MAVENCLAD® (cladribine) 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.
Treatment with MAVENCLAD may increase your risk of cancer. You should follow healthcare provider instructions about screening for cancer. Because of the risk of birth defects, do not take MAVENCLAD if you are pregnant, or of childbearing potential and not using effective birth control
Please see full Prescribing Information and Medication Guide including serious side effects.
At what point in your relapsing MS journey did you two begin working together?
SELMA: Oh, gosh, I found Dr. Berkovich at a pretty low point in my journey. I had really been through the ringer and I felt like nothing was working for me. So when I went, first went to see her, my walking was really bad. I had to use my cane and, y’know, I’d have my other hand on the wall for balance. Like, I felt like I was battling a windstorm while having these kind of pseudo flares, or in a flare. Yeah, it was pretty much, a little rocky still for me.
DR. BERKOVICH: Yes, Selma was experiencing significant worsening of her RMS symptoms after her previous therapy. She was having muscle spasms and had significant speaking difficulties, and she was not able to articulate her words very clearly back then. And that would be a tragedy for anyone, let alone Selma since she’s a public figure and relies so heavily on her voice.
What is your relationship like now? How have you built trust?
SELMA: Our relationship, I mean, our relationship is wonderful. And I feel like part of how we’ve built trust is just being totally honest with each other. I don’t hide or sugar coat anything for her. I wear everything, like right on my sleeve. Neither one of us is afraid to “tell it like is”, y’know?
DR. BERKOVICH: That’s true! In fact, I told Selma from the very beginning that the only way I can treat her is if we agree from the beginning that our relationship will be a physician patient relationship and I disregard her celebrity status. I told her that is the only way I can be absolutely genuine in my role and authentic to it.
SELMA: And I was like “YES! That’s exactly what I want!” I just want the truth. I don’t want anyone to just be told a nice story. I don’t just wanna hear, whatever, just get me out the door. I’ve also come to trust her because she actually listens to my concerns in a way I hadn’t experienced before with other doctors. Plus, she looks at more than just my MRIs. She’s always checking my gait, and my cognition and really looking at me as whole person.
What was your experience like on your previous treatments?
SELMA: I tried a few therapies, even something really aggressive, but I kept facing active flare-ups and was having lots of side effects, umm, before when I was trying things. Plus, with some of the other treatments, I didn't like having to take something regularly.
How did you work together to make the decision to try MAVENCLAD?
DR. BERKOVICH: When we saw yet new activity on Selma’s MRI, I explained we needed to plan for the future, and not just address the current symptoms or relapse. We considered many treatment options and, after reviewing the risks and potential benefits of each, we came to the conclusion together that MAVENCLAD would be the right choice for Selma. Obviously, the efficacy was a factor, and we reviewed the results of the clinical trials.
DR. BERKOVICH: But another factor was that it’s not taken continuously and doesn’t continuously suppress the immune system. It gives the immune system a chance to recover after each of two treatment courses.
DR. BERKOVICH: Of course, I explained that MAVENCLAD can cause serious side effects, including the risk of cancer, birth defects, low white blood cell counts, serious infections, and liver problems.
SELMA: But she also reassured me that I’d be monitored before, during, and after treatment. Still, I was initially hesitant, after my experiences with other therapies. I wasn’t sure I wanted another one, but I trusted her recommendation.
SELMA: And when she told me it was an oral treatment and I would only have to take 10 pills a year for two years, I was like, “Ok I’ll try it.”
What was your experience like when you first switched to MAVENCLAD?
SELMA: I mean, it was an adjustment for me to get used the idea that I didn’t have to take something…
SELMA: on an ongoing basis. I was like, “is this actually working if I’m not taking it all the time?”
DR. BERKOVICH: I explained to Selma that MAVENCLAD still works even when you’re not actually dosing or taking it.
SELMA: Right, when I was not actively dosing it was still my body taking in these effects. So, it was reassuring. And once I understood that, it was nice to not have a constant reminder of my disease that comes from having to take a medication all the time. That lets me focus on other things, like being a mom, that kind of stuff.
When I first switched, I also was really grateful when MS LifeLines reached out to offer support during my treatment journey with MAVENCLAD. That was nice.
How is the treatment journey going?
SELMA: It’s going great. My last MRI showed no new lesions, I’m walking and talking a lot better.
SELMA: I mean, I still have glitches when I speak sometimes. But I’ve made gains as I’ve gotten stronger too. I’m moving more and doing physical therapy. I even noticed I was able to take a little jump recently, like, it sounds silly but I could actually figure out how to jump which surprised me, my muscles are really starting to regain some of the strength and balance that I had lost over the years. I’ve been able to ride my horse again sometimes which make me so happy. Of course, I know this is just my experience and not everyone’s will be the same, but I’ve been pleased so far.
DR. BERKOVICH: She’s showing great progress. Selma hasn’t needed her cane and can occasionally wear heels. Her mobility has improved, with less fatigue. She’s also traveling for photo shoots and filming, which is important for her.
SELMA: Yep.
Can you remember some moments when you realized that you were doing better?
SELMA: Actually, well, one time I really felt that way was when I could ride my horse again without worrying about my foot falling out of the stirrup and with a greater ability to control my arms, which are essentially connected to his mouth! One morning, I woke up at 6 AM, I got on my horse, and thought, "Oh my god, I’m actually doing this."
Or there was one time recently, I was up in the middle of the night taking care of my son during an asthma attack. And I had a realization: I wasn’t as worried about how tired I was going to be the next day because my symptoms were under control with MAVENCLAD.
What are conversations like during follow-ups, now that you've completed your 2 treatment courses?
DR. BERKOVICH: It’s a lot of talk about the monitoring that we continue to do. I regularly assess my patients EDSS scores, which is disability score, which, for Selma has dropped, that means it improved, less disability, and reflects better mobility and overall functionality. And then of course we discuss any remaining issues, like occasional muscle spasms, but overall, Selma’s improvement is clear and consistent.
SELMA: You know, it’s like working with a close friend. It’s a comfort to have that support and know she’s there to keep me on track. And every time I walk in, she'll be like, “look at you, your hips are moving!” because you know, it took a while to get some movement back. But overall its great to check in and just be able to track my progress.
What advice would you give to someone still struggling to find the MS treatment that is right for them?
SELMA: I know it can feel incredibly hard and overwhelming sometimes when you have to spend so much time and energy that you don’t even have finding what’s right for you. I would say, don’t be afraid to speak up, keep advocating for yourself, and don’t be afraid to ask for help. You’re not alone in this journey. Lean on your loved ones when it feels like too much. And do your best to find a doctor that really takes the time to listen. I can’t stress how important that was for me.
MAVENCLAD (cladribine) tablets
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. Women 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.
o For women 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.
o Ask your healthcare provider which contraceptive method is right for you. Women and men being treated with MAVENCLAD should use effective birth control (contraception) on the days on which they 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, consisting of 2 treatment weeks (cycles) about a month apart.
· Handle MAVENCLAD with dry hands and take immediately after opening the blister pack. Take with water and do not chew the tablet. MAVENCLAD can be taken with or without food and should be taken at least 3 hours apart from other medicines.
· Wash your hands after handling MAVENCLAD. Limit contact with your skin (especially on your face). Wash skin and surfaces with water if contact occurs.
· 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.
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:
o life-threatening or fatal infections caused by bacteria, viruses, parasites or fungi.
o 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.
o 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. 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. Your doctor will perform blood tests to check your liver during treatment.
· 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 heartbeat, 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. To report SUSPECTED ADVERSE REACTIONS, contact EMD Serono at: 1-800-283- 8088 ext. 5563 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information and Medication Guide, including serious side effects.