Crystal, a wife and mother of four, has been living with relapsing multiple sclerosis (MS) for nearly twenty years. Getting a proper diagnosis for her condition was not easy. She began struggling with fatigue, numbness, tingling, and pain in adolescence, but when she sought help for her symptoms in high school and college, her doctors didn’t take her complaints seriously. It was not until she fainted and ended up in the emergency room, suffering from blindness and paralysis on her left side, that she was diagnosed with MS.
Individualizing Treatments for Relapsing MS Patients
Given the difficulty Crystal faced in identifying her disease, she decided that she wanted to educate herself about MS and the various treatment options. She tried a few treatments but found that she could not tolerate them because of their side effects. Crystal’s experience highlights an important point about treating MS, which is that there is no one-size-fits-all approach that works equally well for all patients.
“No two patients will have the same experience with MS,” says Sangjin Oh, MD, an expert in MS who was not involved in Crystal’s treatment. “Progression of disability varies widely with each patient. This is why it is important to tailor the treatment of relapsing MS to each individual patient. When discussing treatment options with my patients, it is important to balance the efficacy and safety of each medication and think about the needs of each patient.”
Crystal’s Treatment – MAVENCLAD® (cladribine) tablets
When Crystal learned about MAVENCLAD, she was initially intrigued by its dosing schedule. The medication requires tablets to be taken for no more than 10 days each year over a two-year period, and the specific recommended dose depends on a patient’s weight. Screening and monitoring should be performed before, during, and after treatment.
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 can cause serious side effects including the risk of cancer (malignancies) and risk of 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 serious 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. Crystal 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.
How COVID-19 Can Affect Managing a Chronic Disease
Doctors treating patients with MS have been presented with a unique set of challenges as they navigate how to best serve their patients amid the COVID-19 outbreak. “My practice has incorporated CDC guidelines, and we have encouraged telemedicine visits with our patients,” states Dr. Oh. “When we need to see patients in the office, we have limited patients and their family in the waiting room. We have a strict mask mandate for the patients and staff.”
In Crystal’s case, she has been able to continue her MAVENCLAD treatment in 2020. “Completing year two of MAVENCLAD in the middle of a pandemic was interesting. My doctor had me come in to the office to perform lab work followed by several telemedicine visits to discuss my results. It was important to make sure we were both comfortable with moving forward as it does lower my white blood cell count putting me more at-risk of infection, says Crystal.” says Crystal. “So far, treatment with MAVENCLAD has worked well for me, but this is my own personal experience.”
Living with MS During the Pandemic
Regardless of which medication an MS patient is taking, or if they are not taking one at all, each person living with MS is affected by COVID-19 in different ways. For some, the challenges are mostly logistical like they are for people who do not have MS. These people may for instance be focused on how to get their groceries and medications in the safest way possible. Others though, may struggle mentally due to the restrictions COVID-19 has placed on us or due to anxieties related to COVID-19 infection.
For Crystal, the hardest part has been the isolation: “Relapsing MS has given me anxiety that I never used to deal with, so isolation along with the fear of ‘what if’ got to me at first. I am on a medication that makes me more susceptible to infections during the months following my dosing. Eventually my doctor ordered more frequent labs to monitor my white cell count so we knew when my levels increased so that I felt better about going out in public (with a mask and social distancing, of course).”
Selecting an MS treatment for your specific needs continues to be important, despite the global pandemic. People living with MS should continue to follow up with their doctors about their MS and the best ways to address their symptoms while also acknowledging the ways that COVID-19 may be complicating their lives or treatment.
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 relapsing MS and hope that continues.”
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.
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