2022-03-23T07:01:00
(BPT) – Multiple sclerosis (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.
Erika, who works in Government and Public Affairs, was diagnosed with relapsing-remitting MS (RMS) six years ago. All forms of MS, including RMS, can be difficult to diagnose since, when assessed individually, there are no specific symptoms, physical findings or laboratory tests that determine if a person has MS. Making it even more difficult to diagnose, MS has heterogeneous clinical and imaging manifestations, which not only differ between patients, but also vary in individual patients over time. In Erika’s case, her RMS was identified quickly after initial symptoms appeared and was later confirmed through a diagnosis of optic neuritis, followed by an MRI, which showed old and active brain lesions, suggesting she had been living with RMS for quite some time, without her being aware.
The landscape for people living with MS has changed significantly over the last two decades, offering hope that may not have been previously present. Today, more than 20 MS treatments are approved in the U.S., allowing patients and their physicians the option to consider individual patient circumstances when establishing a treatment plan and strategy that addresses clinical needs.
Choosing the Appropriate RMS Treatment
Erika has had a strong relationship with her neurologists. In fact, the neurologist who confirmed her RMS helped her to feel optimistic about her diagnosis, especially given the number of approved treatment options available.
Erika notes, “This may sound strange, but I remember feeling a sense of hope when I was diagnosed because of the treatments available at that time and that so many more were being investigated.”
After her diagnosis, Erika’s neurologist referred her to MS specialist Heidi Crayton, MD. Over the years, Erika tried several medications, but in 2019 after experiencing side effects and new disease activity, she and Dr. Crayton discussed trying a disease-modifying therapy (DMT) that was approved and became available at that time – MAVENCLAD® (cladribine) tablets 10 mg.
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 six 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.
“When I share more information about MAVENCLAD with my patients they are intrigued,” states Dr. Crayton. “Part of this is due to the dosing schedule of MAVENCLAD where it is taken no more than 10 days a year over a two-year period. In addition, patients find comfort in the fact that MAVENCLAD was approved after 10 years of safety follow up.”
Upon completing the initial screening and education component, including the use of effective contraception and the need for ongoing monitoring and doctor visits, Erika began her MAVENCLAD treatment. “Learning about MAVENCLAD was really important. The dosing schedule really worked for me, though this is my own personal experience and could vary for others,” says Erika. “I completed my final dose in 2021, and now that I am not taking DMT pills every day of the year, I find that I am not thinking about my RMS as much as I was during my previous therapies. I continue to touch base with my neurologist, as needed, and schedule my routine exams.”
The Importance of Working with Your Doctor
For Erika, it was important to work closely with her neurologist while continuing to manage her RMS, from initial diagnosis through treatment selection and every step along the way.
“This is my body and my RMS, so I was very involved when it came to treatment choice. I respected and trusted my neurologist to provide the best options,” notes Erika. “We had many candid conversations. I had a lot of questions and received solid responses that made me feel comfortable with MAVENCLAD.”
As someone who was immunocompromised, having a strong relationship with her neurologist proved even more important during the COVID-19 pandemic.
MAVENCLAD works by depleting certain cells of the immune system, so ongoing discussions and trust in her neurologist made her feel armed with the appropriate information to make decisions during the pandemic.
“Throughout the COVID-19 pandemic, I received a lot of questions from my MS patients about their treatments, as many thought that all DMTs were the same,” said Dr. Crayton. “As they are not all the same, I believe it’s important to share more information about the proposed mechanism of action for their respective treatments to better understand how their immune system may be affected, and further discuss vaccination considerations along with safety tips.”
When it comes to those newly diagnosed with MS, Erika has several pieces of advice:
- Make sure you feel comfortable with your neurologist as well as the nurses and front desk personnel because they all are part of your MS multidisciplinary treatment team.
- Keep track of symptoms and be prepared to discuss them at your appointment. Track everything in your calendar – no symptom is too small and may or may not be related to MS – so it is important for your doctor to be aware.
- We live in an era where we have all of the information in the world readily available to us. Please do yourself a favor and keep it simple: when it comes to your MS and your treatment, the best resource for information is your neurologist.
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.
Erika and Dr. Crayton are sponsored by EMD Serono, Inc.
US-MAV-01485 February 2022 Intended for US only
