’s Medicare savings came to $111 million, and its Medicaid savings totaled $37 million. (“When you pay for a name brand, it’s super expensive. Do you know what it’s like to have a drug that costs your car payment each month? If it weren’t for these generic medications, I don’t know where my life would be. I can afford things.” Meet Jonnie of Skiatook, WY)

During the COVID-19 pandemic, generics are saving lives and containing health care costs. When federal and state policy makers secure our savings, they help us all to be healthier and more productive.

2020-12-18T11:01:01

(BPT) – Tiffany Williams went to the doctor to see if something could be done about her severe back pain, but the root cause was something she wasn’t planning on. She learned she had multiple myeloma. As the doctor explained this rare form of blood cancer and how it would impact her life, her brain latched on to a single phrase: “Incurable but treatable.”

As the news settled in over the following days and weeks, she held on to that fearful term, “incurable.”

She says, “I was shocked and surprised to learn that while multiple myeloma is considered a rare disease, it is the most common form of blood cancer among African Americans.”

Learning more about her diagnosis

Prior to being diagnosed with multiple myeloma, Tiffany had always been in great health, with a vibrant personality. Though her career was in healthcare, her work never focused on cancer treatment, or even caring for patients with a cancer diagnosis. Despite her background, she found she knew little of what to expect once she learned she had multiple myeloma.

Navigating a new normal

The most challenging part of living with multiple myeloma, Tiffany says, is the physical challenges. Some weeks she found herself too sick to get out of bed for two- or three-day stretches. Feeling the changes taking place in her body was most difficult to accept.

For an idea of what was happening to Tiffany, here’s a look at some characteristics of multiple myeloma, which is the second most common form of blood cancer in the U.S.

Multiple myeloma affects plasma cells, a type of white blood cell in the bone marrow that helps the body fight infection. The myeloma cells rapidly produce abnormal antibodies called M proteins, which crowd out other important blood cells. A high level of these M proteins is a hallmark characteristic of multiple myeloma.

Patients with multiple myeloma may or may not experience symptoms. The common symptoms patients present with include the body’s calcium levels spiking, which can lead to kidney issues, anemia as well as bone pain.

The disease is most often diagnosed in patients between the ages of 65-74. It’s more common in males and twice as common in African Americans than white Americans, for reasons that are not clearly understood. While many African American patients have a lower-risk genetic profile and could achieve treatment results equal to those seen in other multiple myeloma patient populations, barriers to appropriate treatment and lack of awareness of the disease contribute to inconsistent treatment approaches.

In 2020, there were an estimated 32,270 new cases in the U.S, and an estimated 275,000 new cases will develop worldwide by 2040.

The current COVID-19 pandemic adds another challenge for multiple myeloma patients. Because multiple myeloma affects infection-fighting plasma cells, it impacts the immune system’s ability to root out infectious diseases, including COVID-19. Therefore, patients with multiple myeloma and other blood cancers are particularly vulnerable to the virus. Research indicates that patients whose cancer progressed during a COVID-19 diagnosis had an increased risk of death. Additionally, routine doctor visits that could potentially lead to an earlier cancer diagnosis have been delayed or avoided because of the pandemic. The Centers for Disease Control and Prevention reports 4 in 10 U.S. adults have avoided medical care because of concerns related to COVID-19.

Getting treatment: An ongoing process

Tiffany worked closely with her care team to help her evaluate her treatment options and make the best-informed decisions. She recalls how she felt as she anticipated the first part of her treatment plan – an autologous stem cell transplant – which is a standard of care in multiple myeloma that uses healthy stem cells from one’s own body.

“I was really anxious about starting treatment,” she says. “Very nervous. I remember being nauseous on the way to treatment. But once we got through the first day, my anxiety was relieved.”

As a maintenance therapy following her stem cell transplant, she now takes Revlimid^® (lenalidomide), a prescription medicine that’s used to treat adults with multiple myeloma following an autologous stem cell transplant.

REVLIMID^® (lenalidomide) is a prescription medicine, used to treat adults with multiple myeloma (MM) in combination with the medicine dexamethasone, or as maintenance treatment after autologous hematopoietic stem cell transplantation (a type of stem cell transplant that uses your own stem cells). REVLIMID should not be used to treat people who have chronic lymphocytic leukemia (CLL) unless they are participants in a controlled clinical trial. It is not known if REVLIMID is safe and effective in children.

WARNING: Risk to unborn babies, risk of low blood counts and blood clots.

Before you begin taking REVLIMID, you must read and agree to all of the instructions in the REVLIMID REMS^® program. Before prescribing REVLIMID, your healthcare provider will explain the REVLIMID REMS program to you and have you sign the Patient-Physician Agreement Form.

Please see additional Important Safety Information below, and full Prescribing Information, including Boxed WARNINGS and Medication Guide, on REVLIMID.com

Tiffany explains that after the stem cell transplant, there would be residual disease that remains in the blood.

“Revlimid has been my maintenance therapy to prolong the response (of the stem cell transplant),” she says.

This is the story of a patient’s experience with Revlimid^® (lenalidomide). Not all patient experiences will be the same.

How Revlimid works and what to expect

Revlimid is a prescription medicine, used to treat adults with multiple myeloma. It is used in several FDA-approved therapy combinations, or as a maintenance therapy after an autologous stem cell transplant to help sustain the response or delay disease progression. Revlimid is not a traditional chemotherapy, injection or infusion. It is a once-daily capsule taken at home or wherever is convenient.

Most common side effects include: diarrhea, itching and rash, nausea, constipation, tiredness or weakness, fever, itching, swelling of your arms, hands, legs, feet, and skin, sleep problems (insomnia), headache, muscle cramps or spasms, shortness of breath, cough, sore throat, and other symptoms of the common cold, upper respiratory tract infection or bronchitis, inflammation of the stomach and intestine (“stomach flu”), nose bleed, shaking or trembling (tremor), joint aches, and pain in your back or stomach area (abdomen).

Patients experiencing side effects should report them to their doctor.

Please see more information below; these are not all possible side effects. Talk to your healthcare provider for more information. Always talk to your doctor if you have side effects.

Maintaining her treatment along with her spirits

Living with multiple myeloma has been challenging for Tiffany. Fortunately, her family is her support system that keeps her motivated and helps her stay optimistic.

Her husband, Adrian, has been her rock, she says. It was he who helped her shift her focus from “incurable” to “treatable.”

Tiffany has also found it empowering to give voice to the struggles of multiple myeloma and being an advocate for others who share her diagnosis.

“I think the most important tip that I can give other patients is the importance of maintaining an open line of communication with their care team. Keeping regular communication with my doctor has made it easy for him to adjust my dosage as needed to remain on therapy, which is very important to me.”

Individual results can vary.

What is REVLIMID^® (lenalidomide)?
REVLIMID^® (lenalidomide) is a prescription medicine, used to treat adults with multiple myeloma (MM) in combination with the medicine dexamethasone, or as maintenance treatment after autologous hematopoietic stem cell transplantation (a type of stem cell transplant that uses your own stem cells). REVLIMID should not be used to treat people who have chronic lymphocytic leukemia (CLL) unless they are participants in a controlled clinical trial. It is not known if REVLIMID is safe and effective in children.

WARNING: Risk to unborn babies, risk of low blood counts and blood clots.

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

Before you begin taking REVLIMID, you must read and agree to all of the instructions in the REVLIMID REMS^® program. Before prescribing REVLIMID, your healthcare provider will explain the REVLIMID REMS program to you and have you sign the Patient-Physician Agreement Form.

REVLIMID may cause serious side effects, including:

• Possible birth defects (deformed babies) or death of an unborn baby. Females who are pregnant or who plan to become pregnant must not take REVLIMID.

REVLIMID is similar to the medicine thalidomide which is known to cause severe life-threatening birth defects. REVLIMID has not been tested in pregnant females. REVLIMID has harmed unborn animals in animal testing.

Females must not get pregnant:

• For at least 4 weeks before starting REVLIMID
• While taking REVLIMID
• During any breaks (interruptions) in your treatment with REVLIMID
• For at least 4 weeks after stopping REVLIMID

Females who can become pregnant:

• Must have pregnancy tests weekly for 4 weeks, then every 4 weeks if your menstrual cycle is regular, or every 2 weeks if your menstrual cycle is irregular.
• If you miss your period or have unusual bleeding, you will need to have a pregnancy test and receive counseling.
• Must agree to use 2 different forms of effective birth control at the same time, for at least 4 weeks before, while taking, during any breaks (interruptions) in your treatment, and for at least 4 weeks after stopping REVLIMID.
• Talk with your healthcare provider to find out about options for effective forms of birth control that you may use to prevent pregnancy before, during, and after treatment with REVLIMID.
• If you had unprotected sex or if you think your birth control has failed, stop taking REVLIMID immediately and call your healthcare provider right away.

If you become pregnant while taking REVLIMID, stop taking it right away and call your healthcare provider. If your healthcare provider is not available, you can call Celgene Customer Care Center at 1-888-423-5436. Healthcare providers and patients should report all cases of pregnancy to:

• FDA MedWatch at 1-800-FDA-1088, and
• Celgene Corporation, a Bristol Myers Squibb company, at 1-888-423-5436.

There is a pregnancy exposure registry that monitors the outcomes of females who take REVLIMID during pregnancy, or if their male partner takes REVLIMID and they are exposed during pregnancy. You can enroll in this registry by calling Celgene Corporation, a Bristol Myers Squibb company, at the phone number listed above.

REVLIMID can pass into human semen:

• Males, including those who have had a vasectomy, must always use a latex or synthetic condom during any sexual contact with a pregnant female or a female that can become pregnant while taking REVLIMID, during any breaks (interruptions) in your treatment with REVLIMID, and for up to 4 weeks after stopping REVLIMID.
• Do not have unprotected sexual contact with a female who is or could become pregnant. Tell your healthcare provider if you do have unprotected sexual contact with a female who is or could become pregnant.
• Do not donate sperm while taking REVLIMID, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping REVLIMID. If a female becomes pregnant with your sperm, the baby may be exposed to REVLIMID and may be born with birth defects.

Men: If a female becomes pregnant with your sperm, you should call your HCP right away.

• Low white blood cells (neutropenia) and low platelets (thrombocytopenia). REVLIMID causes low white blood cells and low platelets in most people. You may need a blood transfusion or certain medicines if your blood counts drop too low. Your healthcare provider should check your blood counts often, especially during the first several months of treatment with REVLIMID, and then at least monthly. Tell your healthcare provider if you develop any bleeding or bruising during treatment with REVLIMID.
• Blood clots. Blood clots in the arteries, veins, and lungs happen more often in people who take REVLIMID. This risk is even higher for people with multiple myeloma who take the medicine dexamethasone with REVLIMID. Heart attacks and strokes also happen more often in people who take REVLIMID with dexamethasone. To reduce this increased risk, most people who take REVLIMID will also take a blood thinner medicine.

Before taking REVLIMID, tell your healthcare provider:

• if you have had a blood clot in the past;
• if you have high blood pressure, smoke, or if you have been told you have a high level of fat in your blood (hyperlipidemia); and
• about all the medicines you take. Certain other medicines can also increase your risk for blood clots

Call your healthcare provider or get medical help right away if you get any of the following during treatment with REVLIMID:

Signs or symptoms of a blood clot in the lung, arm, or leg may include: shortness of breath, chest pain, or arm or leg swelling

Signs or symptoms of a heart attack may include: chest pain that may spread to the arms, neck, jaw, back, or stomach area (abdomen), feeling sweaty, shortness of breath, feeling sick or vomiting

Signs or symptoms of stroke may include: sudden numbness or weakness, especially on one side of the body, severe headache or confusion, or problems with vision, speech, or balance

Who should not take REVLIMID?

Do not take REVLIMID if you:

• are pregnant, plan to become pregnant, or become pregnant during treatment with REVLIMID. See “What is the most important information I should know about REVLIMID?”
• are allergic to lenalidomide or any of the ingredients in REVLIMID. See the Medication Guide for a complete list of ingredients in REVLIMID.

What should I tell my healthcare provider before taking REVLIMID?

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

• have liver problems
• have kidney problems or receive kidney dialysis treatment
• have thyroid problems
• have had a serious skin rash with thalidomide treatment. You should not take REVLIMID.
• are lactose intolerant. REVLIMID contains lactose.
• are breastfeeding. Do not breastfeed during treatment with REVLIMID. It is not known if REVLIMID passes into your breast milk and can harm your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. REVLIMID and other medicines may affect each other, causing serious side effects. Talk with your healthcare provider before taking any new medicines. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist.

How should I take REVLIMID?

Take REVLIMID exactly as prescribed and follow all the instructions of the REVLIMID REMS program

• Swallow REVLIMID capsules whole, with water, 1 time a day. Do not open, break, or chew your capsules.
• REVLIMID may be taken with or without food.
• Take REVLIMID at about the same time each day.
• Do not open the REVLIMID capsules or handle them any more than needed. If powder from the
  REVLIMID capsule comes in contact with:
• your skin, wash the skin right away with soap and water.
• inside of your eyes, nose, or mouth, flush well with water.
• If you miss a dose of REVLIMID and it has been less than 12 hours since your regular time, take it as soon as you remember. If it has been more than 12 hours, just skip your missed dose. Do not take 2 doses at the same time.
• If you take too much REVLIMID, call your healthcare provider right away.

What should I avoid while taking REVLIMID?

• See “What is the most important information I should know about REVLIMID?”
• Females: Do not get pregnant and do not breastfeed while taking REVLIMID.

• Males: Do not donate sperm.

• Do not share REVLIMID with other people. It may cause birth defects and other serious problems
• Do not donate blood while you take REVLIMID, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping REVLIMID. If someone who is pregnant gets your donated blood, her baby may be exposed to REVLIMID and may be born with birth defects.

What are the possible side effects of REVLIMID?

REVLIMID can cause serious side effects, including:

• See “What is the most important information I should know about REVLIMID?”
• Increased risk of death in people who have chronic lymphocytic leukemia (CLL). People with CLL who take REVLIMID have an increased risk of death compared with people who take the medicine chlorambucil. REVLIMID may cause you to have serious heart problems that can lead to death, including atrial fibrillation, heart attack, or heart failure. You should not take REVLIMID if you have CLL unless you are participating in a controlled clinical trial.
• Risk of new cancers (malignancies). An increase in new (second) cancers has happened in patients who received REVLIMID and melphalan, or a blood stem cell transplant, including certain blood cancers, such as acute myelogenous leukemia (AML), myelodysplastic syndromes (MDS), and certain other types of cancers of the skin and other organs. Talk with your healthcare provider about your risk of developing new cancers if you take REVLIMID. Your healthcare provider will check you for new cancers during your treatment with REVLIMID.
• Severe liver problems, including liver failure and death. Your healthcare provider should do blood tests to check your liver function during your treatment with REVLIMID. Tell your healthcare provider right away if you develop any of the following symptoms of liver problems:
• yellowing of your skin or the white part of your eyes (jaundice)
• dark or brown (tea-colored) urine
• pain on the upper right side of your stomach area (abdomen)
• bleeding or bruising more easily than normal
• feeling very tired

• Severe skin reactions and severe allergic reactions can happen with REVLIMID and may cause death.

Call your healthcare provider right away if you develop any of the following signs or symptoms during treatment with REVLIMID:

• a red, itchy, skin rash
• peeling of your skin or blisters
• severe itching
• fever

Get emergency medical help right away if you develop any of the following signs or symptoms during treatment with REVLIMID:

• swelling of your lips, mouth, tongue, or throat
• trouble breathing or swallowing
• raised red areas on your skin (hives)
• a very fast heartbeat
• You feel dizzy or faint

• Tumorlysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your healthcare provider may do blood tests to check you for TLS.
• Worsening of your tumor (tumor flare reaction). Tell your healthcare provider if you get any of these symptoms of tumor flare reaction while taking REVLIMID: tender, swollen lymph nodes; low-grade fever, pain, or rash.
• Thyroid problems. Your healthcare provider may check your thyroid function before you start taking REVLIMID and during treatment with REVLIMID.
• Risk of early death in MCL. In people who have mantle cell lymphoma (MCL), there may be a risk of dying sooner (early death) when taking REVLIMID. Talk with your healthcare provider about any concerns and possible risk factors.

The most common side effects of REVLIMID include:

• diarrhea
• rash
• nausea
• constipation
• tiredness or weakness
• fever
• itching
• swelling of your arms, hands, legs, feet, and skin
• sleep problems (insomnia)
• headache
• muscle cramps or spasms
• shortness of breath
• cough, sore throat, and other symptoms of a cold
• upper respiratory tract infection or bronchitis
• inflammation of the stomach and intestine (“stomach flu”)
• nose bleed
• shaking or trembling (tremor)
• joint aches
• pain in your back or stomach area (abdomen)

These are not all of the possible side effects of REVLIMID. Your healthcare provider may tell you to decrease your dose, temporarily stop or permanently stop taking REVLIMID if you develop certain serious side effects during treatment with REVLIMID. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide, on REVLIMID.com

REVLIMID^®, and REVLIMID REMS^® are registered trademarks of Celgene Corporation, a Bristol Myers Squibb company.

© 2020 Bristol-Myers Squibb Company. 12/20. US-REV-20-0531

2020-12-18T07:01:00

(BPT) – Crystal is a wife, mother of four and a frontline healthcare worker who also happens to have multiple sclerosis (MS). Though she had experienced numbness, tingling and pain since she was a child, doctors initially downplayed her symptoms. It was not until 2003, while Crystal was in nursing school, that she received her MS diagnosis after she became unconscious and ended up in the emergency room, blind and paralyzed on her left side.

According to an estimate from the National Multiple Sclerosis Society, nearly 1 million people over the age of 18 are living with MS in the United States. MS is a chronic and unpredictable disease of the central nervous system (CNS) and is thought to be an immune-mediated disorder, in which the immune system attacks healthy tissue in the CNS.

“Once I entered rehab to regain my strength, I met a nurse who helped me realize it was possible to live a fulfilling life with MS,” said Crystal. “It’s not always easy, but having MS has taught me to stand up for myself and go after the things I love.” In addition to working full time, Crystal is also a patient ambassador for EMD Serono who shares her story with other patients with how she manages the challenges of living with the condition.

While COVID-19 has become part of life for everyone in 2020, it presents unique challenges for both MS patients like Crystal and the healthcare professionals treating them.

“No two MS patients will have the exact same symptoms – and symptoms can change over time,” said Dr. Barry Hendin, neurologist and Chief Medical Officer for the Multiple Sclerosis Association of America. “Therefore, as physicians, we are continually looking for additional treatment options to offer patients based on their individual needs and to address the different challenges they may face.”

Crystal tried other medications to treat her MS, but was not able to tolerate them due to certain side effects. She began researching MAVENCLAD^® (cladribine) tablets, and was intrigued by its dosing schedule – which is taken for no more than 10 days a year over a two-year period and has weight-based dosing – and asked her doctor about it.

MAVENCLAD is a prescription medicine used to treat relapsing forms of MS, to include relapsing-remitting disease and active secondary progressive disease in adults. Because of its safety profile, MAVENCLAD is generally used in people who have tried another MS medicine that they could not tolerate or that has not worked well enough. MAVENCLAD is not recommended for use in people with clinically isolated syndrome (CIS). MAVENCLAD may cause serious side effects including the risk of cancer (malignancies) and birth defects if used during pregnancy. Females must not be pregnant when they start treatment with MAVENCLAD or become pregnant during MAVENCLAD dosing and within 6 months after the last dose of each yearly treatment course. Additional side effects can include low blood cell counts, serious infections such as TB, hepatitis B or C, shingles, or progressive multifocal leukoencephalopathy (PML), liver problems, allergic reactions and heart failure. The most common side effects of MAVENCLAD include upper respiratory infection, headache, and low white blood cell count. She began treatment with the medication in 2019 after completing initial screening and education, including the use of effective contraception and the need for ongoing monitoring and doctor visits.

“Completing year two of MAVENCLAD in the middle of a pandemic was interesting. My doctor and I had several telemedicine visits making sure we were both comfortable with moving forward, as it does lower my white blood cell count putting me more at-risk of infections,” said Crystal. “So far, treatment with MAVENCLAD has worked well for me, but this is my own personal experience.”

Patients and healthcare providers continue to adapt to the “new normal” of life during the COVID-19 pandemic.

“My patients are remaining cautious by wearing protective face coverings, washing their hands regularly and practicing social distancing,” said Dr. Hendin. “However, some of my patients still do not feel safe coming to appointments, even to get treatments. For this reason, we try to do as many appointments as possible via phone or video calls, which is a good alternative for the time being, though cannot fully replace in-office appointments.”

Though life during the pandemic has been challenging, Crystal remains optimistic.

“I am doing well. Physically I feel the same, which is a win. Mentally I am tired, but that’s probably because I started a new job and the whole COVID-19 mess makes me mentally exhausted sometimes,” said Crystal. “I’m at a good place with managing my MS and hope that continues through the pandemic.”

Please see Important Safety Information below and accompanying full Prescribing Information, including boxed WARNING, and Medication Guide.

MAVENCLAD^® Indication and Important Safety Information

What is MAVENCLAD?

MAVENCLAD is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, MAVENCLAD is generally used in people who have tried another MS medicine that they could not tolerate or that has not worked well enough. MAVENCLAD is not recommended for use in people with clinically isolated syndrome (CIS). It is not known if MAVENCLAD is safe and effective in children under 18 years of age and is therefore not recommended.

MAVENCLAD may cause serious side effects, including:

• Risk of cancer (malignancies). You should follow healthcare provider instructions about screening for cancer.
• MAVENCLAD may cause birth defects if used during pregnancy. Females must not be pregnant when they start treatment with MAVENCLAD or become pregnant during MAVENCLAD dosing and within 6 months after the last dose of each yearly treatment course. You should stop treatment with MAVENCLAD and contact your healthcare provider right away if you become pregnant during treatment with MAVENCLAD.
• For females who are able to become pregnant:
  • Your healthcare provider should order a pregnancy test before you begin your first and second yearly treatment course of MAVENCLAD to make sure that you are not pregnant.
  • Use effective birth control (contraception) on the days on which you take MAVENCLAD and for at least 6 months after the last dose of each yearly treatment course.
  • Talk to your healthcare provider if you use oral contraceptives (the “pill”).
  • You should use a second method of birth control on the days on which you take MAVENCLAD and for at least 4 weeks after your last dose of each yearly treatment course.

• For males with female partners who are able to become pregnant:
• Use effective birth control (contraception) during the days on which you take MAVENCLAD and for at least 6 months after the last dose of each yearly treatment course.

Do not take MAVENCLAD if you:

• have cancer (malignancy).
• are pregnant, plan to become pregnant, or are a woman of childbearing age or a man able to father a child and you are not using birth control.
• are breastfeeding.
• are human immunodeficiency virus (HIV) positive.
• have active infections, including tuberculosis (TB), hepatitis B or C.
• are allergic to cladribine.

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

• think you have an infection.
• have taken, take, or plan to take medicines that affect your immune system or blood cells, or other treatments for MS. Certain medicines can increase your risk of getting an infection.
• have had a recent vaccination or are scheduled to receive any vaccinations. You should not receive live or live-attenuated vaccines within the 4 to 6 weeks preceding treatment with MAVENCLAD or receive these types of vaccines during your treatment with MAVENCLAD and unless directed by your healthcare provider.
• have heart failure.
• have or have had cancer.
• have liver or kidney problems.
• are breastfeeding or plan to breastfeed. It is not known if MAVENCLAD passes into your breast milk. Do not breastfeed on the days on which you take MAVENCLAD, and for 10 days after the last dose.

How should I take MAVENCLAD?

• MAVENCLAD is given as two yearly treatment courses.
• Each yearly treatment course consists of 2 treatment weeks (also called cycles) that will be about a month apart.
• Take MAVENCLAD with water and swallow whole without chewing. MAVENCLAD can be taken with or without food.
• Swallow MAVENCLAD right away after opening the blister pack.
• Your hands must be dry when handling MAVENCLAD and washed well with water afterwards.
• Limit contact with your skin. Avoid touching your nose, eyes and other parts of the body. If you get MAVENCLAD on your skin or on any surface, wash it right away with water.
• Take MAVENCLAD at least 3 hours apart from other medicines taken by mouth during the 4- to 5-day MAVENCLAD treatment week.
• If you miss a dose, take it as soon as you remember on the same day. If the whole day passes before you remember, take your missed dose the next day. Do not take 2 doses at the same time. Instead, you will extend the number of days in that treatment week.

Your healthcare provider will continue to monitor your health during the 2 yearly treatment courses, and for at least another 2 years during which you do not need to take MAVENCLAD. It is not known if MAVENCLAD is safe and effective in people who restart MAVENCLAD treatment more than 2 years after completing 2 yearly treatment courses.

MAVENCLAD can cause serious side effects. If you have any of these symptoms listed below, call your healthcare provider right away:

• low blood cell counts have happened and can increase your risk of infections during treatment with MAVENCLAD. Blood tests are needed before you start treatment with MAVENCLAD, during your treatment with MAVENCLAD, and afterward, as needed.
• serious infections such as:
  • TB, hepatitis B or C, and shingles (herpes zoster). Fatal cases of TB and hepatitis have happened with cladribine during clinical studies. Tell your healthcare provider right away if you get any symptoms of the following infection related problems or if any of the symptoms get worse, including: fever, aching painful muscles, headache, feeling of being generally unwell, loss of appetite, burning, tingling, numbness or itchiness of the skin in the affected area, skin blotches, blistered rash, or severe pain.
  • progressive multifocal leukoencephalopathy (PML). PML is a rare brain infection that usually leads to death or severe disability. Although PML has not been seen in MS patients taking MAVENCLAD, it may happen in people with weakened immune systems. Tell your healthcare provider right away if you have any new or worsening neurologic signs or symptoms. These may include: weakness on 1 side of your body, loss of coordination in your arms and legs, decreased strength, problems with balance, changes in your vision, changes in your thinking or memory, confusion, or changes in your personality.
• liver problems. Blood tests should be performed to check your liver before you start taking MAVENCLAD. Symptoms of liver problems may include: nausea, vomiting, stomach pain, tiredness, loss of appetite, dark urine, or your skin or the whites of your eyes turn yellow.
• allergic reactions (hypersensitivities). You should stop treatment and seek immediate medical attention if any signs or symptoms of allergic reactions occur. Symptoms of an allergic reaction may include: skin rash, swelling or itching of the face, lips, tongue or throat, or trouble breathing.
• heart failure. MAVENCLAD may cause heart failure, which means your heart may not pump as well as it should. Call your healthcare provider or go to the closest emergency room for medical help right away if you have any signs or symptoms such as shortness of breath, a fast or irregular heart beat, or unusual swelling in your body.

The most common side effects of MAVENCLAD include: upper respiratory infection, headache, and low white blood cell counts.

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

Please see full Prescribing Information/Medication Guide, including serious side effects, for additional Important Safety Information.

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